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:

AuroMedics Pharma LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Thiamine hydrochloride injection, USP 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, USP 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, USP 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, USP is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vit

Product summary:

Thiamine Hydrochloride Injection, USP is a sterile, clear and colorless to pale yellow color solution and is supplied as follows: 200 mg per 2 mL (100 mg/mL): 2 mL Multiple-Dose Vials in a Carton of 25                                                  55150-273-25 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. The vial stoppers are not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: November 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THIAMINE HYDROCHLORIDE - THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
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THIAMINE HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Thiamine Hydrochloride Injection, USP is a sterile, clear and
colorless to pale yellow color
solution of thiamine hydrochloride in Water for Injection for
intramuscular (IM) or slow
intravenous (IV) administration.
Each mL contains: Thiamine hydrochloride USP 100 mg; monothioglycerol
0.5%; water
for injection q.s. Sodium hydroxide may have been added for pH
adjustment (2.5 to
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 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
1
vitamin content. Absorption of thiamine following IM administration is
rapid and
complete.
Thiamine combines with adenosine triphosphate (ATP) to form thiamine
pyrophosphate,
also kno