Clotrimazole (vaginal)

Clotrimazole (vaginal)
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

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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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 isn’t 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

Clotrimazole (vaginal)
Systematic (IUPAC) name
1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole
Identifiers
CAS number	23593-75-1
ATC code	A01AB18 D01AC01 (WHO) G01AF02 (WHO) Template:ATCvet
PubChem	2812
DrugBank	DB00257
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	344.837 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	Poor oral absorption (troche), negligible absorption through intact skin (topical)
Protein binding	90%
Metabolism	hepatic
Half life	2 hours
Excretion	?
Therapeutic considerations
Pregnancy cat.	A(AU) C (oral) and B (topical) (US)
Legal status	?(US)
Routes	topical, troche

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

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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.

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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

References

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