Each capsule contains: Thiamine Mononitrate (Vitamin B1), USP 300 mg, Pyridoxine Hydrochloride (Vitamin B6), USP 100 mg, Cyanocobalamin (Vitamin B12), USP 100 mcg.
Each capsule contains a high potency formulation of the three neutropic vitamin B1, B6, B12 which is scientifically-based. This pharmacodynamic and neutropic concentration of Thiamine, Pyridoxine and Cyanocobalamin precisely works in providing etiologic and symptomatic therapy of painful neurological conditions. Characterized by white to off-white powder free from dirt and lumps encapsulated in empty gelatin capsule size #0 with brown cap and brown body.
Pharmacology: Pharmacodynamics and Pharmacokinetics: Vitamin B-Complex (Benerva Forte) is a combination of three essential neurotropic Vitamins (B1, B6 and B12) in high dosage. Vitamins B1, B6 and B12 are of special importance for the metabolism in the peripheral and central nervous system. Vitamins B1, B6 and B12 are indispensable to normal nerve cell metabolism and this combination greatly enhances their therapeutic efficacy as compared to the effect of the respective factors given individually. In the human body, Thiamine hydrochloride is converted to Thiamine pyrophosphate (active form), which is a coenzyme in the decarboxylation of a-keto acids. On the other hand, Pyridoxol HCl, will be transferred to Pyridoxol phosphate, co-enzyme reaction in carboxylation and transmination, which are involved in protein and amino acid metabolism. Vitamin B12 is essential in nucleic acid and myelin synthesis, for cell growth and replication and maintaining the integrity of the nervous tissue.
For the prevention and treatment of Vitamin B1, B6 and B12 deficiencies.
For therapeutic use, 2-4 capsules may be given daily until acute symptoms subside. For chronic cases, a longer therapy may be required and dosage may be adjusted upon the physician's recommendation. For prophylactic administration, 1-2 capsules daily, or as prescribed by the physician.
Prolonged overdosage of Vitamin B6, for longer than 2 months and >1 g daily, may lead to neurotoxic effects.
Hypersensitivity to any of the active ingredients or excipients of Vitamin B1, B6 and B12.
Use in Children: Vitamin B1, B6 and B12 capsules are not suitable for the treatment of children due to high content of Vitamin B Complex.
Neuropathies are described under long-term intake (6-12 months) of >50 mg mean daily dose of Vitamin B6. Therefore, under long-term treatment, regular monitoring is recommended.
No risks have become known associated with the use of Vitamin B-Complex (Benerva Forte) during pregnancy at the recommended dosage. Vitamins B1, B6 and B12 are secreted into human breast milk, but risks of overdosage for the infant are not known. In individual cases, high doses of vitamin B6 ie, >600 mg daily, may inhibit the production of breast milk.
The vitamin contained in Vitamin B-Complex are completely non-toxic even in high doses and usually, no side effect occurs. Hypersensitivity to Vitamin B1 however, may sometimes be encountered if administration is at prolonged intervals, irregular, or if initial dose are low and suddenly increased. Liver dysfunction could also predispose patients to hypersensitivity reactions. Nevertheless, it must be stressed that hypersensitivity to Vitamin B1, is very rare when orally given unlike if administered by intravenous injection where hypersensitivity is more often encountered.
The vitamins contained in Vitamin B-Complex are completely non-toxic even in high doses and usually, no side effects occur. Sensitivity to Vitamin B1 however, may sometimes be encountered if administration is at prolonged intervals, irregular, or if initial dose are low and suddenly increased. Liver dysfunctions could also predispose patients to hypersensitivity reactions. Nevertheless, it must be stressed that hypersensitivity to Vitamin B1 is very rare when orally given unlike if administered by intravenous injection where hypersensitivity is more often encountered.
The effect of levodopa may be reduced when vitamin B6 is administered concomitantly. Pyridoxine-Antagonists eg, Isoniazid, Cycloserine, Penicillamine, Hydralazine: The efficacy of vitamin B6 (pyridoxine) may be decreased.
Loop Diuretics eg, Furosemide: In long-term use, the blood level of thiamine may be reduced.
Store at temperatures not exceeding 30°C.
Protect from light.
A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.