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Melpred

Methylprednisolone Sodium Succcinate

IM/IV Injection 500 mg/vial Allopathic Glucocorticoids

Indications

Vestibular neuritis

Indication detailsView

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.

Therapeutic classView

Glucocorticoids

PharmacologyView

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.

DosageView

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.

Side effectsView

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.

ContraindicationsView

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.

PrecautionsView

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.

InteractionsView

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.

Pregnancy & lactationView

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.

Pediatric usageView

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 effectsView

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.

ReconstitutionView

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.

StorageView

Protect from light. Store at controlled room temperature 20° to 25°C. Store solution at controlled room temperature 20° to 25°C.Use solution within 48 hours after mixing.

Melpred

Methylprednisolone Sodium Succcinate

IM/IV Injection 1 gm/vial Allopathic Glucocorticoids

Indications

Vestibular neuritis

Indication detailsView

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.

Therapeutic classView

Glucocorticoids

PharmacologyView

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.

DosageView

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.

Side effectsView

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.

ContraindicationsView

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.

PrecautionsView

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.

InteractionsView

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.

Pregnancy & lactationView

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.

Pediatric usageView

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 effectsView

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.

ReconstitutionView

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.

StorageView

Protect from light. Store at controlled room temperature 20° to 25°C. Store solution at controlled room temperature 20° to 25°C.Use solution within 48 hours after mixing.

Meltix

Flupentixol + Melitracen

Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

Indications

Psychosis

Indication detailsView

Flupentixol and Melitracen tablet is indicated in-

Anxiety
Depression
Apathy
Psychogenic depression.
Depressive neurosses.
Masked depression.
Psychosomatic affections accompanied by anxiety and apathy.
Menopausal depressions.
Dysphoria and depression in alcoholics and drug addicts.

Therapeutic classView

Combined anxiolytics & anti-depressant drugs

PharmacologyView

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

DosageView

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

Side effectsView

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

ContraindicationsView

The immediate recovery phase after myocardial infarction.
Defects in bundle-branch conduction.
Untreated narrow-angle glaucoma.
Acute alcohol, barbiturate and opiate intoxications.
This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.

PrecautionsView

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

InteractionsView

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

Pregnancy & lactationView

This tablet should preferably not be given during pregnancy and lactation.

Overdose effectsView

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Melxit

Flupentixol + Melitracen

Tablet 0.5 mg+10 mg Allopathic Combined anxiolytics & anti-depressant drugs

Indications

Psychosis

Indication detailsView

Flupentixol and Melitracen tablet is indicated in-

Anxiety
Depression
Apathy
Psychogenic depression.
Depressive neurosses.
Masked depression.
Psychosomatic affections accompanied by anxiety and apathy.
Menopausal depressions.
Dysphoria and depression in alcoholics and drug addicts.

Therapeutic classView

Combined anxiolytics & anti-depressant drugs

PharmacologyView

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

DosageView

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

Side effectsView

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

ContraindicationsView

The immediate recovery phase after myocardial infarction.
Defects in bundle-branch conduction.
Untreated narrow-angle glaucoma.
Acute alcohol, barbiturate and opiate intoxications.
This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.

PrecautionsView

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

InteractionsView

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

Pregnancy & lactationView

This tablet should preferably not be given during pregnancy and lactation.

Overdose effectsView

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Memanto

Memantine Hydrochloride

Tablet 5 mg Allopathic

Indications

Mild to moderate dementia in Alzheimer’s disease

Indication detailsView

Memantine is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.

PharmacologyView

Persistent activation of N-methyl-D-aspartate (NMDA) receptors in Central Nervous System by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity as an uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.

Memantine is well absorbed after oral administration and has linear pharmacokinetics over the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half-life of about 60-80 hours. Following oral administration, Memantine is highly absorbed with peak concentrtions reached in about 3-7 hours. Food has no effect on the absorption of Memantine. The mean volume of distribution of Memantine is 9-11 L/kg and the plasma protein binding is low (45%). emantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine; the remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy Memantine and 1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate. The hepatic microsomal CYP-450 enzyme system does not play a significant role in the metabolism of Memantine.

DosageView

The recommended maintenance dose of Memantine for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks, achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage guideline:

Week 1 (Everyday): Morning- 5 mg (1 tablet), Night- No dose
Week 2 (Everyday): Morning- 5 mg (1 tablet), Night- 5 mg (1 tablet)
Week 3 (Everyday): Morning- 10 mg (2 tablets), Night- 5 mg (1 tablet)
Week 4 and onwards (Everyday): Morning- 10 mg (2 tablets), Night- 10 mg (2 tablets)

Missed Dose: If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.

In case renal impairment: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes) per day.

In case of hepatic impairment: In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.

Children under 18 years: Memantine is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Side effectsView

Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive. If there is a history of epileptic seizures, there is a slight chance that Memantine may increase the probability of an attack.

ContraindicationsView

Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.

PrecautionsView

Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.

Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.

Operating Vehicles or Machinery: Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.

InteractionsView

Due to the pharmacological effects and mechanism of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Memantine should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.

Pregnancy & lactationView

Pregnancy Category B. Yet there are no adequate and well controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.

StorageView

Store in a cool and dry place, protected from light. Keep this medication out of reach of children.

Memanto

Memantine Hydrochloride

Tablet 10 mg Allopathic

Indications

Mild to moderate dementia in Alzheimer’s disease

Indication detailsView

Memantine is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.

PharmacologyView

Persistent activation of N-methyl-D-aspartate (NMDA) receptors in Central Nervous System by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity as an uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.

Memantine is well absorbed after oral administration and has linear pharmacokinetics over the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half-life of about 60-80 hours. Following oral administration, Memantine is highly absorbed with peak concentrtions reached in about 3-7 hours. Food has no effect on the absorption of Memantine. The mean volume of distribution of Memantine is 9-11 L/kg and the plasma protein binding is low (45%). emantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine; the remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy Memantine and 1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate. The hepatic microsomal CYP-450 enzyme system does not play a significant role in the metabolism of Memantine.

DosageView

The recommended maintenance dose of Memantine for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks, achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage guideline:

Week 1 (Everyday): Morning- 5 mg (1 tablet), Night- No dose
Week 2 (Everyday): Morning- 5 mg (1 tablet), Night- 5 mg (1 tablet)
Week 3 (Everyday): Morning- 10 mg (2 tablets), Night- 5 mg (1 tablet)
Week 4 and onwards (Everyday): Morning- 10 mg (2 tablets), Night- 10 mg (2 tablets)

Missed Dose: If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.

In case renal impairment: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes) per day.

In case of hepatic impairment: In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.

Children under 18 years: Memantine is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Side effectsView

Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive. If there is a history of epileptic seizures, there is a slight chance that Memantine may increase the probability of an attack.

ContraindicationsView

Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.

PrecautionsView

Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.

Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.

Operating Vehicles or Machinery: Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.

InteractionsView

Due to the pharmacological effects and mechanism of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Memantine should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.

Pregnancy & lactationView

Pregnancy Category B. Yet there are no adequate and well controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.

StorageView

Store in a cool and dry place, protected from light. Keep this medication out of reach of children.

Memogen

Memantine Hydrochloride

Tablet 10 mg Allopathic

Indications

Mild to moderate dementia in Alzheimer’s disease

Indication detailsView

Memantine is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.

PharmacologyView

Persistent activation of N-methyl-D-aspartate (NMDA) receptors in Central Nervous System by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity as an uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.

Memantine is well absorbed after oral administration and has linear pharmacokinetics over the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half-life of about 60-80 hours. Following oral administration, Memantine is highly absorbed with peak concentrtions reached in about 3-7 hours. Food has no effect on the absorption of Memantine. The mean volume of distribution of Memantine is 9-11 L/kg and the plasma protein binding is low (45%). emantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine; the remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy Memantine and 1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate. The hepatic microsomal CYP-450 enzyme system does not play a significant role in the metabolism of Memantine.

DosageView

The recommended maintenance dose of Memantine for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks, achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage guideline:

Week 1 (Everyday): Morning- 5 mg (1 tablet), Night- No dose
Week 2 (Everyday): Morning- 5 mg (1 tablet), Night- 5 mg (1 tablet)
Week 3 (Everyday): Morning- 10 mg (2 tablets), Night- 5 mg (1 tablet)
Week 4 and onwards (Everyday): Morning- 10 mg (2 tablets), Night- 10 mg (2 tablets)

Missed Dose: If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.

In case renal impairment: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes) per day.

In case of hepatic impairment: In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.

Children under 18 years: Memantine is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Side effectsView

Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive. If there is a history of epileptic seizures, there is a slight chance that Memantine may increase the probability of an attack.

ContraindicationsView

Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.

PrecautionsView

Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.

Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.

Operating Vehicles or Machinery: Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.

InteractionsView

Due to the pharmacological effects and mechanism of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Memantine should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.

Pregnancy & lactationView

Pregnancy Category B. Yet there are no adequate and well controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.

StorageView

Store in a cool and dry place, protected from light. Keep this medication out of reach of children.

Memopil

Piracetam

Syrup 500 mg/5 ml Allopathic Adjunct anti-epileptic drugs

Indications

Cortical myoclonus

Indication detailsView

Cerebral vascular accidents and cerebral insufficiencies: Ischaemic or even haemorrhagic acute accidents, chronic manifestations of the above accidents or of cerebral atherosclerosis.

Mental retardation in children: Ease of resuming individual contact, sociability and learning, improved intellectual performances and school results.

Behaviour and psychotic problems in old age: Memory deficits, particularly with regard to fixation and evocation asthenia adaption disorders, disturbed psychomotor reactions. Patients suffering from myoclonus of cortical origin.

Therapeutic classView

Adjunct anti-epileptic drugs, Drugs used in tremor, tics & related disorder

PharmacologyView

Piracetam's mechanism of action is not fully understood. The drug influences neuronal and vascular functions and influences cognitive function without acting as a sedative or stimulant. Piracetam is a positive allosteric modulator of the AMPA receptor. It is hypothesized to act on ion channels or ion carriers, thus leading to increased neuron excitability. GABA brain metabolism and GABA receptors are not affected by piracetam

It has been found to increase blood flow and oxygen consumption in parts of the brain, but this may be a side effect of increased brain activity rather than a primary effect or mechanism of action for the drug.

Piracetam improves the function of the neurotransmitter acetylcholine via muscarinic cholinergic (ACh) receptors, which are implicated in memory processes. Furthermore, piracetam may have an effect on NMDA glutamate receptors, which are involved with learning and memory processes. Piracetam is thought to increase cell membrane permeability. Piracetam may exert its global effect on brain neurotransmission via modulation of ion channels (i.e., Na+, K+). It has been found to increase oxygen consumption in the brain, apparently in connection to ATP metabolism, and increases the activity of adenylate kinase in rat brains. Piracetam, while in the brain, appears to increase the synthesis of cytochrome b5, which is a part of the electron transport mechanism in mitochondria. But in the brain, it also increases the permeability of the mitochondria of some intermediaries of the Krebs cycle.

DosageView

Oral: Adults:

In cerebro-cortical insufficiency disorders, usual dose is one tablet (800 mg) 3 times a day.
In myoclonic seizures, a dose of 7.2 gm daily, increasing by 4.8 gm per day every 3 to 4 days up to maximum of 20 gm daily, given in 2 or 3 divided doses.

Oral: Children: The daily dosage depends on the weight of the child, 50 mg/kg of body weight in 3 divided doses. Once the desired results has been obtained, reduce the initial dose by half.

Parenteral formulations: When parenteral administration is needed (e.g. swallowing difficulties, unconsciousness) Piracetam can be administered intravenously. When treating severe symptoms, 12 g daily may need to be administered as an intravenous infusion.

Side effectsView

The side effects reported include nervousness, agitation, irritability, anxiety and sleep disturbances. The incidence of these during clinical trials was (≤ 5%) and they were more often noted in the older patients taking > 2.4 gm daily. In the majority of cases, a dose reduction sufficed to make these symptoms disappear. Some patients may complain of fatigue or drowsiness, gastrointestinal problems, e.g. nausea, vomiting, diarrhoea and stomachache have also been reported but their incidence during clinical trials was ≤ 2%. Other symptoms e.g. vertigo, headache, trembling and sexual stimulation have occasionally been reported.

ContraindicationsView

Piracetam is contra-indicated in patients with severe renal insufficiency (creatinine clearance < 20 ml/min) and hepatic impairment. As the principal route of elimination for Piracetam is via the kidney, special care must be taken when treating patients known to suffer from renal insufficiency. Monitoring of renal function is recommended in such cases. The increase in half-life is directly related to the decrease in renal function and creatinine clearance. This is also true for the older patient in whom creatinine clearance is dependent on age. When the creatinine clearance is < 60 ml/min, or serum creatinine is >1.25 mg/100 ml, the dosage prescribed should be calculated as following:

CrCl 60-40 ml/min: Dosage should be 1/2 of normal dose
CrCl 40-20 ml/min: Dosage should be 1/4 of normal dose

InteractionsView

In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenyton, phenobarbitone and sodium valporate, based on a small number of studies.

Pregnancy & lactationView

Piracetam should not be prescribed during pregnancy or when breast feeding, except under exceptional circumstances. Piracetam is able to cross the placenta.

Pediatric usageView

Children: No formal pharmacokinetic study has been conducted in children.

Elderly: In the elderly, the half-life of piracetam is increased and the increase is related to the decrease in renal function in this population (see Section Dosage and Administration).

Renal impairment: Piracetam clearance is correlated to creatinine clearance. It is therefore recommended to adjust the daily dose of piracetam based on creatinine clearance in patients with renal impairment

Hepatic impairment: The influence of hepatic impairment on the pharmacokinetics of piracetam has not been evaluated. Because 80 to 100% of the dose is excreted in the urine as unchanged drug, hepatic impairment solely would not be expected to have a significant effect on piracetam elimination.

Overdose effectsView

Piracetam appears to be devoid of toxicity even at very high doses and, therefore, the need for specific measures to be taken in case of an overdose is avoided. Drug Interactions: In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenytoin, phenobarbitone and sodium valproate, based on a small number of studies.

ReconstitutionView

Piracetam is compatible (physico-chemical compatibility) with the perfusions of:

Glucose 5%, 10%, 20%
Fructose 5%, 10%, 20%
Sodium chloride 0.9%
Dextran 40 (10% in a 0.9% NaCl solution)
Ringer Mannitol 20%
HES solution (Hydroxy Ethyl Starch) 6% and 10%

The stability of these solutions has been demonstrated up to 24 hours.

StorageView

Store in a cool and dry place at a temperature below 30˚C , Keep away from sunlight. Keep out of the reach of children.

Memopil

Piracetam

Tablet 800 mg Allopathic Adjunct anti-epileptic drugs

Indications

Cortical myoclonus

Indication detailsView

Cerebral vascular accidents and cerebral insufficiencies: Ischaemic or even haemorrhagic acute accidents, chronic manifestations of the above accidents or of cerebral atherosclerosis.

Mental retardation in children: Ease of resuming individual contact, sociability and learning, improved intellectual performances and school results.

Behaviour and psychotic problems in old age: Memory deficits, particularly with regard to fixation and evocation asthenia adaption disorders, disturbed psychomotor reactions. Patients suffering from myoclonus of cortical origin.

Therapeutic classView

Adjunct anti-epileptic drugs, Drugs used in tremor, tics & related disorder

PharmacologyView

Piracetam's mechanism of action is not fully understood. The drug influences neuronal and vascular functions and influences cognitive function without acting as a sedative or stimulant. Piracetam is a positive allosteric modulator of the AMPA receptor. It is hypothesized to act on ion channels or ion carriers, thus leading to increased neuron excitability. GABA brain metabolism and GABA receptors are not affected by piracetam

It has been found to increase blood flow and oxygen consumption in parts of the brain, but this may be a side effect of increased brain activity rather than a primary effect or mechanism of action for the drug.

Piracetam improves the function of the neurotransmitter acetylcholine via muscarinic cholinergic (ACh) receptors, which are implicated in memory processes. Furthermore, piracetam may have an effect on NMDA glutamate receptors, which are involved with learning and memory processes. Piracetam is thought to increase cell membrane permeability. Piracetam may exert its global effect on brain neurotransmission via modulation of ion channels (i.e., Na+, K+). It has been found to increase oxygen consumption in the brain, apparently in connection to ATP metabolism, and increases the activity of adenylate kinase in rat brains. Piracetam, while in the brain, appears to increase the synthesis of cytochrome b5, which is a part of the electron transport mechanism in mitochondria. But in the brain, it also increases the permeability of the mitochondria of some intermediaries of the Krebs cycle.

DosageView

Oral: Adults:

In cerebro-cortical insufficiency disorders, usual dose is one tablet (800 mg) 3 times a day.
In myoclonic seizures, a dose of 7.2 gm daily, increasing by 4.8 gm per day every 3 to 4 days up to maximum of 20 gm daily, given in 2 or 3 divided doses.

Oral: Children: The daily dosage depends on the weight of the child, 50 mg/kg of body weight in 3 divided doses. Once the desired results has been obtained, reduce the initial dose by half.

Parenteral formulations: When parenteral administration is needed (e.g. swallowing difficulties, unconsciousness) Piracetam can be administered intravenously. When treating severe symptoms, 12 g daily may need to be administered as an intravenous infusion.

Side effectsView

The side effects reported include nervousness, agitation, irritability, anxiety and sleep disturbances. The incidence of these during clinical trials was (≤ 5%) and they were more often noted in the older patients taking > 2.4 gm daily. In the majority of cases, a dose reduction sufficed to make these symptoms disappear. Some patients may complain of fatigue or drowsiness, gastrointestinal problems, e.g. nausea, vomiting, diarrhoea and stomachache have also been reported but their incidence during clinical trials was ≤ 2%. Other symptoms e.g. vertigo, headache, trembling and sexual stimulation have occasionally been reported.

ContraindicationsView

Piracetam is contra-indicated in patients with severe renal insufficiency (creatinine clearance < 20 ml/min) and hepatic impairment. As the principal route of elimination for Piracetam is via the kidney, special care must be taken when treating patients known to suffer from renal insufficiency. Monitoring of renal function is recommended in such cases. The increase in half-life is directly related to the decrease in renal function and creatinine clearance. This is also true for the older patient in whom creatinine clearance is dependent on age. When the creatinine clearance is < 60 ml/min, or serum creatinine is >1.25 mg/100 ml, the dosage prescribed should be calculated as following:

CrCl 60-40 ml/min: Dosage should be 1/2 of normal dose
CrCl 40-20 ml/min: Dosage should be 1/4 of normal dose

InteractionsView

In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenyton, phenobarbitone and sodium valporate, based on a small number of studies.

Pregnancy & lactationView

Piracetam should not be prescribed during pregnancy or when breast feeding, except under exceptional circumstances. Piracetam is able to cross the placenta.

Pediatric usageView

Children: No formal pharmacokinetic study has been conducted in children.

Elderly: In the elderly, the half-life of piracetam is increased and the increase is related to the decrease in renal function in this population (see Section Dosage and Administration).

Renal impairment: Piracetam clearance is correlated to creatinine clearance. It is therefore recommended to adjust the daily dose of piracetam based on creatinine clearance in patients with renal impairment

Hepatic impairment: The influence of hepatic impairment on the pharmacokinetics of piracetam has not been evaluated. Because 80 to 100% of the dose is excreted in the urine as unchanged drug, hepatic impairment solely would not be expected to have a significant effect on piracetam elimination.

Overdose effectsView

Piracetam appears to be devoid of toxicity even at very high doses and, therefore, the need for specific measures to be taken in case of an overdose is avoided. Drug Interactions: In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract. At present, no interaction has been observed with the following anti-epileptic drugs, clonazepam, carbamazepine, phenytoin, phenobarbitone and sodium valproate, based on a small number of studies.

ReconstitutionView

Piracetam is compatible (physico-chemical compatibility) with the perfusions of:

Glucose 5%, 10%, 20%
Fructose 5%, 10%, 20%
Sodium chloride 0.9%
Dextran 40 (10% in a 0.9% NaCl solution)
Ringer Mannitol 20%
HES solution (Hydroxy Ethyl Starch) 6% and 10%

The stability of these solutions has been demonstrated up to 24 hours.

StorageView

Store in a cool and dry place at a temperature below 30˚C , Keep away from sunlight. Keep out of the reach of children.

Menactra

Polysaccharide Diphtheria Toxoid Conjugate Vaccine

SC Injection 0.5 ml/vial Allopathic Vaccines, Anti-sera & Immunoglobulin

Indications

Meningococcal infection

Indication detailsView

Polysaccharide Diphtheria Toxoid Conjugate Vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. This vaccine is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.

Therapeutic classView

Vaccines, Anti-sera & Immunoglobulin

PharmacologyView

The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease. Menactra induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y and W-135.

DosageView

Primary Vaccination:

Children 9 through 23 months of age: Two doses, three months apart.
Individuals 2 through 55 years of age: A single dose.

Booster Vaccination:

A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.

Side effectsView

Common (≥10%): solicited adverse events in infants and toddlers 9 and 12 months of age were injection site tenderness, erythema, and swelling; irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever.

Common (≥10%): solicited adverse events in individuals 2 through 55 years of age who received a single dose were injection site pain, redness, induration, and swelling; anorexia and diarrhea. Other common solicited adverse events were irritability and drowsiness (2-10 years of age), headache, fatigue, malaise, and arthralgia (11-55 years of age).

ContraindicationsView

Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM 197-containing vaccine, or to any component of Menactra

PrecautionsView

Persons previously diagnosed with Guillain-Barre syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. The decision to give Menactra should take into account the potential benefits and risks.

InteractionsView

When Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) are to be administered to children 4 through 6 years of age, preference should be given to simultaneous administration of the 2 vaccines or administration of Menactra prior to Polysaccharide Diphtheria Toxoid Conjugate Vaccine. Administraton of Menactra one month after Polysaccharide Diphtheria Toxoid Conjugate Vaccine has been shown to reduce meningococcal antibody responses to Menactra

Pneumococcal antibody responses to some serotypes in Prevnar (PCV7) were decreased following co-administration of Menactra and PCV7.

Pregnancy & lactationView

Safety and effectiveness of Polysaccharide Diphtheria Toxoid Conjugate Vaccine have not been established in children younger than 9 months of age, pregnant women, nursing mothers, and adults older than 55 years of age.

StorageView

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8 °C. Do not freeze. Discard solution if frozen. Protect from light.

Menaquin

Menaquinone-7

Capsule 200 mcg Allopathic Drugs for Osteoarthritis

Indications

Rheumatoid arthritis

Indication detailsView

This capsule is indicated for the treatment and prevention of-

Osteoporosis
Coronary artery calcification
Rheumatoid arthritis

Therapeutic classView

Drugs for Osteoarthritis

PharmacologyView

Menaquinone-7 is a fat soluble vitamin which is also known as vitamin K2. Menaquinone-7 is an especial key isomer of vitamin K2 that is produced using Bacillus subtilis. Menaquinone-7 is the active trans-isomer of natural vitamin K2 with the highest bioavailability and longest half-life in blood. This makes Menaquinone-7 also available for tissues outside the liver, namely bones, arteries and soft tissues. It is a powerful cofactor in transporting excess calcium out of the arteries and depositing it into the bones thus prevents hardening of arteries. Menaquinone-7 is very essential for healthy bone and artery.

DosageView

Orally 1-2 capsules daily or as advised by the physician.

Side effectsView

Generally well tolerated in recommended dose. From a large number of clinical trials using dosages in excess of 40 mg/day, there were no reports of side effects associated with any type of hypercoagulable state.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Menaquinone-7. Use of Menaquinone-7 is contraindicated with warfarin.

InteractionsView

Menaquinone-7 may alter the effect of warfarin. Concomitant use with orlistat may decrease the absorption of Menaquinone-7.

Pregnancy & lactationView

Menaquinone-7 can be used during pregnancy. Use of Menaquinone-7 during pregnancy may help both mother and child in formation and maintaining proper bone health.

StorageView

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

Menaril

Betahistine Dihydrochloride

Tablet 16 mg Allopathic Drugs used in meniere's diseases

Indications

Vertigo

Indication detailsView

Meniere's disease and Meniere-like syndromes are characterized by attacks of vertigo, tinnitus and/or progressive loss of hearing, usually accompanied by nausea and vomiting.

Therapeutic classView

Drugs used in meniere's diseases

PharmacologyView

The mechanism of action of betahistine is multifactorial. Meniere's disease is thought to result from a disruption of endolymphatic fluid homeostasis in the ear. Betahistine mainly acts as a histamine H1-receptor agonist. The stimulation of H1-receptors in the inner ear causes a vasodilatory effect leading to increased permeability of blood vessels and a reduction in endolymphatic pressure; this action prevents the rupture of the labyrinth, which can contribute to the hearing loss associated with Ménière's disease. Betahistine is also purported to act by reducing the asymmetrical functioning of sensory vestibular organs and increasing vestibulocochlear blood flow, relieving symptoms of vertigo.

In addition to the above mechanisms, betahistine also acts as a histamine H3-receptor antagonist, increasing the turnover of histamine from postsynaptic histaminergic nerve receptors, subsequently leading to an increase in H1-agonist activity. H3-receptor antagonism elevates levels of neurotransmitters including serotonin in the brainstem, inhibiting the activity of vestibular nuclei, thus restoring proper balance and decreasing vertigo symptoms.

DosageView

The usual initial dose: 8 mg to 16 mg three times daily taken preferably with meals.

Maintenance dose: Up to 48 mg daily has been recommended. Betahistine is not recommended for use in children.

Side effectsView

Betahistine is generally well tolerated and there is no known serious adverse effects. In some circumstances gastrointestinal disturbances, headache, rashes and pruritus have been reported.

ContraindicationsView

Betahistine is contraindicated in pheochromocytoma.

PrecautionsView

Caution should be exercised in patients with bronchial asthma and peptic ulceration.

InteractionsView

There are no proven cases of hazardous interactions. Though an antagonism between Betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.

Pregnancy & lactationView

In Pregnancy: The safety of Betahistine in human pregnancy has not been completely established, although there is no known teratogenic effect in animals. A careful assessment of potential benefits should be made before prescribing Betahistine in pregnancy.

In Lactation: Betahistine is excreted in the breast milk of nursing mothers in concentrations similar to those found in plasma. Toxicity to the neonate at these concentrations is not known.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Menaril

Betahistine Dihydrochloride

Tablet 8 mg Allopathic Drugs used in meniere's diseases

Indications

Vertigo

Indication detailsView

Meniere's disease and Meniere-like syndromes are characterized by attacks of vertigo, tinnitus and/or progressive loss of hearing, usually accompanied by nausea and vomiting.

Therapeutic classView

Drugs used in meniere's diseases

PharmacologyView

The mechanism of action of betahistine is multifactorial. Meniere's disease is thought to result from a disruption of endolymphatic fluid homeostasis in the ear. Betahistine mainly acts as a histamine H1-receptor agonist. The stimulation of H1-receptors in the inner ear causes a vasodilatory effect leading to increased permeability of blood vessels and a reduction in endolymphatic pressure; this action prevents the rupture of the labyrinth, which can contribute to the hearing loss associated with Ménière's disease. Betahistine is also purported to act by reducing the asymmetrical functioning of sensory vestibular organs and increasing vestibulocochlear blood flow, relieving symptoms of vertigo.

In addition to the above mechanisms, betahistine also acts as a histamine H3-receptor antagonist, increasing the turnover of histamine from postsynaptic histaminergic nerve receptors, subsequently leading to an increase in H1-agonist activity. H3-receptor antagonism elevates levels of neurotransmitters including serotonin in the brainstem, inhibiting the activity of vestibular nuclei, thus restoring proper balance and decreasing vertigo symptoms.

DosageView

The usual initial dose: 8 mg to 16 mg three times daily taken preferably with meals.

Maintenance dose: Up to 48 mg daily has been recommended. Betahistine is not recommended for use in children.

Side effectsView

Betahistine is generally well tolerated and there is no known serious adverse effects. In some circumstances gastrointestinal disturbances, headache, rashes and pruritus have been reported.

ContraindicationsView

Betahistine is contraindicated in pheochromocytoma.

PrecautionsView

Caution should be exercised in patients with bronchial asthma and peptic ulceration.

InteractionsView

There are no proven cases of hazardous interactions. Though an antagonism between Betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported.

Pregnancy & lactationView

In Pregnancy: The safety of Betahistine in human pregnancy has not been completely established, although there is no known teratogenic effect in animals. A careful assessment of potential benefits should be made before prescribing Betahistine in pregnancy.

In Lactation: Betahistine is excreted in the breast milk of nursing mothers in concentrations similar to those found in plasma. Toxicity to the neonate at these concentrations is not known.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Mendil

Diphenhydramine + Levomenthol

Syrup (14 mg+2 mg)/5 ml Allopathic Combined cough expectorants

Indications

Productive cough

Indication detailsView

This preparation is indicated for the relief of cough and associated congestive symptoms. It is also used to relieve runny nose, sneezing, watery eyes, itchy nose/eyes/throat and other allergic symptoms.

Therapeutic classView

Combined cough expectorants

PharmacologyView

Diphenhydramine possesses antitussive and antihistaminic properties. It relieves cough centrally (brain stem) and treats sneezing, runny nose and allergy (itchy eyes, nose, skin). Levomenthol has decongestant and anti-inflammatory properties which helps soothe cough and reduces congestion and inflammation in the nasal passage and lungs that makes breathing easier.

DosageView

Adults and Children over 12 years: The recommended dose is 10 ml of syrup 4 times a day. Maximum daily dose is 40 ml syrup.

Side effectsView

Diphenhydramine may cause drowsiness, dizziness, gastrointestinal disturbance, dry mouth/nose/throat, difficulty in urination or blurred vision

ContraindicationsView

This preparation is contraindicated in individuals with known hypersensitivity to the product or any of its constituents and in individuals with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by the physician. It should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks.

PrecautionsView

This preparation may cause drowsiness. Caution should be exercised in patients with moderate to severe renal or hepatic dysfunction or urinary retention when using this preparation. Diphenhydramine should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy.

InteractionsView

Diphenhydramine may potentiate the effects of alcohol, codeine, CNS depressants, the effects of anticholinergics (ex- some psychotropic drugs and atropine) and other antihistamines. MAO inhibitors potentiate and intensify the anticholinergic effects of antihistamines.

Pregnancy & lactationView

Diphenhydramine has been in widespread use for many years without ill consequence. However, it is known to cross the placenta and has been detected in breast milk. Therefore, it is only used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.

Overdose effectsView

The signs and symptoms of overdose may include drowsiness, hyperpyrexia and anticholinergic effects. With higher doses, CNS excitation including hallucinations and coma or cardiovascular collapse may appear. Treatment of overdose should be symptomatic and supportive, rapid gastric emptying (with Syrup of Ipecac-induced emesis or gastric lavage and activated charcoal) may be useful. Seizures may be controlled with Diazepam or Thiopental Sodium and Physostigmine IV may be efficacious to antagonise severe antichlolinergic symptoms.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Menem

Meropenem Trihydrate

IV Injection or Infusion 500 mg/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.

Pneumonia and Nosocomial Pneumonia
Urinary Tract Infections
Intra-abdominal Infections
Gynaecological Infections, such as endometritis and pelvic inflammatory disease
Skin and Skin Structure Infections
Meningitis
Septicaemia
Pulmonary infections in cystic fibrosis
Empiric treatment for presumed infections in patients with febrile neutropenia.

Therapeutic classView

Other beta-lactam Antibiotics

PharmacologyView

Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

DosageView

The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:

The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
Cystic fibrosis: Upto 2 gm every 8 hours.
Meningitis: 2 gm IV every 8 hours.

Children:

3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
Intra-abdominal infections: 20 mg/kg every 8 hours.
Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
Meningitis: 40 mg/kg IV every 8 hours.
Febrile neutropenia: 20 mg/kg every 8 hours.
Children over 50 kg weight: use adult dosage.
There is no experience in children with hepatic or renal impairment.

AdministrationView

Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes

Side effectsView

Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.

ContraindicationsView

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

PrecautionsView

If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.

InteractionsView

Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.

Pregnancy & lactationView

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.

Pediatric usageView

Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.

Overdose effectsView

Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.

ReconstitutionView

Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25^oC or 13 hours at up to 5^oC

StorageView

Vial store in a cool, dry place (below 30^oC), away from light & moisture. Keep out of the reach of children.

Menem

Meropenem Trihydrate

IV Injection or Infusion 1 gm/vial Allopathic Other beta-lactam Antibiotics

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.

Pneumonia and Nosocomial Pneumonia
Urinary Tract Infections
Intra-abdominal Infections
Gynaecological Infections, such as endometritis and pelvic inflammatory disease
Skin and Skin Structure Infections
Meningitis
Septicaemia
Pulmonary infections in cystic fibrosis
Empiric treatment for presumed infections in patients with febrile neutropenia.

Therapeutic classView

Other beta-lactam Antibiotics

PharmacologyView

Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

DosageView

The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-

Adults:

The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
Cystic fibrosis: Upto 2 gm every 8 hours.
Meningitis: 2 gm IV every 8 hours.

Children:

3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
Intra-abdominal infections: 20 mg/kg every 8 hours.
Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
Meningitis: 40 mg/kg IV every 8 hours.
Febrile neutropenia: 20 mg/kg every 8 hours.
Children over 50 kg weight: use adult dosage.
There is no experience in children with hepatic or renal impairment.

AdministrationView

Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes

Side effectsView

Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.

ContraindicationsView

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

PrecautionsView

If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.

InteractionsView

Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.

Pregnancy & lactationView

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.

Pediatric usageView

Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.

Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.

Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.

Use in Children: Efficacy and tolerability in infants under 3 months have not been established.

Overdose effectsView

Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.

ReconstitutionView

Preparation of solution:

Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.

Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.

Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25^oC or 13 hours at up to 5^oC

StorageView

Vial store in a cool, dry place (below 30^oC), away from light & moisture. Keep out of the reach of children.

Menida

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Menida

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Menilet

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Menocare

Black Cohosh [Cimicifuga Racemosa]

Capsule 40 mg Herbal Herbal and Nutraceuticals

Indications

Vertigo

Indication detailsView

Black Cohosh is indicated in Premenstrual discomfort, Dysmenorrhea, Menopausal complaints such as hot flashes, heart palpitations, nervousness, irritability, sleep disturbances, tinnitus, vertigo, perspiration and depression.

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Black cohosh (Cimicifuga racemosa) is popular as an alternative to hormonal therapy in the treatment of menopausal (climacteric) symptoms such as hot flashes, mood disturbances, diaphoresis, palpitations and vaginal dryness.

DosageView

1-2 capsules daily or as directed by the physician. Duration of treatment should be maximum six months at a time.

Side effectsView

Black cohosh is safe for most people. It might cause some mild side effects such as stomach upset, cramping, headache, rash, a feeling of heaviness, and weight gain. Occasional gastrointestinal discomfort may occur.

ContraindicationsView

No significant contraindication is observed.

PrecautionsView

Black cohosh should be used cautiously in patients with liver disease, kidney disease and seizure disorders.

InteractionsView

Black cohosh may interact with birth control pills, hormone replacement therapy, sedatives or antihypertensive.

Pregnancy & lactationView

Not recommended during pregnancy due to an increased risk of spontaneous abortion. Not recommended during lactation.

StorageView

Store in a cool and dry place, away from light & moisture. Keep out of reach of children.