BIROVIT HUP

Thiamine or thiamin, also known as vitamin B1, is a colorless compound with the chemical formula C12H17N4OS.

It is soluble in water and insoluble in alcohol.

Thiamine decomposes if heated.

Thiamine was first discovered by Umetaro Suzuki in Japan when researching how rice bran cured patients of Beriberi.

Thiamine plays a key role in intracellular glucose metabolism and it is thought that thiamine inhibits the effect of glucose and insulin on arterial smooth muscle cell proliferation.

Thiamine plays an important role in helping the body convert carbohydrates and fat into energy.

It is essential for normal growth and development and helps to maintain proper functioning of the heart and the nervous and digestive systems.

Thiamine cannot be stored in the body; however, once absorbed, the vitamin is concentrated in muscle tissue.

For the treatment of thiamine and niacin deficiency states, Korsakov's alcoholic psychosis, Wernicke-Korsakov syndrome, delirium, and peripheral neuritis.

Thiamine is a vitamin with antioxidant, erythropoietic, cognition-and mood-modulatory, antiatherosclerotic, putative ergogenic, and detoxification activities.

Thiamine has been found to protect against lead-induced lipid peroxidation in rat liver and kidney.

Thiamine deficiency results in selective neuronal death in animal models.

The neuronal death is associated with increased free radical production, suggesting that oxidative stress may play an important early role in brain damage associated with thiamine deficiency.

Thiamine plays a key role in intracellular glucose metabolism and it is thought that thiamine inhibits the effect of glucose and insulin on arterial smooth muscle cell proliferation.

Inhibition of endothelial cell proliferation may also promote atherosclerosis.

Endothelial cells in culture have been found to have a decreased proliferative rate and delayed migration in response to hyperglycemic conditions.

Thiamine has been shown to inhibit this effect of glucose on endothelial cells.

Absorbed mainly from duodenum, by both active and passive processes.

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Thiamine toxicity is uncommon; as excesses are readily excreted, although long-term supplementation of amounts larger than 3 gram have been known to cause toxicity.

Oral mouse

LD 50 = 8224 mg/kg, oral rat LD 50 = 3710 mg/kg.

This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.

Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration.

Deaths have resulted from IV or

IM administration of thiamine See ADVERSE REACTIONS.

Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity.

Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection.

If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes.

If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection.

Be prepared to treat anaphylactic reactions regardless of the precautions taken.

Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines.

history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. See WARNINGS for further information..

"Wet" beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation See WARNINGS.

In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks. See WARNINGS regarding repeated injection of thiamine. An oral therapeutic multivitamin preparation containing to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation.

Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV.

Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive to 10 mg of thiamine hydrochloride IM daily.

In the treatment of

Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of to 100 mg daily until the patient is consuming a regular, balanced diet. See WARNINGS regarding repeated injections of thiamine. Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Injection, USP is supplied as follows Store at 20° to 25°C (68° to 77° F) .

Use only if solution is clear and seal intact.

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