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:

Fresenius Kabi USA, LLC

INN (International Name):

THIAMINE HYDROCHLORIDE

Composition:

THIAMINE HYDROCHLORIDE 100 mg in 1 mL

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 b

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THIAMINE - THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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THIAMINE HYDROCHLORIDE INJECTION, USP
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, 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
py