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Vitamin B1 (thiamine): Drug information

Vitamin B1 (thiamine): Drug information
(For additional information see "Vitamin B1 (thiamine): Patient drug information" and see "Vitamin B1 (thiamine): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Betaxin [DSC];
  • Thiamiject;
  • Vitamin B1
Pharmacologic Category
  • Vitamin, Water Soluble
Dosing: Adult
Alcohol withdrawal syndrome

Alcohol withdrawal syndrome (adjunctive agent) (off-label use): Parenteral administration is preferred for inpatient management of alcohol withdrawal, particularly for patients with malabsorption, poor nutritional status, or severe alcohol withdrawal (ASAM 2020; Sechi 2007). Optimal doses and regimens have not been identified; refer to institutional protocols.

Wernicke encephalopathy, prevention:

IV (preferred route), Oral, IM: 100 to 200 mg once daily for 3 to 5 days (ASAM 2020; Galvin 2010). Note: Administration prior to dextrose is recommended when feasible (Flannery 2016; Galvin 2010). Higher doses are used in patients for treatment of suspected or confirmed Wernicke encephalopathy (see “Alcohol Withdrawal Syndrome, Wernicke Encephalopathy, Treatment”).

Wernicke encephalopathy, treatment: Note: Oral administration should not be used for initial treatment (ASAM 2020).

IV (preferred route), IM: 200 to 500 mg 3 times daily for 2 to 7 days, followed by 250 mg once daily for an additional 3 to 5 days, then decrease to at least 100 mg daily until no longer at risk (Galvin 2010; Latt 2014; Sechi 2007; So 2021; Thomson 2002). Note: Administration prior to dextrose is recommended when feasible (Flannery 2016; Galvin 2010).

Ethylene glycol poisoning

Ethylene glycol poisoning (off-label use): IV: 100 mg per day until the intoxication has resolved (Hoffman 2015)

Marginal thiamine status

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.

Parenteral nutrition supplementation

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

Sepsis or septic shock

Sepsis (severe) or septic shock (off-label use): IV: 200 mg every 12 hours over 30 minutes for 4 days or until ICU discharge; administer in combination with IV ascorbic acid (vitamin C) and IV hydrocortisone (Marik 2017).

Thiamine deficiency

Thiamine deficiency (beriberi): 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.

Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice. 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.

Dosing: Kidney Impairment: Adult

No dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

No dosage adjustment provided in manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Vitamin B1 (thiamine): Pediatric drug information")

Note: Dosing presented in mcg/kg, mg/kg, and mg/day; use precaution.

Parenteral nutrition, maintenance requirement (Vanek 2012): Limited data available: 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 breast-fed, 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: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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 [DSC]

Tablet, Oral, as mononitrate:

Generic: 100 mg

Tablet, Oral, as mononitrate [preservative free]:

Generic: 100 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection, as hydrochloride:

Betaxin: 100 mg/mL ([DSC])

Thiamiject: 100 mg/mL (1 mL, 10 mL)

Generic: 100 mg/mL (1 mL, 10 mL, 30 mL)

Administration: Adult

IM, IV: Parenteral form may be administered by IM or IV injection. Various rates of IV administration have been reported; an extended infusion time (eg, over 15 to 30 minutes) has been suggested for doses ≥100 mg, although doses up to 250 mg have been safely administered via IV push (over 1 to 2 minutes) (Gahart 2021; Latt 2014; McLaughlin 2020; Sechi 2007; Tjugum 2019). If thiamine and nutrition support with parenteral carbohydrates (eg, glucose, dextrose) are both indicated, thiamine should be administered prior to parenteral carbohydrate solutions to prevent precipitation of acute symptoms of thiamine deficiency when feasible (Flannery 2016; Gahart 2021; Galvin 2010; Latt 2014; Yin 2019).

Administration: Pediatric

Oral: May administer with or without food (IOM 1998)

Parenteral: May be administered by IM or IV injection. For IV administration, various rates of administration have been reported (eg, 100 mg over 5 minutes in adults). 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.

Use: Labeled Indications

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

Use: Off-Label: Adult

Alcohol withdrawal syndrome (adjunctive agent), prevention of Wernicke encephalopathy; Ethylene glycol poisoning; Sepsis (severe) or septic shock

Medication Safety Issues
Sound-alike/look-alike issues:

Thiamine may be confused with Tenormin, Thalomid, Thorazine

International issues:

Doxal [Brazil] may be confused with Doxil brand name for doxorubicin [US]

Doxal: Brand name for pyridoxine/thiamine [Brazil], but also the brand name for doxepin [Finland]

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

Contraindications

Hypersensitivity to thiamine or any component of the formulation

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.

Metabolism/Transport Effects

None known.

Drug Interactions

Etamsylate: May diminish the therapeutic effect of Thiamine. Management: If a patient is to receive intravenous (IV) etamsylate and an IV infusion containing thiamine, administer etamsylate first to avoid thiamine degradation by sulfites contained in the etamsylate product. Risk D: Consider therapy modification

Food Interactions

Food: High carbohydrate diets may increase thiamine requirement.

Pregnancy Considerations

Water soluble vitamins cross the placenta. Thiamine requirements are increased in during pregnancy (IOM 1998).

Pregnant females are at increased risk of thiamine deficiency when prolonged nausea and vomiting (including hyperemesis gravidarum) occurs; deficiency may present as a polyneuropathy or Wernicke encephalopathy (Chiossi 2006; Karjalainen 1965; WHO 1999).

Thiamine supplementation is recommended in pregnant females with prolonged vomiting. Initial treatment with IV thiamine is needed when Wernicke encephalopathy is suspected. Oral, IM, or IV therapy may be considered depending on severity of thiamine deficiency (Berdai 2016; Chiossi 2006; Palacios-Marqués 2012). When intravenous hydration is used in the management of hyperemesis gravidarum, thiamine should be administered prior to infusing dextrose to prevent Wernicke encephalopathy (ACOG 189 2018).

Breastfeeding Considerations

Thiamine is present in breast milk (IOM 1998).

Thiamine concentrations in breast milk are similar in well-nourished mothers who use supplements and those that do not (IOM 1998).

Thiamine requirements are increased in breastfeeding females (IOM 1998). Females with a thiamine deficiency may lead to a deficiency in exclusively breastfed infants (Barennes 2015; Coats 2012). When a deficiency is present, supplementation of both the mother and infant is recommended (WHO 1999)

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.

Dietary reference intake (IOM 1998):

0 to 6 months: Adequate intake: 0.2 mg/day

7 to 12 months: Adequate intake: 0.3 mg/day

1 to 3 years: RDA: 0.5 mg

4 to 8 years: RDA: 0.6 mg

9 to 13 years: RDA: 0.9 mg

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

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

Pregnancy, lactation: RDA: 1.4 mg

Reference Range

Normal, serum: 1.1-1.6 mg/dL

Mechanism of Action

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

When used for the treatment of ethylene glycol poisoning, thiamine is theorized to increase the formation of glycine, a nontoxic metabolite.

Pharmacokinetics

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)

Pricing: US

Solution (Thiamine HCl Injection)

100 mg/mL (per mL): $4.15 - $5.97

Tablets (Thiamine HCl Oral)

100 mg (per each): $0.03 - $0.09

Tablets (Thiamine Mononitrate Oral)

100 mg (per each): $0.03 - $0.19

Tablets (Vitamin B-1 Oral)

100 mg (per each): $0.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Abery (JP);
  • Actamin (JP);
  • AFI-B (NO);
  • Aliaron D 10 (JP);
  • Anerex (MX);
  • Aneurin-AS (DE);
  • Arcavit-B1 (AT);
  • B1-ASmedic (DE);
  • B1-Vicotrat (DE);
  • Becaps (BR);
  • Benalgis (IN);
  • Benerva (AE, AR, BB, BE, BH, BM, BR, BS, BZ, CH, CY, EG, ES, FR, GB, GH, GR, GY, IL, IQ, IR, IT, JM, JO, KE, KW, LB, LU, LY, NL, OM, PE, QA, SA, SE, SR, SY, TT, TZ, UG, YE, ZM);
  • Beneuran (AT);
  • Beneurol (LU);
  • Beneuron (IN);
  • Bermin B (JP);
  • Beta-Sol (AU);
  • Beta-Tabs (AU);
  • Betabion (DE);
  • Betamin (AU);
  • Betamine (LU);
  • Bevitine (FR);
  • Bevitol (AT);
  • Biogen (JP);
  • Bwerin (IN);
  • Dagravit B1 (PT);
  • Dexabion (MX);
  • Hiace (JP);
  • Hithia (JP);
  • Incremin con Hierro (MX);
  • Kirin B1 (JP);
  • Lophakomp-B1 (DE);
  • Metabolin (JP);
  • Mutsutamin (JP);
  • Neo-Panlacticos (MX);
  • Neuramin (FI);
  • Pagavit (MX);
  • Pharmaton (MX);
  • Plivit B1 (HR);
  • Suma-B (MX);
  • Thiamine Injection (AU);
  • Tiacur (NO);
  • Tiamidexal (MX);
  • Tiamin ”Dak” (DK);
  • Tiamina (CO);
  • Tiaminal (MX);
  • Tolima (DE);
  • Tribedoce (MX);
  • Trifosfaneurina (PT);
  • Tyvera (MT);
  • Vit. B1 Agepha (AT);
  • Vita-B1 (FI);
  • Vitamin B1 (HU);
  • Vitamin B1 Jenapharm (DE);
  • Vitamin B1 Kattwiga (DE);
  • Vitamin B1-Hevert (DE);
  • Vitamin B1-Injektopas (DE);
  • Vitamin B1-ratiopharm (DE);
  • Vitamina B1 Biol (AR);
  • Vitaminum B1 (PL);
  • Vitanon[inj.] (JP)


For country abbreviations used in Lexicomp (show table)

REFERENCES

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