Clotrimazole (mucous membrane)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, 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
Clotrimazole (mucous membrane) is an azole antifungal that is FDA approved for the treatment of tinea pedis, tinea cruris and tinea corporis. Common adverse reactions include nausea and vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Anti-Fungal
- Dosing information
- Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of clotrimazole in adult patients.
Non–Guideline-Supported Use
Candidal vulvovaginitis
- Dosing information
- 0.5 grams administered once weekly for 2 weeks[1]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- There is limited information regarding FDA-Labeled Use of Clotrimazole (mucous membrane) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of clotrimazole in pediatric patients.
Non–Guideline-Supported Use
- There is limited information regarding Off-Label Non–Guideline-Supported Use of clotrimazole in pediatric patients.
Contraindications
Hypersensitivity to clotrimazole.
Warnings
- For exteranl use only.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Do not use on children under 2 years of age unless directed by a doctor.
- Avoid contact with the eyes.
- If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
- Keep out of reach of children
Adverse Reactions
Clinical Trials Experience
Postmarketing Experience
- FDA package insert for clotrimazole contains no information regarding Post marketing experience.
Drug Interactions
There is limited information regarding Clotrimazole (mucous membrane) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Clotrimazole (mucous membrane) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clotrimazole (mucous membrane) in women who are pregnant.
Labor and Delivery
- There is no FDA guidance on use of Clotrimazole (mucous membrane) during labor and delivery.
Nursing Mothers
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to nursing mothers.
Pediatric Use
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to pediatric patients.
Geriatic Use
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to geriatric patients.
Gender
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to specific gender populations.
Race
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) with respect to specific racial populations.
Renal Impairment
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) in patients with renal impairment.
Hepatic Impairment
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) in patients with hepatic impairment.
Females of Reproductive Potential and Males
- There is no FDA guidance on the use of Clotrimazole (mucous membrane) in women of reproductive potentials and males.
Immunocompromised Patients
- There is no FDA guidance one the use of Clotrimazole (mucous membrane) in patients who are immunocompromised.
Administration and Monitoring
Administration
- For exteranl use only.
Monitoring
- FDA package insert for clotrimazole contains no information regarding drug monitoring.
IV Compatibility
- There is limited information about the IV compatibility.
Overdosage
There is limited information regarding Clotrimazole (mucous membrane) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
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Clotrimazole (mucous membrane)
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| Systematic (IUPAC) name | |
| 1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole | |
| Identifiers | |
| CAS number | |
| ATC code | A01 D01AC01 (WHO) G01AF02 (WHO) Template:ATCvet |
| PubChem | |
| DrugBank | |
| 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 | & |
| 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. | |
| Legal status |
?(US) |
| Routes | topical, troche |
Mechanism of Action
There is limited information regarding Clotrimazole (mucous membrane) Mechanism of Action in the drug label.
Structure
There is limited information regarding Clotrimazole (mucous membrane) Structure in the drug label.
Pharmacodynamics
- There is limited information regarding Pharmacodynamics of Clotrimazole (mucous membrane) in the drug label.
Pharmacokinetics
- There is limited information regarding Pharmacokinetics of Clotrimazole (mucous membrane) in the drug label.
Nonclinical Toxicology
- There is limited information regarding Nonclinical Toxicology of Clotrimazole (mucous membrane) in the drug label.
Clinical Studies
- There is limited information regarding Clinical Studies of Clotrimazole (mucous membrane) in the drug label.
How Supplied
There is limited information regarding Clotrimazole (mucous membrane) How Supplied in the drug label.
Storage
There is limited information regarding Clotrimazole (mucous membrane) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- There is limited information regarding Patient Counseling Information of Clotrimazole (mucous membrane) in the drug label.
Precautions with Alcohol
- Alcohol-Clotrimazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
3 Day Vaginal Cream Clotrim Antifungal Cruex Prescription Strength Gyne-Lotrimin Gyne-Lotrimin 3 Lotrimin Lotrimin AF Mycelex
Look-Alike Drug Names
There is limited information regarding Clotrimazole (mucous membrane) 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.
- ↑ Sobel JD, Schmitt C, Meriwether C (1989). "Clotrimazole treatment of recurrent and chronic candida vulvovaginitis". Obstet Gynecol. 73 (3 Pt 1): 330–4. PMID 2644595.
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