Medlon 16

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Description COMPOSITION: Methylprednisolone ................................................................... 16 mg Excipients q.s............................................................................ 1 tablet (Avicel M101, lactose monohydrate, dicalcium phosphate, aerosil, PVP K30, sodium lauryl sulphate, kollidon CL-M, talc, magnesium stearate) DOSAGE FORM: Tablet. PRESENTATION: Box of 3 blisters x 10 tablets. Box of 10 blisters x 10 tablets. PHARMACODYNAMICS: Medlon contains the active ingredient Methylprednisolone, a glucocorticoid, which is an anti-inflammatory, anti-allergic agent with the capacity to profoundly inhibit the immune system. Due to methylation of prednisolone, the corticoid effect on sodium metabolism was excluded; so methylprednisolone rarely causes sodium, water retention and oedema. The anti-inflammatory activity of methylprednisolone is 20% stronger than that of prednisolone. A dose of 4 mg methylprednisolone has the same effect as 20 mg hydrocortisone. PHARMACOKINETICS: Bioavailability of methylprednisolone is about 80%. Peak plasma concentrations are obtained 1 - 2 hours after oral administration. It has an elimination half-life of about 3 hours. Methylprednisolone is metabolized in the liver and its metabolites are excreted in the urine. INDICATIONS: Treatment of inflammation and immune depression in: rheumatoid arthritis, systemic lupus erythematosus, certain angiitis, temporal arteritis and polyarteritis nodosa, sarcoidosis, bronchial asthma, chronic duodenal ulcer, hemolytic anemia, granulocytopenia, severe allergy including anaphylactic shock; in the treatment of cancers: acute leukemia, lymphoma, breast cancer, prostate cancer. Methylprednisolone is also indicated in the treatment of primary nephrotic syndrome. CONTRAINDICATIONS: Hypersensitivity to methylprednisolone. Severe infections, excepting for septic shock and tuberculous meningitis. Skin injury due to virus, fungus or tuberculosis. Administration of live vaccines. PRECAUTIONS: Particular care is required in patients with osteoporosis, newly involved in connection of blood vessels, mental disorders, gastro-duodenal ulcer, diabetes, hypertension, heart failure; and in children during the growth phase. The common adverse effects of systemic corticosteroids may be associated in old age; treatment should be limited to the minimum dosage for the shortest period of time. Abrupt withdrawal of methylprednisolone dosage following prolonged treatment or presence of stress can lead to acute adrenal insufficiency. Large doses may affect the action of the vaccine immunization. PREGNANCY AND LACTATION: When administered for long periods during pregnancy, systemic corticosteroids may decrease birth weight. Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risk. Corticosteroids do not contraindicate to nursing mothers. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The drug should be used cautiously because undesirable effects are possible in drivers, machinery operators. INTERACTIONS: Methylprednisolone is a cytochrome P450 enzyme inducer and is a P450 3A4 enzyme substrate; therefore, mutual inhibition of metabolism occurs with concurrent use of methylprednisolone with ciclosporin, erythromycin, phenobarbital, phenytoin, carbamazepine, ketoconazole, and rifampicin. The effect of methylprednisolone may be reduced by phenytoin, phenobarbital, rifampin and hypokalemic diuretics. Methylprednisolone may cause hyperglycemia; a higher dose of insulin should be recommended. ADVERSE EFFECTS: Adverse effects may occur following prolonged administration and high doses of methylprednisolone. Methylprednisolone inhibits prostaglandin synthesis, and therefore, it inactivates the actions of prostaglandin on gastrointestinal tract, including suppression of gastric acid secretion and protection of gastric mucous membrane. Common: insomnia, excitable nerve; increased appetite, dyspepsia; hirsutism; diabetes; arthralgia; cataract, glaucoma; epistaxis. Uncommon: dizziness, seizures, psychosis, pseudotumor cerebri, headache, mood changes, delirium, hallucination, cheeriness; edema, hypertension; acne, skin atrophy, bruise, hyperchromasia; Cushing's syndrome; stomach ulcers, nausea, vomiting, abdominal distention, ulcerative esophagitis, pancreatitis; muscle weakness, osteoporosis, fractures; hypersensitive reactions. Inform a physician about any adverse effects occur during the treatment. OVERDOSE: Symptoms of overdose associated with prolonged use include Cushing's syndrome, muscle weakness, osteoporosis, adrenal suppression. Temporary discontinuation or termination of the drug should be considered. DOSAGE & ADMINISTRATION: Dosage requirements depend on the condition being treated and response of the patient. The initial dose should be 6 - 40 mg of methylprednisolone daily. A necessary dosage to maintain a desired therapeutic effect is lower than that to obtain an initial effect. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. In long-term treatment with large dose, the drug should be indicated in every other day when the diseases being controlled. This minimizes certain undesirable effects due to recovery time among doses. In this therapy, methylprednisolone is given single morning dose every two days according to natural secretion time of glucocorticoids. Acute asthma: 32 - 48 mg/day for 5 days. An additional treatment with a lower dose should be applied within one week. If the acute course disappears, the dosage should be reduced gradually and promptly. Acute course of rheumatoid arthritis: 16 - 32 mg/day. Thereafter, the dosage should be reduced gradually and promptly. Acute course of chronic ulcerative colitis: 8 - 24 mg/day. Primary nephrotic syndrome: The initial dose should be 0.8 - 1.6 mg/ kg/day for 6 weeks, then reducing gradually the dosage for 6 to 8 weeks. Hemolytic anemia due to immunity: 64 mg/day for at least 6 - 8 weeks. Or as directed by the physician. Read the directions carefully before use. Consult the physician for more information. This drug is for prescriptions only. Shelf-life: 24 months from the manufacturing date. Storage conditions: Store in dry places; not exceeding 30oC, protect from light. Specifications: Manufacturer’s.

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