Thiamine hydrochloride injection is available as a 100-mg/mL solution in 2-mL vials.3827; 3828 Each mL of solution contains thiamine hydrochloride 100 mg and monothioglycerol 0.5% in water for injection.3827; 3828 Multiple-dose vials may also contain chlorobutanol 0.5% as a preservative.3827 Sodium hydroxide may be added to adjust the pH.3827; 3828 Aluminum also is present.3827
pH
From 2.5 to 4.5.3827
Aluminum Content
Aluminum content may vary depending on the product; specific product labeling should be consulted.
Thiamine hydrochloride injection (Fresenius Kabi) is stated to contain no more than 400 mcg of aluminum per L.3827
Thiamine hydrochloride injection may be administered by intramuscular or slow intravenous injection.3827; 3828 An intradermal test dose has been recommended for patients with suspected thiamine sensitivity.3827; 3828
Thiamine hydrochloride injection in intact containers should be stored at controlled room temperature and protected from light.3827; 3828
Thiamine hydrochloride under simulated summer conditions in paramedic vehicles was exposed to temperatures ranging from 26 to 38°C over four weeks. Analysis found no loss of the drug under these conditions.2562
Thiamine hydrochloride is stated to be incompatible with oxidizing and reducing agents.4 In solutions with sulfites or bisulfites, it is rapidly inactivated.52; 1072; 1925 Oxidation of thiamine hydrochloride results in the formation of the highly blue-colored and biologically inactive compound thiochrome.734; 1072
pH Effects
Thiamine hydrochloride is stable in acid solutions, losing activity very slowly at pH 4 or less. It is maximally stable at pH 2.1072 Thiamine hydrochloride is unstable in neutral or alkaline solutions.1072; 3827
Syringes
Thiamine hydrochloride (Lilly) 100 mg/mL was repackaged in glass syringes (Glaspak), back-fill glass syringes (Hy-Pod), and plastic syringes (Stylex). Half of the syringes were filled with thiamine hydrochloride injection filtered through 5-µm stainless steel depth filters (Extemp filter pin), and the rest were filled with unfiltered drug. The syringes containing 1 mL of thiamine hydrochloride injection were stored protected from light (amber UV-light-inhibiting plastic bags) at 22 to 24°C for 84 days. No color changes were observed, and changes in pH were minimal. Furthermore, no differences between filtered or unfiltered samples occurred, with all solutions retaining approximately 100% over the 84 days.734
Sorption
Thiamine hydrochloride (Merck) 30 mg/L did not display significant sorption to a PVC plastic test strip in 24 hours.12
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Parenteral Nutrition Solutions
The stability of thiamine hydrochloride 50 mg/L was studied in representative parenteral nutrition solutions exposed to fluorescent light, indirect sunlight, and direct sunlight for eight hours. One 5-mL vial of multivitamin concentrate (Lyphomed) containing 50 mg of thiamine hydrochloride and also 1 mg of folic acid (Lederle) were added to a liter of parenteral nutrition solution composed of amino acids 4.25%-dextrose 25% (Travenol) with standard electrolytes and trace elements. Thiamine hydrochloride was stable over the eight-hour study period at room temperature under fluorescent light and indirect sunlight, but direct sunlight caused a 26% loss.842
A 50% initial drop in thiamine concentration immediately after admixture of multivitamins in a parenteral nutrition solution composed of amino acids, dextrose, electrolytes, and trace elements in PVC bags was reported. The thiamine concentration then remained relatively constant for 120 hours when stored at both 4 and 25°C.1063
The stability of numerous vitamins in parenteral nutrition solutions composed of amino acids (Kabi-Vitrum), dextrose 30%, and lipid emulsion 20% (Kabi-Vitrum) in a 2:1:1 ratio with electrolytes, trace elements, and both fat- and water-soluble vitamins was reported. The admixtures were stored in darkness at 2 to 8°C for 96 hours with no significant loss of thiamine mononitrate.1225
The stability of several vitamins from M.V.I.-12 (Armour) admixed in parenteral nutrition solutions composed of different amino acid products, with or without Intralipid 10%, when stored in glass bottles and PVC bags at 25 and 5°C for 48 hours was reported. Thiamine hydrochloride was stable in the parenteral nutrition solutions prepared with amino acid products without bisulfite.1431
The stability of several vitamins following admixture (as M.V.I-12) with four different amino acid products (Novamine, Neopham, FreAmine III, Travasol) with or without Intralipid when stored in glass bottles or PVC bags at 25°C for 48 hours was reported. Exposure to high intensity phototherapy light did not affect thiamine.487
The stability of thiamine hydrochloride from a multiple vitamin product in dextrose 5% and sodium chloride 0.9% in PVC and ClearFlex containers was evaluated. Thiamine hydrochloride was stable at 23°C when exposed to or protected from light, exhibiting losses of 11% or less in 24 hours.1509
The degradation of vitamins A, B1, C, and E from Cernevit (Roche) multivitamins in NuTRIflex Lipid Plus (B. Braun) admixtures prepared in ethylene vinyl acetate (EVA) bags and in multilayer bags was evaluated. After storage for up to 72 hours at 4, 21, and 40°C, greater vitamin losses occurred in the EVA bags. Thiamine hydrochloride losses were 25%. In the multilayer bags (presumably a better barrier to oxygen transfer), losses were less. Thiamine hydrochloride losses were 10%.2618
The vitamins in Cernevit (Baxter) diluted in three 2-in-1 parenteral nutrition admixtures were tested for stability over 48 hours. Most of the other vitamins, including thiamine hydrochloride, retained their initial concentrations.2796
For a list of references cited in the text of this monograph, search the monograph titled References.