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)

Dosing and uses of Gyne-Lotrimin-3 Combination Pack, Gyne-Lotrimin-3 Vaginal Cream (clotrimazole)

• Adult
• Pediatric

 

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)