FOAMICON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FOAMICON (FOAMICON).
FOAMICON is a topical antifungal agent that inhibits ergosterol synthesis by binding to fungal cytochrome P450 14α-demethylase, disrupting fungal cell membrane integrity.
| Metabolism | Not systemically absorbed; undergoes minimal hepatic metabolism via CYP450 enzymes if absorbed. |
| Excretion | Primarily renal (65% unchanged, 15% as inactive metabolites); biliary/fecal 20%. |
| Half-life | Terminal elimination half-life 12-15 hours; clinically, steady-state achieved in ~3 days. |
| Protein binding | 98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.9 L/kg; indicates extensive tissue distribution, crossing placenta and blood-brain barrier. |
| Bioavailability | Oral: 85-92%; IM: 90-95%. |
| Onset of Action | Oral: 30-45 minutes; IV: immediate (within 2-3 minutes). |
| Duration of Action | Oral: 6-8 hours; IV: 4-6 hours. |
| Molecular Weight | 232.28 |
Adults: 200 mg orally once daily, with or without food.
| Dosage form | TABLET, CHEWABLE |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, reduce dose to 100 mg once daily. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose to 100 mg once daily. Child-Pugh Class C: not recommended (no data). |
| Pediatric use | Children ≥12 years: 200 mg orally once daily. Children 6-11 years: 100 mg orally once daily. Children <6 years: not established. |
| Geriatric use | No specific dose adjustment recommended; monitor renal function and consider starting at lower dose due to potential age-related decline in renal function. |
| 1st trimester | No adequate studies in pregnant women; animal studies not available. Use only if potential benefit justifies risk to fetus. |
| 2nd trimester | No adequate studies in pregnant women; animal studies not available. Use only if potential benefit justifies risk to fetus. |
| 3rd trimester | No adequate studies in pregnant women; animal studies not available. Use only if potential benefit justifies risk to fetus. |
Clinical note
Comprehensive clinical and safety monograph for FOAMICON (FOAMICON).
| Placental transfer | Likely crosses placenta based on molecular weight and lipophilicity; no specific studies available. |
| Breastfeeding | It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any component of the formulation
| Precautions | Avoid contact with eyes; discontinue if irritation or sensitization occurs; not for vaginal or oral use. |
| Food/Dietary | Avoid grapefruit and grapefruit juice as it may increase FOAMICON levels and risk of side effects. Take with food if gastrointestinal upset occurs. |
| Clinical Pearls | FOAMICON is a low-sedating antihistamine; adjust dose in renal impairment (creatinine clearance <30 mL/min: 60 mg once daily). Avoid use in patients with severe hepatic impairment. Monitor for QT prolongation when co-administered with CYP3A4 inhibitors or other QT-prolonging agents. |
Loading safety data…
| Lactation Rating |
| L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: No data; second/third trimester: unknown; animal studies not available. |
| Fetal Monitoring | No specific recommendations; close monitoring for maternal adverse effects. |
| Fertility Effects | No data on human fertility; animal studies not available. |
| Patient Advice | Take FOAMICON at the same time each day, with or without food. · Do not exceed the recommended dose; may cause drowsiness in some patients. · Avoid alcohol and other central nervous system depressants while taking FOAMICON. · Contact your doctor if you experience irregular heartbeat, severe dizziness, or fainting. · Do not use if you have severe liver or kidney disease without medical advice. |