Thiamine Hydrochloride

Pronunciation

Class: Vitamin B Complex
VA Class: VT105
Chemical Name: thiazolium,3- [(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-chloride, monochloride
CAS Number: 67-03-8

Introduction

Water-soluble, B complex vitamin.a

Uses for Thiamine Hydrochloride

Thiamine Deficiency

Treatment of thiamine deficiency syndromes (e.g., beriberi, Wernicke’s encephalopathy syndrome). b

Dietary Requirements

Adequate intake needed to prevent thiamine deficiency (beriberi).109

Adequate thiamine intake can be accomplished through consumption of foodstuffs.109 Enriched, fortified, or whole grain products; bread and bread products; mixed foods with grain as a main ingredient; and ready-to-eat cereals are the major contributors of thiamine in the diet of US adults and children.109

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Recommended Dietary Allowance (RDA) in adults based on erythrocyte transketolase activity, urinary thiamine excretion, and other findings.109

Requirements slightly lower in women than men based on women's size and average energy utilization.109

Adequate intake (AI) established for infants ≤6 months of age based on observed mean thiamine intake of infants fed principally human milk; AI for infants 7–12 months of age based on AI for younger infants and data in adults.109

RDA for children 1–18 years of age based on data in adults.109

Metabolic Disorder

Has been used in thiamine-responsive maple syrup urine disease and subacute necrotizing encephalomyelopathy (Leigh's disease).a

Thiamine Hydrochloride Dosage and Administration

Administration

Usually administered orally.a May be administered by IV or IM injection when indicated or when oral administration is not feasible.b

For solution and drug compatibility information, see Compatibility under Stability.

Dosage

Available as thiamine hydrochloride; dosage expressed in terms of the salt.a b

Pediatric Patients

Thiamine Deficiency
Oral

Noncritically ill children: 10–50 mg daily, given in divided doses.a

IM or IV

Critically ill children (e.g., infantile beriberi): 10–25 mg.a b

Dietary and Replacement Requirements
Oral

Infants ≤6 months of age: Recommended AI is 0.2 mg (0.03 mg/kg) daily.109

Infants 7–12 months of age: Recommended AI is 0.3 mg (0.03 mg/kg) daily.109

Children 1–3 years of age: RDA is 0.5 mg daily.109

Children 4–8 years of age: RDA is 0.6 mg daily.109

Children 9–13 years of age: RDA is 0.9 mg daily.109

Boys 14–18 years of age: RDA is 1.2 mg daily.109

Girls 14–18 years of age: RDA is 1 mg daily.109

RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.109

Adults

Thiamine Deficiency
Oral

Noncritically ill adults: 5–30 mg daily, as a single dose or 3 divided doses, for 1 month.a

IV followed by IM

Wernicke's syndrome: Initially 100 mg IV, followed by 50–100 mg IM daily until patient can consume a balanced diet.b

IV or IM

Critically ill thiamine-deficient adult or patient with malabsorption syndrome: 5–100 mg 3 times daily.a

IM

Beriberi: 10–20 mg 3 times daily for up to 2 weeks.b

Dietary and Replacement Requirements
Oral

Men ≥19 years of age: RDA is 1.2 mg daily.109

Women ≥19 years of age: RDA is 1.1 mg daily.109

RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.109

Prescribing Limits

Single doses >30 mg not likely to be utilized.a

Special Populations

Pregnant Women

RDA for pregnant women is 1.4 mg daily.109

Thiamine intake >1.4 mg daily needed by women who are pregnant with >1 fetus.109

Requirements increased in pregnant women to cover increased energy utilization and growth in the maternal and fetal compartments.109

Lactating Women

RDA for lactating women is 1.5 mg daily.109

Thiamine intake >1.5 mg daily needed by women who are nursing >1 infant.109

Requirements increased in lactating women to ensure adequate concentration of the vitamin in milk.109

Cautions for Thiamine Hydrochloride

Contraindications

Known sensitivity to thiamine or any ingredient in formulation.a b

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Possible severe hypersensitivity reactions/anaphylaxis, especially following repeated parenteral administration.b

Skin Test

Administer an intradermal test dose prior to parenteral administration of therapeutic doses of thiamine in patients who may be sensitive to the drug.b

General Precautions

Aluminum Content

Some thiamine hydrochloride injection preparations contain aluminum, which may be toxic.b Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.b Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.b

Research indicates that patients with impaired kidney function, including premature neonates, who receive aluminum parenterally in quantities of >4–5 mcg/kg daily accumulate aluminum at levels associated with CNS and bone toxicity.b Tissue loading may occur at even lower rates of administration.b

Specific Populations

Pregnancy

Category A.b

Lactation

Distributed into milk.a Caution if parenteral preparation is used in nursing women.b

Common Adverse Effects

Relatively nontoxic; feelings of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, angioedema, tightness in the throat, cyanosis, pulmonary edema, GI bleeding reported with parenteral administration.a b

Interactions for Thiamine Hydrochloride

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Neuromuscular blocking agents

Possible enhanced neuromuscular blocking actiona

Clinical importance unknowna

Schack and Waxler determination of serum theophylline concentrations

Large doses of thiamine may interfere with this testa

Test for uric acid

Possible false-positive result with the phosphotungstate methoda

Test for urobilinogen using Ehrlich's reagent

Possible false-positive resulta

Thiamine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Small doses are readily absorbed from the GI tract.a

Completely absorbed following IM administration.b

Food

Rate, but not extent, of GI absorption is decreased when administered with meals.a

Distribution

Extent

Distributed into all tissues; highest concentrations in liver, brain, kidney, and heart.b

Elimination

Elimination Route

Excreted in urine as unchanged drug and metabolites.a

Stability

Storage

Oral

Tablets

Tight, light-resistant container at <40°C; preferably between 15–30°C.a

Parenteral

Injection

20–25°C.b Protect from light.b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextran 6% in dextrose 5%

Dextran 6% in sodium chloride 0.9%

Dextrose–Ringer's injection combinations

Dextrose-Ringer’s injection, lactated, combinations

Dextrose-saline combinations

Dextrose 2½, 5, or 10% in water

Fat emulsion 10%, IV

Fructose 10% in sodium chloride 0.9%

Fructose 10% in water

Invert sugar 5 and 10% in sodium chloride 0.9%

Invert sugar 5 and 10% in water

Ionosol products

Ringer's injection

Ringer's injection, lactated

Sodium chloride 0.45 or 0.9%

Sodium lactate (1/6) M

Drug Compatibility
Y-Site CompatibilityHID

Compatible

Famotidine

Actions

  • An exogenous source of thiamine is required for carbohydrate metabolism. a

  • Functions as a coenzyme in the metabolism of carbohydrates and branched-chain amino acids.109

Advice to Patients

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a

  • Importance of proper dietary habits, including taking appropriate AI or RDA of thiamine.109

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • Importance of informing patients of other important precautionary information.a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Thiamine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Tablets

25 mg*

50 mg*

100 mg*

250 mg*

500 mg*

Parenteral

Injection

100 mg/mL*

Thiamine salts are also commercially available for oral use in combination with other vitamins, minerals, amino acids, protein supplements, and infant formulas. For IV infusion, thiamine hydrochloride is commercially available in combination with other vitamins in caloric and electrolyte solutions.a

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1985; 50:25170-1.

101. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1982; 47:424-7.

102. Food and Drug Administration and American Society for Parenteral and Enteral Nutrition. Deaths associated with thiamine-deficient total parenteral nutrition. MMWR Morb Mortal Wkly Rep. 1989; 38:43-6. [IDIS 250221] [PubMed 2492074]

103. Velez RJ, Myers B, Guber MS. Severe acute metabolic acidosis (acute beriberi): an avoidable complication of total parenteral nutrition. J Parenter Enteral Nutr. 1985; 9:216-9.

104. Mattioli S, Miglioli M, Montagna P et al. Wernicke’s encephalopathy during total parenteral nutrition: observation in one case. J Parenter Enteral Nutr. 1988; 12:626-7.

105. Reuler JB, Girard DE, Cooney TG. Wernicke’s encephalopathy. N Engl J Med. 1985; 312:1035-8. [IDIS 198729] [PubMed 3885034]

106. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:125-32.

107. Lactic acidosis traced to thiamine deficiency related to nationwide shortage of multivitamins for total parenteral nutrition–United States, 1997. MMWR. 1997; 46:523-8. (Also published in JAMA. 1997; 278:109-11.)

108. American Society for Parenteral and Enteral Nutrition (ASPEN). Multivitamin shortage–Update #17: fatality reported. Press release. 1997 Jul 21.

109. Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)

110. American Psychiatric Association. Practice guidelines for the treatment of patients with delirium. Am J Psychiatry. 1999; 156(Suppl 5):1-20.

a. AHFS drug information 2007. McEvoy GK, ed. Thiamine. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 3626-7.

b. Abraxis Pharmaceuticals. Thiamine injection prescribing information. Schaumburg, IL; 2005 Jun.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1538-40.

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