THIAMINE HYDROCHLORIDE injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Dr. Reddy's Laboratories Inc.

Toedieningsweg:

INTRAMUSCULAR

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Made in India Issued: December 2022

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

THIAMINE HYDROCHLORIDE- THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
DR. REDDY'S LABORATORIES INC.
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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. Sodium Hydroxide
and/or Hydrochloric
Acid may have been used to adjust pH between 2.5 and 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, USP 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 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 thiamine
pyrophosph