THIAMINE HYDROCHLORIDE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine - UNII:X66NSO3N35)

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

Thiamine Hydrochloride

הרכב:

Thiamine Hydrochloride 100 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Additional barcode label applied by: Physicians Total Care, Inc. Tulsa, Oklahoma    74146

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

THIAMINE HYDROCHLORIDE - THIAMINE HYDROCHLORIDE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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THIAMINE HCL 100 MG/ML INJECTION, USP 2 ML MULTI DOSE VIAL
DES CRIPTION
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; chlororbutanol
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)mythyl]-5-(2-hydroxyethyl)-4-methyl-chloride,
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
p