Dosing & Uses
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
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%)
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
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.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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Formulary
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