Capsaicin

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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 the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains
- 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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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
- Dermatologic: Application site erythema (63% ), application site pain (42% ), application site rash (6% ), pruritus,application Site (6% )
- Gastrointestinal: Nausea (5% )
- Respiratory: Nasopharyngitis (4% )
Serious
- Cardiovascular: Hypertension (2% )

# 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

## 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 - 30C (59 - 86F)

# Images

## Drug Images

## Package and Label Display Panel

# 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