Vitamin B 1, 6, 12

Indication

For the treatment of Vitamin B1, B6, B12 deficiency.

In the treatment of neuritic pain; acute or chronic neuritis, polyneuritis, neuralgia, radiation sickness, idiopathic sideroblastic anaemia, diabetic polyneuropathy and disturbances of peripheral nerves.

Dosage and Administration

One caplet or tablet should be taken once daily with meal or as prescribed by the physician.

Composition

Each film-coated tablet contains:

Thiamine Mononitrate B.P (Vit B1) ... 100 mg

Pyridoxine Hydrochloride B.P (Vit B6) ... 200 mg

Cyanocobalamin B.P (Vit B12) ... 200 mcg.

Description

Chemically, Thiamine Mononitrate is 3-[(4-Amino-2- methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)-4- methylthiazolium nitrate. Molecular formula is C12H17N504S and its molecular weight is 327.4.

Pyridoxine Hydrochloride is (5-hydroxy-6-methylpyridine-3,4-diyl) dimethanol hydrochloride. Its molecular formula is C8H1FIN03 and its molecular weight is 205.6.

Cyanocobalamin is a-(5,6-Dimethylbenzimidazol-l-yl) cobamide cyanide. Molecular fonnula is C63H88CoN14O14P and its molecular weight is 1355.

Clinical Pharmacology

Thiamine Mononitrate (Vitamin B1): Thiamine pyrophosphate, the active form of thiamine, is a coenzyme involved in carbohydrate metabolism and nerve conduction.

Pyridoxine hydrochloride (Vitamin B6): Pyridoxal phosphate, the active form of pyridoxine, is involved in several metabolic transformation of amino acid, carbohydrate, fat and is also required for haemoglobin synthesis.

Cyanocobalamin (Vitamin B12): Methylcobalamin and 5-deoxy-adenosyl-cobalamin are the active forms of cyanocobalamin which act as coenzymes in nucleic acid synthesis, control folate metabolism in haemato­poiesis and maintain the functions of myelin sheath.

Pharmacokinetics

Thiamine mononitrate is well-absorbed, excreted in the urine (as unchanged drug and as pyrimidine after body storage site become saturated).

Pyridoxine hydrochloride is well absorbed and metabolized via 4-pyridoxic acid (active form) and other metabolites. It is excreted in the urine.

Cyanocobalamin: Once absorbed, it is transported to the various cells of the body bound to a family of specialized glycoproteins, transcobalamin T, TT, TTT. Excess B12 is stored in the liver.

Contraindication

Hypersensitivity to thiamine, pyridoxine, cyanocobalamin or any component of formulation.

Precaution

Thiamine may occasionally cause anaphylactic shock in breastfeeding.

Heavy overdose of pyridoxine can cause neurotoxicity and symptoms of dependency.

Treatment of vitamin B12 megaloblastic anaemia may result in severe hypokalemia when anaemia corrects due to cellular potassium requirements.

Adverse Effects

Rarely causes allergic reactions. Can cause sensory neuropathy when given with high dose for extended period.

Drug Interaction

Pyridoxine may decrease serum levels of levodopa, phenobarbital and phenytoin. Ethanol decrease B12 absorption.

Storage

Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.

Presentation

20 x 10's Blisters.