Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)
AuroMedics Pharma LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
Thiamine hydrochloride injection, USP 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, USP 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, USP 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, USP is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vit
Thiamine Hydrochloride Injection, USP is a sterile, clear and colorless to pale yellow color solution and is supplied as follows: 200 mg per 2 mL (100 mg/mL): 2 mL Multiple-Dose Vials in a Carton of 25 55150-273-25 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. The vial stoppers are not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: November 2021
Abbreviated New Drug Application
THIAMINE HYDROCHLORIDE - THIAMINE HYDROCHLORIDE INJECTION, SOLUTION AUROMEDICS PHARMA LLC ---------- THIAMINE HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION Thiamine Hydrochloride Injection, USP is a sterile, clear and colorless to pale yellow color solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride USP 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 USP, 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: 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 two to three times. If intake is insufficient, tissues become depleted of their 1 vitamin content. Absorption of thiamine following IM administration is rapid and complete. Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also kno Izlasiet visu dokumentu