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Vitamin B1 (thiamine): Pediatric drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • True Vitamin B1 [OTC]
Brand Names: Canada
  • Thiamiject;
  • Vitamin B1
Therapeutic Category
  • Nutritional Supplement;
  • Vitamin, Water Soluble
Dosing: Neonatal

Dosage guidance:

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

Enteral daily recommendation; adequate intake:

Note: Recommended intake from dietary sources (eg, breast milk, formula).

Preterm neonates: 140 to 300 mcg/kg/day (Ref). Note: Needs will vary based on disease state, feeding tolerance, and other patient-specific factors (Ref).

Term neonates: 0.2 mg/day (Ref).

Parenteral nutrition, maintenance requirement of thiamine

Parenteral nutrition, maintenance requirement of thiamine: Preterm and term neonates: IV: 0.35 to 0.5 mg/kg/day; maximum daily dose: 1.2 mg/day (Ref).

Dosing: Pediatric

Dosage guidance:

Dosing: Dosing presented in mg/kg and mg/day; use caution.

Parenteral nutrition, maintenance requirement

Parenteral nutrition, maintenance requirement: Limited data available (Ref):

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

Children and Adolescents: IV: 1.2 mg/day.

Thiamine deficiency; treatment

Thiamine deficiency; treatment: Note: Thiamine deficiency is largely associated with severely malnourished states, including malignancy, surgery, or patient diet consisting mostly of polished rice or other thiamine-deficient food sources (Ref).

Infants: Severe deficiency (eg, beriberi, Wernicke encephalopathy): Various regimens reported; optimal dose not established:

Initial dose: IV, IM: 100 mg once daily is most often reported in the literature; reported dose range: 25 to 100 mg once daily or 75 mg twice daily; reported durations varied from a single one-time dose to daily dosing for up to 7 days; often followed by oral maintenance therapy (Ref); some experts recommend 25 to 50 mg IV once, followed by 10 mg IM once daily for 7 days and then transition to oral therapy (Ref).

Maintenance dose: Oral: 10 mg once daily is often reported; doses ranging from 3 to 25 mg/day have been used; duration is variable and has been reported up to 3 months (Ref); WHO recommends 3 to 5 mg once daily for at least 6 weeks (Ref).

Children and Adolescents: Various regimens reported; optimal dose not established:

Initial dose: IV, IM: 100 mg once daily for up to 7 days is the most commonly reported regimen in case reports; higher doses of 150 mg once daily for 3 days followed by 100 mg daily have been reported; some experts recommend 10 to 25 mg IV once daily for 2 weeks followed by oral maintenance therapy (Ref).

Maintenance dose: Oral: 3 to 10 mg once daily (Ref).

Refeeding syndrome, treatment in at-risk patients

Refeeding syndrome, treatment in at-risk patients: Limited data available: Note: Administer before feeding or prior to initiating dextrose-containing IV fluids in high-risk patients.

Infants, Children, and Adolescents: Oral: 2 mg/kg/dose once daily up to a usual daily dose range of 100 to 200 mg/day; maximum reported daily dose: 300 mg/day; continue for 5 to 7 days; longer supplementation may be required in patients with severe starvation, other high risk for deficiency, and/or signs of thiamine deficiency (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: Adult

(For additional information see "Vitamin B1 (thiamine): Drug information")

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: Continuous IV infusion: 6 mg/day (Ref). In some situations (eg, prevention of refeeding syndrome or Wernicke encephalopathy in patients at risk), a higher dose of thiamine (eg, up to 100 to 200 mg/day) is generally given separately prior to starting and during parenteral nutrition (PN) (Ref). May incorporate thiamine at doses >6 mg/day into the PN solution; however, evidence regarding physical and chemical stability of higher thiamine doses in PN is very limited (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). If using the IV route, guidelines suggest administering over 30 minutes, though various administration times have been reported (Ref).

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

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Although the pharmacokinetics of thiamine in kidney impairment have not been studied, excess thiamine is generally excreted in the urine, so it is likely that there are pharmacokinetic differences between the general population and those with kidney impairment. Although no dosage adjustments are likely to be necessary in acute cases of thiamine deficiency, more chronic treatment may require measurement of thiamine concentrations to avoid under or over treatment (Ref).

Altered kidney function: No dosage adjustment likely to be necessary for any degree of kidney impairment (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzable (4% to 49% (Ref): No dosage adjustment likely to be necessary (Ref). When scheduled dose falls on a hemodialysis day, administer after hemodialysis.

Peritoneal dialysis: Dialyzable (% unknown): No dosage adjustment likely to be necessary (Ref).

CRRT: No dosage adjustment likely to be necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment likely to be necessary (Ref).

Dosing: Hepatic Impairment: Adult

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

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.

Dosage Forms: US

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

Solution, Injection, as hydrochloride:

Generic: 100 mg/mL (2 mL); 200 mg/2 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:

True Vitamin B1: 50 mg, 100 mg

Generic: 100 mg

Tablet, Oral, as mononitrate [preservative free]:

Generic: 100 mg

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Thiamine HCl Injection)

100 mg/mL (per mL): $3.94 - $5.97

Tablets (Thiamine HCl Oral)

100 mg (per each): $0.04 - $0.09

Tablets (Thiamine Mononitrate Oral)

100 mg (per each): $0.04 - $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.

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)

Extemporaneous Preparations

100 mg/mL Oral Suspension

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, Decarie D. Stability of thiamine in extemporaneously compounded suspensions. Can J Hosp Pharm. 2005;58(1):26-30.
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; most common reported rate in pediatric patients is 100 mg over 30 minutes (Ref); administration over 20 minutes and 60 minutes has also been described (Ref). Thiamine administration may be considered prior to feeding or administration of dextrose-containing IV fluids in high-risk patients (eg, malnourished patients) to prevent precipitation of acute symptoms of thiamine deficiency (Ref).

Administration: Adult

IM, IV: Parenteral form may be administered by IM or IV injection. Various rates of IV administration have been reported, and the optimal administration rate is unknown; refer to institutional protocols. For example, an extended infusion time (eg, over 15 to 30 minutes) has been suggested for doses ≥100 mg; limited data suggest that doses up to 500 mg have been safely administered via IV push (over 1 to 2 minutes), though efficacy data are lacking (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).

Storage/Stability

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

Use

Treatment of infantile beriberi with acute collapse (FDA approved in infants); treatment of thiamine deficiency (including thiamine deficiency in pregnancy associated with neuropathy), beriberi (dry or wet variety), Wernicke encephalopathy, cardiovascular disease due to thiamine deficiency, or marginal thiamine status in individuals receiving IV dextrose (FDA approved in adults).

Oral: Dietary supplement (OTC products: FDA approved in adults).

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]

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

Patiromer: May decrease the serum concentration of Thiamine. Management: Administer oral thiamine at least 3 hours before or 3 hours after patiromer. Risk D: Consider therapy modification

Food Interactions

Food: High carbohydrate diets may increase thiamine requirement.

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; NIH 2023):

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

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

1 to 3 years: Recommended dietary allowance (RDA): 0.5 mg/day.

4 to 8 years: RDA: 0.6 mg/day.

9 to 13 years: RDA: 0.9 mg/day.

14 to 18 years: RDA:

Males: 1.2 mg/day.

Females: 1 mg/day.

≥19 years: RDA:

Males: 1.2 mg/day.

Females: 1.1 mg/day.

Pregnancy, lactation: RDA: 1.4 mg/day.

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).

Reference Range

Note: No single indicator provides an adequate estimate of thiamine status (IOM 1998).

Erythrocyte transketolase activity (ETKA): Adequate: ≤15%, moderate risk for deficiency: 16% to 25%, high risk for deficiency: >25% (Frank 2015).

Thiamine pyrophosphate (TPP): 70 to 180 nmol/L (Frank 2015).

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 (Adult Data Unless Noted)

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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Benerva | Bevitine | Thiavit | Vitamin B1;
  • (AR) Argentina: Benerva | Tiamin sigma | Tiamina austral;
  • (AT) Austria: Beneuran | Bevitol | Vitamin B1;
  • (AU) Australia: Betamin | Betavit | Thiamine HCL | Vit b1 | Vitamin B1;
  • (BD) Bangladesh: A-B1 | Avitron V | B One | Bemin | Benavit | Beone | Beovit | Berin | Kvit-th | Neurovit | Neuvit | Onevit | Renerv | Thiabin | Thiacon | Thianomin | Thiason | Thiatab | Thiobion | Thiolex | Thiomin | Thiosina | Thiovit | Thita | Tone | Vita 1;
  • (BE) Belgium: Aneurol | Benerva | Beneurol | Betamine;
  • (BG) Bulgaria: Vitamin B1;
  • (BR) Brazil: Acesyl | Benerva | Beneum | Beum | Beviter | Cloridrato de tiamina | Fonti B1 | Nervamin | Nerven | Neurivit | Vitamina b1 | Vitamina b1 neo quimica | Vitaum;
  • (CH) Switzerland: Benerva | Vitamin B1;
  • (CL) Chile: Tiamina;
  • (CN) China: Vitamin B1;
  • (CO) Colombia: B-uno | Benerva | Tiamina | Tiamina clorhidrato | Tiamina ecar | Tiavit | Vitamina b1 | Vitamina B1 Mckesson | Vitiam;
  • (CZ) Czech Republic: Thiamin | Thiamine chloride;
  • (DE) Germany: B1 asmedic | B1 kattwiga | B1 Vicotrat | Betabion | Tolima | Vitamin B1 | Vitamin B1 Hevert;
  • (DK) Denmark: Apovit b1 vitamin;
  • (DO) Dominican Republic: Neurodom | Vitamina b1;
  • (EC) Ecuador: Beneuril | Clorhidrato de tiamina | Complexigeme | Tiamina | Vitamina b1;
  • (EE) Estonia: Vitamin B1;
  • (ES) Spain: Benerva;
  • (FI) Finland: B1 vitamin | Vita B1;
  • (FR) France: Benerva | Bevitine | Vitamine b1 aguettant | Vitamine b1 arrow conseil | Vitamine b1 richard;
  • (GB) United Kingdom: Benerva | Thiamine | Thiamine chanelle | Thiamine zanza | Tyvera;
  • (GR) Greece: Benerva;
  • (HK) Hong Kong: Betamine | Bevit | Hudson vitamin B1 | Neo active vitamin b1 | Thiamine HCL | Vitamin B1 | Vitamin b1 natural;
  • (HU) Hungary: Beres b1 vitamin | Vitamin B1;
  • (ID) Indonesia: Aneurine | Benavit | Betabion | Betamin | Licobevit | Nervin | Thiamina | Vitamin B1;
  • (IE) Ireland: Benerva | Tyvera;
  • (IL) Israel: Vitamin B1;
  • (IN) India: Biminox | Thiacros | Thianuron | Vitamin B1;
  • (IQ) Iraq: Samavit b1 | Vitasaf b1;
  • (IT) Italy: Benerva | Betabion | Vitamina b1 | Vitamina b1 salf;
  • (JP) Japan: Aktivin | Aliaron d | Allithgen f | B Kapp | Biogen | Daechimin | Daiomin | Daithia | Dianoinamin | Galnamin t amel | Galnamin t nisshin kyorin sei | Galta f | Harumigen f | Hi ozevita f | Hinonamin f | Hithiamin s | Metapron | Mitan | Neodiamin | Neolamin | Thiamidin f seiko | Thiamine hcl nisshin kyorin sei | Vitanon | Vitanon alfresa;
  • (KR) Korea, Republic of: Aconitonbi | Thiamin Hcl | Thiamine HCL | Thiamine hcl sinil;
  • (KW) Kuwait: Thiavit;
  • (LB) Lebanon: Benerva | Vitamin B1;
  • (LT) Lithuania: Benfothiamin | Thiamin | Thiamine | Vita B1 | Vitamin B1;
  • (LU) Luxembourg: Benerva | Beneurol | Betamine;
  • (LV) Latvia: Benfothiamin | Thiamin | Thiamine chlorid | Vitamin B1;
  • (MX) Mexico: Benerva;
  • (MY) Malaysia: Aneurine | Benerva | Dyna b1 | Thiamine | Vitamin B1;
  • (NG) Nigeria: Thiovit;
  • (NL) Netherlands: Thiamine HCL;
  • (NO) Norway: Benerva | Tiamin Aurora Medical | Tiamin krageroe | Tiamin life medical | Tiamin naf;
  • (NZ) New Zealand: Apo thiamine | Apo-thiamine | Betamin | Solgar vitamin b1 | Thiamine HCL | Vitamin B1;
  • (PE) Peru: Be gross 300 | Benerva | Betamin | Tiamina | Vitamina b1;
  • (PK) Pakistan: Benerva;
  • (PL) Poland: Benerva | Thiamin | Vitamin B1 | Vitamin b1 ratiopharm | Vitaminum b1;
  • (PR) Puerto Rico: Thiamine HCL | Vit b1 | Vitamin B1;
  • (PT) Portugal: Trifosfaneurina;
  • (QA) Qatar: AWS-100 | Thiavit;
  • (RU) Russian Federation: Phosphaden | Thiamin | Thiamine | Thiamine chloride echo | Thiamine solopharm | Thiamine vial | Tribexol | Vitamin B1;
  • (SA) Saudi Arabia: Thiavit;
  • (SE) Sweden: Benerva | Tiamin ebb;
  • (SG) Singapore: Thiamine HCL | Vitamin B1;
  • (SI) Slovenia: Aneurin;
  • (SK) Slovakia: Plivit b1 | Thiamin;
  • (TH) Thailand: B.a.f | B1 | Benerva | Beratex | Chlobi | Med-b1 | S.co tamin | Thiamine | Vida-b | Vitamin B1;
  • (TR) Turkey: Benerva | Bevigen | Vitamin B1;
  • (TW) Taiwan: Beetomin | Metrodin | Thiamine | Thiamine HCL | Thiamine nitrate | Vitamin B1;
  • (UA) Ukraine: Thiamine chloride | Vitamin B1;
  • (UY) Uruguay: B1 | Benerva | Vitamina b1;
  • (VE) Venezuela, Bolivarian Republic of: Clorhidrato de tiamina | Vitamina b1;
  • (ZA) South Africa: Thiamine | Vitamin B1
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