PYRIDOXINE API

Pyridoxine is the 4-methanol form of vitamin B6, an important water-soluble vitamin that is naturally present in many foods.

As its classification as a vitamin implies, Vitamin B6 (and pyridoxine) are essential nutrients required for normal functioning of many biological systems within the body.

While many plants and microorganisms are able to synthesize pyridoxine through endogenous biological processes, animals must obtain it through their diet.

More specifically, pyridoxine is converted to pyridoxal 5-phosphate in the body, which is an important coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, and aminolevulinic acid.

It's important to note that Vitamin B6 is the collective term for a group of three related compounds, pyridoxine, pyridoxal, and pyridoxamine, and their phosphorylated derivatives, pyridoxine 5'-phosphate, pyridoxal 5'-phosphate and pyridoxamine 5'-phosphate.

Although all six of these compounds should technically be referred to as vitamin B6, the term vitamin B6 is commonly used interchangeably with just one of them, pyridoxine 1.

B6, principally in its biologically active coenzyme form pyridoxal 5'-phosphate, is involved in a wide range of biochemical reactions, including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemogloblin, sphingomyelin and other sphingolipids, and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA) 2.

Pyridoxine is used medically for the treatment of vitamin B6 deficiency and for the prophylaxis of isoniazid-induced peripheral neuropathy (due to Isoniazid's mechanism of action which competitively inhibits the action of pyridoxine in the above-mentioned metabolic functions).

It is also used in combination with Doxylamine (as the commercially available product Diclectin) for the treatment of nausea and vomiting in pregnancy.

Pyridoxine is indicated for the treatment of vitamin B6 deficiency and for the prophylaxis of Isoniazid -induced peripheral neuropathy.

It is also approved by Health

Canada for the treatment of nausea and vomiting in pregnancy in a with Doxylamine (as the commercially available product Diclectin).

B6 (pyridoxine) is a water-soluble vitamin used in the prophylaxis and treatment of vitamin B6 deficiency and peripheral neuropathy in those receiving isoniazid (isonicotinic acid hydrazide, INH).

B6 has been found to lower systolic and diastolic blood pressure in a small group of subjects with essential hypertension.

Hypertension is another risk factor for atherosclerosis and coronary heart disease.

Another study showed pyridoxine hydrochloride to inhibit ADP.

• or epinephrine-induced platelet aggregation and to lower total cholesterol levels and increase HDL-cholesterol levels, again in a small group of subjects.

B6, in the form of pyridoxal 5'-phosphate, was found to protect vascular endothelial cells in culture from injury by activated platelets.

Endothelial injury and dysfunction are critical initiating events in the pathogenesis of atherosclerosis.

Human studies have demonstrated that vitamin

B6 deficiency affects cellular and humoral responses of the immune system.

B6 deficiency results in altered lymphocyte differentiation and maturation, reduced delayed-type hypersensitivity (DTH) responses, impaired antibody production, decreased lymphocyte proliferation and decreased interleukin (IL)-2 production, among other immunologic activities.

B vitamins are readily absorbed from the gastrointestinal tract, except in malabsorption syndromes.

Pyridoxine is absorbed mainly in the jejunum.

Cmax of pyridoxine is achieved within 5.5 hours.

Pyridoxine main active metabolite, pyridoxal 5'-phosphate, is released into the circulation (accounting for at least 60% of circulating vitamin B6) and is highly protein bound, primarily to albumin.

Pyridoxine is a prodrug primarily metabolized in the liver.

The metabolic scheme for pyridoxine is complex, with formation of primary and secondary metabolites along with interconversion back to pyridoxine.

Pyridoxine's major metabolite is 4-pyridoxic acid.

The major metabolite of pyridoxine, 4-pyridoxic acid, is inactive and is excreted in urine.

The total adult body pool consists of 16-25 mg of pyridoxine.

Its half-life appears to be 15-20 days.

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Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR).

Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).

Store at 20°.

• 25°C (68° - 77°F); excursions permitted to 15°.

• 30°C (59° - 86°F).