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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SERVISONE (SERVISONE).
| Breastfeeding | Excreted in breast milk; M/P ratio 10.3. Use caution, especially with high doses or prolonged therapy; monitor infant for growth and adrenal suppression. |
| 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 |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Absolute: systemic fungal infection, known hypersensitivity to the drug. Relative: active infections, diabetes mellitus, hypertension, peptic ulcer disease, osteoporosis, glaucoma, and ocular herpes simplex.
| 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. |
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| 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. |