THIAMINE HYDROCHLORIDE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

thiamine hydrochloride (UNII: M572600E5P) (thiamine ion - UNII:4ABT0J945J)

Disponible depuis:

Sagent Pharmaceuticals

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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. Retain in carton until time of use. Use only if solution is clear and seal intact. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2020 Sagent Pharmaceuticals, Inc. Revised: January 2020 SAGENT Pharmaceuticals®

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

THIAMINE HYDROCHLORIDE- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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THIAMINE HYDROCHLORIDE INJECTION, USP
(FOR INTRAVENOUS OR INTRAMUSCULAR USE)
SAGENT
Rx only
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,
®
1
12
17
4
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.
Th