clotrimazole (Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream, Gyne-Lotrimin-3 Vaginal Suppositories, Gyne-Lotrimin-7, Mycelex-7, Mycelex-7 Combination Pack, Mycelex vaginal)
Classes: Antifungals, Other
- Dosing and uses of Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole)
- Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole)
Dosing and uses of Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole)
Adult dosage forms and strengths
troche
- 10mg
vaginal cream
- 1%
- 2%
Candidiasis
Cream with applicator: If 1%, insert 1 applicatorful per day, preferably at bedtime, for 7 days; for 3 days if 2% vaginal cream used
Topical 1% cream: With finger, gently spread cream onto irritated area of vulva; apply qDay/q12hr for up to 7 days PRN to relieve external vulvar itching
Troches: 10 mg administered only as lozenge that must be slowly dissolved in mouth; administer 1 troche 5 times/day for 14 consecutive days
Pouchitis (Orphan)
Topical treatment of children and adults with pouchitis
Orphan indication sponsor
- Atlantic Healthcare LTD; Maple House: Halsted, Essex CO9 4BB, UK
Pediatric dosage forms and strengths
troche
- 10mg
vaginal cream
- 1%
- 2%
Candidiasis
<3 years
- Safety and efficacy not established
>3 years
- Cream with applicator: If 1%, insert 1 applicatorful per day, preferably at bedtime, for 7 days; for 3 days if 2% vaginal cream used
- Topical 1% cream: With finger, gently spread cream onto irritated area of vulva; apply qDay/q12hr for up to 7 days PRN to relieve external vulvar itching
- Troches: 10 mg administered only as lozenge that must be slowly dissolved in mouth; administer 1 troche 5 times/day for 14 consecutive days
Pouchitis (Orphan)
Topical treatment of children and adults with pouchitis
Orphan indication sponsor
- Atlantic Healthcare LTD; Maple House: Halsted, Essex CO9 4BB, UK
Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole) adverse (side) effects
>10%
Abnl LFTs
1-10%
Nausea/vomiting (troches)
Mild burning, irritation, stinging to skin or vaginal area (vaginal tabs/cream)
Warnings
Contraindications
Hypersensitivity
Not for ophthalmic use
Cautions
Not for use in the treatment of systemic fungal infection
Pregnancy and lactation
Pregnancy category: B (vaginal cream); C (troches)
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 of Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole)
Mechanism of action
Alters Candida cell membrane permeability; binds to phospholipids in fungal cell membrane, which alters cell wall permeability and results in the loss of intracellular elements; fungistatic and fungicidaL
Absorption
Peak plasma time
- Oral: Salivary levels occur within 3 hr following 30 min of dissolution time
- Vaginal cream: High vaginal levels, 8-24 hr
- Vaginal tablet: High vaginal levels, 1-2 d
Elimination
Excretion: Feces (as metabolites)