MYCO-TRIACET II
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYCO-TRIACET II (MYCO-TRIACET II).
MYCO-TRIACET II contains triamcinolone acetonide, neomycin, and nystatin. Triamcinolone acetonide is a corticosteroid that suppresses inflammation by inhibiting phospholipase A2 and reducing prostaglandin and leukotriene synthesis. Neomycin is an aminoglycoside antibiotic that binds to bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibiting protein synthesis. Nystatin is a polyene antifungal that binds to ergosterol in fungal cell membranes, increasing permeability and causing cell death.
| Metabolism | Triamcinolone acetonide is primarily metabolized by CYP3A4. Neomycin is not metabolized and is excreted unchanged in urine. Nystatin is not absorbed systemically and is excreted unchanged in feces. |
| Excretion | Renal: ~70% as unchanged drug (nystatin) via glomerular filtration; biliary/fecal: ~30% as metabolites/hydrolyzed products. Renal elimination is predominant. |
| Half-life | Nystatin: not detectable systemically (<0.1% absorbed); triacetin: not applicable. Clinical half-life is irrelevant due to negligible absorption. |
| Protein binding | Nystatin: <1% bound (albumin); triacetin: negligible binding (<5%) due to rapid hydrolysis to acetic acid. |
| Volume of Distribution | Not applicable (local/topical drug); Vd is 0 L/kg as systemic absorption is <0.1%. |
| Bioavailability | Topical: 0% systemic bioavailability; nystatin is not absorbed through intact skin or mucous membranes. Triacetin is hydrolyzed locally. |
| Onset of Action | Topical: antifungal effect begins within 24-72 hours of application; measurable reduction in fungal burden by 3-5 days. |
| Duration of Action | Duration of treatment: 2-4 weeks for complete eradication; residual effect persists until re-epithelialization. No systemic duration. |
Apply thin layer to affected area twice daily.
| Dosage form | OINTMENT |
| Renal impairment | No dosage adjustment required. |
| Liver impairment | No dosage adjustment required. |
| Pediatric use | Not recommended for children under 2 years of age; for children 2 years and older, apply thin layer to affected area twice daily. |
| Geriatric use | No specific dosage adjustment; use caution in elderly with impaired skin integrity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYCO-TRIACET II (MYCO-TRIACET II).
| Breastfeeding | Nystatin is not absorbed systemically and unlikely to pass into breast milk. Triamcinolone is excreted in breast milk; M/P ratio is unknown. Use only if benefit outweighs risk, avoiding application to breast area. |
| Teratogenic Risk | MYCO-TRIACET II contains nystatin and triamcinolone. Nystatin is poorly absorbed and not associated with teratogenicity; triamcinolone is a corticosteroid with reported increased risk of oral clefts in first trimester (epidemiologic studies) and fetal growth restriction with prolonged use in second/third trimester. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component (triamcinolone acetonide, neomycin, nystatin, or other corticosteroids/aminoglycosides)","Viral skin infections (e.g., herpes simplex, vaccinia, varicella)","Fungal or bacterial infections without concomitant appropriate antifungal/antibacterial therapy","Perioral dermatitis and rosacea"]
| Precautions | ["Systemic absorption of corticosteroids may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intraocular pressure.","Prolonged use may lead to overgrowth of non-susceptible organisms including fungi.","Neomycin may cause ototoxicity and nephrotoxicity if absorbed systemically, especially in patients with renal impairment or prolonged use on damaged skin.","Avoid use on large areas, denuded skin, or under occlusive dressings.","Use with caution in patients with known hypersensitivity to any component."] |
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| Fetal Monitoring |
| Monitor for signs of maternal adrenal suppression (if large doses/topical corticosteroids used), fetal growth parameters with prolonged use, and assess for intrauterine growth restriction. |
| Fertility Effects | No known adverse effects on fertility from topical nystatin or triamcinolone at recommended doses. |