Thiamine Hydrochloride

Thiamine Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

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.

Serious 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

History

There is currently no drug history available for this drug.

Other Information

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:

Formula

Thiamine Hydrochloride Manufacturers


  • General Injectables & Vaccines, Inc
    Thiamine Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]
  • Physicians Total Care, Inc.
    Thiamine Hydrochloride Injection, Solution [Physicians Total Care, Inc.]
  • Mylan Institutional Llc
    Thiamine Hydrochloride Injection, Solution [Mylan Institutional Llc]
  • General Injectables & Vaccines, Inc
    Thiamine Hydrochloride Injection, Solution [General Injectables & Vaccines, Inc]

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