CYCLOCORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CYCLOCORT (CYCLOCORT).
Topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive actions. Suppresses cytokine production, inhibits phospholipase A2, and reduces prostaglandin synthesis.
| Metabolism | Absorbed percutaneously and metabolized primarily in the liver via cytochrome P450 enzymes, followed by renal excretion. |
| Excretion | Primarily hepatic metabolism; inactive metabolites excreted renally (<1% unchanged) and in feces (biliary). |
| Half-life | 3.5 hours (terminal); clinical effect duration longer due to tissue binding. |
| Protein binding | 75–85% bound to albumin and corticosteroid-binding globulin. |
| Volume of Distribution | 0.2–0.5 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Topical: minimal systemic absorption (1–5%) except on damaged skin; intramuscular: 100%. |
| Onset of Action | Topical: within hours for anti-inflammatory effect; intramuscular: 24–48 hours for systemic effect. |
| Duration of Action | Topical: up to 24 hours after single application; intramuscular: up to 4 weeks. |
| Molecular Weight | 502.6 |
Apply a thin film topically to affected area twice daily (morning and evening). Not for ophthalmic use.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required. Systemic absorption minimal with topical use. |
| Liver impairment | No dose adjustment required. Systemic absorption minimal with topical use. |
| Pediatric use | Apply a thin film topically to affected area twice daily. Use the least amount that controls symptoms; avoid prolonged use due to higher systemic absorption. |
| Geriatric use | Apply a thin film topically to affected area twice daily. Use caution due to thinner skin and increased systemic absorption risk; avoid prolonged use. |
| 1st trimester | Avoid use during first trimester unless potential benefit outweighs risk. Topical corticosteroids, including amcinonide, are generally avoided due to theoretical risk of cleft palate, though data are limited. |
| 2nd trimester | Use with caution; prolonged or high-dose use may lead to fetal growth restriction and adrenal suppression. Short-term, low-potency use is preferred. |
| 3rd trimester | Use with caution; may cause fetal adrenal suppression if used extensively. Discontinue before delivery if possible. |
Clinical note
Comprehensive clinical and safety monograph for CYCLOCORT (CYCLOCORT).
| Placental transfer | Corticosteroids, including amcinonide, cross the placenta to varying degrees. The extent of placental transfer is dependent on molecular weight and lipid solubility; amcinonide is a high-potency corticosteroid with moderate lipid solubility. |
| Breastfeeding | Topical application of amcinonide results in minimal systemic absorption; however, use on large areas or occluded skin may expose infant to significant amounts. Avoid application to breasts and nipples. Use lowest effective dose for shortest duration. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to amcinonide or any excipientUntreated bacterial, viral, or fungal skin infectionsPerioral dermatitisRosacea
| Precautions | Systemic absorption may cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria., Prolonged use may cause local atrophy, striae, telangiectasias, or secondary infection., Use with caution on face, intertriginous areas, or under occlusive dressings., Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body weight ratio. |
| Food/Dietary | No known food interactions. Avoid alcohol if it causes flushing or aggravates the underlying condition. |
Loading safety data…
| Lactation Rating | L3: Limited Data - Probably Compatible |
| Teratogenic Risk | Topical corticosteroids have not been established as teratogenic in humans. Cyclocort (amcinonide) is classified as Pregnancy Category C. Animal studies have shown teratogenicity with systemic administration at relatively low doses. In pregnant women, topical application may result in minimal systemic absorption, but fetal risk cannot be ruled out. Use only if potential benefit justifies risk to fetus. First trimester: Avoid use unless necessary. Second and third trimesters: Use with caution, avoid prolonged use on large areas or occlusive dressings. |
| Fetal Monitoring | No specific monitoring required for maternal or fetal well-being. However, in cases of extensive or prolonged topical use, monitor for signs of maternal adrenal suppression (e.g., fatigue, hypotension) and fetal growth parameters if used extensively during pregnancy. |
| Fertility Effects | Systemic corticosteroids have been associated with decreased fertility in animal studies. Amcinonide is a topical corticosteroid; significant systemic absorption is unlikely with appropriate use. No specific human data on fertility effects. |
| Clinical Pearls |
| Cyclocort (amcinonide) is a high-potency topical corticosteroid; limit use to 2 consecutive weeks to avoid adrenal suppression. Do not use on face, groin, or axillae due to increased risk of atrophy and telangiectasia. Occlusion increases systemic absorption; avoid occlusive dressings unless directed. Monitor for signs of local irritation or allergic contact dermatitis. |
| Patient Advice | Apply a thin layer to the affected area only; do not use on open wounds or broken skin. · Wash hands before and after application unless treating the hands. · Avoid covering the treated area with bandages or wraps unless instructed by your doctor. · Do not use on the face, groin, or underarms unless specifically directed. · Do not use for more than 2 weeks without re-evaluation by your healthcare provider. · Report any signs of skin thinning, irritation, or infection to your doctor. |