Label: THIAMINE HYDROCHLORIDE injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 14, 2024

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  • DESCRIPTION
    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 ...
  • 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 ...
  • INDICATIONS
    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 ...
  • CONTRAINDICATIONS
    A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See - WARNINGS  - for further information.)
  • WARNINGS
    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 ...
  • PRECAUTIONS
    General - Simple vitamin B - 1deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy. Information for Patients - The patient should be ...
  • ADVERSE REACTIONS
    To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch. An occasional individual may develop a ...
  • OVERDOSAGE
    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 ...
  • DOSAGE AND ADMINISTRATION
    “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 ...
  • HOW SUPPLIED
    Thiamine Hydrochloride Injection, USP is supplied as follows: 200 mg per 2 mL (100 mg per mL) multiple dose vials packed in cartons containing 25 vials per carton. NDC: 70518-4230-00 - NDC ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Thiamine Hydrochloride - GENERIC: Thiamine Hydrochloride - DOSAGE: INJECTION, SOLUTION - ADMINSTRATION: INTRAMUSCULAR - NDC: 70518-4230-0 - NDC: 70518-4230-1 - PACKAGING: 1 in 1 VIAL - OUTER PACKAGING: 25 ...
  • INGREDIENTS AND APPEARANCE
    Product Information