THIAMINE HYDROCHLORIDE INJECTION, SOLUTION injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

HF Acquisition Co LLC, DBA HealthFirst

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 given. A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)

Ringkasan produk:

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: HF ACQUISITION CO LLC, DBA HEALTHFIRST 11629 49TH PL W. MUKILTEO, WA 98275

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

THIAMINE HYDROCHLORIDE INJECTION, SOLUTION- THIAMINE HYDROCHLORIDE
INJECTION, SOLUTION INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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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 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, USP 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 t