Thiamine Hydrochloride Injection, Solution
Generic Name: thiamine hydrochloride injection, solution
Brand Names:
Thiamine Hydrochloride Injection, Solution
DESCRIPTION Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride, USP in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s.
Overview
DESCRIPTION Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride, USP in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s.
Uses
INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.
Dosage
DOSAGE AND ADMINISTRATION "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 5 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.
Side Effects
ADVERSE REACTIONS An occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to thiamine, especially after repeated injections. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS ).
Warnings
WARNINGS WARNING: 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 4 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. CONTRINDICATIONS A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)
Storage
HOW SUPPLIED Thiamine Hydrochloride Injection, USP is supplied as follows Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Distributor: HF ACQUISITION CO LLC, DBA HEALTHFIRST 11629 49TH PL W. MUKILTEO, WA 98275 HOW SUPPLIED
Frequently Asked Questions
What is Thiamine Hydrochloride Injection, Solution used for?▼
INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.
What are the side effects of Thiamine Hydrochloride Injection, Solution?▼
ADVERSE REACTIONS An occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to thiamine, especially after repeated injections. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS ).
What are the important warnings for Thiamine Hydrochloride Injection, Solution?▼
WARNINGS WARNING: 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 4 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. CONTRINDICATIONS A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.