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Thiamine

Pronunciation

Pronunciation

(THYE a min)

Index Terms

  • Aneurine Hydrochloride
  • Thiamin
  • Thiamine HCl
  • Thiamine Hydrochloride
  • Thiaminium Chloride Hydrochloride
  • Vitamin B1

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Generic: 50 mg

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (2 mL)

Tablet, Oral, as hydrochloride:

Generic: 50 mg, 100 mg, 250 mg

Tablet, Oral, as hydrochloride [preservative free]:

Generic: 100 mg

Pharmacologic Category

  • Vitamin, Water Soluble

Pharmacology

An essential coenzyme in carbohydrate metabolism by combining with adenosine triphosphate to form thiamine pyrophosphate

Absorption

Oral: Adequate; IM: Rapid and complete

Distribution

Highest concentrations found in brain, heart, kidney, liver

Metabolism

In the liver

Excretion

Urine (as unchanged drug and as pyrimidine after body storage sites become saturated)

Use: Labeled Indications

Treatment of thiamine deficiency, beriberi (dry or wet variety), Wernicke encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, neuritis associated with pregnancy, or when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure; dietary supplement.

Off Label Uses

Alcohol withdrawal syndrome (adjunct)

Data from a limited number of patients studied suggest that thiamine may be beneficial as an adjunct in the management of alcohol withdrawal syndrome to prevent Wernicke encephalopathy [Cook 1998], [Latt 2014], [Sechi 2007], [Thomson 2002]. Additional data may be necessary to further define the role of thiamine in this condition.

Contraindications

Hypersensitivity to thiamine or any component of the formulation

Dosing: Adult

Recommended daily intake: Oral:

≥19 years: Females: 1.1 mg; Males: 1.2 mg

Pregnancy, lactation: 1.4 mg

Marginal thiamine status (to avoid precipitating heart failure): IV: 100 mg thiamine in each of the first few liters of IV fluid in patients with marginal thiamine status to whom dextrose is being administered.

Neuritis of pregnancy: IM: 5 to 10 mg daily in patients unable to take oral therapy due to severe vomiting.

Parenteral nutrition supplementation (Vanek 2012): IV: 6 mg/day

Thiamine deficiency (beriberi):

Manufacturer's labeling: 10 to 20 mg IM 3 times daily for as long as 2 weeks followed by an oral multivitamin preparation containing 5 to 10 mg thiamine administered daily for 1 month.

Alternate dosing: 5 to 30 mg/dose IM or IV 3 times daily (if critically ill); then 5 to 30 mg orally daily in single or divided doses 3 times daily for 1 month.

Alcohol withdrawal syndrome (adjunct) (off-label use): 100 to 250 mg IV or IM once daily for 3 to 5 days (Cook 1998; Latt 2014; Sechi 2007; Thomson 2002) followed by 100 mg orally 3 times daily for 1 to 2 weeks then 100 mg orally daily thereafter (Latt 2014). Additional data may be necessary to further define the role of thiamine in this condition.

Wernicke encephalopathy:

Prophylaxis (off-label use): 100 to 250 mg IV or IM once daily for 3 to 5 days (Cook 1998; Latt 2014; Sechi 2007; Thomson 2002) followed by 100 mg orally three times daily for 1 to 2 weeks then 100 mg orally daily thereafter (Latt 2014).

Treatment:

Manufacturer's labeling: Initial: 100 mg IV, then 50 to 100 mg IM daily until consuming a regular, balanced diet.

Alternate dosing: Initial: 200 to 500 mg IV 3 times daily for 2 to 7 days (Cook 1998; Latt 2014; Sechi 2007; Thomson 2002). If response to thiamine, continue with 250 mg IV or IM once daily for an additional 3 to 5 days (or until clinical improvement ceases) followed by 30 mg orally twice daily thereafter (Sechi 2007) or 100 mg orally 3 times daily for 1 to 2 weeks followed by 100 mg orally once daily thereafter (Latt 2014).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Adequate Intake:

0 to 6 months: 0.2 mg/day

7 to 12 months: 0.3 mg/day

Recommended daily intake:

1 to 3 years: 0.5 mg

4 to 8 years: 0.6 mg

9 to 13 years: 0.9 mg

14 to 18 years: Females: 1 mg; Males: 1.2 mg

≥19 years: Refer to adult dosing.

Parenteral nutrition supplementation (Vanek 2012): IV:

Infants: 0.35 to 0.5 mg/kg/day; maximum daily dose: 1.2 mg/day

Children: 1.2 mg/day

Thiamine deficiency (beriberi) treatment (critically ill):

Infants: Various regimens reported: Initial: IV: 25 to 50 mg once, followed by 10 mg IM once daily for a week then 3 to 5 mg orally once daily for at least 6 weeks (WHO 1999). Other regimens with higher initial doses have also been reported. One study used an oral dose of 100 mg/day given as 25 mg, 25 mg, and 50 mg doses administered 30 minutes apart for 3 days (Coats 2012). Another study administered 30 mg orally once daily for 20 days (Barennes 2015). Note: If patient is being breastfed, the mother should also be considered for thiamine deficiency treatment (Bowman 2013).

Children: Limited data available: IM, IV: 10 mg once daily for the first week (if critically ill), then 3 to 5 mg orally once daily for at least 6 weeks (Kliegman 2016).

Adolescents: Limited data available: IM, IV: 100 mg once daily for up to 7 days (if critically ill), then 10 mg orally once daily. Dosing based on several case reports (n=3, age 14 to 17 years) of beriberi treatment after gastric bypass surgery (Towbin 2004).

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer's labeling.

Extemporaneously Prepared

A 100 mg/mL oral suspension may be made with commercially available thiamine powder. Add 10 g of powder to a mortar. Add small portions of a 1:1 mixture of Ora-Sweet® and Ora-Plus® and mix to a uniform paste; mix while adding the vehicle in equal proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 100 mL. Label "shake well". Stable 91 days under refrigeration or at room temperature.

Ensom MH and Decarie D, "Stability of Thiamine in Extemporaneously Compounded Suspensions," Can J Hosp Pharm, 2005, 58(1):26-30.

Administration

Parenteral form may be administered by IM or IV injection. Various rates of administration have been reported (eg, 100 mg over 5 minutes). An extended infusion time is preferred for doses ≥100 mg. Local injection reactions may be minimized by slow administration (~30 minutes) into larger, more proximal veins. Thiamine should be administered prior to parenteral glucose solutions to prevent precipitation of acute symptoms of thiamine deficiency in the poorly nourished.

Dietary Considerations

Dietary sources include legumes, pork, beef, whole grains, yeast, and fresh vegetables. A deficiency state can occur in as little as 3 weeks following total dietary absence.

Storage

Injection: Store at 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Test Interactions

False-positive for uric acid using the phosphotungstate method and for urobilinogen using the Ehrlich's reagent; large doses may interfere with the spectrophotometric determination of serum theophylline concentration

Adverse Reactions

Adverse reactions reported with injection. Frequency not defined.

Central nervous system: Flushing sensation, restlessness

Dermatologic: Diaphoresis, pruritus, skin sclerosis (at the injection site following IM administration), urticaria

Gastrointestinal: Nausea

Hematologic & oncologic: Hemorrhage (into the gastrointestinal tract)

Hypersensitivity: Anaphylaxis (following IV administration), angioedema, hypersensitivity reaction (following IV administration)

Local: Tenderness at injection site (following IM administration)

Neuromuscular & skeletal: Weakness

Respiratory: Cyanosis, pharyngeal edema, pulmonary edema

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Have been reported following repeated parenteral doses; consider skin test in individuals with history of allergic reactions.

Concurrent drug therapy issues:

• Dextrose: Administration of dextrose may precipitate acute symptoms of thiamine deficiency; use caution when thiamine status is marginal or suspect.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002).

Other warnings/precautions:

• Parenteral administration: Use with caution with parenteral route (especially IV) of administration.

• Vitamin deficiency: Single vitamin deficiency is rare; evaluate for other deficiencies.

Pregnancy Risk Factor

A

Pregnancy Considerations

Water soluble vitamins cross the placenta. Thiamine requirements may be increased during pregnancy (IOM, 1998). Severe nausea and vomiting (hyperemesis gravidarum) may lead to thiamine deficiency manifested as Wernicke encephalopathy (Chiossi 2006).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, sensation of warmth, agitation, sweating a lot, weakness, or injection site irritation. Have patient report immediately to prescriber skin discoloration, black, tarry, or bloody stools, vomiting blood, severe abdominal pain, or shortness of breath (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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