Biotin

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Biotin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Biotin is a vitamin that is FDA approved for the treatment of to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root and helps oxygenate the hair turn slowing the loss and provides resilience and resistence to hair. Common adverse reactions include gastrointestinal upset, administration of anticonvulsant medications may impair biotin absorption.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Biotin is a major component of the formulation acts to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root and helps oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair.
  • Apply amount of the hair follicle and massage until absorbed. Use every 12 hours for the fast and sustained effect.
  • Suitable for children, adolescents, adults and seniors.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • BIOTINIDASE DEFICIENCY, oral: 10 to 40 milligrams daily
  • BRITTLE NAILS, oral, tablet: 2.5 milligrams daily
  • CARBOXYLASE DEFICIENCY, intravenous, solution: 18.4 micromoles daily
  • HOLOCARBOXYLASE DEFICIENCY IN PREGNANCY, oral: 10 milligrams daily
  • PARENTERAL ALIMENTATION-INDUCED DEFICIENCY, oral, solution or tablet: 0.1 to 1 milligram daily
  • RECOMMENDED DIETARY ALLOWANCE (RDA), oral: 30 to 100 micrograms daily
  • VAGINAL CANDIDIASIS, oral: 20 milligrams daily

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Biotin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Biotin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • ALOPECIA AREATA, oral: 20 milligrams daily with oral zinc aspartate 100 milligrams and topical clobetasol propionate 0.025%
  • BASAL-GANGLIA DISEASE, BIOTIN-responsive, oral or solution: 5 to 10 milligrams/kilogram daily
  • BETA-METHYLCROTONYL-GLYCINURIA, solution, oral: 10 milligrams daily
  • BIOTINIDASE DEFICIENCY, solution or tablet, oral: 6 to 40 milligrams daily
  • PARENTERAL ALIMENTATION-INDUCED DEFICIENCY, solution or tablet, oral: 0.1 to 1 milligram daily
  • PARTIAL BIOTINIDASE DEFICIENCY, solution or tablet: 5 to 10 milligrams daily or less.
  • PROTEIN-ENERGY MALNUTRITION, solution or tablet, oral: BIOTIN 10 milligrams daily along with standard treatment for malnutrition
  • PYRUVATE-CARBOXYLASE DEFICIENCY, solution or tablet, oral: BIOTIN 10 milligrams (mg) daily, thiamine 80 mg daily, pyridoxine 300 mg daily
  • RECOMMENDED DIETARY ALLOWANCE, oral, diet or tablet: 50 micrograms daily
  • UNCOMBABLE HAIR SYNDROME, solution or tablet, oral: 0.9 milligram daily in three divided doses

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Biotin in pediatric patients.

Contraindications

  • Hypersensitivity to Biotin

Warnings

This product is for topical application, if this product to contact with eyes rinse immediately with water and consult your doctor.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Biotin in the drug label.

Postmarketing Experience

  • Gastrointestinal upset
  • Administration of anticonvulsant medications may impair Biotin absorption

Drug Interactions

There is limited information regarding Biotin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Biotin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Biotin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Biotin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Biotin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Biotin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Biotin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Biotin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Biotin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Biotin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Biotin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Biotin in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Biotin in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Biotin in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Biotin in the drug label.

Pharmacology

Biotin[1]
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IUPAC name 5-[(3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl]pentanoic acid
Other names Vitamin B7; Vitamin H; Coenzyme R; Biopeiderm
Identifiers
CAS number 58-85-5
PubChem 171548
DrugBank DB00121
KEGG D00029
ChEBI 15956
ATC code A11HA05
SMILES O=C1N[C@@H]2[C@@H](SC[C@@H]2N1)CCCCC(=O)O
InChI InChI=1/C10H16N2O3S/c13-8(14)4-2-1-3-7-9-6(5-16-7)11-10(15)12-9/h6-7,9H,1-5H2,(H,13,14)(H2,11,12,15)/t6-,7-,9-/m0/s1
Properties
Molecular formula C10H16N2O3S
Molar mass 244.31 g mol-1
Appearance White crystalline needles
Melting point

232 to 233 °C, Expression error: Unrecognized word "to". K, Expression error: Unrecognized word "to". °F

Solubility in water 22 mg/100 mL
Hazards
NFPA 704

NFPA 704.svg

1
1
0
 
Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)

Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Biotin Mechanism of Action in the drug label.

Structure

There is limited information regarding Biotin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Biotin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Biotin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Biotin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Biotin in the drug label.

How Supplied

Storage

There is limited information regarding Biotin Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Biotin in the drug label.

Precautions with Alcohol

  • Alcohol-Biotin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • BIONA-VIT ®[2]

Look-Alike Drug Names

There is limited information regarding Biotin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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