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Indications

This tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia; nutrient malabsorption or inadequate dietary intake; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary, peripheral, or cerebral vessels, or neurological disorders.

Pharmacology

Pyrodoxine (Vitamin B6) is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.

Folic acid (Vitamin B9)
 is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Cyanocobalamin (Vitamin B12) is vital to growth, hematopoiesis and nucleoprotein and myelin synthesis. As a hematopoietic agent, it is converted to coenzyme B12 needed in the conversion of methylmalonate to succinate and production of methionine from homocysteine, a reaction requiring folate. In the absence of folate, such metabolites cannot be formed and folate deficiency occurs. It is also involved in the maintenance of reduced sulfhydryl (SH) groups which are required by various SH-activated enzyme systems. Through such processes, cyanocobalamin participates in fat and carbohydrate metabolism as well as protein synthesis.

Dosage & Administration

Usual adult dose is one to two tablets daily or as directed by a physician.

Interaction

Pyridoxine Hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by Pyridoxine Hydrochloride. However; Pyridoxine Hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.

Contraindications

Known hypersensitivity to any of the components in the product is a contraindication.

Side Effects

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia, somnolence, nausea and headache have been reported with pyridoxine hydrochlloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.

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Pregnancy & Lactation

Pregnancy category- Not classified

Precautions & Warnings

Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Unmetabolized Folic Acid has the potential to reduce natural killer cells cytotoxicity, which may result in an impaired immune response.

Therapeutic Class

Specific combined vitamin preparations, Vitamin-B preparations