METI-DERM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for METI-DERM (METI-DERM).
METI-DERM contains methylprednisolone aceponate, a corticosteroid that binds to glucocorticoid receptors, modulating gene expression to inhibit pro-inflammatory cytokines, phospholipase A2, and prostaglandin synthesis, thereby reducing inflammation, pruritus, and vasodilation.
| Metabolism | Methylprednisolone aceponate is hydrolyzed by esterases in the skin and systemically to methylprednisolone, which undergoes hepatic metabolism via CYP3A4 to inactive metabolites. |
| Excretion | Renal: ~60% as unchanged drug and metabolites; biliary/fecal: ~35% as metabolites and unchanged drug; minor respiratory elimination. |
| Half-life | Terminal elimination half-life: 6–8 hours in healthy adults; prolonged to 12–15 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 88% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd: 0.8–1.2 L/kg; indicates moderate tissue distribution with accumulation in inflamed tissues. |
| Bioavailability | Topical: ~2–5% systemic bioavailability; oral: ~70–80% with first-pass metabolism. |
| Onset of Action | Topical: within 1–2 hours for anti-inflammatory effect; peak plasma concentrations at 4–6 hours after topical application. |
| Duration of Action | Topical: anti-inflammatory effects persist for 12–24 hours; systemic effects may last up to 24 hours after single dose. |
Apply a thin film topically to affected area once or twice daily.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | For children 2 years and older, apply a thin film topically to affected area once or twice daily. Safety and efficacy in children under 2 years have not been established. |
| Geriatric use | Use with caution due to potential for skin atrophy and increased systemic absorption; apply the smallest amount for the shortest duration necessary. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for METI-DERM (METI-DERM).
| Breastfeeding | Unknown if excreted in breast milk; M/P ratio not determined; caution advised due to potential for systemic absorption in infant. |
| Teratogenic Risk | Insufficient human data; animal studies not performed; use only if benefit outweighs risk; potential fetal harm cannot be excluded. |
| Fetal Monitoring | Monitor fetal growth ultrasound if used during second/third trimester; assess for signs of maternal adrenal suppression. |
■ FDA Black Box Warning
None (not an FDA boxed warning drug)
| Serious Effects |
["Hypersensitivity to methylprednisolone aceponate or any component of the formulation","Untreated cutaneous bacterial, fungal, or viral infections (e.g., herpes simplex, vaccinia, varicella)"]
| Precautions | ["Topical corticosteroids may cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria upon systemic absorption, especially with use on large surface areas, occlusive dressings, or in pediatric patients.","Local adverse reactions include skin atrophy, striae, telangiectasias, burning, itching, and allergic contact dermatitis.","Avoid use in the presence of untreated bacterial, fungal, or viral cutaneous infections.","Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body weight ratios.","Not for ophthalmic or oral use. Discontinue if irritation develops."] |
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| Fertility Effects | No known impairment of fertility in animal studies; human data lacking. |