MYCOLOG-II
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYCOLOG-II (MYCOLOG-II).
MYCOLOG-II (nystatin and triamcinolone acetonide) combines nystatin, a polyene antifungal that binds to ergosterol in fungal cell membranes causing leakage of cellular contents, and triamcinolone acetonide, a corticosteroid that inhibits phospholipase A2, reducing inflammatory mediators.
| Metabolism | Nystatin is not absorbed systemically and is excreted unchanged in feces. Triamcinolone acetonide is metabolized hepatically via CYP3A4. |
| Excretion | Nystatin: negligible systemic absorption; >99% eliminated unchanged in feces via biliary/fecal route. Triamcinolone acetonide: ~30% renal, ~60% biliary/fecal as metabolites; <10% unchanged. |
| Half-life | Nystatin: not applicable (local action, negligible absorption). Triamcinolone acetonide: terminal elimination half-life approximately 2-4 hours in plasma; clinical effect duration relates to local tissue retention. |
| Protein binding | Nystatin: negligible protein binding. Triamcinolone acetonide: approximately 78-80% bound to corticosteroid-binding globulin and albumin. |
| Volume of Distribution | Nystatin: not applicable (topical, not absorbed). Triamcinolone acetonide: approximately 1.4 L/kg (varies with formulation); systemic distribution following topical application is minimal. |
| Bioavailability | Topical: nystatin bioavailability is negligible (<0.1%) via intact skin; triamcinolone acetonide systemic bioavailability is approximately 1-5% through intact skin, higher with occlusive dressings or inflamed skin. |
| Onset of Action | Topical: nystatin initiates antifungal effect within 24-48 hours; triamcinolone acetonide provides relief from inflammation within hours of application. |
| Duration of Action | Topical: nystatin requires continued application for full treatment (usually 2 weeks); triamcinolone acetonide duration of anti-inflammatory effect is 6-12 hours per application. |
Apply topically twice daily. Each gram contains 100,000 units nystatin and 0.1 mg triamcinolone acetonide.
| Dosage form | OINTMENT |
| Renal impairment | No dosage adjustment required for topical use; systemic absorption negligible. |
| Liver impairment | No dosage adjustment required for topical use; systemic absorption negligible. |
| Pediatric use | Apply topically twice daily; use smallest amount sufficient to cover affected area. Not recommended in children under 2 years due to triamcinolone content unless directed by physician. |
| Geriatric use | Use with caution due to increased risk of skin atrophy and systemic absorption from prolonged use; apply sparingly to small areas. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYCOLOG-II (MYCOLOG-II).
| Breastfeeding | Nystatin is not absorbed systemically; triamcinolone acetonide excretion in milk unknown. Given minimal absorption of nystatin and potential for systemic corticosteroid effects, caution; M/P ratio not available. |
| Teratogenic Risk | Mycolog-II (nystatin/triamcinolone acetonide): No adequate studies in pregnant women. Nystatin is poorly absorbed and considered low risk. Triamcinolone acetonide is a corticosteroid; animal studies show increased risk of cleft palate at high doses. Risk cannot be ruled out; use only if benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to nystatin, triamcinolone acetonide, or any component","Viral skin infections (e.g., herpes simplex, vaccinia, varicella)","Ophthalmic use","Untreated bacterial or fungal infections of the skin"]
| Precautions | ["Topical corticosteroids may cause reversible HPA axis suppression with potential glucocorticosteroid insufficiency after withdrawal","Risk of skin atrophy, striae, telangiectasias, and secondary infection","Use with caution in patients with impaired skin integrity or large surface area application"] |
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| Fetal Monitoring |
| Monitor fetal growth if used extensively. Assess for signs of maternal adrenal suppression with prolonged use. |
| Fertility Effects | No specific data. Corticosteroids may impair fertility in animal studies; relevance unknown. |