TOPICORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TOPICORT (TOPICORT).
Topical corticosteroid that induces phospholipase A2 inhibitory proteins, collectively called lipocortins, which inhibit the release of arachidonic acid, thereby reducing production of prostaglandins and leukotrienes, leading to anti-inflammatory, antipruritic, and vasoconstrictive effects.
| Metabolism | Metabolized primarily in the liver via cytochrome P450 enzymes; systemic absorption after topical application is minimal. |
| Excretion | Renal (metabolites): ~75%; Fecal: ~25% |
| Half-life | Terminal elimination half-life: 2-4 hours for parent drug; clinical effect lasts longer due to receptor binding |
| Protein binding | ~99% bound to plasma proteins, primarily albumin and corticosteroid-binding globulin |
| Volume of Distribution | Vd: 0.5-1.0 L/kg; indicates extensive tissue distribution |
| Bioavailability | Topical: variable, <1% systemic absorption through intact skin; enhanced by occlusion or damaged skin |
| Onset of Action | Topical: within 1-2 hours for vasoconstriction; systemic effects not clinically relevant |
| Duration of Action | Topical: anti-inflammatory effect persists for 12-24 hours after single application; duration depends on formulation and site |
Apply a thin film to the affected skin areas twice daily. Maximum adult dose: 50 g/week. Not for use on the face, axillae, or groin. Do not use under occlusive dressings.
| Dosage form | CREAM |
| Renal impairment | No specific dosing adjustments required for renal impairment; topical application results in minimal systemic absorption. No GFR-based data available. |
| Liver impairment | No specific dosing adjustments required for hepatic impairment; topical application results in minimal systemic absorption. No Child-Pugh based data available. |
| Pediatric use | Not recommended for use in children under 12 years of age due to increased risk of HPA axis suppression and systemic toxicity. For children 12-18 years: apply sparingly to affected areas once or twice daily for no more than 2 consecutive weeks. Maximum 25 g/week. Avoid use on face, intertriginous areas, or under occlusion. |
| Geriatric use | Use with caution in elderly patients due to thinner skin and increased risk of adverse effects. Apply sparingly to affected areas once or twice daily for the shortest duration necessary. Avoid use on face, intertriginous areas, or under occlusion. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TOPICORT (TOPICORT).
| Breastfeeding | It is unknown whether topical desoximetasone is excreted in human milk. However, systemic corticosteroids are excreted, and after topical application, systemic absorption is minimal for low potency formulations. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The M/P ratio is not established due to lack of data. |
| Teratogenic Risk | Topical corticosteroids are generally considered low risk for teratogenicity when used in small amounts on small areas of skin. However, systemic absorption can increase with extensive use, occlusive dressings, or prolonged treatment. In animal studies, systemic corticosteroids have been associated with increased risk of cleft palate and intrauterine growth restriction, but data for topical corticosteroids are limited. According to FDA pregnancy category C, risk cannot be ruled out. During the first trimester, avoid use unless clearly needed. During second and third trimesters, use only if potential benefit justifies risk to fetus. Avoid high potency formulations and prolonged use. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component of the formulation","Viral, fungal, or bacterial skin infections (without appropriate antimicrobial coverage)","Tuberculosis of the skin","Vaccinia, varicella, and herpes simplex infections"]
| Precautions | ["Systemic absorption may produce reversible HPA axis suppression","Cushing's syndrome, hyperglycemia, and glucosuria may occur","Local adverse reactions including atrophy, striae, and telangiectasias","Use with caution in children due to greater skin surface-to-body weight ratio","Avoid prolonged use, occlusive dressings, and application on face, axillae, or groin"] |
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| Fetal Monitoring | Monitor for maternal adrenal suppression if large areas are treated or occlusive dressings are used. Fetal monitoring includes standard prenatal care, with attention to fetal growth if prolonged use occurs. No specific fetal monitoring is routinely required beyond routine obstetric care. |
| Fertility Effects | Available data are insufficient to determine effects on fertility. In animal studies, systemic corticosteroids have been shown to impair fertility, but relevance to topical use is unknown. No specific fertility effects have been reported for topical desoximetasone. |