Each film-coated tablet contains: Metadoxine 500 mg.
Chemistry: Pyridoxine L-2-pyrrolidone-5-carboxylate.
Pharmacotherapeutic Group: Hepato protective.
Pharmacology: Mechanism of Action: Metadoxine antagonizes the lipid peroxidation in liver cells, restoring liver damage resulting from prolonged alcohol intake and reduces fatty liver in chronic hepatitis.
Furthermore, metadoxine acts specifically on the neurotransmitter systems involved in alcoholic Intoxication, increasing the release of γ-aminobutyric acid (GABA) and acetylcholine.
Metadoxine improves ethanol metabolism, reducing plasma ethanol levels during alcohol intake and improves the cognitive impairment, as well as the main psychological symptoms (aggressiveness, agitation, mood and behavioral disturbances) due to occasional or prolonged alcohol abuse.
Therapeutic Efficacy: Metadoxil reduces the stay-time of ethanol in the organism; thus, minimizing its toxic effects on cells. Metadoxil also protects cell structure and function, acting on those biochemical processes which defend them.
Due to these peculiar pharmacological properties, Metadoxil reduces detoxification time in acute ethanol intoxication, and prevents or reduces the hepatic and neuropsychic consequences of habitual intake of alcohol.
Metadoxine is Pyridoxine pidolate. Metadoxine has a direct effect on alcohol metabolism. It accelerates the transformation of alcohol into acetaldehyde and is excreted in urine. It aids in preventing liver damage resulting from prolonged alcohol intake and helps in reversing fatty liver. It improves Alcohol metabolism and accelerates the elimination of alcohol from the blood. Metadoxine reduces the toxic effects of alcohol.
Antifibrotic agent: In hepatic stellate cells, Metadoxine prevents the collagen synthesis & reduces fibrosis. Metadoxine acts as Antifibrotic agent. Metadoxine is a synthetic antioxidant, provides stronger antioxidant protection. Metadoxine, prevents the redox imbalance and tumor necrosis factor (TNF-α) one of the earliest event in hepatic damage. Metadoxine increases the cerebral release of GABA and acetylcholine and the cerebral levels of ATP. Metadoxine is therefore an antagonist of alcohol-metabolic effects and helps to restore normal neuropsychological behavior.
Pharmacokinetics: Absorption: It is readily absorbed after oral administration.
Distribution: It is mainly distributed in the body in protein bound form. It is stored primarily in the liver and to a lesser extent muscle and brain.
Metabolism: It is metabolised in the liver.
For fatty liver due to alcohol; liver diseases caused by prolonged alcohol intake; maintenance in abstinence after alcohol intoxication; acute and chronic intoxication from alcohol.
It is indicated for treatment of patients suffering from acute alcohol intoxication. It is also indicated for supportive treatment of acute and chronic liver diseases alcoholic fatty liver.
2 tabs daily given orally.
Oral: Acute alcohol intoxication: Adult: 500-1000 mg daily.
Oral: Alcoholic fatty liver: Adult: 1000 mg daily.
Oral: Supportive treatment of acute and chronic liver diseases: Adult: 1000 mg daily.
Give supportive measures and symptomatic treatment. The signs of overdose can be resolved by discontinuation (withdrawal) of the drug.
Known hypersensitivity to metadoxine or to any of the components of Metadoxil.
Caution must be exercised in Parkinsonians treated with levodopa, as Metadoxil may antagonize the drug's effect.
Metadoxil ampoules contain sodium metabisulfite. This substance may cause allergic reactions and severe asthmatic attacks in sensitive patients, particularly in asthmatics.
Use in pregnancy & lactation: Metadoxil should not be administered during pregnancy and lactation.
Caution when used in patients with CHF especially those with unstable or acute heart failure. Risk of lactic acid accumulation increases with the degree of renal impairment. May need to discontinue treatment in patients with stress-related states e.g. fever, trauma, infection or surgery. Metformin should be temporarily discontinued for 48 hr in patients undergoing radiologic studies involving intravascular admin of iodinated contrast materials. Elderly. Monitor renal function regularly. May impair ability to drive or operate machinery.
Metadoxil should not be administered during pregnancy and lactation.
Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Lactation: should not be administered during lactation.
Anorexia, nausea, vomiting, diarrhoea, wt loss, flatulence, occasional metallic taste; weakness; hypoglycaemia; rash, malabsorption of vit B12. Chest discomfort, flushing, palpitation, chills, headache, lightheadedness, indigestion, abdominal discomfort.
Potentially Fatal: Lactic acidosis in presence of renal failure and alcoholism.
Metadoxine may increase the peripheral decarboxylation of levodopa, decreasing its efficacy.
Incompatibilities: With iron salts, alkaline solutions, oxidant solutions.
Additive effect with sulphonylurea. Glycaemic control may be affected by diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid. Sympathomimetics, calcium channel blockers, chlorpromazine and isoniazid. Metformin effects may be increased by ACE inhibitors, disopyramide, MAOIs. Cimetidine may increase the serum levels of metformin. Concurrent use with contrast agents may increase the risk of metformin-induced lactic acidosis. May decrease the anticoagulant effect of phenprocoumon, therefore routine anticoagulant monitoring is recommended.
Potentially Fatal: Lactic acidosis with alcohol. Thrombocytopenia has been reported with Ketotifen.
A05BA09 - metadoxine ; Belongs to the class of drugs used in liver therapy.
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