API

Thiamine nitrate, Pyridoxine hydrochloride, Cyanocobalamin

Drug classification

Dosage form

Film-Coated Tablet

API strength per dosage

200mg:50mg:1000mcg

Dose

Adults: 1–2 tablets daily. Pediatrics: 1 tablet daily or as directed by a physician. Dose adjustments may be required in renal or hepatic impairment; consult a physician. Each tablet contains thiamine nitrate 100 mg, pyridoxine hydrochloride 200 mg, and cyanocobalamin 200 mcg.

Mechanism of action

Thiamine acts as a coenzyme for pyruvate dehydrogenase and transketolase, facilitating carbohydrate metabolism. Pyridoxine is converted to pyridoxal 5'-phosphate, a coenzyme for aminotransferases and decarboxylases in amino acid metabolism. Cyanocobalamin serves as a cofactor for methionine synthase and methylmalonyl-CoA mutase in DNA synthesis and fatty acid metabolism.

Indications

Prevention and treatment of vitamin B1, B6, and B12 deficiencies, peripheral neuropathy, neuritis, neuralgia, alcoholic neuropathy, diabetic neuropathy, supportive therapy in neurological and metabolic disorders.

Side effects

Allergic reactions, urticaria, rash, pruritus, gastrointestinal upset, nausea, vomiting, peripheral neuropathy (with prolonged high-dose pyridoxine), photosensitivity, headache, paresthesia, ataxia.

Pregnancy category

Category A

Precautions

Hypersensitivity to ingredients, severe renal impairment, Parkinson’s disease treated with levodopa alone, pregnancy and lactation (use with caution), risk of neuropathy with prolonged high-dose use, possible interaction with certain medications (e.g., isoniazid, oral contraceptives), monitor for allergic reactions, avoid overdose.

Contraindications

Hypersensitivity to thiamine, pyridoxine, cyanocobalamin, or any excipients, Leber’s disease (hereditary optic neuropathy), severe renal impairment (for pyridoxine), known hypersensitivity to cobalt.