METHYCOBAL TABLET (TABLET)

Description: Nonproprietary name: Mecobalamin (JAN, INN). Chemical name: Coα-[α-(5,6-Dimethyl-1H-benzoimidazol-1-yl)]- Coβ-methylcobamide. Molecular formula: C63H91CoN13014P. Molecular weight: 1344.38. Mecobalamin occurs as dark red crystals or crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol (99.5), and practically insoluble in acetonitrile. It is degraded by light. Dosage / Direction for Use: Tablet: The usual adult dose for oral use is 3 tablets (1,500 mcg of mecobalamin) daily divided into three doses. The dose may be adjusted depending on the patient's age and symptoms. Injection: Peripheral Neuropathies: The usual adult dose is 1 ampoule (500 mcg of mecobalamin) daily, administered intramuscularly or intravenously 3 times a week. The dose may be adjusted depending on the patient's age and symptoms. Megaloblastic Anemia: The usual adult dose is 1 ampoule (500 mcg of mecobalamin) daily, administered intramuscularly or intravenously 3 times a week. After about 2 months of medication, the dose should be reduced to a single administration of 1 ampoule at 1 to 3 months intervals for maintenance therapy. Overdosage: Experience to date with deliberate or accidental overdose is limited. No specific antidote is known. As in any case of overdose, treatment should be symptomatic and general supportive measure should be utilised. Administration: May be taken with or without food. Contraindications: Patients with history of hypersensitivity to any ingredients of Mecobalamin (METHYCOBAL). Special Precautions: Mecobalamin (METHYCOBAL) should not be used for more than a month in patients if no clinically therapeutic outcome is observed. Tablet: The prolonged use of larger doses of Mecobalamin (METHYCOBAL) is not recommended for patients whose occupation requires the handling of mercury or mercury compounds. Use In Pregnancy & Lactation: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy. Clinical studies have been done on pregnant women and no harmful effects have been reported. Mecobalamin with the approved dosage can be used during pregnancy. It has been shown that Mecobalamin is excreted in the milk of lactating rats. Side Effects / Adverse Reactions: Anorexia, nausea, vomiting, diarrhea, anaphylactoid reaction eg, decrease in BP or dyspnea. Caution for Usage: Injection: Precautions concerning Use: Administration: Mecobalamin (METHYCOBAL) is susceptible to photolysis. It should be used promptly after the package is opened, and caution should be taken so as not to expose the ampoules to direct light. Intramuscular administration: In intramuscular administration, caution should be exercised by following the instructions mentioned as follows to avoid adverse effects on tissues or nerves: Avoid repeated injection at the same site. Particular caution should be exercised when administering Mecobalamin (METHYCOBAL) to premature infants, neonates, nursing infants and children. Do not inject in densely innervated site. If insertion of the injection needle causes intense pain or if blood flows back into the syringe, withdraw the needle immediately and inject at a different site. Opening the ampoule: Mecobalamin (METHYCOBAL) is supplied in one-point-cut ampoules. The cut point of the ampoules should be wiped with an alcohol swab before opening. Precaution for Handling: Mecobalamin (METHYCOBAL) is packaged in the LPE (Light Protect Easy open pack) to ensure quality during storage. The LPE pack should be opened immediately before using.