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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CYCLOCORT (CYCLOCORT).
| Breastfeeding | It is not known whether topical amcinonide is excreted in human milk. Systemic corticosteroids appear in breast milk and could suppress growth or interfere with endogenous corticosteroid production. A risk to the infant cannot be excluded. Use with caution in nursing mothers, and avoid application to breast area prior to feeding. M/P ratio: Not available. |
| 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. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component of the formulation","Untreated bacterial, fungal, viral, or parasitic infections at treatment site"]
| 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."] |
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| 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. |