HYDELTRA-TBA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYDELTRA-TBA (HYDELTRA-TBA).
Prednisolone is a synthetic glucocorticoid that binds to the glucocorticoid receptor, modulating gene transcription to suppress inflammation, immune response, and adrenal function.
| Metabolism | Hepatic; primarily via 11β-hydroxysteroid dehydrogenase (HSD11B) and 5α/5β-reductase; also metabolized by CYP3A4 in some contexts. |
| Excretion | Primarily renal (80-90% as inactive metabolites and unchanged drug). Biliary excretion accounts for <5%. |
| Half-life | Plasma t1/2 ~2.5-3.5 hours. Duration of adrenal suppression may persist for 24-48 hours. |
| Protein binding | 70-80% bound primarily to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | Vd ~0.5-1.0 L/kg. Distributes widely into tissues, including synovial fluid. |
| Bioavailability | Oral: 60-70% (variable due to first-pass metabolism); IM: 100%. |
| Onset of Action | IM: 1-2 hours; IV: rapid (minutes); Oral: 1-2 hours. |
| Duration of Action | IM: 4-8 days (repository formulation); Oral: 24-36 hours; IV: 6-12 hours. |
20-40 mg intramuscularly every 3 weeks; for intra-articular use: 20-40 mg per large joint, 10-20 mg per medium joint, 4-10 mg per small joint.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment recommended; use with caution in severe renal impairment due to potential fluid retention and hypertension. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: consider dose reduction by 50%; Child-Pugh C: avoid use or use lowest possible dose with close monitoring. |
| Pediatric use | 0.5-2 mg/kg/day intramuscularly divided every 12-24 hours; maximum 40 mg/day. |
| Geriatric use | Use lowest effective dose; monitor for hyperglycemia, osteoporosis, and fluid retention; consider reduced initial dose due to increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYDELTRA-TBA (HYDELTRA-TBA).
| Breastfeeding | Prednisolone is excreted into breast milk. M/P ratio approximately 0.4. Single doses up to 50 mg are considered safe; however, high doses (>80 mg daily) may require waiting 4 hours after dose to breastfeed to minimize infant exposure. |
| Teratogenic Risk | Prednisolone (active metabolite of prednisone) crosses the placenta. First trimester: increased risk of oral clefts (odds ratio 3.4). Second/third trimester: associated with fetal growth restriction, preterm birth, and maternal hypertension. Chronic use may cause fetal adrenal suppression. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Systemic fungal infections","Hypersensitivity to prednisolone or any component","Administration of live or live attenuated vaccines in patients receiving immunosuppressive doses"]
| Precautions | ["Immunosuppression and increased susceptibility to infections","Hypothalamic-pituitary-adrenal (HPA) axis suppression with prolonged use","Osteoporosis risk with long-term therapy","Gastrointestinal perforation (especially in IBD)","Exacerbation of systemic fungal infections","Live or live attenuated vaccines contraindicated in immunosuppressed patients","May cause posterior subcapsular cataracts and glaucoma","Psychiatric disturbances (e.g., euphoria, psychosis)"] |
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| Fetal Monitoring |
| Monitor maternal blood pressure, blood glucose (gestational diabetes), and fetal growth via ultrasound. Assess for signs of preterm labor. Newborn monitoring for adrenal insufficiency if maternal use continues until delivery. |
| Fertility Effects | High doses may disrupt menstrual cycles and ovulation. No known permanent impairment; effects are reversible upon dose reduction or discontinuation. |