ACTICORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ACTICORT (ACTICORT).
Topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive actions. Suppresses cytokine production and inflammatory mediators via glucocorticoid receptor binding.
| Metabolism | Hepatic metabolism via CYP3A4; inactive metabolites excreted renally and biliary. |
| Excretion | Renal (70% as unchanged drug and metabolites), biliary/fecal (30%) |
| Half-life | 1.5-2.5 hours; prolonged in hepatic impairment (up to 10 hours) and renal impairment (up to 6 hours) |
| Protein binding | 90% bound to albumin and corticosteroid-binding globulin |
| Volume of Distribution | 1.2-1.5 L/kg; indicates extensive tissue distribution |
| Bioavailability | Oral: 80-90%; IM: 100% |
| Onset of Action | Oral: 30-60 minutes; IM: 1-2 hours; IV: immediate |
| Duration of Action | Oral: 4-6 hours; IM: 6-8 hours; IV: 2-4 hours |
| Molecular Weight | 362.46 Da (hydrocortisone: 362.46; clioquinol: 210.5, but monograph refers to hydrocortisone component) |
| Action Class | Glucocorticoids |
| Brand Substitutes | Monocortil 10mg Tablet, Predly 10mg Tablet, Nucort Forte 10mg Tablet, Pednisol 10mg Tablet, Pcort 10mg Tablet, Predly 5mg Tablet, Predicort 5mg Tablet, Pednisol 5mg Tablet, Monocortil 5mg Tablet, Prednij 5mg Tablet, Nisolone 20mg Tablet, Neopred Forte 20mg Tablet, Emsolone 20mg Tablet, Predly 20mg Tablet, Solon 20mg Tablet |
5-60 mg orally once daily, or divided twice daily, depending on condition severity and response.
| Dosage form | LOTION |
| Renal impairment | No dose adjustment necessary for acute use; for chronic therapy in severe renal impairment (eGFR <30 mL/min/1.73 m2), consider dose reduction by 50% to minimize mineralocorticoid effects. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use or reduce dose by 75% due to reduced clearance. |
| Pediatric use | 0.05-2 mg/kg/day orally divided every 6-8 hours, not to exceed 80 mg/day; adjust based on response and severity. |
| Geriatric use | Initiate at lowest effective dose (e.g., 5 mg/day) and titrate slowly due to increased risk of osteoporosis, glucose intolerance, and immunosuppression; monitor for adverse effects. |
| 1st trimester | Contains hydrocortisone (topical corticosteroid) and clioquinol (antifungal). Topical corticosteroids are generally low risk in first trimester, but systemic absorption can occur. Clioquinol is poorly absorbed; however, animal data insufficient. Use only if clearly needed. |
| 2nd trimester | Limited human data. Low systemic absorption expected with topical use. No known teratogenicity. Use caution and limit application area. |
| 3rd trimester | Prolonged use of high-potency topical corticosteroids in third trimester may cause fetal adrenal suppression or low birth weight. Avoid extensive use near term. |
Clinical note
Comprehensive clinical and safety monograph for ACTICORT (ACTICORT).
| Placental transfer | Corticosteroids cross placenta; extent depends on potency and molecular weight. Clioquinol crosses placenta in animal studies; human data limited. Barrier provided by topical application minimizes systemic absorption. |
| Breastfeeding |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to hydrocortisone, clioquinol, or any componentViral skin infections (e.g., herpes simplex, varicella)Fungal infections without concomitant antifungal (except candidiasis)Use on deep or puncture wounds
| Precautions | HPA axis suppression with prolonged use or large surface area, Local irritation and skin atrophy, Systemic absorption with occlusive dressings, Potential for rebound effects after discontinuation |
| Food/Dietary | No clinically significant food interactions. Alcohol may increase systemic absorption if tympanic membrane is perforated, but generally avoid alcohol-based ear drops if perforation suspected. |
Loading safety data…
| Topical application of hydrocortisone and clioquinol results in minimal systemic levels. Use only on small areas and for short duration. Avoid application to breast or nipple area to prevent infant ingestion. |
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | First trimester: Increased risk of cleft palate and cardiac defects (OR 1.3-3.5). Second/third trimesters: Risk of fetal growth restriction, adrenal suppression, and oligohydramnios with chronic use. Avoid use unless maternal benefit outweighs risks. |
| Fetal Monitoring | Monitor maternal blood glucose, blood pressure, and signs of infection. Fetal surveillance including growth ultrasound every 4-6 weeks in second half of pregnancy if chronic therapy. Newborn monitoring for adrenal insufficiency if maternal corticosteroids continued until delivery. |
| Fertility Effects | No known negative impact on fertility in either gender at therapeutic doses. High-dose corticosteroids may transiently suppress HPA axis, but fertility returns after cessation. |
| Clinical Pearls |
| ACTICORT (hydrocortisone/neomycin/polymyxin B) is a topical combination used for inflammatory ear conditions. Avoid prolonged use (>10 days) to prevent sensitization and overgrowth of non-susceptible organisms. Tympanic membrane perforation is a contraindication due to ototoxicity risk. Use the otic solution not the ophthalmic suspension for ear infections. |
| Patient Advice | Instill drops while lying down with affected ear upward, then remain in position for 5 minutes. · Do not touch dropper to ear or any surface to avoid contamination. · Complete full course even if symptoms improve; do not use longer than prescribed. · Report worsening redness, swelling, or hearing loss immediately. · Avoid getting water in ear during treatment; use a cotton ball soaked in petroleum jelly to protect ear when showering. |