Thiamine 100 mg/mL
Thiamine Hydrochloride · INJECTION, SOLUTION · NorthStar Rx LLC
Thiamine is a injection, solution containing thiamine hydrochloride at 100 mg/mL, taken intramuscular. Manufactured by NorthStar Rx LLC.
Key Facts
- Brand Name
- Thiamine
- Generic Name
- Thiamine Hydrochloride
- NDC Code (Product)
72603-139- Manufacturer
- NorthStar Rx LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA215692
- Marketing Start
- 04/20/2023
Recall History
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Promise Pharmacy, LLC
Lack of sterility assurance.
McGuff Compounding Pharmacy Services, Inc.
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Mylan Institutional LLC
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Medaus, Inc.
Lack of Assurance of Sterility
US Specialty Formulations LLC
Lack of Assurance of Sterility
AnazaoHealth Corporation
Presence of Particulate Matter.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 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.
Dosage & Administration
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 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. Infantile beriberi 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. Patients with 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. In 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 reg…
Warnings
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 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 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 histo…
Contraindications
CONTRINDICATIONS A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)
Adverse Reactions
ADVERSE REACTIONS An occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to thiamine, especially after repeated injections. 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 ).
Frequently Asked Questions
What is Thiamine used for?
Thiamine contains Thiamine Hydrochloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Thiamine a controlled substance?
Thiamine is not classified as a controlled substance by the DEA.
What is the generic name for Thiamine?
The generic name for Thiamine is Thiamine Hydrochloride. There are 11 other brand versions of Thiamine Hydrochloride.
What is the NDC code for Thiamine 100 mg/mL?
The NDC (National Drug Code) for Thiamine 100 mg/mL is 72603-139, listed by NorthStar Rx LLC.
Other Thiamine Dosages
Other Thiamine Brands
See all →- THIAMINE HYDROCHLORIDE injection, solution100 mg/mL51662-1635
- Thiamine Hydrochloride100 mg/mL70518-4230
- Thiamine Hydrochloride100 mg/mL0641-6228
- Thiamine Hydrochloride100 mg/mL31722-363
- thiamine hydrochloride200 mg/2mL68083-567
- THIAMINE HYDROCHLORIDE100 mg/mL0404-9799
- Thiamine Hydrochloride100 mg/mL67457-196
- Thiamine Hydrochloride100 mg/mL72266-260
- thiamine hydrochloride100 mg/mL25021-500
- Vitamin B Complex2 mg/mL67457-146
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)