May
09

Polynerv 250 Film-Coated Tablet

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THIAMINE HCl

PYRIDOXINE HCl

CYANOCOBALAMIN

POLYNERV™ 250

250 mg/250 mg/1 mg Film-coated Tablet

VITAMIN

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FORMULATION:

Each film-coated tablet contains:

Thiamine Hydrochloride (Vitamin B1) ….. 250 mg
Pyridoxine Hydrochloride (Vitamin B6) ….. 250 mg
Cyanocobalamin (Vitamin B12) ….. 1 mg (eq. to 1,000 mcg)

DESCRIPTION:

Vitamins B1, B6 and B12 (POLYNERV™ 250) is a high potency formulation of the neurotropic vitamins B1, B6 and B12. This fortified combination of the most essential B vitamins, is a valuable adjuvant in the comprehensive management of neural disorders and certain diseases associated with painful neurologic manifestations.

Vitamins B1, B6 and B12 (POLYNERV™ 250) is useful in the prevention and treatment of vitamin B deficiencies arising from poor dietary intake, chronic alcoholism, impaired B vitamins absorption (as in excessive vomiting, prolonged diarrhea and antibiotic therapy) and intake of certain drugs which interfere with the utilization of B vitamins (i.e. isoniazid, estrogen, phenothiazine).

PROPERTIES AND ACTIONS:

The neurotropic agents, Vitamins B1, B6 and B12 activate specific biochemical pathways involved in nervous system physiology.

Normal cellular activities depend on the availability of the biochemical energy derived mainly from the metabolism of food nutrients. In the metabolic systems of the body, the breakdown products of carbohydrates, fats and proteins are acted upon by enzymes together with their coenzymes (primarily vitamins B1, B6 and B12) in order that the cellular reactions by which these nutrients are further biotransformed and utilized may continue. Vitamins B1, B6 and B12 stimulate the various metabolic processes which produce the energy needed to fuel the cellular activities of the body, specifically the physiologic activities of the nervous system.

Thiamine (Vitamin B1) functions as a coenzyme, operating as a cocarboxylase in various reactions of glucose metabolism (i.e. decarboxylation of pyruvic acid and other alpha-keto acids, leading to synthesis of ATP). Thiamine enhances production of energy from glucose and storage of energy as fat, making energy available to support normal celllular processes.

Thiamine as coenzyme of carbohydrate metabolism ensures the efficient production of energy from glucose and the conversion of glucose into other substances such as ribose, a major component of DNA and RNA. Glucose provides the basic nutritional needs of the nervous system serving as a major energy source. Thiamine deficiency impairs production of energy on which the activity of the smooth muscle of the heart and blood vessel is highly dependent.

Independent of its coenzyme function, Thiamine acts as modulator in the transmission of neural impulses. Thiamine deficiency results in symptoms of cardiovascular, gastrointestinal and neurologic disturbances. Thiamine deficiency can also cause degeneration of myelin sheaths in the peripheral nerves and in the CNS.

Thiamine as coenzyme ensures that energy is available for the vital organs of the body to do their work. The smooth muscle cells of the heart, blood vessels, and the secretory glands of the gastrointestinal tract depend on the energy derived from metabolism of glucose. Thiamine helps improve muscle tone of the intestine, stomach, heart and blood vessels. Without sufficient energy, the muscles of the heart and blood vessel walls dilate leading to fluid accumulation.

Pyridoxine (Vitamin B6) participates in many cellular reactions of lipid and amino acid metabolism (i.e. transaminations, decarboxylation). The active form of B6, pyridoxal phosphate, acts as a coenzyme in several metabolic transformations of amino acids which are in turn needed for tissue building and in the synthesis of certain compounds and blood elements. Pyridoxine is required in the synthesis of delta-aminolevulinic acid, the heme precursor necessary for the formation of hemoglabin molecule.

Vitamins B1, B6 and B12 (POLYNERV™ 250) tablet contains high amount of Cyanocobalamin (Vitamin B12), a coenzyme involved in several metabolic pathways (i.e. conversion of methyl malonyl CoA to succinyl CoA, fatty acid synthesis). The most important action of cyanocobalamin is to act as a coenzyme of nucleic acid metabolism, reducing ribonucleotides to deoxyribonucleotides, a step that is essential in the replication of genes and formation of new cells. Cyanocobalamin is also an important cofactor in the formation and maturation of red blood cells in the bone marrow. Deficiency of B12 results in megaloblastic anemia.

The inhibition of normal fatty acid synthesis in the brain and nerve tissues leads to faulty structure and impaired functions manifested as neurological symptoms. Deficiency of vitamin B12 also results in demyelination of the large nerve fibers of the spinal cord.

As the well known actions of B1, B6 and B12 are directed towards the CNS, the purported action of high doses of these B vitamins revolve around the central nervous system.

INDICATIONS:

For the prevention and treatment of Vitamin B deficiencies.

PHARMACOKINETICS:

Following oral administration, thiamine is absorbed from the gastrointestinal tract and is widely distributed into most body tissues. Thiamine is mostly present within the cells as diphosphate. It is not stored in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites.

Pyridoxine is readily absorbed from the gastrointestinal tract. It is converted to the active form pyridoxal phosphate and is stored mainly in the liver. Amounts in excess of the body’s requirements are excreted unchanged in the urine.

Pyridoxal diffuses across the placenta and appears in breast milk.

Vitamin B12 compounds which bind to intrinsic factor, a glycoprotein secreted by the gastric mucosa are then actively absorbed from the gastrointestinal tract. Little amount is absorbed by passive diffusion but the process becomes increasingly important with larger amounts.

Vitamin B12 is extensively bound to transcobalamin, a plasma protein. Vitamin B12 is stored in the liver and excreted in the bile. Part of a dose is excreted in the urine. Vitamin B12 diffuses across the placenta and is also distributed into breast milk.

ADMINISTRATION AND DOSAGE:

For therapeutic use, 2-4 tablets of Vitamins B1, B6 and B12 (POLYNERV™ 250) should be administered daily until acute symptoms subside. Chronic cases may require longer therapy.

For prophylactic administration when disease or drugs are likely to lead to neurological complications, the recommended dosage is 1-2 tablets daily. Or as prescribed by the physician.

DRUG INTERACTION:

Drugs that increase the requirements for pyridoxine include hydralazine, isoniazid, penicillamine and oral contraceptives. Neomycin, aminosalicylic acid, metformin, histamine H2-antagonists and colchicine may reduce the absorption of vitamin B12. Oral contraceptives may reduce serum concentrations of vitamin B12. Though unlikely to be of clinical significance, many interactions of vitamin B12 should be taken into account when performing assays for blood concentration.

PRECAUTION:

Cyanocobalamin (Vitamin B12) should not be used to treat megaloblastic anemia of pregnancy. Administration of doses greater than 10 mcg of Vitamin B12 daily may produce a haematological response in patients with folate deficiency; indiscriminate use may mask the precise diagnosis. Cyanocobalamin or hydroxocobalamin should, if possible, not be given to patients with suspected vitamin B12 deficiency without first confirming the diagnosis. Regular monitoring of the blood is advisable.

CONTRAINDICATIONS:

Contraindicated in patients with history of hypersensitivity to the components. Cyanocobalamin should not be given to patients with suspected vitamin B12 deficiency without confirmation of the diagnosis. Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

ADVERSE EFFECTS:

Adverse effects seldom occur after oral administration of thiamine and cyanocobalamin, but hypersensitivity reactions have been reported after parenteral administration. Hypersensitivity reactions to thiamine ranged from very mild to very rarely, anaphylactic shock. Hypersensitivity reactions have occured rarely following oral administration of cyanocobalamin.

Long-term administration of large doses of pyridoxine is associated with the development of peripheral neuropathies.

AVAILABILITY:

Alu-alu blister Pack x 10’s (Box of 100’s)

CAUTION:

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORE AT TEMPERATURES NOT EXCEEDING 30ºC.