thiamine hydrochloride injection, solution
General Injectables & Vaccines, Inc
----------Thiamine HCL 100 mg/mL Injection, USP 2 mL Multi Dose Vial
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:
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.
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 metabolism is the decarboxylation of
pyruvic acid in the blood and -ketoacids to acetaldehyde and carbon dioxide.
Increased levels of pyruvic acid in the blood indicate vitamin B1 deficiency.
The requirement for thiamine is greater when the carbohydrate content of the
diet is raised. Body depletion of vitamin B1 can occur after approximately three
weeks of total absence of thiamine in the diet.
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
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
WARNING: This product contains aluminum that may be toxic. Aluminum may reach
toxic levels with prolonged parenteral administration if kidney function is
impaired. Premature neonates are particularly at risk because their kidneys are
immature, and they require large amounts of calcium and phosphate solutions,
which contain aluminum.
Research indicates that patients with impaired kidney
function, including premature neonates, who receive parenteral levels of
aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels
associated with central nervous system and bone toxicity. Tissue loading may
occur at even lower rates of administration.
hypersensitivity/anaphylactic reactions can occur, especially after repeated
administration. Deaths have resulted from IV or IM administration of thiamine
(see package insert for ADVERSE REACTIONS).
Routine testing for
hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless,
a skin test should be performed on patients who are suspected of drug allergies
or previous reactions to thiamine, and any positive responders should not
receive thiamine by injection.
If hypersensitivity to thiamine is suspected
(based on history of drug allergy or occurrence of adverse reactions after
thiamine administration), administer one-hundredth of the dose intradermally and
observe for 30 minutes. If no reaction occurs, full dose can be given; the
patient should be observed for at least 30 minutes after injection. Be prepared
to treat anaphylactic reactions regardless of the precautions taken.
Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines.
Simple vitamin B1 deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.
Information for Patients
The patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy.
Usage in Pregnancy
Pregnancy Category A- Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy. If the drug is sued during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother.
An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injection. collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS).
Parenteral doses of 100 to 500 mg singly have been administered without toxic effects. However, dosages exceeding 30 mg three times a day are not utilized effectively.
When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake of thiamine is further increased, it appears unchanged in the urine.
“Wet” beriberi with myocardial failure must be treated as an emergency cardiac
condition, and thiamine must be administered slowly by the IV route in this
situation (see WARNINGS).
In the treatment of beriberi, 10 to 20 mg of thiamine
hydrochloride are given IM three times daily for as long as two weeks. (See
WARNINGS regarding repeated injection of thiamine.) An oral therapeutic
multivitamin preparation containing 5 to 10 mg thiamine, administered daily for
one month, is recommended to achieve body tissue saturation.
that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg
may cautiously be given IV.
Poor dietary habits should be corrected and an
abundant and well-balanced dietary intake should be prescribed.
neuritis of pregnancy in whom vomiting is severe enough to preclude adequate
oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily.
the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been
administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100
mg daily until the patient is consuming a regular, balanced diet. (See WARNINGS
regarding repeated injections of thiamine.)
Patients with marginal thiamine
status to whom dextrose is being administered should receive 100 mg thiamine
hydrochloride in each of the first few liters of IV fluid to avoid precipitating
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|Product No.||NDC No.||Thiamine HCL/mL||Volume|
|1302||63323-013-02||100 mg||2 mL
thiamine hydrochloride injection, solution
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Labeler - General Injectables & Vaccines, Inc (108250663)|