Thiamine Hydrochloride
Injection, Solution · Intramuscular, Intravenous
Uses
INDICATIONS AND USAGE: 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 and 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 injections 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 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 heart failure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications
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
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 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.
Precautions
PRECAUTIONS: General Simple vitamin B 1 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 used 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. Nursing Mothers 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.
Side effects
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 ).
Overdosage
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 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.
Description
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: Thiamine hydrochloride 100 mg; chlorobutanol 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 B 1 , 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)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula: C 12 H 17 CIN 4 OS HCl M.W. 337.27 structural-formula
How supplied
HOW SUPPLIED: Thiamine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Strength Each NDC 23155-933-41 Unit of 25 200 mg per 2 mL (100 mg per mL) NDC 23155-933-31 2 mL Multiple Dose Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Manufactured by: OneSource Specialty Pharma Limited Bengaluru - 560076, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1-866-901-DRUG (3784) Revised: 06/2025 avet-logo
Label text from the FDA structured product label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (revised Jul 31, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Thiamine Hydrochloride in 13 products
Thiamine Hydrochloride NDC products (13)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 31722-363 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Camber Pharmaceuticals, Inc. | ANDA |
| 43598-050 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Dr. Reddy's Laboratories Inc. | ANDA |
| 55150-273 | Thiamine Hydrochloride 200 mg/2mL Injection, Solution | Eugia US LLC | ANDA |
| 72266-260 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Fosun Pharma USA Inc. | ANDA |
| 68083-567 | Thiamine Hydrochloride 200 mg/2mL Injection, Solution | Gland Pharma Limited | ANDA |
| 0404-9799 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Henry Schein, Inc. | ANDA |
| 0404-9963 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Henry Schein, Inc. | ANDA |
| 23155-933 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 0641-6228 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 67457-196 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Mylan Institutional LLC | ANDA |
| 83270-004 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | ONESOURCE SPECIALTY PHARMA LIMITED | ANDA |
| 70518-4230 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | REMEDYREPACK INC. | ANDA |
| 25021-500 | Thiamine Hydrochloride 100 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
Thiamine Hydrochloride recalls
- D-0601-2021 Jun 9, 2021 · Class III · Terminated
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.
Frequently asked questions
What is Thiamine Hydrochloride used for?
INDICATIONS AND USAGE: 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…
What are the side effects of Thiamine Hydrochloride?
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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,… See the full label for the complete list.
Who makes Thiamine Hydrochloride?
Thiamine Hydrochloride is listed by 12 labelers in the FDA NDC directory, including Camber Pharmaceuticals, Inc., Dr. Reddy's Laboratories Inc., Eugia US LLC, Fosun Pharma USA Inc..
Has Thiamine Hydrochloride been recalled?
The FDA enforcement database lists 1 recall for Thiamine Hydrochloride, most recently D-0601-2021 (class iii): 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.