Dosing & Uses
Dosage Forms & Strengths
troche
- 10mg
lozenge
- 10mg
Candidiasis
Oropharyngeal candidiasis (prophylaxis)
- 10 mg PO slowly dissolved in mouth tid or until steroids reduced to maintenance levels
Opharyngeal candidiasis (treatment)
- 10 mg PO slowly dissolved in mouth 5 times daily for 14 consecutive days; when used for initial HIV-1 treatment, duration is typically 7-14 days
Pouchitis (Orphan)
Topical treatment of children and adults with pouchitis
Orphan indication sponsor
- Atlantic Healthcare LTD; Maple House: Halsted, Essex CO9 4BB, UK
Dosage Forms & Strengths
troche
- 10mg
lozenges
- 10mg
Candidiasis
<3 years
- Safety and efficacy not established
>3 years
- Oropharyngeal candidiasis (prophylaxis): 10 mg PO slowly dissolved in mouth tid or until steroids reduced to maintenance levels
- Oropharyngeal candidiasis (treatment): 10 mg PO slowly dissolved in mouth 5 times daily for 14 consecutive days; when used for initial HIV-1 treatment, duration is typically 7-14 days
Pouchitis (Orphan)
Topical treatment of children and adults with pouchitis
Orphan indication sponsor
- Atlantic Healthcare LTD; Maple House: Halsted, Essex CO9 4BB, UK
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Abnl LFTs
1-10%
Nausea/vomiting (troches)
Mild burning, irritation, stinging to skin or vaginal area (vaginal tabs/cream)
Warnings
Contraindications
Hypersensitivity
Cautions
Abnormal LFTs reported, including abnormal aspartate aminotransferase reported; monitor LFTs periodically, especially in patients with hepatic impairment
Use caution; abnormal LFTs reported; elevation usually minimal; monitor LFTs periodically
Not for treatment of systemic fungal infections
For maximum efficacy, must dissolve dosage form in mouth
Pregnancy & Lactation
Pregnancy category: C
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
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)
Images
Patient Handout
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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