Godex DS

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Pharmacology: Pharmacodynamics: Carnitine orotate is the pharmacologically active salt of carnitine and orotic acid. These two compounds act synergistically for histological restoration and lipotropic effect in the liver. Carnitine, an indispensable bio-stimulant for the metabolism of fat, promotes β-oxidation of free fatty acids in hepatocytes. Orotic acid is a precursor in nucleic acid (i.e. DNA and RNA) biosynthesis which is essential in the synthesis of proteins. Orotic acid prohibits the necrosis of injured liver cells by normalizing cell proliferation and the enzymatic system in the liver.
The 17 amino acids (i.e. purified liver extract hydrolysate) detoxify intrinsic and extrinsic hepatotoxic substances. Pyridoxine, cyano-cobalamin, and adenosine act through amino acid metabolism, thereby augmenting the treatment of hepatic disease.
The combined substances result in marked improvement on various histological profiles (i.e. SGOT, SGPT, bilirubin, biopsy) and vital signs (i.e. weight loss, nausea).
Pharmacokinetics: General: Godex DS peak plasma concentrations are observed about 30 min after dosing.
Absorption and Distribution: Carnitine orotate is non-hygroscopic and less deliquescent than L-carnitine. The ionic complex salt is also more soluble and more easily absorbed by the injured cells compared to the administration of carnitine individually.
Pyridoxine Hydrochloride (Vitamin B6) is readily absorbed from the gastrointestinal tract, mainly in the jejunum and is converted to pyridoxal phosphate which is totally bound to plasma proteins.
Adenine combines with the sugar ribose to form adenosine, which in turn can be bonded with from one to three phosphoric acid units, yielding AMP, ADP and ATP. These Adenine derivatives perform important functions in cellular metabolism. Adenine is one of four nitrogenous bases utilized in the synthesis of nucleic acids.
Riboflavin or vitamin B2 is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolising of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity. Cyanocobalamin (Vitamin B12) the chemical name is 5,6-dimethylbenzimidazolyl cyanocobamide; the molecular formula is C₆₃H₈₈CoN₁₄O₁₄P. The cobalt content is 4.34%. The molecular weight is 1355.39. Vitamin B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins.
Hepatic Extract Antitoxic Fraction is a specifically hydrolyzed 17 amino acid complexes, which is prepared by enzymatic hydrolysis from the liver, and readily absorbed from the gastrointestinal tract.
Elimination: Carnitine orotate is metabolized in the liver, which when metabolized leaves its free carnitine content. A different behavior was observed in the elimination of exogenous carnitine via urine. In a test in healthy humans, the moderate ingestion of Carnitine orotate does not produce increased carnitine elimination in the urine. This retention of carnitine in the body tissues means a better utilization of the substance in the body.
Pyridoxine is stored mainly in the liver, with lesser amounts stored in muscle and brain. Biotransformation is hepatic and almost entirely as metabolites excreted in the urine. Excess beyond daily needs is excreted, largely unchanged, in the urine. In dialysis - removed by hemodialysis.
After a single oral dose, riboflavin's biologic half-life is about 66 to 84 minutes in healthy people. Riboflavin is metabolized to FMN in erythrocytes, GI mucosal cells, and the liver; FMN is converted to FAD in the liver. About 9% of drug is excreted unchanged in urine after normal ingestion. Excretion involves renal tubular secretion and glomerular filtration. Amount renally excreted unchanged is directly proportional to the dose. Drug removal by hemodialysis is slower than by natural renal excretion.
Within 48 hours after injection of 100 or 1,000 mcg of Cyanocobalamin, 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.
Carnitine Orotate + Hepatic Extract Antitoxic Fraction + Adenine HCl + Pyridoxine HCl + Riboflavin + Cyanocobalamin (Godex DS) is predominantly metabolized in the liver and excreted via urine.

Used for the treatment of the fatty liver: Non-Alcoholic Fatty Liver Disease (NAFLD) and Alcoholic Fatty Liver Disease (ADLF), Steatohepatitis: Non-Alcoholic Steatohepatitis (NASH) and Alcoholic Steatohepatitis (ASH), acute and chronic viral hepatitis, liver cirrhosis, drug-induced liver injury, alcoholic intoxication and general intoxication.

For adults, 1 capsule of Carnitine Orotate + Hepatic Extract Antitoxic Fraction + Adenine HCl + Pyridoxine HCl + Riboflavin + Cyanocobalamin (Godex DS); Capsule 3 times a day for 4-12 months or as prescribed by the physician.

Supportive therapy should be instituted according to symptoms in cases of suspected overdosage. There is presently a lack of experience with overdosage with the product.

Patients with history of hypersensitivity to any components of the drug.

Administration of doses greater than 10 mcg of Cyanocobalamin daily may produce a hematological response in patients with folate deficiency. Indiscriminate use may mask the precise diagnosis. Long-term use of large doses of pyridoxine is associated with the development of severe peripheral neuropathies.

It is not known whether it can cause fetal harm when taken by a pregnant woman. Seek medical advice before use.

Gastrointestinal disturbances such as nausea, vomiting, diarrhea, and abdominal cramps have been reported after the daily use of large doses of carnitine. Body odor has also been noticed in some patients, possibly due to the formation of the metabolite trimethylamine. Upon observance of any untoward reaction, discontinue use and seek medical attention. For suspected adverse reaction, report to the FDA, www.fda.gov.ph.

Pyridoxine reduces the effects of levodopa and activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin. Absorption of Vitamin B12 from the gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, H2 antagonists, and colchicine.

Store at temperature not exceeding 30°C. Avoid exposure to direct sunlight. Keep cool and dry.

Cardiac Drugs / Cholagogues, Cholelitholytics & Hepatic Protectors

A05BA - Liver therapy ; Used in liver therapy.

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