CUTIVATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CUTIVATE (CUTIVATE).
Glucocorticoid receptor agonist; modulates gene expression to inhibit inflammatory mediators, vasoconstriction, and immunosuppression.
| Metabolism | Hepatic; primarily via CYP3A4-mediated oxidation and glucuronidation. |
| Excretion | Primarily hepatic metabolism; metabolites are excreted renally and fecally. Unchanged drug is negligible in urine. Route: renal (~60% as metabolites), fecal (~40% as metabolites). |
| Half-life | 2-4 hours (terminal elimination half-life); short half-life supports twice-daily dosing for maintenance of clinical effect. |
| Protein binding | Approximately 88-94% bound to plasma proteins, primarily albumin and corticosteroid-binding globulin. |
| Volume of Distribution | 0.5-1.0 L/kg after systemic absorption; extensive distribution to tissues due to moderate lipophilicity. |
| Bioavailability | Topical: minimal systemic absorption (approximately 1-5% of applied dose) when applied to intact skin. Absorption increases with occluded or damaged skin. |
| Onset of Action | Topical: improvement often noted within 1 week of regular twice-daily application; effect may be seen as early as 2-3 days in some patients. |
| Duration of Action | Duration of effect is approximately 12-24 hours after topical application, necessitating twice-daily application for continuous efficacy. |
Apply a thin layer to affected skin areas once or twice daily. Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
| Dosage form | LOTION |
| Renal impairment | No dose adjustment required. |
| Liver impairment | No dose adjustment required for topical use. |
| Pediatric use | Apply a thin layer to affected areas once or twice daily. Use the least amount necessary to control symptoms. Treatment duration should be limited to the minimum necessary due to increased systemic absorption. Not recommended for use in children under 12 years of age unless directed by a physician. |
| Geriatric use | Use with caution. Apply the smallest amount for the shortest duration necessary to achieve desired clinical benefit due to increased risk of skin atrophy and systemic effects. Monitor for local adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CUTIVATE (CUTIVATE).
| Breastfeeding | It is unknown if fluticasone propionate is excreted in human milk after topical administration. Systemically administered corticosteroids appear in breast milk and could cause growth suppression or interfere with endogenous corticosteroid production. The M/P ratio is not established. Use caution; apply minimal amount to smallest area for shortest duration. Consider alternative therapies in nursing mothers. |
| Teratogenic Risk | CUTIVATE (fluticasone propionate) is a topical corticosteroid. Systemic absorption is minimal with topical use, but high-dose or prolonged application may increase risk. In animal studies, corticosteroids have shown teratogenicity (cleft palate, intrauterine growth retardation). For humans, data are limited; avoid use in first trimester unless benefit outweighs risk. In second and third trimesters, use lowest effective dose for shortest duration. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Hypersensitivity to fluticasone propionate or any excipient","Untreated bacterial, fungal, or viral skin infections"]
| Precautions | ["HPA axis suppression","Cushing's syndrome","Systemic absorption with prolonged use or large surface area","Local adverse reactions (e.g., atrophy, striae, acneiform eruptions)","Allergic contact dermatitis","Ophthalmic effects (e.g., glaucoma, cataracts)"] |
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| Fetal Monitoring | Monitor for signs of adrenal suppression in the mother if used extensively, especially with occlusive dressings. In pregnancy, monitor fetal growth via ultrasound if prolonged use of high-potency corticosteroid. Assess for maternal hyperglycemia and hypertension. No specific fetal monitoring required for short-term low-potency use. |
| Fertility Effects | No studies on fertility effects of topical fluticasone propionate in humans. Animal studies with corticosteroids have shown reduced fertility at high systemic doses. Topical use with minimal absorption is unlikely to impact fertility significantly. |