HEMSOL-HC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HEMSOL-HC (HEMSOL-HC).
Corticosteroid that binds to glucocorticoid receptors, modulating gene expression to reduce inflammation and immune response.
| Metabolism | Hepatic via CYP3A4; excreted renally |
| Excretion | Renal: >90% as unconjugated and conjugated metabolites; biliary/fecal: <10% |
| Half-life | Terminal elimination half-life: 1.2-2.5 hours; clinically, dose adjustments needed in hepatic impairment due to prolonged clearance |
| Protein binding | 75-80% primarily to corticosteroid-binding globulin and albumin |
| Volume of Distribution | 0.5-1.5 L/kg; high tissue penetration including brain |
| Bioavailability | Oral: 60-80%; Topical: 1-5% (varies by formulation and skin condition) |
| Onset of Action | Intravenous: 5-15 min; Oral: 1-2 hours; Topical: 2-3 days |
| Duration of Action | Intravenous: 4-6 hours; Oral: 4-6 hours; Topical: 3-4 weeks for plaque psoriasis |
Intravenous: 100 mg hydralazine hydrochloride (equivalent to 80.5 mg hydralazine base) administered over 30 minutes, every 6 hours as needed, for a maximum of 48 hours. Oral: 10–50 mg every 6 hours, adjusted based on response.
| Dosage form | CREAM |
| Renal impairment | GFR 10–50 mL/min: administer every 8 hours. GFR <10 mL/min: administer every 8–16 hours. Hemodialysis: dose after dialysis if needed; not significantly removed by peritoneal dialysis. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% and increase dosing interval to every 8 hours. Child-Pugh C: reduce dose by 75% and increase dosing interval to every 12 hours. |
| Pediatric use | Hypertension: Oral: 0.75–3 mg/kg/day in 2–4 divided doses; maximum 7.5 mg/kg/day (up to 200 mg/day). IV: 0.15–0.6 mg/kg/dose every 6 hours; maximum 20 mg/dose. |
| Geriatric use | Initiate at lowest adult dose; reduce maintenance dose by 50% due to increased sensitivity and higher risk of hypotension and reflex tachycardia. Monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HEMSOL-HC (HEMSOL-HC).
| Breastfeeding | Corticosteroids like hydrocortisone are excreted into breast milk in low amounts. M/P ratio is approximately 0.25–0.5. At maternal doses up to 80 mg/day, infant exposure is estimated at <0.1% of maternal dose. No adverse effects reported with short-term use. Low risk with moderate doses, but high-dose or prolonged therapy should be used cautiously. |
| Teratogenic Risk | First trimester: Epidemiologic studies suggest a small increased risk of oral clefts (odds ratio ~1.3-1.5). Second/third trimester: Prolonged use may cause fetal adrenal suppression, intrauterine growth restriction, and oligohydramnios. Human data overall show low absolute risk, but corticosteroids are not advised for chronic use in pregnancy unless clearly indicated. |
■ FDA Black Box Warning
Do not use for rectal bleeding or if infection is present without proper antimicrobial coverage.
| Serious Effects |
Hypersensitivity to hydrocortisone; systemic fungal infections; tuberculous or viral skin lesions.
| Precautions | May mask signs of infection; avoid prolonged use; use caution in diabetes, hypertension, or immunosuppression. |
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| Fetal Monitoring | Monitor maternal blood pressure, blood glucose, and signs of infection. Fetal monitoring includes ultrasound for growth restriction and amniotic fluid volume if used chronically in second/third trimester. Newborns exposed to prolonged therapy should be assessed for adrenal suppression. |
| Fertility Effects | No direct evidence of adverse effects on fertility. Chronic high-dose use may suppress hypothalamic-pituitary-adrenal axis and cause menstrual irregularities, potentially reducing fertility temporarily. Effects are reversible upon dose reduction or discontinuation. |