CORMAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORMAX (CORMAX).
Corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive effects. Binds to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reduce prostaglandin and leukotriene synthesis, and suppress cytokine release.
| Metabolism | Primarily hepatic via cytochrome P450 enzymes; undergoes glucuronidation and sulfation. Topical administration limits systemic absorption, but absorbed fraction is metabolized similarly. |
| Excretion | Renal: 90% unchanged; minor biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 3.5 hours (range 2.5-4.5 h); clinical context: dosing every 4-6 hours to maintain therapeutic levels |
| Protein binding | 70% bound to albumin |
| Volume of Distribution | 2.5 L/kg (0.5-4.0 L/kg); clinical meaning: extensive extravascular distribution, therapeutic levels achieved in tissues |
| Bioavailability | Oral: 85% (range 75-95%); topical: 15-25% systemic absorption |
| Onset of Action | Oral: 30-60 minutes; IV: immediate; Topical: 2-4 hours for local effect |
| Duration of Action | Oral/IV: 6-8 hours; Topical: 8-12 hours; clinical note: duration prolonged in hepatic impairment |
| Molecular Weight | 355.43 |
| Action Class | Analgesic & Antipyretic-PCM |
| Brand Substitutes | Calpol 500mg Tablet, Dolo 500 Tablet, T-98 Tablet, Pacimol 500 Tablet, Parazex 500mg Tablet, Algina 650 Tablet, Pyrakem 650mg Tablet, PUC 650 Tablet, Paracip 650 Tablet, Dolopar 650 Tablet |
2.5 mg orally twice daily; maximum 10 mg/day.
| Dosage form | CREAM |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 20-50 mL/min: reduce dose by 50%; GFR <20 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | 0.05 mg/kg orally twice daily; maximum 5 mg/day. |
| Geriatric use | Initiate at 1.25 mg orally twice daily; increase cautiously, maximum 7.5 mg/day. |
| 1st trimester | Limited human data; avoid use unless benefit outweighs risk. Animal studies have shown teratogenicity at high doses. |
| 2nd trimester | Use only if clearly needed, as no well-controlled studies exist. |
| 3rd trimester | Avoid use in late pregnancy due to potential for premature closure of ductus arteriosus and fetal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for CORMAX (CORMAX).
| Placental transfer | Crosses the placenta; fetal plasma levels can reach 30-50% of maternal levels. |
| Breastfeeding | Small amounts are excreted into breast milk; however, adverse effects in nursing infants are unlikely with short-term use. Caution is advised, especially in infants with renal impairment. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
History of hypersensitivity to CORMAX or any NSAIDActive peptic ulcer disease or gastrointestinal bleedingSevere renal impairment (CrCl <30 mL/min)Third trimester of pregnancyHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsUndergoing coronary artery bypass graft (CABG) surgery
| Precautions | Systemic absorption may cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria., Prolonged use or use on large areas may increase systemic absorption., Children may be more susceptible to systemic toxicity due to higher skin surface-to-body weight ratio., Avoid use on face, axillae, or groin unless directed by physician., May mask signs of infection or cause secondary infections., Do not use for diaper dermatitis or under occlusive dressings unless specified. |
| Food/Dietary | No known food interactions with topical clobetasol propionate. Systemic absorption is minimal with proper use, but oral ingestion of large amounts could theoretically cause systemic effects; avoid ingesting the product. |
Loading safety data…
| L2 (Safer) - limited data but appears safe |
| Teratogenic Risk | CORMAX (clobetasol propionate, a super-high potency topical corticosteroid) is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Systemic absorption of topical corticosteroids has resulted in fetal abnormalities in animal studies. In the first trimester, risks are theoretical; use only if potential benefit justifies risk. In the second and third trimesters, prolonged use or large areas can cause intrauterine growth restriction and adrenal suppression in the neonate. Avoid use in large quantities or for prolonged periods. |
| Fetal Monitoring | Monitor maternal adrenal axis function if used over large body surface areas or for prolonged periods (assess cortisol levels). Monitor fetal growth with serial ultrasounds if prolonged use during pregnancy. In neonates exposed in utero, monitor for signs of hypothalamic-pituitary-adrenal axis suppression, including low cortisol, hypoglycemia, and poor weight gain. |
| Fertility Effects | No specific human studies on fertility. Animal studies have shown no impairment of fertility at topical doses. Potential effects are unknown; however, systemic corticosteroids can affect reproductive hormones. Use with caution in patients attempting to conceive. |
| Clinical Pearls | CORMAX (clobetasol propionate) is a super-high-potency topical corticosteroid. Limit use to 2 consecutive weeks; avoid use on face, groin, or axillae due to increased risk of atrophy and striae. Do not use under occlusion unless directed. Monitor for hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with large surface area use. Use only for inflammatory and pruritic dermatoses responsive to corticosteroids. |
| Patient Advice | Apply a thin layer to affected areas only, usually twice daily, as directed by your doctor. · Do not use for more than 2 weeks unless specifically instructed by your healthcare provider. · Avoid contact with eyes, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water. · Do not cover the treated area with bandages or other occlusive dressings unless told to do so by your doctor. · Wash hands after applying the medication, unless treating the hands. · Inform your doctor if you experience skin thinning, easy bruising, or signs of infection at the application site. · Do not use this medication for any condition other than that for which it was prescribed. · Keep out of reach of children. Do not use on children under 12 years of age unless specifically prescribed. |