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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYCHEL-S (MYCHEL-S).
| Breastfeeding | Chloramphenicol is excreted into breast milk; M/P ratio ~0.5-0.6. Contraindicated during breastfeeding due to risk of dose-dependent bone marrow suppression and idiosyncratic aplastic anemia in nursing infants. |
| 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 |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to sulconazole or any component of the formulation.
| 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). |
Loading safety data…
| 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. |