PREDAIR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREDAIR (PREDAIR).
Prednisone is a prodrug that is converted to prednisolone, which binds to the glucocorticoid receptor, leading to anti-inflammatory and immunosuppressive effects via modulation of gene expression.
| Metabolism | Primarily hepatic, via reduction to inactive metabolites; prednisone is converted to active prednisolone by 11-beta-hydroxysteroid dehydrogenase. |
| Excretion | Renal: 75-90% as unchanged drug; Biliary/Fecal: 10-25% as metabolites and unchanged drug. |
| Half-life | 3-4 hours (terminal) in patients with normal renal function; prolonged to 12-24 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 90-95% bound primarily to albumin. |
| Volume of Distribution | 0.3-0.4 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral: 60-70% due to first-pass metabolism. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-10 minutes. |
| Duration of Action | 4-6 hours for oral; 2-4 hours for intravenous; may persist up to 12 hours in renal impairment. |
| Molecular Weight | 360.44 Da |
10-60 mg orally once daily in the morning, gradually tapered as tolerated. Maintenance dose 5-10 mg orally once daily.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No adjustment required for renal impairment; use with caution in severe renal failure. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B and C: reduce dose by 50% or use alternative. |
| Pediatric use | 0.14-2 mg/kg/day orally divided twice daily, maximum 60 mg/day. Titrate to lowest effective dose. |
| Geriatric use | Start at lowest effective dose (5-10 mg/day) and titrate slowly due to increased risk of osteoporosis and hyperglycemia. |
| 1st trimester | Prednisolone is associated with a small increased risk of oral clefts when used in the first trimester. Use only if clearly needed. |
| 2nd trimester | Risk of fetal growth restriction and adrenal suppression if used chronically. Monitor fetal growth. |
| 3rd trimester | Prolonged use may cause neonatal adrenal suppression and hypoglycemia. Use lowest effective dose. |
Clinical note
Comprehensive clinical and safety monograph for PREDAIR (PREDAIR).
| Placental transfer | Prednisolone is partially inactivated by 11β-HSD2 in placenta, but up to 10-12% of maternal dose reaches fetus. Crosses placenta with higher fetal exposure from prednisone vs prednisolone. |
| Breastfeeding | Prednisolone is excreted into breast milk in low amounts (<0.1% of maternal dose). Doses up to 50 mg/day are unlikely to cause adverse effects in full-term infants. Monitor infant for growth and adrenal suppression with high doses. |
■ FDA Black Box Warning
None.
| Serious Effects |
Systemic fungal infectionsKnown hypersensitivity to prednisolone or any component
| Precautions | Immunosuppression and increased susceptibility to infections, Adrenal insufficiency with withdrawal, Osteoporosis with long-term use, Hyperglycemia and diabetes mellitus, Gastrointestinal perforation, Psychiatric disturbances, Cushing's syndrome with prolonged use |
| Food/Dietary | No specific food interactions. Grapefruit may increase systemic exposure to budesonide, but clinical significance is minimal with inhaled doses. Avoid high-potassium foods if taking diuretics, but not specifically related to Predair. |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: Increased risk of cleft palate (odds ratio 1.5-3.0). Second/third trimester: Fetal adrenal suppression, growth restriction, oligohydramnios with prolonged use. |
| Fetal Monitoring | Maternal: Blood pressure, blood glucose, bone density (long-term). Fetal: Ultrasound for growth and amniotic fluid volume (oligohydramnios) with prolonged use. |
| Fertility Effects | No significant impairment; may suppress ovulation at high doses due to hormonal disruption; reversible upon dose reduction/discontinuation. |
| Clinical Pearls |
| Predair is a combination inhaler containing budesonide (an inhaled corticosteroid) and formoterol (a long-acting beta2-agonist). Use for maintenance therapy in asthma or COPD; not for acute bronchospasm. Rinse mouth after use to prevent oral candidiasis. Monitor for increased pneumonia risk in COPD patients. Formoterol carries a black box warning for asthma-related death if used without a controller. |
| Patient Advice | Use exactly as prescribed; do not use for sudden breathing problems. · Rinse mouth with water after each use to prevent fungal infections. · Do not stop this medication suddenly; consult your doctor first. · Carry a rescue inhaler (e.g., albuterol) for acute symptoms. · Report worsening breathing, chest tightness, or signs of oral thrush (white patches in mouth). |