PRED FORTE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PRED FORTE (PRED FORTE).
Corticosteroid that binds to glucocorticoid receptors, causing inhibition of phospholipase A2, arachidonic acid release, and synthesis of inflammatory mediators. Reduces inflammation by suppressing leukocyte infiltration and cytokine production.
| Metabolism | Primarily hepatic via CYP3A4; some metabolites are active. Prednisolone is the active form (prednisolone acetate). |
| Excretion | Primarily hepatic metabolism; renal excretion of inactive metabolites accounts for approximately 80% of elimination, with biliary/fecal elimination <20%. |
| Half-life | 2-3 hours (terminal) after IV administration; for topical ophthalmic use, systemic half-life is similar but local ocular half-life is prolonged due to corneal reservoir. |
| Protein binding | ~90% bound, primarily to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.7-1.0 L/kg, indicating distribution into total body water. |
| Bioavailability | Ophthalmic: ~0.1% systemically (low due to ocular barriers and rapid metabolism); oral: 60-100% (not a standard route for prednisolone acetate); IV: 100%. |
| Onset of Action | Ophthalmic: 1-2 hours with peak intraocular concentration at 2-5 minutes post-instillation; systemic (IV/IM): rapid (within minutes). |
| Duration of Action | Ophthalmic: 4-6 hours for anti-inflammatory effect; systemic: dose-dependent, typically 24-36 hours for HPA axis suppression. |
| Action Class | Glucocorticoids |
| Brand Substitutes | Predace 4 Tablet, Coelone 4mg Tablet, Pilsone 4mg Tablet, Premisol 4mg Tablet, Cortilog 4mg Tablet, Rednisol 8 Tablet, Prelid 8mg Tablet, Predace 8mg Tablet, Sterio 8 Tablet, MP 8mg Tablet, 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, Prelid 16mg Tablet, Predace 16 Tablet, Mepresso T 16mg Tablet, Medrol 16mg Tablet, Rednisol 16mg Tablet |
1-2 drops in the conjunctival sac every 1-2 hours during the day and every 4 hours at night initially, then taper to every 4-8 hours as inflammation resolves. Severe cases may require hourly dosing.
| Dosage form | SUSPENSION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. Systemic absorption is minimal. |
| Liver impairment | No dose adjustment required for hepatic impairment. Use caution in severe hepatic disease due to potential for systemic corticosteroid effects. |
| Pediatric use | Same as adult dosing: 1-2 drops every 1-2 hours initially, then taper. Safety and efficacy in pediatric patients have not been established, but use is based on clinical experience. |
| Geriatric use | No specific dose adjustment. Use caution due to increased risk of intraocular pressure elevation and cataract formation. Monitor intraocular pressure regularly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PRED FORTE (PRED FORTE).
| Breastfeeding | Prednisolone (active metabolite) is excreted into breast milk with an M/P ratio of 0.39–0.58. Systemic absorption from ophthalmic use is minimal; doses >20 mg/day prednisolone equivalent may warrant discarding milk for 4 hours post-dose. Generally considered compatible with breastfeeding. |
| Teratogenic Risk | First trimester: Increased risk of orofacial clefts (odds ratio 3.35) with systemic corticosteroids; risk lower with topical ocular use. Second/third trimester: Potential for fetal adrenal suppression, intrauterine growth restriction, and premature birth with prolonged high-dose systemic exposure. Ophthalmic use minimizes systemic absorption, but risk cannot be fully excluded. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to prednisolone or any component.","Active ocular infections (e.g., fungal, viral, bacterial) without appropriate anti-infective therapy.","Epithelial herpes simplex keratitis (dendritic keratitis).","Vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva.","Mycobacterial infections of the eye."]
| Precautions | ["Prolonged use may increase intraocular pressure (IOP) and risk of glaucoma, cataract formation, and secondary ocular infections.","May mask or worsen infections; caution in herpes simplex keratitis or other viral/fungal infections.","Systemic absorption can occur with frequent or prolonged use, leading to HPA axis suppression.","Use with caution in patients with corneal thinning or perforation risk."] |
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| Fetal Monitoring | Monitor intraocular pressure and signs of ocular infection in the mother. For prolonged use, assess fetal growth via ultrasound and consider monitoring for maternal adrenal suppression. No routine fetal monitoring required for topical use. |
| Fertility Effects | No adverse effects on fertility reported with ophthalmic prednisolone acetate. Systemic corticosteroids may disrupt menstrual cycles and impair fertility, but topical use is unlikely to have significant impact. |