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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
  • Thiamiject;
  • Vitamin B1
Pharmacologic Category
  • Vitamin, Water Soluble
Dosing: Adult
Beriberi treatment

Beriberi treatment:

Initial: IM, IV (preferred routes if critically ill), Oral: 100 to 200 mg 3 times daily for 2 to 3 days, followed by maintenance therapy (Ref).

Maintenance: Oral: 5 to 100 mg once daily until no longer at risk for deficiency (Ref). Note: Doses lower than 100 mg may be obtained in a multivitamin formulation.

Ethylene glycol poisoning

Ethylene glycol poisoning (adjunctive agent) (off-label use):

Note: For use as an adjunct to antidote therapy (Ref).

IV: 100 mg as a one-time dose (Ref).

Thiamine supplementation, including prevention of Wernicke encephalopathy

Thiamine supplementation, including prevention of Wernicke encephalopathy:

Note: Patients at high risk for developing thiamine deficiency include those with alcohol use disorder, GI disease and/or surgery (including bariatric surgery), hyperemesis gravidarum, or malignancy (Ref).

Wernicke encephalopathy, prevention, including those with alcohol withdrawal syndrome (off label): IV (preferred route), Oral, IM: 100 to 200 mg once daily for 3 to 5 days (Ref). Note: Administration prior to dextrose is recommended when feasible (Ref). Higher doses are used in patients for treatment of suspected or confirmed Wernicke encephalopathy (see “Wernicke Encephalopathy Treatment”).

Bariatric surgery, postoperative (off label): Oral: 12 to 100 mg/day in 1 or 2 divided doses; continue indefinitely. Note: Doses lower than 100 mg may be obtained in a multivitamin formulation (Ref).

Parenteral nutrition supplementation: IV: 6 mg/day (Ref).

Wernicke encephalopathy treatment

Wernicke encephalopathy treatment:

Initial: Note: Oral administration should not be used for initial treatment (Ref).

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, followed by maintenance therapy (Ref). Note: Administration prior to dextrose is recommended when feasible (Ref).

Maintenance: Oral: 100 mg daily until no longer at risk for deficiency (Ref).

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

Parenteral nutrition, maintenance requirement (Ref): 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; treatment

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 (Ref). 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 (Ref). Another study administered 30 mg orally once daily for 20 days (Ref). Note: If patient is being breast-fed, the mother should also be considered for thiamine deficiency treatment (Ref).

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 (Ref).

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 (Ref).

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.

Capsule, Oral, as hydrochloride:

Generic: 50 mg

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (2 mL)

Solution, Injection, as hydrochloride [preservative free]:

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

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.

Solution, Injection, as hydrochloride:

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

Generic: 100 mg/mL (1 mL, 10 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) (Ref). 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 (Ref).

Administration: Pediatric

Oral: May administer with or without food (Ref).

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 marginal thiamine status in individuals receiving IV dextrose; dietary supplement.

Use: Off-Label: Adult

Ethylene glycol poisoning; Thiamine supplementation, including prevention of Wernicke encephalopathy

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

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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): $3.94 - $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): $0.17 - $0.23

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);
  • Strong Vita-B Injection (TW);
  • 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 code abbreviations (show table)
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