Indications

Antioxidant vitamins are used in a wide range of conditions where free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides. The main role of the antioxidant vitamins is as follows:

β carotene prevents free radical formation by quenching singlet oxygen, a highly reactive form of oxygen. Vitamin C is another free radical scavenger which deactivates free radicals. It works specially in the plasma, lung fluid, aqueous humour and interstitial fluid. It can increase white blood cell activity; play important roles in the biochemistry of antibodies, prostaglandin E 1 , B and T lymphocytes, and interferon. Vitamin E also scavenges free radicals in the blood along with β carotene and vitamin C. Moreover, vitamin E is essential to protect against some of the ill effects of smog and smoke. In relation to other nutrients vitamin E protects vitamin A from being destroyed in the body.

Pharmacology

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

Dosage & Administration

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

Interaction

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

Contraindications

Carocet is contraindicated in patients with hypersensitivity to any of its components.

Side Effects

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Pregnancy & Lactation

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Precautions & Warnings

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Therapeutic Class

Anti-oxidant Multivitamin preparations

Storage Conditions

Should be stored in a dry place below 30˚C.

Price:

Unit price :-3 tk

Box price -90tk

Indications

This cream is used to temporarily relieve pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak, and poison sumac, dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Pharmacology

Diphenhydramine is an antihistamine and works as a topical anti-allergic and analgesic by blocking the releases of histamine at its sources. Zinc is used as a skin protectant.

Dosage & Administration

Adults & children above 2 years: Apply to the affected area 3 to 4 times daily. Before application of cream, the skin should be clean, cool and dry. Should not have a hot shower or bath before applying. Apply the cream lightly on the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.

For babies under 2 years: Initially consult with the physician, if it is recommended, apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth. Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8 hours treatment time (such as after washing the hands).

Contraindications

Use of cream is contraindicated in individuals with a known allergy to its components, other pyrethroids or pyrethrins.

Side Effects

Contact dermatitis with mild erythematous vesicular lesions and papules has occasionally been reported.

Pregnancy & Lactation

In the absence of specific studies in pregnant women its use in pregnancy should only follow medical advice. However, teratogenic effects would not be anticipated. Although caution should be exercised in administration of diphenhydramine to nursing mothers, levels in breast milk following topical application are likely to be very low.

Precautions & Warnings

For external use only. Flammable, keep away from fire or flame. Do not use on large areas of the body with any other product containing diphenhydramine, even should not be taken by mouth. Consult with the physician before use on chicken pox, on measles. When using this product, avoid contact of eyes.

Therapeutic Class

Local Antipruritic, Topical Antihistamines

Storage Conditions

Store below 30°C. Protect from light. Do not freeze.

Price:

5 mg tube  -22tk

10mg tube -35 tk

15 mg tube – 55 tk

Indications

Aciclovir is indicated for-

• The treatment of viral infections due to Herpes simplex virus (type I & II) and Varicella zoster virus (herpes zoster & chicken pox).

• The treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes and herpes labialis.

• The prophylaxis of Herpes simplex infections in immunocompromised patients

Pharmacology

Aciclovir is a synthetic purine derivative. Aciclovir exerts its antiviral effect on Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with herpes virus, the antiviral activity of Aciclovir appears to depend principally on the intracellular conversion of the drug to Aciclovir Triphosphate. Aciclovir is converted to Aciclovir Monophosphate principally via virus coded thymidine kinase; the monophosphate is phosphorylated to the diphosphate via cellular guanylate kinase and then via another cellular enzyme to the triphosphate, which is the pharmacologically active form of the drug. 15-30% of an oral dose of the drug is absorbed from Gl tract. Peak plasma concentrations usually occur within 1.5-2 hours after oral administration. It is widely distributed into body tissues and fluids including the brain, saliva, lungs, liver, muscle, spleen, uterus, vaginal mucosa and secretions, CSF, and herpetic vesicular fluid. Aciclovir is excreted through the kidney by the glomerular filtration & tubular secretion.

Dosage & Administration

Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.

For immunocompromised patients:

• Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.

• Children under 2 years: Half of the adult dose.

• Children over 2 years: Adult dose.

Prevention of recurrence of herpes simplex:

• Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.

• Children under 2 years: Half of the adult dose.

• Children over 2 years: Adult dose.

Prophylactic treatment of herpes simplex in the immunocompromised patients:

• Adult: 200 to 400 mg 4 times daily.

• Children under 2 years: Half of the adult dose.

• Children over 2 years: Adult dose.

Treatment of vericella (chicken pox):

• Adult and children over 40 kg: 800 mg 4 times daily for 5 days.

• Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.

• Children 1 month-2 years: 200 mg 4 times daily for 5 days.

• Children 2-5 years:400 mg 4 times daily for 5 days.

• Children 6-12 years:800 mg 4 times daily for 5 days.

Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.

Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.

Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.

Interaction

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Contraindications

Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.

Side Effects

Rash, gastrointestinal disturbance, rise in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decrease in hematological indices, headache, neurological reaction, fatigue.

Pregnancy & Lactation

Pregnancy category B. Aciclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to a nursing mother.

Precautions & Warnings

Aciclovir should be administered with caution in patients with renal impairment and doses should be adjusted according to creatinine clearance. Monitor neutrophil count at least twice weekly in neonates.

Therapeutic Class

Herpes simplex & Varicella-zoster virus infections

Price:

200 mg tab-14 tk

400mg tab-22 tk

70 ml bottle-125 tk

Indications

Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).

Pharmacology

Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.

Dosage & Administration

Adult Dosage:

Cold Sores: 2 grams every 12 hours for 1 day

Genital Herpes:

• Initial episode: 1 gram twice daily for 10 days

• Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy

• Immunocompetent patients: 1 gram once daily

• Alternate dose in patients with < 9 recurrences/year: 500 mg once daily

• HIV-infected patients: 500 mg twice daily

• Reduction of transmission: 500 mg once daily

Herpes Zoster: 1 gram 3 times daily for 7 days

Pediatric Dosage:

• Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day

• Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

Interaction

No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Contraindications

Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.

Side Effects

The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).

Pregnancy & Lactation

Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.

Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.

Precautions & Warnings

Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients

Use in Special Populations

Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.

Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.

Therapeutic Class

Herpes simplex & Varicella-zoster virus infections

Price:

500mg tablet-40tk

1gm tablet -75 tk

Indications

Lidocaine Jelly is indicated for-

• Surface anaesthesia of the male and female urethra

• Topical treatment of painful urethritis

• Anaesthetic lubrication for endotracheal intubation

• Adequate analgesia in endoscopy.

Description

This Jelly is a sterile local anaesthetic product which contains Lidocaine Hydrochloride USP in a water-soluble Jelly base. It is used for topical/surface anaesthesia. The onset of action is 3-5 minutes. It may be rapidly and almost completely absorbed following topical application to mucous membrane and systemic effects may occur.

Pharmacology

Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.

Dosage & Administration

Urethral anaesthesia:

• Surface anaesthesia of the male adult urethra: For adequate analgesia in males 400 mg is required.

• Surface anaesthesia of the female adult urethra: Instil 100-200 mg in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed prior to perform in the urological procedure.

Lubrication for endotracheal intubation: 100 mg applied on the surface of the tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube.

Endoscopy: Instillation of 200-400 mg is recommended for adequate analgesia and a small amount should be applied on the instrument for lubrication. Debilitated, elderly patients and children should be given doses commensurate with their age and physical condition.

Note: The applicator is sterilized for 5 minutes in boiling water, cooled and attached to the tube. The jelly is instilled slowly as required. The applicator should be detached after each use and keep the tube tightly closed.

Interaction

Lidocaine should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide since the toxic effects are additive.

Contraindications

It is contraindicated in patients with a known history of hypersensitivity of local anaesthetics of the amide type.

Side Effects

Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactic reactions (cutaneous lesion, urticaria, oedema).

Pregnancy & Lactation

There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Lidocaine enters the mother's milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

Precautions & Warnings

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Lidocaine Jelly should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.

If the dose or site of administration is likely to result in high blood levels, Lidocaine, in common with other local anaesthetics, should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock.

The use of oropharyngeal topical anaesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.

Therapeutic Class

Local & Surface anesthesia

Indications

It is a topical eye antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers)

Pharmacology

This eye gel contains the active ingredient, Ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which acts as an antiviral agent by inhibiting the synthesis of viral DNA in two ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of DNA replication.

Dosage & Administration

The recommended dosing regimen for Ganciclovir eye gel 0.15% is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals and then 1 drop 3 times per day for 7 days.

Contraindications

It is contraindicated to the patients with known hypersensitivity to Ganciclovir.

Side Effects

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Pregnancy & Lactation

Pregnancy Category C. Ganciclovir has been shown to be embryo toxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption.

Nursing Mothers: It is not known whether topical eye ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when it is administered to nursing mothers.

Precautions & Warnings

It is indicated for topical eye use only. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with it.

Use in Special Populations

Pediatric Use: Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdose Effects

Overdose through local or accidental oral administration is not likely.

Therapeutic Class

Ophthalmic Anti-viral Products

Price:

5 gm tube-200tk

Indications

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.

• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.

• Symptomatic treatment of allergy such as hayfever, urticaria.

Pharmacology

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Dosage & Administration

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Interaction

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Contraindications

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

Side Effects

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

Pregnancy & Lactation

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

Precautions & Warnings

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Overdose Effects

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Therapeutic Class

Cromoglycate & related drugs

Storage Conditions

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Price: 1mg-2tk

100ml bottle-55tk

Indications

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Pharmacology

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

Dosage & Administration

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Interaction

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

Contraindications

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

Side Effects

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Pregnancy & Lactation

This can be given to pregnant and lactating mothers as per recommendation of physician.

Precautions & Warnings

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Overdose Effects

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Therapeutic Class

Specific mineral & vitamin combined preparations

Storage Conditions

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Unit price: 15 tk

Indications

This Gel is a substitute tear fluid for the alleviation of dry eye conditions as well as for the management of an unstable tear film.

Pharmacology

This eye for all patients with ocular discomfort. The slight hypotonicity of the gel is rapidly "neutralised" by the slightly hypertonic tear fluid caused by dry eyes.

Dosage & Administration

Instill 1 drop in the conjunctival sac of the affected eye(s), as needed. The frequency of administration depends on the severity of the condition. On average, one drop is administered 1-3 times daily. If needed, This Gel may be administered more frequently.

Contraindications

Hypersensitivity to any of the ingredients of this product.

Side Effects

This Gel is very well tolerated by users. However, some cases of burning, stinging, allergic reactions or red eyes after instillation have been reported. Transient blurring of vision after administration has also been reported.

Pregnancy & Lactation

Use in pregnancy & lactation: There is no experience regarding the safety of this Gel in human pregnancy or lactation.

Precautions & Warnings

• If eye pain, changes in vision, continued redness or irritation of the eye are noticed, this Gel must be discontinued and a doctor should be consulted.

• If this gel colour is change or becomes cloudy, the product should not be used.

• It should never be injected subconjunctivally, nor should be directly introduced into the anterior chamber of the eye.

• It is not intended to be used during surgery.

Use in Special Populations

Use in children: Studies in the pediatric population have not been performed.

Use in elderly patients: There is no indication that dosage needs to be modified for the elderly.

Price – 10mg tube – 250tk

Indications

It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

Pharmacology

Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.

This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.

Dosage & Administration

Instill 1 drop in the affected eye(s) 4 times a day or as needed.

Interaction

Not known.

Contraindications

This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.

Side Effects

Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.

Pregnancy & Lactation

Safe use during pregnancy and lactation has not been established.

Precautions & Warnings

Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.

Use in Special Populations

Pediatric use: This eye drop should not be used in infants and small children under 3 years.

Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Price: 15 ml drop -475 tk

Indications

Methylprednisolone Sodium Succinate IM/IV is indicated in the following conditions:

Endocrine disorder: Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock unresponsive to conventional, congenital adrenal hyperplasia, Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.

Rheumatic disorder: Rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.

Collagen disease: During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic carditis, systemic dermatomyositis (polymyositis).

Dermatological disease: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.

Allergic states: Controls bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reaction, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice), anaphylactic reactions.

Ophthalmic disease: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis and chroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.

Gastrointestinal disease: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy), Crohn’s disease.

Respiratory disease: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy, Loafer syndrome not manageable by other means, aspiration pneumonitis.

Hematologic disorder: Acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (IV only, IM administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.

Neoplastic disease: For palliative management of: leukemias and lymphoma in adults, acute leukemia of childhood.

Edematous state: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.

Pharmacology

Methylprednisolone, a naturally occurring glucocorticoid (hydrocortisone and cortisone), which has also salt-retaining properties, is used as replacement therapy in adrenocortical deficiency states. This synthetic analog is primarily used for its potent anti-inflammatory effects in disorders of many organ systems. The intravenous injection of Methylprednisolone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection. Its anti-inflammatory potency is greater than prednisolone in the ratio of 5 to 4. It has only minimal mineralocorticoid properties and has less tendency than prednisolone to induce sodium and water retention. It influences carbohydrate, protein, fat and purine metabolism, electrolyte and water balance, and the functional capacities of the cardiovascular system, the kidney, the skeletal muscle, nervous system and other organs and tissues. It exerts a suppressive effect on the immune response.

Dosage & Administration

Methylprednisolone may be administered by IM or IV or by IV infusion. To administer by IM or IV injection, prepare solution as direction for reconstitution. The desired dose may be administered intravenously over a period of several minutes. When high dose therapy is desired, the recommended dose of Methylprednisolone Sodium Succinate for Injection, USP is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours. In general, high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized usually not beyond 48 to 72 hours.

Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

In other indications, the initial dosage will vary from 10 to 40 mg of Methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticoid therapy is an adjunct to, and not a replacement for conventional therapy.

Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

In pediatric patients, the initial dose of Methylprednisolone may vary depending on the specific disease being treated. The initial dose is 0.11-1.6 mg/day in three or four divided doses. Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size but it should not be less than 0.5 mg per kg every 24 hours.

In the treatment of acute exacerbations of multiple sclerosis daily doses is 160 mg daily for 3 days. Methylprednisolone powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.

Interaction

• Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.

• Amphotericin B injection and potassium-depleting agents- When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., amphotericin B, diuretics), patients should be observed closely for the development of hypokalemia.

• Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

• Anticholinesterases- Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

• Anticoagulants, oral- Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.

• Antidiabetics- Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

• Antitubercular drugs- Serum concentrations of isoniazid may be decreased.

• Cholestyramine may increase the clearance of corticosteroids.

• Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

• Digitalis glycosides- Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

• Estrogens, including oral contraceptives- Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

• Hepatic Enzyme Inhibitors- Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids.

• Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.

• Nonsteroidal anti-inflammatory agents (NSAIDs)- Concomitant use of aspirin and corticosteroids increases the risk of gastrointestinal side effects.

• Skin tests- Corticosteroids may suppress reactions to skin tests.

• Vaccines- Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.

Contraindications

Methylprednisolone Sterile Powder is contraindicated:

• In systemic fungal infections and patients with known hypersensitivity to the product and its constituents.

• For intrathecal administration. Reports of severe medical events have been associated with this route of administration.

• Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Side Effects

Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.

Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, severe arthralgia, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, osteoporosis.

Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, may suppress reactions to skin tests.

Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.

Endocrine: Development of Cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.

Others: Negative nitrogen balance due to protein catabolism.

The following additional adverse reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.

Pregnancy & Lactation

Pregnancy: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Precautions & Warnings

Methylprednisolone, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. For chronic conditions, discontinuation of corticosteroids may result in clinical improvement.

Use in Special Populations

Pediatric Use: The adverse effects of corticosteroids in pediatric patients are similar to those in adults. Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, refecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

Overdose Effects

Treatment of acute over dosage is by supportive and symptomatic therapy. For chronic over dosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily or alternate day treatment may be introduced.

Therapeutic Class

Glucocorticoids

Reconstitution

Directions for Reconstitution-

• Remove protective plastic flip-of seal.

• Cleanse stopper with a suitable germicide.

• Aseptically add 8 mL Water for Injection BP for the 500 mg vial or 16 ml for 1 gm vial by means of a syringe into the vial.

• Agitate to effect solution to dissolve the powder content.

• Invert vial. Insert the needle through the target area of stopper until the tip is just visible. Withdraw dose.

Price: 500mg inj- 600tk ,1gm-1000tk ,125mg -200tk

Indications

Pheniramine Maleate is indicated for-

• Allergic conditions including hay fever, drug rashes, angioneurotic edema, serum sickness, allergic conjunctivitis, food allergy etc.

• Conditions of the respiratory tract that are accompanied by increased secretion, including vasomotor rhinitis and acute rhinitis.

• All itching skin conditions, including neurodermatitis, eczema of any origin, lichen planus, acute and chronic urticaria, pruritis of the anus or genitals, pruritus in icterus and diabetes, radiation sickness etc.

• Prevention and treatment of motion sickness.

• Prevention and treatment of nausea, vomiting and vertigo due to Meniere’s disease and other labyrinthine disturbances.

Description

Pheniramine is a competitive H1 histamine receptor antagonist. Like other alkylamine antihistamines it is also antagonist of muscarinic cholinergic receptors and possesses local anesthetic properties. However, the concentration required for the latter effect is probably not achieved at therapeutic dose

Pharmacology

Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.

Dosage & Administration

Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.

To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.

Pheniramine Maleate tablets:

• In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.

• Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.

Interaction

• MAO-inhibitors may prolong and intensify the anticholinergic effect of pheniramine (see Contraindications).

• Adverse CNS effects of pheniramine may be enhanced when it is taken with alcohol or other CNS depressants (eg. hypnotics, sedatives, tranquilizers).

• Atropine and related drugs may enhance the anticholinergic activity of pheniramine.

Contraindications

• Patients with hypersensitivity to pheniramine or any other ingredient (eg. Methyl hydroxybenzoate or propyl hydroxybenzoate in the syrup).

• Patients with symptomatic prostatic hypertrophy.

• Patients receiving MAO-inhibitor therapy.

• Newborn and premature infants.

Side Effects

The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.

• Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.

• Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.

• Genitourinary: Urinary retention.

• Cardiovascular: Palpitations, headache.

• Ocular: Blurred vision, increased intraocular pressure.

• Musculoskeletal: Muscular weakness.

• Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.

Pregnancy & Lactation

pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.

Precautions & Warnings

• Pheniramine Maleate may cause drowsiness. Both the dosage and the time of administration should be carefully considered in patients whose activities (e.g. driving a car or operating machinery) demand special concentration.

• Patients should be cautioned against the simultaneous ingestion of alcohol and other central nervous system depressants. Pheniramine Maleate may possibly be hallucinogenic in toxic doses. Due to the possible CNS stimulating effects of antihistamines, pheniramine has the potential for abuse.

• Due to the anticholinergic effect of pheniramine, caution and close monitoring are required if it is used in patients with conditions such as prostatic hypertrophy, narrow angle glaucoma, asthma or severe cardiovascular disease.

• The anti-emetic effect of pheniramine may mask the signs of other conditions. Products containing pheniramine should not be taken on an empty stomach.

Overdose Effects

Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.

Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.

Therapeutic Class

Sedating Anti-histamine

Price; 2 ml -8 tk

Indications

Eye: Inflammatory conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis, blepharitis and episcleritis) where development of bacterial infection is likely.

Ear: Otitis externa and other inflammatory conditions where bacterial infection is present or suspected.

Nose: Inflammatory conditions where infection is present or suspected.

Pharmacology

Betamethasone is a corticosteroid which is effective in inflammatory dermatoses. It is also effective in less responsive conditions such as psoriasis.  Betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium and water retaining properties of the fluorine atom bound at carbon 9.

Neomycin sulfate is bactericidal against many bacteria which are commonly associated with skin infections. Neomycin is a broad spectrum antibiotic which actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30s subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

Dosage & Administration

Drops:

• Eye: 1 drop instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.

• Ear: 2 or 3 drops instilled into the ear, every two or three hours until control is achieved, when the frequency can be reduced.

• Nose: 2 or 3 drops instilled into each nostril two or three times daily.

Eye Ointment: It should be applied thinly and evenly to the conjunctival sac at night (If eye drops used during day) or 3-4 times daily (if ointment used alone).

Contraindications

Viral, fungal, tuberculous or purulent conditions. Use in the eye is contra-indicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Preparations containing neomycin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

Side Effects

Acute sensitization to neomycin is a rare event but can occur after topical application to the eye. Eye drops containing corticosteroids cause a serious rise in intra-ocular pressure in a small percentage of the population, including most of those with a family history of glaucoma. A milder rise may be experienced by a larger proportion of subjects if treatment is continued for longer than a few weeks. Thinning of the cornea leading to perforation has occurred with use of topical corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with topical corticosteroids.

Pregnancy & Lactation

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category. Topical administration of corticosteroid to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

Precautions & Warnings

Steroids should not be administered to "red eyes" until a definitive diagnosis has been made. Ophthalmological treatment with steroid preparations should not be repeated or prolonged without regular review to exclude raised intra-ocular pressure or unsuspected infections. The unnecessary topical use of neomycin containing products should be avoided in order to minimize the occurrence of neomycin-resistant organisms (and organism cross-resistant to other aminoglycosides).

Therapeutic Class

Ophthalmic steroid - antibiotic combined preparations

Price: 5 ml drop -32 tk

Indications

Malignant Diseases:

Cyclophosphamide is indicated for the treatment of:

• Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma

• Multiple myeloma

• Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)

• Mycosis fungoides (advanced disease)

• Neuroblastoma (disseminated disease)

• Adenocarcinoma of the ovary

• Retinoblastoma

• Carcinoma of the breast

Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.

Minimal Change Nephrotic Syndrome in Pediatric Patients:

Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.

Pharmacology

Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.

Dosage

Intravenous (Adult)-

Malignancies: 

• Low dose regimen: 2-6 mg/kg wkly as a single dose;

• Moderate dose regimen: 10-15 mg/kg wkly as a single dose;

• High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.

Alternatively,

• 80-300 mg/m² daily as a single dose, or

• 300-600 mg/m² wkly as a single dose, or

• 600-1,500 mg/m² as a single dose or

• Short infusion at 10- to 20-day intervals.

Oral (Child)-

Nephrotic syndrome: 

• 2 mg/kg daily for 8-12 wk.

• Max cumulative dose: 168 mg/kg.

• Max duration: 90 days.

Oral (Adult)-

Malignancies: 

• Low dose regimen: 2-6 mg/kg wkly in divided dose.

• Alternatively, 100-300 mg daily in divided doses, or

• 50-250 mg/m² daily or 80-300 mg/m² daily in divided doses.

Administration

Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.

Interaction

Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).

Contraindications

Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.

Side Effects

Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.

Pregnancy & Lactation

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Precautions & Warnings

Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.

Overdose Effects

Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.

Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.

Therapeutic Class

Cytotoxic Chemotherapy

Reconstitution

Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.

Price : unit price-34tk

Indications

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma

• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)

• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Pharmacology

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Dosage & Administration

Adults and adolescents with asthma or seasonal allergic rhinitis: 

• The dosage for adults and adolescents 15 years of age and older: Montelukast 10 mg tablet once daily.

Pediatric patients with asthma or seasonal allergic rhinitis:

• The dosage for pediatric patients 6 to 14 years of age: Montelukast 5 mg tablet once daily.

• The dosage for pediatric patients 2 years to 5 years of age: Montelukast 4 mg tablet once daily.

• The dosage for pediatric patients 6 months to 5 years of age: Montelukast 4 mg oral granules once daily. This can be administered either directly in the mouth, or mixed with a spoonful of cold water or soft food at room temperature

Use in the pediatric patient: The safety and efficacy of Montelukast have been established in adequate and well-controlled studies in pediatric patients with asthma 6 months to 14 years of age. Safety and efficacy profiles in this age group are similar to those seen in adults.

Hepatic Insufficiency: No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency.

Renal Insufficiency: No dosage adjustment is recommended in patients with renal insufficiency.

Elderly use: The pharmacokinetic profile and the oral bioavailability of a single 10-mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required.

Interaction

Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug interaction studies, the recommended clinical dose of Montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin. Although additional specific interaction studies were not performed, Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as phenobarbital or rifampin, are co-administered with Montelukast.

Contraindications

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Side Effects

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Pregnancy & Lactation

Montelukast crosses the placenta following oral dosing in rats and rabbits. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Montelukast should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Montelukast  is given to a nursing mother.

Precautions & Warnings

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued during acute exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Although Montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Overdose Effects

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Therapeutic Class

Leukotriene receptor antagonists

Price :

4mg-6tk

5mg-9 tk

10mg-17 tk

Indications

Baricitinib is indicated for the treatment of adult patients with moderate to severely active Rheumatoid Arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Limitation of Use: Use of Baricitinib in combination with other JAK inhibitors, biologic DMARDs or with potent immunosuppressants such as Azathioprine and cyclosporine is not recommended.

Pharmacology

Baricitinib is a selective and reversible inhibitor of Janus kinase JAK1 and JAK2. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function. Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell. Baricitinib modulate these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.

Dosage & Administration

Adult dose: The recommended dose of Baricitinib is 2 mg once daily. It may be used as monotherapy or in combination with Methotrexate or other Disease-modifying antirheumatic drugs (DMARDS). Baricitinib can be given orally with or without food.

Pediatric Use: The safety and effectiveness of Baricitinib in pediatric patients have not been established.

Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.

Hepatic Impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment.

Renal impairment: Baricitinib is not recommended for use in patients with estimated GFR of less than 60 mL/min/I .73 m2.

Interaction

Strong OAT3 Inhibitors: Baricitinib exposure is increased when it is co-administered with strong OAT3 inhibitors (such as probenecid).

Other JAK Inhibitors or Biologic DMARDs: Baricitinib has not been studied in combination with other JAK inhibitors or with biologic DMARDS.

Contraindications

• Anemia: Avoid initiation or interrupt Baricitinib in patients with hemoglobin less than 8 g/dL.

• Lymphopenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Lymphocyte Count less than 500 cells/mm³.

• Neutropenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Neutrophil Count less than 1000 cells/mm³.

Side Effects

The most commonly reported adverse drug reactions (ADRs) occurring in 2% of patients treated with Baricitinib monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6%), upper respiratory tract infections (14.7%) and nausea (2.8%).

Pregnancy & Lactation

Baricitinib is contraindicated during pregnancy. No information is available on the presence of Baricitinib in human milk.

Precautions & Warnings

• Serious Infections: Avoid use of Baricitinib in patients with an active, serious infection, including localized infections.

• Tuberculosis: Baricitinib should not be given to patients with active TB.

• Malignancy and Lymphoproliferative Disorders: Consider the risks and benefits of Baricitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Baricitinib in patients who develop a malignancy.

• Thrombosis: Baricitinib should be used with caution in patients who may be at increased risk of thrombosis.

• Gastrointestinal Perforations: Baricitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation.

• To be dispensed only by the prescription of a registered physician.

Overdose Effects

In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Therapeutic Class

Immunosuppressant

Price : unit price -25tk

Indications

Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis, osteomalacia, hypocalcaemia, tetany and rickets in patients with vitamin D3 deficiency. Cholecalciferol, synthetic form of Vitamin-D 

Pharmacology

Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.

Dosage & Administration

For capsule: Adults:

• Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.

• Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.

• Addition to specific therapy for osteoporosis: 20000 IU once a month.

For capsule: Children (12-18 years):

• Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.

• Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.

For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.

For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.

For Syrup:
For patients with risk of Cholecalciferol deficiency:

• 0-1 yr: 400 IU/ day (2 ml)

• >1 Yr: 600 lU/ day (3 ml)

For Cholecalciferol deficient patients:

• 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks

• 1 -18 yrs: 2000 IU/ day for 6 weeks.

Injection: Prevention: 

• Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.

• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.

• Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.

• Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.

• Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.

Injection: Vitamin D deficiency:

• 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

Interaction

It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.

Contraindications

It is contraindicated in patients with known hypersensitivity to Vitamin D3.

Side Effects

The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.

Pregnancy & Lactation

Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment

Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.

Precautions & Warnings

It should be used with caution in patients with impaired renal function.

Use in Special Populations

The safety & efficacy of Vitamin D3 in children under 12 years have not been established.

Overdose Effects

It can lead to hypervitaminosis D.

Therapeutic Class

Vitamin in bone formation, Vitamin-D preparations

Indications

Fluticasone Propionate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive eczema/dermatitis.

Pharmacology

Fluticasone propionate is a glucocorticoid with high topical anti-inflammatorypotency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. Fluticasone propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids. Fluticasone propionate has weak affinity forthe progesterone receptor, andvirtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the Fluticasone propionate glucocorticoid-receptor complex is approximately 10 hours.

Dosage & Administration

Cream: Apply a thin layer of Fluticasone propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of Fluticasone propionate Ointment to the affected skin areas twice daily.

Interaction

No information is available.

Contraindications

Fluticasone propionate is contraindicated in Rosacea, Acne vulgaris, Perioral dermatitis, Primary cutaneous viral infections (e.g., Herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of Fluticasone propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Side Effects

The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.

Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.

Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.

Pregnancy & Lactation

Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breastfeeding mothers, the therapeutic benefits must be weighed against the potential hazards to the mother and baby.

Precautions & Warnings

Fluticasone propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of the body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.

Overdose Effects

Acute overdosage is very unlikely to occur, however, in case of chronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, the application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.

Therapeutic Class

Fluticasone & combined preparations topical

Price: 10mg – 90tk

Indications

Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:

• Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.

• Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.

Pharmacology

The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.

Dosage & Administration

Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.

Interaction

CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.

PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.

Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.

Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.

Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.

Contraindications

• Patients with known hypersensitivity to Dapoxetine Hydrochloride.

• Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.

• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.

• Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.

Side Effects

Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.

Pregnancy & Lactation

Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.

Precautions & Warnings

Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.

Overdose Effects

There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.

Therapeutic Class

Drugs for Erectile Dysfunction

Indications

Tadalafil is indicated in-

• Erectile Dysfunction (ED)

• Benign Prostatic Hyperplasia (BPH)

• Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Pharmacology

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

Dosage & Administration

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Interaction

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Contraindications

• Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates

• Hypersensitivity reactions to Tadalafil

Side Effects

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

Pregnancy & Lactation

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

Precautions & Warnings

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

Therapeutic Class

Drugs for Erectile Dysfunction

Indications

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)

• Chronic irritable colon

• Spastic constipation

• Mucous colitis

• Colicky abdominal pain

• Persistent non-specific diarrhoea

Description

Mebeverine is a musculotropic antispasmodic agent used to relieve cramps or spasms of the stomach and intestine (gut). It is particularly useful in treating irritable bowel syndrome (IBS) and similar conditions. It works by relaxing the muscles and helping restore the normal movement of the gut.

Dosage & Administration

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.

• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Contraindications

Hypersensitivity to the drug or any other ingredients.

Side Effects

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Pregnancy & Lactation

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

Precautions & Warnings

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

Overdose Effects

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Therapeutic Class

Anticholinergics

Price: 135mg-7tk

200mg -10tk

Indications

Mebendazole is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.

Pharmacology

Mebendazole is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Mebendazole is principally used in the treatment of intestinal nematode infection. Mebendazole inhibits the formation of the worms' microtubules and causes the worms' glucose depletion. After oral administration about 2-10% of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Mebendazole is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.

Dosage & Administration

Adult and Child over 2 years-

• Threadworms: 100 mg or 1 teaspoonful: Single dose.

• Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.

If reinfection occurs the second dose may be needed after 2 weeks.

Interaction

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.

Contraindications

Mebendazole is contraindicated in patients with known hypersensitivity to Mebendazole, or to any component of the formulation.

Side Effects

• Gastrointestinal: Transient symptoms of abdominal pain and diarrhoea in case of massive infection and expulsion of worms.

• Hypersensitivity: Rash, urticaria and angioedema have been observed on rare occasions.

• Central Nervous System: Very rare cases of convulsions have been reported.

• Haematologic: Neutropenia and agranulocytosis.

Pregnancy & Lactation

Mebendazole is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.

Precautions & Warnings

General: Periodic assessment of organ system functions, including haematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients: Patients should be informed of the potential risk to the foetus in women taking mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.

Use in Special Populations

Paediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

Overdose Effects

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

Therapeutic Class

Anthelmintic

Indications

Rifaximin is indicaed in-

• Treatment of traveler's diarrhea by noninvasive strains of E. coli

• reduction in risk of overt hepatic encephalopathy

• bacterial overgrowth of irritable bowel syndrome.

Pharmacology

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

Dosage & Administration

Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.
Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.
Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food

Interaction

In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.

Contraindications

Contraindicated in patients with a hypersensitivity to Rifaximin or to any of the rifamycin antimicrobial agents, or any components of this product

Side Effects

Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.

Pregnancy & Lactation

Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.

Precautions & Warnings

Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Use in Special Populations

Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.

Overdose Effects

No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.

Therapeutic Class

4-Quinolone preparations

Indications

Alverine Citrate is indicated in-

• Irritable Bowel Syndrome

• Bowel movement disturbances caused by small sacs or pouches in the wall of the gut (diverticular disease)

• Abdominal pain associated with menstrual periods (Primary dysmenorrhea)

• Relief of other conditions associated with spasm of involuntary muscle

Pharmacology

Alverine Citrate is a smooth muscle relaxant. Smooth muscle is a type of muscle that is not under voluntary control; it is the muscle present in places such as the gut and uterus. Alverine Citrate acts directly on the muscle in the gut, causing it to relax. This prevents the muscle spasm which occur in the gut in conditions such as irritable bowel syndrome and diverticular disease. Alverine Citrate also relaxes the smooth muscle in the uterus. It is therefore also used to treat painful menstruation, which is caused by muscle spasm in the uterus (dysmenorrhea).

Dosage & Administration

Adult: Orally: 60-120 mg 1-3 times daily.

Interaction

There are no drug interactions reported with this medicine.

Contraindications

Paralytic ileus or known hypersensitivity to any of the ingredients.

Side Effects

Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions.

Pregnancy & Lactation

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies are limited.

Precautions & Warnings

Avoid Alverine Citrate in patients with intestinal obstruction or paralytic ileus.

Use in Special Populations

Children under 12 years: Not recommended

Overdose Effects

Can produce hypotension and atropine like-toxic effects. Management for overdose is as like as atropine poisoning with continuation of supportive therapy for hypotension.

Therapeutic Class

Indications

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-

• Major Depressive Disorder (MDD)

• Generalized Anxiety Disorder (GAD)

• Diabetic Peripheral Neuropathic Pain (DPNP)

• Fibromyalgia and

• Chronic Musculoskeletal Pain.

Pharmacology

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Dosage & Administration

Major Depressive Disorder (MDD)-

• Starting Dose: 40 mg/day to 60 mg/day

• Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day

• Maximum Dose: 120 mg/day

Generalized Anxiety Disorder (GAD)-

• Starting Dose: 60 mg/day

• Target Dose: 60 mg/day (once daily)

• Maximum Dose: 120 mg/day

Diabetic Peripheral Neuropathic Pain (DPNP)-

• Starting Dose: 60 mg/day

• Target Dose: 60 mg/day (once daily)

• Maximum Dose: 60 mg/day

Fibromyalgia-

• Starting Dose: 30 mg/day

• Target Dose: 60 mg/day (once daily)

• Maximum Dose: 60 mg/day

Chronic Musculoskeletal Pain-

• Starting Dose: 30 mg/day

• Target Dose: 60 mg/day (once daily)

• Maximum Dose: 60 mg/day

Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

Interaction

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

Contraindications

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

Side Effects

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Pregnancy & Lactation

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Precautions & Warnings

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Use in Special Populations

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

Overdose Effects

There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.

Therapeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)