Medication Guide App

Thiamine (Systemic)


VA CLASSIFICATION
Primary: VT150

Commonly used brand name(s): Betaxin; Bewon; Biamine.

Another commonly used name is
vitamin B 1 .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Nutritional supplement (vitamin)—
Note: Thiamine (vitamin B 1) is a water-soluble vitamin.



Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Thiamine deficiency (prophylaxis and treatment)—Thiamine is indicated for prevention and treatment of thiamine deficiency states. Thiamine deficiency may occur as a result of inadequate nutrition or intestinal malabsorption but does not occur in healthy individuals receiving an adequate balanced diet. Simple nutritional deficiency of individual B vitamins is rare since dietary inadequacy usually results in multiple deficiencies. For prophylaxis of thiamine deficiency, dietary improvement, rather than supplementation, is advisable. For treatment of thiamine deficiency, supplementation is preferred. {27}
—Deficiency of thiamine may lead to beriberi (dry or wet) or Wernicke's encephalopathy. {01} {04}
—Requirements may be increased and/or supplementation may be necessary in the following persons or conditions (based on documented thiamine deficiency):

• Alcoholism {04} {06} {15}


• Burns


• Fever, chronic {25}


• Gastrectomy


• Hemodialysis, chronic {25}


• Hepatic-biliary tract disease {05}—alcoholism with cirrhosis, hepatic function impairment


• Hyperthyroidism {07}


• Infection, prolonged {05}


• Intestinal disease—celiac, ileal resection, tropical sprue, regional enteritis, persistent diarrhea {07} {25}


• Manual labor, heavy, for long periods of time {03}


• Stress, prolonged

—Recommended intakes for thiamine are related to caloric intake. {03}
—Some unusual diets (e.g., reducing diets that drastically restrict food selection) may not supply minimum daily requirements for thiamine. Supplementation is necessary in patients receiving total parenteral nutrition (TPN) {04} or undergoing rapid weight loss or in those with malnutrition, because of inadequate dietary intake.
—Recommended intakes for all vitamins and most minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). {16} Taking excessive amounts of a multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided.
—Recommended intakes for all vitamins and most minerals are increased during breast-feeding. {08}

[Encephalomyelopathy, subacute necrotizing (treatment)]{04}{07}{25}
[Maple syrup urine disease (treatment)]{03}{04}
[Pyruvate carboxylase deficiency (treatment)] or{05}{25}
[Hyperalaninemia (treatment)]{05}—Thiamine has been found to be useful for temporary metabolic correction of genetic enzyme deficiency diseases such as subacute necrotizing encephalomyelopathy (SNE, Leigh's disease), maple syrup urine disease (branched-chain aminoacidopathy), and lactic acidosis associated with pyruvate carboxylase deficiency and hyperalaninemia.

Unaccepted
Thiamine has not been proven effective for appetite stimulation, treatment of cerebellar syndrome, {05} dermatitis, chronic diarrhea, {05} fatigue, mental disorders, multiple sclerosis, neuritis, or ulcerative colitis, or for use as an insect repellant. {26}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    337.27 {28}

pKa—
    4.8 and 9

Mechanism of action/Effect:

Thiamine combines with adenosine triphosphate (ATP) to form a coenzyme, thiamine pyrophosphate (thiamine diphosphate, cocarboxylase), {04} which is necessary for carbohydrate metabolism. {01}

Absorption:

The B vitamins are readily absorbed from the gastrointestinal tract, except in malabsorption syndromes. {25} Thiamine is absorbed mainly in the duodenum. Alcohol inhibits absorption of thiamine. {03} {04} {06}

In individuals with normal gastrointestinal absorption, total maximum daily oral absorption of thiamine is 5 to 15 mg (increased when given in divided daily doses with food). {07}

Biotransformation:

Hepatic. {05}

Elimination:
    Renal (almost entirely as metabolites). {07} Excess beyond daily needs is excreted as unchanged drug and metabolites in urine.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented with intake of normal daily recommended amounts.

FDA Pregnancy Category A (parenteral thiamine). {01}

Breast-feeding

Problems in humans have not been documented with intake of normal daily recommended amounts.

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts.


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts. Studies have shown that the elderly may have impaired thiamine status, thereby requiring thiamine supplementation. {11} {12} {13} {14} {17}


Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Theophylline concentration determinations, serum, by Schack and Waxler spectrophotometric method    (thiamine may interfere with results {05})


Uric acid concentration determinations by phototungstate method or
Urobilinogen determinations using Ehrlich's reagent    (thiamine may produce false-positive results {05})


Note: Usually occurs only with large doses.


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).



Risk-benefit should be considered when the following medical problems exist
Sensitivity to thiamine{05}
Wernicke's encephalopathy    (intravenous glucose loading may precipitate or worsen this condition in thiamine-deficient patients; thiamine should be administered prior to glucose)




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Anaphylactic reaction (coughing; difficulty in swallowing; hives; itching of skin; swelling of face, lips, or eyelids; wheezing or difficulty in breathing)—usually after a large intravenous dose{01}{04}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Thiamine (Vitamin B 1) (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in the body, signs of deficiency, and unproven uses


Importance of diet
Importance of proper nutrition; supplement may be needed because of inadequate dietary intake

Food sources of thiamine; effects of processing

Not using vitamins as substitute for balanced diet

Recommended daily intake for thiamine

Before using this dietary supplement
»   Conditions affecting use, especially:
Sensitivity to thiamine





Use in the elderly—May have impaired thiamine status

Proper use of this dietary supplement

» Proper dosing
Missed dose: No cause for concern because of length of time necessary for depletion; remembering to take as directed

» Proper storage


Side/adverse effects
Signs of potential side effects, especially anaphylactic reaction


General Dosing Information
Because of the infrequency of single B vitamin deficiencies, combinations are commonly administered. Many commercial combinations of B vitamins are available.

For parenteral dosage forms only
In most cases, parenteral administration is indicated only when oral administration is not acceptable (for example, in nausea, vomiting, preoperative and postoperative conditions), or possible (for example, in malabsorption syndromes or following gastric resection).

Diet/Nutrition
Recommended dietary intakes for thiamine are defined differently worldwide.



For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). {08} {25}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare in Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. {29}

Daily recommended intakes for thiamine are generally defined as follows: {08} {29}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
0.3–0.7
0.3–0.6
4 to 6 years of age
0.9
0.7
7 to 10 years of age
1
0.8–1
Adolescent and adult males
1.2–1.5
0.8–1.3
Adolescent and adult females
1–1.1
0.8–0.9
Pregnant females
1.5
0.9–1
Breast-feeding females
1.6
1–1.2


These are usually provided by adequate diets.

The best dietary sources of thiamine include cereals (whole-grain and enriched), meats (especially pork and beef), peas, beans, and nuts. {04} Loss is variable during cooking and may be as high as 50%.



Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

THIAMINE HYDROCHLORIDE ELIXIR USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
1.2–1.5
0.8–1.3
Adolescent and adult females
1–1.1
0.8–0.9
Pregnant females
1.5
0.9–1
Breast-feeding females
1.6
1–1.2


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency. The following dosage has been established: Beriberi (initial in mild or maintenance following severe)—Oral, 5 to 10 mg three times a day. {03}

[Genetic enzyme deficiency diseases]
Oral, 10 to 20 mg per day as a single dose (dosage of up to 4 grams per day in divided doses has been used).


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on intake of normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
0.3–0.7
0.3–0.6
4 to 6 years of age
0.9
0.7
7 to 10 years of age
1
0.8–1


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency. The following dosage has been established: Beriberi (mild)—Oral, 10 per day. {10}


Strength(s) usually available
U.S.—
Not commercially available.

Canada—


250 mcg (0.25 mg) per 5 mL (OTC) [Bewon (16% alcohol) (bisulfites{18})]

Note: The strength of this thiamine preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.


THIAMINE HYDROCHLORIDE TABLETS USP

Usual adult and adolescent dose
See Thiamine Hydrochloride Elixir USP .

Usual pediatric dose
See Thiamine Hydrochloride Elixir USP.

Strength(s) usually available
U.S.—


5 mg (OTC)[Generic]{19}


10 mg (OTC)[Generic]{19}


25 mg (OTC)[Generic]


50 mg (OTC)[Generic]


100 mg (OTC)[Generic]


250 mg (OTC)[Generic]


500 mg (OTC)[Generic]

Canada—


10 mg (OTC)[Generic]


25 mg (OTC)[Generic]


50 mg (OTC)[Generic]


100 mg (OTC)[Generic]


500 mg (OTC)[Generic]{20}

Note: Some strengths of these thiamine preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.



Parenteral Dosage Forms

THIAMINE HYDROCHLORIDE INJECTION USP

Usual adult dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intramuscular or intravenous infusion (slow): 5 to 100 mg three times a day followed by maintanence oral administration. {01}


Usual pediatric dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intramuscular or intravenous infusion (slow), 10 to 25 mg a day. {02}


Strength(s) usually available
U.S.—


100 mg per mL (Rx) [{24}Biamine (0.5% chlorobutanol){21}][Generic]

Canada—


100 mg per mL (Rx) [Betaxin (0.5% chlorobutanol) ( 0.5% monothioglycerol){22}][Generic]{23}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing.

Incompatibilities:
Thiamine is unstable in neutral or alkaline solutions; {01} therefore, administration with carbonates, citrates, barbiturates, or copper ions is not recommended. In addition, stability is poor in intravenous solutions containing sodium bisulfite as an antioxidant or preservative; if these solutions must be used, they should be used immediately after addition of thiamine. {09}



Revised: 05/26/1995



References
  1. Thiamine injectable product information (Wyeth–U.S.) Rev 10/86.
  1. Benitz WE, Tatro DS. The pediatric drug handbook. 1st ed. Chicago: Year Book Medical Publishers, Inc., 1987.
  1. AMA Drug evaluations. 7th ed. Chicago: American Medical Association, September 1990: 1:15–1.16
  1. Wyngaarden J, Smith L, editors. Cecil's Textbook of Medicine. 18th ed. Philadelphia: W.B. Saunders, 1988: 1229–30
  1. McEvoy GK, editor. AHFS Drug information 90. Bethesda, MD: American Society of Hospital Pharmacists, 1990: 2120–1.
  1. Breen K, Buttigieg R, Iossifidis S, et al. Jejunal uptake of thiamin hydrochloride in man: influence of alcoholism and alcohol. Am J Clin Nutr 1985: 42: 121-126.
  1. Gilman AG, Goodman LS, Rall TW, Murad F, editors. Goodman and Gilman's the pharmocological basis of therapeutics. 7th ed. New York: Macmillan, 1985: 1551–5.
  1. National Research Council. Recommended dietary allowances. 10th ed. Washington DC: National Academy Press, 1989: 125–32.
  1. Trissel LA. ASHP handbook on injectable drugs. 5th ed. Bethesda MD: American Society of Hospital Pharmacists, 1988.
  1. Benitz WE, Tatro DS. The pediatric drug handbook. 2nd ed. Chicago: Year Book Medical Publishers, Inc., 1988.
  1. Iber F, Blass J, Brin M, et al. Thiamine in the elderly—relation to alcoholism and to neurological degeneration disease. Am J of Clin Nutr 1982: 6: 1067-82.
  1. Baker H, Frank O, Danner D. Oral versus intramuscular vitamin supplementation for hypovitaminosis in the elderly. J Am Geriatr Soc 1980; 28(1): 42-5.
  1. Yearick E, Wang M, Pisias S. Nutritional status of the elderly dietary and biochemical findings. J of Gerontol 1980; 35(5): 663-71.
  1. Keatinge A, Johnson A, Collins P, et al. Vitamin B 1, B 2, B 6 and C status in the elderly. In Med J 1983; 76(12): 488-90.
  1. Panelist comment, 1991.
  1. Committee on Nutritional Status during Pregnancy, National Academy of Sciences. Washington DC: National Academy Press, 1990: 1-23.
  1. Prinsley D. Nutritional intake patterns and dietary habits of the elderly. J Am Coll Nutr 1990; 9(5): 520(abstract).
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 154.
  1. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 551.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 1356.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, July 1991: 6a.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 152.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 1222.
  1. Per phone call (Lilly—US), 12/21/93.
  1. Wilson JD, Braunwald E, Isselbacher KJ, Petersdorf RG, Martin JB, Fauci AS, Root RK, editors. Harrison's principles of internal medicine. 12th ed. New York: McGraw-Hill, Inc., 1991: 437–9.
  1. Fed Regist 1985 Jun 17; 50(116): 25171–2.
  1. Consensus from Nutrition and Electrolytes Panel meeting 1/95.
  1. Fleeger CA, editor. USP dictionary of USAN and international drug names 1995. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1994: 668.
  1. Health and Welfare Canada. Nutrition recommendations, the report of the scientific committee. Ottawa Canada: Canadian Government Publishing Centre, 1990: 11–2.
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