FLO-PRED
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLO-PRED (FLO-PRED).
Corticosteroid that binds to glucocorticoid receptors, modulating gene expression to reduce inflammation, suppress immune response, and inhibit phospholipase A2, decreasing prostaglandin and leukotriene synthesis.
| Metabolism | Hepatic metabolism primarily via CYP3A4; metabolites are excreted renally. |
| Excretion | FLO-PRED (prednisolone acetate) is primarily eliminated via hepatic metabolism, with inactive metabolites excreted renally. Approximately 20-30% of a dose is excreted unchanged in urine, and less than 5% is eliminated via biliary/fecal routes. |
| Half-life | The terminal elimination half-life of prednisolone is approximately 2-4 hours (mean ~3 hours) in adults with normal hepatic function. This short half-life allows for once-daily or alternate-day dosing to minimize adrenal suppression. |
| Protein binding | Prednisolone is approximately 70-90% bound to plasma proteins, primarily albumin and corticosteroid-binding globulin (CBG, transcortin). Binding is concentration-dependent and saturable at high doses. |
| Volume of Distribution | Volume of distribution is approximately 0.5-1.0 L/kg (mean ~0.7 L/kg), indicating extensive distribution into tissues. The Vd is increased in obesity and decreased in dehydration. |
| Bioavailability | Oral: approximately 80% (range 70-90%) due to first-pass metabolism in the liver. Ophthalmic: systemic absorption is minimal (<1% of applied dose) but can accumulate with prolonged use. Intramuscular: 75-90% bioavailability with slow absorption. |
| Onset of Action | Oral: 1-2 hours; Intramuscular injection: 30-60 minutes; Intravenous push: 1-2 hours; Ophthalmic suspension: 15-30 minutes for anti-inflammatory effect. |
| Duration of Action | Oral/IM/IV: Duration of anti-inflammatory effect is 12-36 hours, depending on dose and disease state. Ophthalmic: 4-8 hours after each topical dose; systemic effects may persist longer due to absorption. |
| Molecular Weight | 360.44 |
Initial: 5-60 mg orally daily in divided doses; maintenance: 5-15 mg orally daily. Also available as ophthalmic suspension (1 drop 2-4 times daily).
| Dosage form | SUSPENSION |
| Renal impairment | No specific dose adjustment required. Monitor for fluid retention and electrolyte disturbances. |
| Liver impairment | Child-Pugh Class A: No adjustment. Class B: Use 50% of dose. Class C: Use 25% of dose or avoid. |
| Pediatric use | 0.14-2 mg/kg/day orally in divided doses; maximum 60 mg/day. |
| Geriatric use | Use lowest effective dose due to increased risk of osteoporosis, diabetes, and infections. Start at 50% of adult dose. |
| 1st trimester | Corticosteroids are generally avoided in first trimester unless maternal benefit outweighs risk; associated with orofacial clefts (odds ratio ~1.5-3.0) and possible growth restriction. |
| 2nd trimester | Use with caution; may cause fetal adrenal suppression, growth retardation, and increased risk of gestational diabetes/hypertension. |
| 3rd trimester | Use with caution; chronic use may lead to neonatal adrenal suppression, low birth weight, and premature delivery. |
Clinical note
Comprehensive clinical and safety monograph for FLO-PRED (FLO-PRED).
| Placental transfer | Prednisolone crosses the placenta; however, about 90% is metabolized to inactive prednisone by placental 11β-hydroxysteroid dehydrogenase type 2, reducing fetal exposure. Higher transfer may occur with maternal doses >20 mg/day. |
| Breastfeeding | Prednisolone is excreted into breast milk at low levels (estimated infant dose ~0.1% of maternal weight-adjusted dose). With maternal doses up to 40 mg/day, no adverse effects have been reported in nursing infants. Theoretical risk of adrenal suppression exists with high chronic doses. Recommend monitoring infant for growth and development. |
■ FDA Black Box Warning
Corticosteroids can cause immunosuppression and increase susceptibility to infections. Live or live attenuated vaccines are contraindicated in patients receiving immunosuppressive doses.
| Serious Effects |
Systemic fungal infectionsHypersensitivity to prednisolone or any componentAdministration of live or live-attenuated vaccines in immunosuppressive dosesCerebral malaria (relative contraindication but absolute in WHO guidelines)Idiopathic thrombocytopenic purpura (use only if life-threatening)
| Precautions | Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, osteoporosis, avascular necrosis, increased risk of infection, masking of infection, perforation risk in GI disease, psychiatric disturbances, growth suppression in children, cataracts, glaucoma, elevated blood pressure, fluid retention, hypokalemia, anaphylactoid reactions. |
| Food/Dietary | No significant food interactions. Grapefruit juice may affect systemic corticosteroids but minimal for ophthalmic use. Avoid alcohol as it may exacerbate side effects. |
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| Lactation Rating | L2 (Safer; limited data indicates no significant risk) |
| Teratogenic Risk | Corticosteroids like FLO-PRED (fludrocortisone) are generally considered low risk for major malformations, but first-trimester exposure may be associated with a small increased risk of oral clefts. Second and third trimester use may cause fetal adrenal suppression, low birth weight, and preterm birth. Chronic use may lead to intrauterine growth restriction. |
| Fetal Monitoring | Monitor maternal blood pressure, serum electrolytes (especially potassium and sodium), and blood glucose. Assess fetal growth by ultrasound if prolonged use. Monitor newborn for adrenal insufficiency (hypoglycemia, lethargy, poor feeding) if used near term. |
| Fertility Effects | Corticosteroids may impair fertility by suppressing hypothalamic-pituitary-adrenal axis and gonadotropin release. Fludrocortisone at standard doses has minimal impact, but high doses can cause menstrual irregularities and ovulatory dysfunction. |
| Clinical Pearls | FLO-PRED (prednisolone acetate) is a corticosteroid for ophthalmic use. Taper dose to avoid adrenal suppression when discontinuing. Monitor IOP in long-term use; may cause elevated IOP, especially in steroid responders. Contraindicated in active ocular infections (viral, fungal, mycobacterial). |
| Patient Advice | Shake well before use. · Avoid touching the dropper tip to any surface. · Do not wear contact lenses during treatment. · Report any vision changes, eye pain, or redness. · Use exactly as prescribed; do not stop abruptly without consulting doctor. · Wash hands before and after administration. |