Properties
What is it?
International Nonproprietary Name - Ademetionin Clinical-Pharmacological Group - Hepatoprotectors Composition and Dosage Form 400mg Lyophilized Powder Vial and 5ml Ampoule Solvent #5 400mg Enteric-Coated Tablets #20 1 vial of lyophilized powder contains 760 milligrams of ademetionine 1,4-butanedisulfonate, equivalent to 400 milligrams of ademetionine cation; excipients: 1 ampoule of solvent contains L-lysine, sodium hydroxide, water for injection; 1 tablet contains 760 milligrams of ademetionine 1,4-butanedisulfonate, equivalent to 400 milligrams of ademetionine cation; excipients: anhydrous colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, polymethacrylate, polyethylene glycol 6000, talc, simethicone, polysorbate. Main Physical-Chemical Properties: Lyophilized powder is a white or yellowish lyophilized mass, free of foreign particles; solvent is a clear liquid, ranging in color from colorless to yellowish, with a characteristic amine odor; the prepared solution is clear, free of foreign particles, and ranges in color from pale yellow to yellow; tablets are practically white, oval-shaped, without cracks or chips, and film-coated. Indications _ Chronic hepatitis; _ Intrahepatic cholestasis; _ Liver cirrhosis; _ Hepatic encephalopathy; _ Depressive syndromes; _ Abstinence syndrome. Dosage and Administration Lyophilized powder, after dissolving in the accompanying solvent, is used at a dose of 400 mg per day, intravenously or intramuscularly, for 15-20 days. Tablets. Take 2-3 tablets per day, orally. It is recommended to start treatment with parenteral administration of the drug and continue with the tablet form of the drug. The duration of therapy depends on the severity and course of the disease and is determined individually by the doctor. Special Instructions for Use. Lyophilized powder is dissolved in the accompanying special solvent immediately before administration. Intravenous administration is very slow. If the color of the powder changes, it should not be used. To open the solvent ampoule, hold it in your left hand (Fig. 1), and press the colored dot with the thumb of your right hand as shown in Fig. 2. Tablets should be swallowed whole. Heptral tablets are coated with a special film that dissolves only in the intestine, resulting in the release of ademetionine in the duodenum. For better absorption of active substances, tablets are taken between meals. Heptral tablets should be removed from the blister immediately before taking. If the color of the tablets changes, refrain from taking them. Side Effects No serious side effects have been reported with prolonged use of high doses of the drug. No dependence has developed with the use of the drug. Very rarely, in some patients, Heptral® may cause disruption of the circadian rhythm (sleep-wake cycle). In such cases, it may be necessary to take sedatives before sleep. After taking the tablets, some patients developed heartburn and unpleasant sensations in the epigastric region, which were not serious and did not require discontinuation of treatment. Contraindications Hypersensitivity to any component of the drug. Pregnancy and Lactation In the presence of specific clinical conditions (cholestasis, vomiting associated with pregnancy), the drug may be used during pregnancy without any effect on the mother or fetus. Children. There is no experience of use in children.