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Neurogen-E

PRODUCT DESCRIPTION
Neurogen E is a maroon, elliptical film-coated tablet, plain on both sides

PHARMACOLOGY
The vitamin B-Complex functions as coenzymes for various metabolic and biochemical reactions.

Thiamine combines with adenosine triphosphate (ATP) to form the coenzyme thiamine pyrophosphate (TPP). Its role in carbohydrate metabolism is the decarboxylation of pyruvic and alpha keto acids. TPP is also involved in transketolation reactions as well as in the utilization of pentose in the hexose monophosphate shunt.

Pyridoxine is converted to its active coenzyme forms, pyridoxal phosphate (codecarboxylase) and pyridoxamine phosphate. Vitamin B6, acts as a coenzyme in the metabolism of protein, carbohydrate and fat. In protein metabolism, it participates in the decarboxylation of amino acids; conversion of tryptophan to niacin or serotinin; and deamination, transamination and transulfuration of amino acids. In carbohydrate metabolism, it is responsible for the breakdown of glycogen to glucose-1-phosphate.

Vitamin B12 (cyanocobalamin and hydroxocobalamin) is converted to co-enzyme B12, its active form. Its role is associated with methylation participation in nucleic acid and protein synthesis. Cyanocobalamin participates in red blood cell formation through activation of folic acid coenzymes. Vitamin B12 may also be involved in maintaining sulthydryl (SH) groups in the reduced form required by many SH-activated enzyme systems. Through these reactions, Vitamin B12 is associated with fat and carbohydrate metabolism and protein synthesis.

Although the exact biological function of vitamin E is unknown, it is an essential element in human nutrition. Many of its actions are related to its antioxidant properties. Vitamin E may protect cellular constituents from oxidation and prevent formation of toxic oxidation products; it preserves red blood cell wall integrity and protects them against hemolysis.

PHARMACOKINETICS
The B-Complex vitamins are generally readily absorbed from the gastrointestinal tract. They are also widely distributed to body tissues. Excretion is through the urine as metabolites or in the original form.

Absorption of Vitamin E depends on the presence of bile and only 20-60% of the vitamin is absorbed. Vitamin E is distributed to all tissues and is stored in adipose tissue. It is metabolized in the liver and excreted primarily in the bile. Some enterohepatic circulation may occur, and small amounts of the metabolites are excreted in the urine.

INDICATIONS
For the treatment of deficiencies in Vitamin B1, B6, B12 and E.

DOSAGE/ ADMINISTRATION
Orally, one tablet daily or as prescribed by the physician.

CONTRAINDICATIONS
Hypersensitivity to any component in the formulation.

ADVERSE REACTIONS
In humans, Vitamin B1, B12 and E are of extremely low toxicity especially when administered orally.

Ataxia and severe sensory neuropathy or neunonopathy have been reported in patients who had consumed pyridoxine in large doses (2 grams or more daily) over a long period of time (2 months or longer). When pyridoxine is discontinued, symptoms lessen. It may take six months for sensation to return to normal. Adverse neurologic effects have also been reported rarely following chronic administration of lower doses, i.e. more than 100 mg daily for more than one year. Complete recovery is observed within six months of stopping pyridoxine.

WARNINGS AND PRECAUTIONS
No data has been established

DRUG INTERACTIONS
Although the clinical importance is unknown, thiamine reportedly may enhance the effect of neuromuscular blocking agents.

Pyridoxine reduces levodopa's effectiveness by accelerating peripheral metabolism of levodopa. Concomitant administration of carbidopa with levodopa prevents the reversal of levodopa's effects by pyridoxine. Preparations containing more than 5 mg pyridoxine in the daily dose must be avoided by patients taking levodopa without carbidopa. Pyridoxine may also reduce serum levels of phenobarbital and phenytoin.

Vitamin B12 absorption from the GI tract may be decreased by aminoglycosides, colchicine, extended release potassium preparations, aminosalicylic acid and its salts, anticonvulsants (e.g. phenytoin, phenobarbital, primidone), cobalt irradiation of the small intestine, and excessive alcohol intake lasting longer than two weeks. Concurrent administration of chloramphenicol and Vitamin B12 may reduce the hematopoietic response to Vitamin B12 in patients with pernicious anemia.

Vitamin E or one of its metabolites reportedly may have anti-vitamin K activity; patients receiving oral anticoagulants may be at risk of hemorrhage after large doses of Vitamin E. In normal volunteers, Vitamin E caused no change in blood clotting. Excessive use of mineral oil may decrease Vitamin E absorption.

OVERDOSAGE AND TREATMENT
No data has been established

STATEMENT ON USAGE DURING PREGNANCY AND LACTATION
No data has been established

FORMULATION

US-RDA

Each tablet contains :

d-Alpha Tocopheryl Acid Succinate (Vitamin E) ... 100 I.U

Thiamine Mononitrate (Vitamin B1) ... 300 mg

Pyridoxine Hydrochloride (Vitamin B6) ... 300 mg

Cyanocobalamin (Vitamin B12) ... 1 mg

30 IU

1.5 mg

2 mg

6 mcg

STORAGE
Store in a dry place at temperatures not exceeding 30C. Keep out of children's reach.

Available in box of 25 strips x 4 tablets

Shelf-life: 36 months from manufacturing date.

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