Clotrimazole (vaginal)

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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
Clotrimazole (vaginal) is an antifungal that is FDA approved for the treatment of vulvar itching and irritation.   Common adverse reactions include nausea and vomiting.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Vaginal antifungal/external vulvar antifungal.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clotrimazole (vaginal) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Clotrimazole (vaginal) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Clotrimazole (vaginal) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clotrimazole (vaginal) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Clotrimazole (vaginal) in pediatric patients.

# Contraindications
There is limited information regarding Clotrimazole (vaginal) Contraindications in the drug label.

# Warnings
- For vaginal or external vulvar use only
- Do not use
- if you have abdominal pain, fever or a foul-smelling vaginal discharge. Contact your doctor immediately.
- In children less than 12 years of age
- Ask a doctor before use if you have
- Vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.
- Symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection with HIV- the virus that causes AIDS).  Please read enclosed educational pamphlet.
- When using this product
- Do not use tampons
- Stop use and ask a doctor if
- Symptoms do not get better in 3 days or infection isnt gone in 7 days. You may have a condition other than a yeast infection.
- If pregnant or breast-feeding
- Ask a health professional before use.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Clotrimazole (vaginal) in the drug label.

## Postmarketing Experience
- Nausea, vomiting

# Drug Interactions
There is limited information regarding Clotrimazole (vaginal) 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 Clotrimazole (vaginal) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Clotrimazole (vaginal) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Clotrimazole (vaginal) with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Clotrimazole (vaginal) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Clotrimazole (vaginal) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Clotrimazole (vaginal) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Clotrimazole (vaginal) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Clotrimazole (vaginal) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Clotrimazole (vaginal) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clotrimazole (vaginal) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Clotrimazole (vaginal) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
There is limited information regarding Monitoring of Clotrimazole (vaginal) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Clotrimazole (vaginal) in the drug label.

# Overdosage
There is limited information regarding Clotrimazole (vaginal) 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 Clotrimazole (vaginal) Mechanism of Action in the drug label.

## Structure
There is limited information regarding Clotrimazole (vaginal) Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Clotrimazole (vaginal) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Clotrimazole (vaginal) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Clotrimazole (vaginal) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Clotrimazole (vaginal) in the drug label.

# How Supplied
There is limited information regarding Clotrimazole (vaginal) How Supplied in the drug label.

## Storage
There is limited information regarding Clotrimazole (vaginal) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Clotrimazole (vaginal) in the drug label.

# Precautions with Alcohol
- Alcohol-Clotrimazole (vaginal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- CLOTRIMAZOLE

# Look-Alike Drug Names
There is limited information regarding Clotrimazole (vaginal) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price