CAPEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CAPEX (CAPEX).
Corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.
| Metabolism | Hepatic metabolism, primarily via CYP3A4. |
| Excretion | Primarily renal (hepatic metabolism to inactive metabolites; <1% excreted unchanged in urine). Fecal elimination accounts for <5%. |
| Half-life | Terminal elimination half-life is approximately 1.5–2 hours. This short half-life supports twice-daily dosing for maintenance of therapeutic levels. |
| Protein binding | Approximately 98% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | Apparent volume of distribution is 0.3–0.5 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Topical: Bioavailability is 1–5% (dependent on skin condition and formulation). Intramuscular: 100% (complete absorption). |
| Onset of Action | Topical: Onset of action within 1–2 weeks of regular application. Intramuscular: Onset within 24–72 hours. Intravenous: Immediate. |
| Duration of Action | Topical: Duration of effect is 12–24 hours after application. Intramuscular: Duration of action 2–3 weeks. Intravenous: Duration 6–12 hours. |
| Molecular Weight | 452.5 |
Topical application of a thin film twice daily to affected areas. Not for ophthalmic, oral, or intravaginal use.
| Dosage form | SHAMPOO |
| Renal impairment | No dose adjustment required for renal impairment; systemic absorption is minimal. |
| Liver impairment | No specific guidelines; use with caution in severe hepatic impairment due to potential for increased systemic exposure. |
| Pediatric use | Apply a thin film to affected areas twice daily in children aged 2 years and older; safety and efficacy in infants <2 years not established. |
| Geriatric use | No specific dose adjustment; use caution due to age-related skin thinning and potential for increased systemic absorption. |
| 1st trimester | Topical corticosteroids like CAPEX (fluocinolone acetonide) are generally avoided during first trimester unless potential benefit outweighs risk; limited data suggest low systemic absorption but animal studies show some teratogenicity. |
| 2nd trimester | Use with caution; prolonged or high-dose use may affect fetal growth. Systemic absorption is minimal with topical application to small areas. |
| 3rd trimester | Use with caution near term; high doses or widespread application may cause fetal adrenal suppression or low birth weight. |
Clinical note
Comprehensive clinical and safety monograph for CAPEX (CAPEX).
| Placental transfer | Fluocinolone acetonide crosses placenta; minimal systemic absorption from topical use limits fetal exposure, but high doses or prolonged use may lead to detectable levels. |
| Breastfeeding | Systemic absorption via topical application is minimal; use on small areas (<10% body surface) and avoid application to breast area to limit infant exposure. No known adverse effects in breastfed infants. |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
Hypersensitivity to fluocinolone acetonide or any component of the formulationUntreated bacterial, fungal, viral, or parasitic skin infectionsTuberculous skin lesionsSyphilitic skin lesionsPerioral dermatitisRosacea
| Precautions | Systemic absorption may cause reversible HPA axis suppression., Local adverse reactions include skin atrophy, telangiectasias, and acneiform eruptions., Prolonged use on face, intertriginous areas, or under occlusion increases risk of local effects., Use in children may cause growth retardation., Avoid use in patients with active infections at treatment site. |
| Food/Dietary | No known food interactions with topical flurandrenolide. Systemic absorption is minimal with proper use, so dietary restrictions are not required. |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | CAPEX (clobetasol propionate) is a high-potency topical corticosteroid. Systemic absorption is minimal with topical use but can increase with large surface area or occlusive dressings. Animal studies show corticosteroids are teratogenic (cleft palate, IUGR). Human data: insufficient for topical use; oral corticosteroids have shown increased risk of oral clefts (OR 1.6-3.4) and IUGR. First trimester: potential but low risk with topical use; second/third trimester: risk of IUGR and adrenal suppression in fetus if significant systemic absorption occurs. |
| Fetal Monitoring | Monitor for signs of maternal adrenal suppression (fatigue, hypotension) with prolonged use over large areas. Fetal monitoring: serial growth ultrasounds if systemic absorption is suspected (e.g., high-dose, occlusive use). Newborn: observe for transient adrenal insufficiency if maternal use was extensive near delivery. |
| Fertility Effects | No studies on clobetasol and human fertility. Animal studies show no impairment of fertility at topical doses. Systemic corticosteroids may cause menstrual irregularities, but topical use is unlikely to affect fertility. |
| Clinical Pearls | CAPEX (flurandrenolide) is a high-potency topical corticosteroid. Limit use to 2 weeks continuously to avoid tachyphylaxis and skin atrophy. Avoid application to face, groin, axillae, or under occlusion unless absolutely necessary. Sudden discontinuation after prolonged use can cause rebound inflammation. Monitor for systemic absorption if used on large surface areas or broken skin. |
| Patient Advice | Apply a thin layer only to affected skin, usually twice daily. · Do not use on face, underarms, or groin unless directed by your doctor. · Avoid covering the area with bandages or wrappings unless instructed. · Do not use for longer than prescribed; prolonged use can thin the skin. · Wash hands after applying, unless treating hands. · Stop use and call your doctor if skin irritation or infection develops. |