THIAMINE HYDROCHLORIDE injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J)

Disponível em:

Hikma Pharmaceuticals USA Inc.

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Thiamine Hydrochloride Injection, USP is supplied as follows: NDC 0641-6228-25: 200 mg per 2 mL (100 mg per mL) multiple dose vials packed in cartons containing 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. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922            Revised March 2020 462-857-00

Status de autorização:

Abbreviated New Drug Application

Características técnicas

THIAMINE HYDROCHLORIDE- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
THIAMINE HYDROCHLORIDE INJECTION, USP
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; chlorobutanol
anhydrous (chloral
derivative) 0.5%; 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
CIN 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 two to three 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 t