SERVISONE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SERVISONE (SERVISONE).
SERVISONE is a corticosteroid that exerts anti-inflammatory and immunosuppressive effects by binding to glucocorticoid receptors, modulating gene transcription, and inhibiting phospholipase A2, thereby reducing prostaglandin and leukotriene synthesis.
| Metabolism | Hepatic via CYP3A4; undergoes 11-beta-hydroxysteroid dehydrogenase metabolism; primarily excreted in urine. |
| Excretion | Renal (70-80% as metabolites, 5-10% unchanged); fecal/biliary (15-20%) |
| Half-life | Terminal elimination half-life is 3-4 hours. Clinically, this supports twice-daily dosing for sustained effect. |
| Protein binding | 85-90% bound to corticosteroid-binding globulin and albumin |
| Volume of Distribution | 0.5-1.0 L/kg. Indicates extensive tissue distribution, with high levels in liver, kidney, and adipose tissue. |
| Bioavailability | Oral: 70-80%; Intravenous: 100% |
| Onset of Action | Oral: 1-2 hours; Intravenous: 5-15 minutes |
| Duration of Action | Oral: 12-24 hours; Intravenous: 6-12 hours. Duration is dose-dependent and increases with higher doses. |
| Molecular Weight | 358.43 |
10-20 mg orally once daily in the morning; higher doses up to 40 mg daily for severe cases.
| Dosage form | TABLET |
| Renal impairment | No adjustment required for mild to moderate renal impairment; use with caution in severe impairment (eGFR < 30 mL/min/1.73 m²) with dose reduction by 50%. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use. |
| Pediatric use | 0.5-2 mg/kg/day orally divided twice daily; maximum 40 mg/day. |
| Geriatric use | Initiate at 5 mg orally once daily; titrate cautiously due to increased risk of osteoporosis and glucose intolerance. |
| 1st trimester | Avoid. Corticosteroids are associated with increased risk of cleft palate (human data limited). Use only if necessary for maternal condition. |
| 2nd trimester | Use with caution if benefit outweighs risk. May cause fetal growth restriction with prolonged use. |
| 3rd trimester | Use with caution. Prolonged use may cause adrenal suppression in neonate. For fetal lung maturity, use betamethasone or dexamethasone (preferred). |
Clinical note
Comprehensive clinical and safety monograph for SERVISONE (SERVISONE).
| Placental transfer | Prednisolone is extensively metabolized in placenta; however, 10-15% of maternal dose reaches fetus. Degree of transfer is low compared to betamethasone/dexamethasone. |
| Breastfeeding | Prednisone/prednisolone (likely active metabolite) is excreted into breast milk in low doses. At maternal doses up to 50 mg/day, levels in milk are low and unlikely to affect the infant. Wait 4 hours after dosing to breastfeed to reduce exposure. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Systemic fungal infectionHypersensitivity to prednisone or any component
| Precautions | May cause immunosuppression, increased risk of infections, adrenal suppression, Cushing's syndrome, osteoporosis, hyperglycemia, and growth retardation in children. Abrupt withdrawal after prolonged use may lead to acute adrenal insufficiency. |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may increase prednisolone levels. Restrict sodium intake if fluid retention or hypertension occurs. Maintain adequate potassium intake (e.g., bananas, oranges) if prolonged therapy. |
| Clinical Pearls |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | First trimester: Increased risk of cleft palate (odds ratio ~3) and neural tube defects. Second/third trimester: Fetal growth restriction, preterm birth, and oligohydramnios with prolonged use. Fetal adrenal suppression possible near term. |
| Fetal Monitoring | Monitor maternal blood pressure, blood glucose, and signs of infection. Serial ultrasound for fetal growth and amniotic fluid volume. Fetal heart rate monitoring if prolonged therapy. |
| Fertility Effects | May impair fertility in both sexes via suppression of hypothalamic-pituitary-adrenal axis; reversible upon discontinuation. High doses may cause menstrual irregularities. |
| SERVISONE is a brand of prednisolone, a corticosteroid. Use lowest effective dose for shortest duration to minimize adrenal suppression. Taper dose upon discontinuation after prolonged use. Monitor for hyperglycemia, hypertension, and osteoporosis with long-term use. Avoid live vaccines during therapy. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not stop abruptly; follow dose tapering schedule. · Report signs of infection (fever, sore throat) promptly. · Monitor blood sugar if diabetic; may require adjustment of antidiabetic medications. · Avoid live vaccines while on this medication. |