clotrimazole topical (Rx, OTC)

Brand and Other Names:Gyne Lotrimin, Lotrimin, more...Lotrimin AF, Mycelex topical

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream/ointment/solution

  • 1%

vaginal cream

  • 1%
  • 2%

Cutaneous Candidiasis/ Dermatophytosis

OTC products indicated for treatment of tinea pedis, tinea cruris, and tinea corporus

Prescription products indicated for Candida albicans and tinea versicolor, in addition to OTC product indications

Apply to affected area q12hr

If no improvement after 4 weeks, re-evaluate diagnosis

See also combo with betamethasone (Lotriderm/Lotrisone)

Vaginal Candidiasis

Cream (1%): Insert 1 applicatorful daily, preferably at bedtime, for 7-14 days

Cream (2%): Insert 1 applicatorful daily, preferably at bedtime, for 3 consecutive days

Superficial Dermatologic Infection

Apply to affected area q12hr for 7 consecutive days

Dosage Forms & Strengths

cream/ointment/topical solution

  • 1%

vaginal cream

  • 1%
  • 2%

Cutaneous Candidiasis/Dermatophytosis

<12 years

  • Safety and efficacy not established

>12 years

  • OTC products indicated for treatment of tinea pedis, tinea cruris, and tinea corporis
  • Prescription products indicated for Candida albicans and tinea versicolor, in addition to OTC product indications
  • Apply to affected area q12hr
  • If no improvement after 4 weeks, re-evaluate diagnosis
  • See also combo with betamethasone (Lotriderm/Lotrisone)

Vaginal Candidiasis

<12 years

  • Safety and efficacy not established

>12 years

  • Cream (1%): Insert 1 applicatorful daily, preferably at bedtime, for 7-14 days
  • Cream (2%): Insert 1 applicatorful daily, preferably at bedtime, for 3 consecutive days

Superficial Dermatologic Infection

<12 years

  • Safety and efficacy not established

>12 years

  • Apply to affected area q12hr for 7 consecutive days
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Adverse Effects

Frequency Not Defined

Blistering

Erythema

Edema

Pruritus

Burning

Stinging

Peeling

Urticaria

Skin fissures

General irritation of the skin

Elevated serum AST (SGOT) concentrations (15%)

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Warnings

Contraindications

Hypersensitivity to clotrimazole or components

Cautions

Avoid contact with eyes

Some dosage forms contain benzyl alcohol; large amounts of benzyl alcohol have been associated with gasping syndrome (potentially fatal) in neonates

Not for use by patients who have never had a vaginal infection diagnosed by a doctor

Not for use with tampons, douches, spermicides, or other vaginal products

Condoms and diagrams may damage and fail to prevent pregnancy or sexually transmitted disease

Not for use when having vaginal intercourse

May cause mild increase in vaginal burning, itching or irritation

Patient should ask doctor if symptoms do not get better in 3 days, symptoms last more than 7 days, or experience rash, abdominal pain, fever, chills, nausea, vomiting, or a foul smelling vagina discharge

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Pregnancy & Lactation

Pregnancy

Small amounts of imidazoles may be absorbed systemically following topical and vaginal administration

Lactation

Excretion in milk unknown; use with caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Antifungal activity

Alters cell membrane permeability, apparently by binding with phospholipids in the fungal cell membrane, causing essential intracellular elements to leak

Absorption

Negligible through intact skin (3-10% absorbed with intravaginal dose)

Time to peak: ~24 hr (vaginal cream)

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.