THIAMINE- thiamine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Caplin Steriles Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Thiamine Hydrochloride Injection, USP is a sterile, nonpyrogenic clear colorless to pale yellow color solution supplied in multiple dose vials as follows: Storage Conditions 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: Caplin Steriles Limited, Gummidipoondi - 601 201,  India. December 2020 CSL/AWC/XXX-XX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THIAMINE - THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
CAPLIN STERILES LIMITED
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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 B1, 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
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