Medlon 4

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Description COMPOSITION: Methylprednisolone .................................................................... 4 mg Excipients q.s .......................................................................... 1 tablet (Lactose, avicel M101, aerosil (colloidal silicon dioxide), sodium starch glycolate, magnesium stearate, PVP K30). PHARMACEUTICAL FORM: Tablet. PHARMACODYNAMIC PROPERTIES: ATC code: H02AB04 Methylprednisolone is 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. PHARMACOKINETIC PROPERTIES: Bioavailability of methylprednisolone is about 80%. Peak plasma concentrations are obtained 1 - 2 hrs after oral administration. It has an elimination half-life of about 3 hrs. Methylprednisolone is metabolized in the liver and its metabolites are excreted in the urine. PRESENTATIONS: Box of 10 blisters x 10 tablets. Box of 1 bottle x 100 tablets. THERAPEUTIC INDICATIONS: Anti-inflammatory and immunosuppressed activities in: rheumatoid arthritis, lupus erythematosus, vasculitis, bronchial asthma, chronic ulcerative colitis, hemolytic anemia, granulocytopenia, severe allergies including anaphylactic shock. Treatment of cancers, including lymphomas, breast cancer, prostate cancer. The drug is also indicated to treat primary nephrotic syndrome. DOSAGE & ADMINISTRATION: Dosage requirements depend on the condition being treated and response of the patient. After a favorable response is noted, 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 (8 - 12 tablets)/ day, for 5 days. Rheumatoid arthritis: 4 - 6 mg/ day. Acute course: 16 - 32 mg (4 - 8 tablets)/ day. Acute course of chronic ulcerative colitis: 8 - 24 mg (2 - 6 tablets)/ day. Hemolytic anemia due to immunity: 64 mg/ day, in at least 6 - 8 weeks. CONTRAINDICATIONS: Hypersensitivity to prednisolone. Severe infections, excepting for septic shock and tuberculousmeningitis. 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 increase the risk of growth retardation in a newborn baby. 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 works: The drug should be used cautiously because undesirable effects are possible in drivers, machines operators, workers at height, and other cases. INTERACTIONS: Methylprednisolone is a cytochrome P450 enzyme inducer and is a P450 3A 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. UNDESIRABLE EFFECTS: Undesirable 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; edema, hypertension; acne, skin atrophy, bruise, hyperchromasia; Cushing's syndrome, pituitary-adrenal suppression, growth retardation, glucose intolerance, hypokalemia, alkalosis, amenorrhoea, sodium and water retention, increased blood glucose; stomach ulcers, nausea, vomiting, abdominal distension, ulcerative esophagitis, pancreatitis; muscle weakness, osteoporosis, fractures; hypersensitive reactions. 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. Read the directions carefully before use. For more information, please consult a physician. This drug is for prescription only. STORAGE CONDITIONS: Store in dry places, not exceeding 300C, protect from light. SHELF-LIFE: 36 months from the manufacturing date. DATE OF REVISION OF THE TEXT: November 3, 2016.

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