Neurobion Forte RF Injection is a multivitamin formulation containing mecobalamin, pyridoxine and nicotinamide as the active ingredients.
Each 2 ml ampoule contains:
Water for injection
Mecobalamin (methylcobalamin), adenosylcobalamin (cobamide) and hydroxycobalamin are various forms of vitamin B12 (a water-soluble vitamin) in the body. Mecobalamin is the predominant among them and is the active form of Vitamin B12. Mecobalamin and cobamide act as coenzymes in nucleic acid synthesis. It is also involved with folic acid in several important metabolic pathways.
Mecobalamin as an endogenous coenzyme plays as important a role in transmethylation of methionine synthetase in the synthesis of methionine from homocysteine. It is transported to nerve cell organelles, and promotes nucleic acid and protein synthesis. Transportation of mecobalamin to nerve cell organelles is better than cyanocobalamin. It is involved in the synthesis of thymidine from deoxyuridine, promotion of deposited folate utilization and metabolism of nucleic acid. It promotes nucleic acid and protein synthesis more than adenosylcobalamin does. Mecobalamin promotes axonal transport and axonal regeneration. Mecobalamin normalizes axonal skeletal protein transport in nerve cells in animal models of diabetes mellitus. It exhibits neuropathological and electrophysiological protective effect on nerve degeneration in animal models of axonal degeneration (adriamycin, acrylamide, and vincristine-induced neuropathies) with spontaneous diabetes mellitus. It promotes myelination (phospholipid synthesis). It promotes the synthesis of lecithin, the main constituent of medullary sheath lipids, and increases myelination of neurons in tissue culture, more than adenosylcobalamin does. It restores delayed synaptic transmission and diminished neurotransmitters to normal.
Vitamin B12 restores end-plate potential induction early by increasing nerve fibre excitability in damaged nerve.
Human urinary excretion of mecobalamin is about ⅓ rd that of a similar dose of cyanocobalamin, indicating substantially greater tissue retention.
Pyridoxine hydrochloride is the biologically active from of pyridoxine (vitamin B6) which serves as a coenzyme for the amino acid metabolism. Vitamin B6 plays an important role in the synthesis of amino acid, biogenic amines (neurotransmitters), such as noradrenaline, dopamine, serotonin and GABA. Pyridoxine is required by the body for utilization of energy in the foods one eat, production of red blood cells, and proper functioning of nerves. It is used to treat and prevent vitamin B6 deficiency resulting from poor diet, certain medications, and some medical conditions.
It acts as a coenzyme in sphingolipid metabolism. Sphingolipids are the essential components in the cell membranes of the myelin sheaths of the nerve cells. Further, they have an extraordinarily rapid metabolic turnover. The maintenance of the structural and thus, the functional integrity of the nervous system, therefore, require a continuous supply of Vitamin B6.
In addition, pyridoxine is a coenzyme of lysyl-oxidase, the enzyme which promotes collagen formation by inducing interlinking of collagen fibrils.
Nicotinamide is the naturally occurring form of water-soluble vitamin B niacin in the body. It is converted into nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP); coenzymes present in all cells and are involved in electron transfer reactions in the respiratory chain. It is essential for tissue metabolism.
Peripheral Neuropathy due to diabetes or states resulting in B6, B12, niacin deficiencies.
Hypersensitivity to vitamin B12, B6, nicotinamide or any other ingredient of Neurobion Forte RF Injection.
Warnings & Precautions
and death have been reported with administration of parenteral vitamin B12
. Adequate and well-controlled studies with Neurobion Forte RF Injection have not been done in pregnant women. However, vitamin B12
is an essential vitamin and requirements are increased during pregnancy.
Adverse drug reactions
Neurobion Forte RF Injection is generally well tolerated. It may cause gastrointestinal disturbances like, nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, itching and transitory exanthema. Pyridoxine may cause side effects like, gastrointestinal upset, headache, sleepiness, tingling, prickling, burning, or sensation of tightness of the hands and feet. Long-term use of large doses of pyridoxine (2 to 6 g daily for 2 to 40 months) is associated with the development of severe peripheral neuropathy. Nicotinamide does not cause vasodilatory adverse effects like nicotinic acid.
There is no evidence of any mutual interaction among the ingredients of Neurobion Forte RF. Serum concentrations of B12 may be reduced by concurrent use of oral contraceptives. Pyridoxine reduces the effects of levodopa (not when a dopa decarboxylase inhibitor is given along). Pyridoxine reduces the activity of altretamine, serum concentrations of Phenobarbital and phenytoin. Many drugs like, hydralazine, isoniazid, penicillamine and oral contraceptives may increase the requirements for pyridoxine. Plasma concentrations of carbamazepine were reported to be increased in patients using nicotinamide.
Dosage and Administration
Neurobion Forte RF injection can be administered either by slow intravenous infusion after dilation or intramuscularly once or twice daily on alternate days depending on the nature and severity of peripheral neuropathy or states resulting in B6, B12, niacin deficiencies. Neurobion Forte RF injection can be diluted with at least 250 ml of Normal Saline, Ringer Lactate or DNS & administered i.v. in slow infusion.
Storage including Special precautions for storage, Instructions of use/handling
For further details kindly refer the full prescribing information