Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Thiamine Hydrochloride (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)
Mylan Institutional LLC
Thiamine Hydrochloride
Thiamine Hydrochloride 100 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g
Thiamine Hydrochloride Injection, USP, 200 mg/2 mL (100 mg/mL), is available in: NDC 67457-196-02 2 mL (200 mg) multiple-dose vial, packaged 25 vials per carton. 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. Preservative Free. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0941L101 Revised: 4/2021 MI:THIAIJ:R4
Abbreviated New Drug Application
THIAMINE HYDROCHLORIDE- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- DESCRIPTION Thiamine hydrochloride injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; monothioglycerol 0.5%; Water for Injection q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B , occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5- pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula: C H CLN OS • HCL M.W. 337.27 CLINICAL PHARMACOLOGY The water soluble vitamins are widely distributed in both plants and animals. They are absorbed in man by both diffusion and active transport mechanisms. These vitamins are structurally diverse (derivatives of sugar, pyridine, purines, pyrimidine, organic acid complexes and nucleotide complex) and act as coenzymes, as oxidation-reduction agents, possibly as mitochondrial agents. Metabolism is rapid, and the excess is excreted in the urine. Thiamine is distributed in all tissues. The highest concentrations occur in liver, brain, kidney and heart. When thiamine intake is greatly in excess of need, tissue stores increase 2 to 3 times. If intake is insufficient, tissues become depleted of their vitamin content. Absorption of thiamine following IM administration is rapid and complete. Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as cocarboxylase, a coenzyme. Its role in carbohydrate metabolism is Leggi il documento completo