CLODERM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLODERM (CLODERM).
Cloderm (clocortolone pivalate) is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortins), which inhibit arachidonic acid release, reducing prostaglandin and leukotriene synthesis.
| Metabolism | Topical corticosteroids undergo hepatic metabolism primarily via cytochrome P450 enzymes, followed by renal excretion of metabolites. |
| Excretion | Primarily hepatic metabolism followed by renal excretion of inactive metabolites; minimal unchanged drug excreted renally (<1%). Biliary/fecal excretion accounts for approximately 20% of total clearance. |
| Half-life | Terminal elimination half-life is 72-120 hours (3-5 days) for clobetasol propionate, reflecting slow release from skin depot after topical application; systemic half-life after intravenous administration is approximately 2-3 hours. |
| Protein binding | Highly protein-bound (98-99%), primarily to albumin and corticosteroid-binding globulin. |
| Volume of Distribution | After topical application, Vd is not clinically applicable due to local action. Systemic Vd after intravenous administration in small studies is approximately 1.0-1.5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Topical bioavailability is variable and depends on skin condition, site, and occlusion; estimated at 1-5% through intact skin, but may increase to 20-30% with compromised skin barrier or occlusion. |
| Onset of Action | Topical: Improvement in pruritus and erythema noted within 1-2 days of twice-daily application; maximal effect on plaque thickness and scaling seen after 1-2 weeks. |
| Duration of Action | Topical: Therapeutic effect persists for 12-24 hours after a single application; with regular use, disease suppression may last days to weeks. Prolonged use (>2 weeks) increases risk of skin atrophy and systemic absorption. |
| Molecular Weight | 466.98 |
| Action Class | Glucocorticoids |
| Brand Substitutes | Topinate Cream, Lozivate Cream, Cortent Cream, Clobital Cream, Cortirate Cream |
Topical: Apply a thin film to affected skin areas twice daily (morning and evening). Duration depends on severity and response.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment due to negligible systemic absorption with topical use. |
| Liver impairment | No dosage adjustment required for hepatic impairment due to negligible systemic absorption with topical use. |
| Pediatric use | Children ≥12 years: Same as adult dose. Children <12 years: Safety and efficacy not established, use only if potential benefit outweighs risk. |
| Geriatric use | Use with caution due to higher risk of skin atrophy and systemic side effects from prolonged use. Limit treatment duration and monitor closely. |
| 1st trimester | Cloderm (clocortolone pivalate) is a topical corticosteroid. Systemic absorption is low, but animal studies have shown teratogenicity with high doses. Use only if potential benefit justifies risk to the fetus. |
| 2nd trimester | Use with caution. Topical corticosteroids are generally considered relatively safe during the second trimester if used sparingly on small areas for short durations. |
| 3rd trimester | Avoid prolonged use, especially on large areas or under occlusive dressings, due to risk of fetal adrenal suppression or low birth weight. |
Clinical note
Comprehensive clinical and safety monograph for CLODERM (CLODERM).
| Placental transfer | Topical corticosteroids can be absorbed percutaneously and may cross the placenta. The degree is dependent on the site, area, and duration of application, as well as skin integrity. |
| Breastfeeding | It is not known if topical clocortolone pivalate is excreted in breast milk after topical application. Systemic absorption is minimal with proper use, but caution is advised to avoid application on the breast or large areas. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to clocortolone pivalate or any component of the formulationUntreated bacterial, fungal, viral, or parasitic skin infections at the application site
| Precautions | Systemic absorption may cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, glucosuria, hypothalamic-pituitary-adrenal axis suppression, pediatric patients may be more susceptible to systemic toxicity, do not use on infected lesions unless anti-infective therapy is given |
| Food/Dietary | No known food interactions. Oral corticosteroids may require monitoring of serum glucose and potassium, but topical absorption is minimal unless applied to large body surface areas or under occlusion. |
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| Lactation Rating | L3 - Moderately Safe (limited data, avoid prolonged use near breast) |
| Teratogenic Risk | FDA Pregnancy Category C. No adequate human studies; animal studies show fetal harm at high doses. Avoid in first trimester unless benefit outweighs risk. |
| Fetal Monitoring | Monitor fetal growth via ultrasound if used long-term during pregnancy; assess maternal blood pressure and glucose levels as corticosteroids may elevate both. |
| Fertility Effects | No specific data on fertility impairment; animal studies show no effect at therapeutic doses. |
| Clinical Pearls | Cloderm (clocortolone pivalate) is a medium-potency topical corticosteroid. Limit use to 2 consecutive weeks on face, groin, axillae, or intertriginous areas. Avoid abrupt discontinuation due to risk of rebound flare. Monitor for skin atrophy, striae, and telangiectasias with prolonged use. Not recommended for diaper dermatitis or under occlusive dressings unless directed. |
| Patient Advice | Apply a thin layer to affected skin only, usually twice daily. · Do not use on broken skin, open wounds, or acne. · Avoid contact with eyes, mouth, or vaginal area. · Do not cover the area with bandages or plastic unless instructed by your doctor. · Wash hands after applying unless treating the hands. · Notify your doctor if symptoms worsen or do not improve within 2 weeks. · Do not use for longer than prescribed; long-term use can cause skin thinning. |