REHEPTIN Tablet

For the management of alcoholic & non-alcoholic fatty liver.

Dosage& administration

1 tablet twice a day. For oral use.

Hypersensitivity to any of the ingredients present in REHEPTIN.

Metadoxine: No side-effects or unfavorable reactions occurred during Metadoxine treatment.

Silymarin: Silymarin has a good safety record and only rare case reports of gastrointestinal disturbances and allergic skin rashes have been reported. Occasional laxative effects. Abdominal bloating, diarrhoea, flatulence, loss of appetite, anorexia, nausea, stomach upset.

L-Ornithine L-Asparate: No side effects are known.

Pyridoxine: Sensory neuropathic syndromes, unstable gait, numb feet, awkwardness of hands, perioral numbness, decreased sensation to touch, temperature & vibrations, paresthesia, photoallergic reactions, ataxia.

Folic Acid: Anorexia, nausea, abdominal distension.

See the package insert about the details below:

Metadoxine: interacts with Levodopa and diminishes its effect.

Silymarin: CYP2C9 substrates, Glucuronidated drugs, Tamoxifen, Silymarin.

L-Ornithine L-Aspartate: Drug interactions are not known.

Pyridoxine: Phenytoin, Amiodarone, Phenobarbital, Levodopa.

Folic Acid: Cimetidine and antacids, Sulfasalazine, Anti-seizure medications (including carbamazepine and phenobarbital), The anticonvulsant drugs (phenytoin and valproic acid)

Not recommended in both the conditions due to the presence of Metadoxine.

Not recommended in children below 12 years of age.

Metadoxine

Metadoxine is the ion-pair between Pyridoxine and pyrrolidone carboxylate. Both substances have been used in the treatment of alcoholic liver disease. Pyridoxine is metabolized in the liver and released to systemic circulation principally as pyridoxal-P. It increases the clearance of alcohol and acetaldehyde and decreases the damaging effect of free radicals, restores ATP and glutathione levels, reduces steatosis and liver fibrosis. Metadoxine reduces the toxic effects of alcohol. In hepatic stellate cells, Metadoxine prevents the collagen synthesis & reduces fibrosis and acts as an Ant fibrotic agent and is a synthetic antioxidant, provides stronger antioxidant protection. Besides of its effect on hepatic enzyme systems with subsequent acceleration of ethanol metabolism. Metadoxine is therefore an antagonist of alcohol-metabolic effects.

Silymarin

Silymarin, a flavonoid from the seeds of ‘milk thistle’ (Silybum marianum), has been widely used from ancient times because of its excellent hepatoprotective action. It is a mixture of mainly three flavonolignans, viz, silybin, silidianin, and silychristine, with silybin being the most active. Silymarin has been used medically to treat liver disorders, including acute and chronic viral hepatitis, toxin/drug -induced hepatitis, and cirrhosis and alcoholic liver disease. It has also been reported to be effective in certain cancers. Its mechanism of action includes reduction of glutathione oxidation to enhance its level in the liver and intestine; antioxidant activity; and stimulation of ribosomal RNA polymerase and subsequent protein synthesis, leading to enhanced hepatocyte regeneration.

Silymarin has metabolic and cell-regulating effects at concentrations found in clinical conditions, namely carrier-medicated regulation of cell membrane permeability, inhibition of the 5-lipoxygenase pathway, scavenging of reactive oxygen species of the R-OH type and action on DNA-expression.

L-Ornithine L-Aspartate (LOLA)

LOLA, the stable salt of the amino acids ornithine and aspartic acid, in several clinical trials has shown to reduce blood ammonia levels and improve psychometric performance in patients with HE. LOLA stimulates the urea cycle and glutamine synthesis, which are important mechanisms in ammonia detoxification. Over the last 2 decades, studies involving use of L-ornithine aspartate in patients with liver cirrhosis have demonstrated beneficial effects. Proposed mechanisms as bass for the use of “Ammonia lowering” drugs, particularly amino acids, such ornithine-aspartate include the following:

- in cirrhotic patients, aspartate and citric dicarboxylates may serve as carbon sources for impaired glutamine synthetase flux in the perivenous scavenger hepatocytes;

- ornithine improves the flux through the impaired urea cycle enzyme system, especially through carbamylphosphate synthetase, localized in the periportal hepatocytes.

Pyridoxine

A deficiency of vitamin B6 has been shown to result in impaired hepatic incorporation of titrated thymidine in vitro and, because of this, hepatic regeneration may be adversely affected. Furthermore, PLP plays an important role in the metabolism of amino acids, whose disordered homeostasis may be important in the pathogenesis of hepatic encephalopathy. Subnormal levels of PLP may well exacerbate abnormalities, as well as leading to impaired utilization of dietary protein. Supplementation with Vitamin B6 should therefore be included in the nutritional management of patients. Deficiency of pyridoxine interfere with metabolism & decrease the availability of ATP needed for protein synthesis. Protein deficiency in general may cause fatty liver.

Folic Acid

Liver injury induced chemically can be experimentally used to mimic many types of liver disease. Folate is being utilized to treat a wide variety of disease like hepatotoxicity viz, selective cellular markers can reduce the toxicity of therapeutics agents. Oxidative stress plays a major role in several liver diseases. Study show that folate supplementation regimens reduce the incidence of elevated liver enzyme levels by acting as an anti oxidant.