Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection 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; 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 cyrstals 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:

A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)

Parenteral doses of 100 mg to 500 mg singly have been administered without toxic effects. However, dosages exceeding 30 mg 3 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.

Thiamine Hydrochloride Injection, USP, 200 mg/2 mL (100 mg/mL), is available in:

NDC 67457-196-02

2 mL (200 mg) multiple dose vial, packaged 25 vials per carton.

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.

Preservative Free.

Mylan®

Manufactured for:

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured by:

Mylan Institutional

Galway, Ireland

REVISED APRIL 2012

0788L102

MI:THIAIJ:R2