MYCHEL-S
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYCHEL-S (MYCHEL-S).
Sulconazole inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
| Metabolism | Not systemically absorbed following topical application; metabolism via hepatic CYP450 pathways if absorbed, but minimal systemic exposure. |
| Excretion | Renal: 70-80% as unchanged drug via glomerular filtration and tubular secretion; biliary/fecal: <5%. |
| Half-life | 3-4 hours in normal renal function; prolonged to 20-40 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | 65-70% bound to serum proteins, primarily albumin. |
| Volume of Distribution | 0.2-0.3 L/kg; limited distribution, primarily extracellular fluid. |
| Bioavailability | IM: ~90%; IV: 100%. |
| Onset of Action | IM: 1-2 hours; IV: immediate. |
| Duration of Action | 6-8 hours for IM; 4-6 hours for IV; monitoring of serum levels recommended for prolonged therapy. |
| Molecular Weight | 1250 |
200 mg orally every 12 hours for 14 days
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: 200 mg every 24 hours; GFR 30-50 mL/min: 200 mg every 12 hours; GFR >50 mL/min: no adjustment |
| Liver impairment | Child-Pugh B or C: avoid use; Child-Pugh A: no adjustment |
| Pediatric use | Not recommended below 12 years of age; ≥12 years: same as adult dosing |
| Geriatric use | No specific dose adjustment; monitor renal function and adjust per renal dosing |
| 1st trimester | Avoid unless clearly needed; animal studies show risk and no adequate human studies. |
| 2nd trimester | Use only if potential benefit justifies potential risk to fetus; may cause fetal harm. |
| 3rd trimester | May cause premature closure of ductus arteriosus and pulmonary hypertension; avoid in third trimester. |
Clinical note
Comprehensive clinical and safety monograph for MYCHEL-S (MYCHEL-S).
| Placental transfer | Yes; crosses placenta and achieves fetal serum concentrations up to 30% of maternal levels. |
| Breastfeeding | Small amounts excreted in breast milk; risk of adverse effects in infant, especially diarrhea and candidiasis. Use with caution only if clearly needed. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to nystatin or any componentCandida infection of the skin or mucous membranes not indicated for systemic treatment
| Precautions | For external use only. Avoid contact with eyes. If irritation or sensitization occurs, discontinue use. Use in pregnancy only if clearly needed (Category C). |
| Food/Dietary | No significant food interactions reported. |
| Clinical Pearls | MYCHEL-S is a combination antifungal containing clotrimazole and betamethasone. For topical use only; avoid prolonged use on intertriginous areas due to risk of skin atrophy. Not for ophthalmic or oral use. Reassess if no improvement after 2 weeks. |
Loading safety data…
| L3 - Moderately Safe |
| Teratogenic Risk | Mychel-S (chloramphenicol) crosses placenta; contraindicated in all trimesters due to dose-dependent bone marrow suppression and risk of gray baby syndrome (fetal cardiovascular collapse) especially near term. Associated with increased risk of cleft palate in animal studies. |
| Fetal Monitoring | Monitor maternal complete blood counts (CBC) weekly for leukopenia, thrombocytopenia, anemia; serum drug levels (peak 15-25 mcg/mL, trough <5 mcg/mL) to avoid toxicity. Fetal monitoring includes ultrasound for growth restriction and signs of fetal distress near term. |
| Fertility Effects | Chloramphenicol can cause reversible sperm motility reduction and impaired spermatogenesis in males; ovarian suppression reported in females. No definitive evidence of permanent infertility; use during pregnancy avoidance due to teratogenicity. |
| Patient Advice | Apply a thin layer to affected skin twice daily, morning and evening. · Avoid contact with eyes, mouth, and open wounds. · Do not cover with bandages or dressings unless directed by your doctor. · Use for the full prescribed duration even if symptoms improve. · Report signs of skin thinning, irritation, or infection worsening. |