Capsaicin

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Capsaicin
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: Kiran Singh, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Capsaicin is a topical analgesic that is FDA approved for the treatment of for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains. Common adverse reactions include erythema, rash, pruritus, nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For use in treating neuralgias, consult a physician

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosage

  • Arthritis - Pain: topical, apply thin film to the affected area 3 to 4 times per day.
  • Musculoskeletal pain: topical, apply thin film to the affected area 3 to 4 times per day.
  • Neuropathic pain, associated with postherpetic neuralgia: (patch) a single 60-minute application of up to 4 patches every 3 months as needed; do not apply more frequently than every 3 months
  • Psoriasis: apply cream 6 times/day for 3 days, then 4 times/day

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Capsaicin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • Safety and effectiveness of capsaicin 8% patch (Qutenza(R)) not established in pediatric patients; consult a physician before using capsaicin cream on patients under 18 years of age

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Capsaicin Contraindications in the drug label.

Warnings

For external use only.

Do not apply to wounds or to damaged or irritated skin.

When using this product

  • You may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
  • Do not get it on mucous membranes, into eyes, or on contract lenses. If this occurs, rinse the affected area thoroughly with water.
  • Do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise.
  • Do not apply heat to the treated areas immediately before or after use.
  • Do not tightly wrap or bandage the treated area.
  • Avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

Stop use and ask a doctor if

  • Condition worsens or does not improve after regular use.
  • Blistering occurs.
  • Difficulty breathing or swallowing occurs.
  • Severe burning persists.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Capsaicin Clinical Trials Experience in the drug label.

Postmarketing Experience

Common

  • Gastrointestinal: Nausea (5% )

Serious

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Capsaicin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Capsaicin in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Capsaicin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Capsaicin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Capsaicin in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Topical

Monitoring

There is limited information regarding Capsaicin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Capsaicin and IV administrations.

Overdosage

There is limited information regarding Capsaicin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Capsaicin
200px
Capsaicin-3D-vdW.png
IUPAC name (E)-N-[(4-Hydroxy-3-methoxyphenyl)methyl]-8-methylnon-6-enamide
Other names 8-Methyl-N-vanillyl-trans-6-nonenamide; trans-8-Methyl-N-vanillylnon-6-enamide; (E)-Capsaicin; Capsicine; Capsicin; CPS
Identifiers
CAS number 404-86-4
PubChem 1548943
EINECS number 206-969-8
KEGG C06866
ChEBI 3374
ATC code M02AB01,N01BX04
SMILES O=C(NCc1cc(OC)c(O)cc1)CCCC/C=C/C(C)C
InChI InChI=1/C18H27NO3/c1-14(2)8-6-4-5-7-9-18(21)19-13-15-10-11-16(20)17(12-15)22-3/h6,8,10-12,14,20H,4-5,7,9,13H2,1-3H3,(H,19,21)/b8-6+
Properties
Molecular formula C18H27NO3
Molar mass 305.41 g mol-1
Appearance crystalline white powder[1]
Odor highly volatile and pungent
Melting point

62-65 °C, 335-338 K, 144-149 °F

Boiling point

210-220 °C, 483-493 K, 410-428 °F (0.01 Torr)

Solubility in water 0.0013 g/100 mL
Solubility soluble in alcohol, ether, benzene
slightly soluble in CS2, HCl, petroleum
λmax 280 nm
Structure
Crystal structure monoclinic
Hazards
MSDS Capsaicin, Natural MSDS
Main hazards Toxic (T)
NFPA 704

NFPA 704.svg

1
2
0
 
R-phrases R24/25
S-phrases S26, S36/37/39, S45
Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)

Infobox disclaimer and references
157px
Heat: Above Peak (SR: 15,000,000-16,000,000)

Mechanism of Action

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

Structure

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

Pharmacodynamics

There is limited information regarding Capsaicin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Capsaicin Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Capsaicin How Supplied in the drug label.

Storage

Store at 15° - 30°C (59° - 86°F)

Images

Drug Images

Package and Label Display Panel

Capsaicinfig.jpg
This image of the FDA label is provided by the National Library of Medicine.
Capsaicin ingredients and appearance.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • For persons under 18 years of age, ask a doctor before using.
  • To avoid getting cream on hands use applicator pad to apply a thin film of cream to the affected area and gently rub in until fully absorbed. Discard applicator pad after use.
  • For optimum relief, apply 3 to 4 times daily.
  • Best results typically occur after 2 to 4 weeks of continuous use.
  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
  • See package insert for more information.

Precautions with Alcohol

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

Brand Names

ZOSTRIX

Look-Alike Drug Names

There is limited information regarding Capsaicin 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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