PARACORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PARACORT (PARACORT).

How it works

Paracort is a corticosteroid that acts by binding to glucocorticoid receptors, leading to modulation of gene expression and suppression of inflammatory mediators such as cytokines and prostaglandins.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; also involves 11β-hydroxysteroid dehydrogenase.
Excretion	Renal elimination of unchanged drug accounts for approximately 70% of the dose; biliary/fecal excretion accounts for 20%; the remainder is metabolized and excreted as inactive metabolites.
Half-life	Terminal elimination half-life is 3.5 hours (range 2.5–4.5 hours) in adults with normal renal function; prolonged to up to 10–15 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	90–95% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	1.5 L/kg (range 1.2–1.8 L/kg); indicates extensive extravascular distribution and tissue binding.
Bioavailability	Oral: 85–95% (well absorbed; minimal first-pass metabolism); Intramuscular: 90–100%; Rectal: 60–70%.
Onset of Action	Oral: 30–60 minutes (peak effect at 1–2 hours); Intravenous: <5 minutes (peak effect at 15–30 minutes); Intramuscular: 10–20 minutes.
Duration of Action	Clinical duration: 4–6 hours for oral and IV routes; up to 8 hours with high doses. Duration is dose-dependent and prolonged in hepatic impairment due to reduced clearance.

Classification & Brands

Dosing & administration

Prednisone 5-60 mg orally once daily; initial dose 5-15 mg daily; for acute conditions, up to 60 mg daily tapered over 2-3 weeks.

Dosage form	TABLET
Renal impairment	No adjustment required for mild to moderate renal impairment. For severe renal impairment (GFR <30 mL/min): use with caution and monitor for fluid retention. No specific dose adjustment guidelines.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% due to impaired corticosteroid metabolism. Child-Pugh C: avoid or use with extreme caution; consider alternative glucocorticoid.
Pediatric use	Oral: 0.1-2 mg/kg/day in divided doses every 6-12 hours; typical starting dose 1-2 mg/kg/day for anti-inflammatory effect; maximum 60 mg/day. For asthma: 1-2 mg/kg/day for 3-5 days.
Geriatric use	Elderly patients: initiate at lower end of dosing range (5-10 mg/day) due to increased risk of osteoporosis, hypertension, and diabetes; taper slowly; monitor for glucose intolerance, fluid retention, and adrenal suppression.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PARACORT (PARACORT).

Breastfeeding	Enters breast milk; M/P ratio approximately 0.3. Low doses (≤20 mg/day prednisone equivalent) considered compatible. High doses may cause infant adrenal suppression; monitor infant growth. Avoid breastfeeding within 4 hours of dose.
Teratogenic Risk	First trimester: Increased risk of orofacial clefts (odds ratio 1.3–3.4) and cardiovascular defects (odds ratio 1.5–2.0). Second/third trimesters: Risk of intrauterine growth restriction, preterm birth, and adrenal suppression in the neonate. Chronic use: Increased risk of premature rupture of membranes.

Warnings & precautions

■ FDA Black Box Warning

None FDA-approved. However, long-term use may suppress hypothalamic-pituitary-adrenal (HPA) axis and increase infection risk.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Systemic fungal infections","Hypersensitivity to paracort or any component","Use of live vaccines"]

Clinical Precautions

Precautions

["Immunosuppression and increased infection risk","Adrenal suppression with prolonged use","Osteoporosis with long-term therapy","Hyperglycemia and diabetes mellitus","Gastrointestinal perforation risk"]

Clinical Tips & Counseling

Drug interactions

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PARACORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PARACORT (PARACORT).

How it works

Paracort is a corticosteroid that acts by binding to glucocorticoid receptors, leading to modulation of gene expression and suppression of inflammatory mediators such as cytokines and prostaglandins.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; also involves 11β-hydroxysteroid dehydrogenase.
Excretion	Renal elimination of unchanged drug accounts for approximately 70% of the dose; biliary/fecal excretion accounts for 20%; the remainder is metabolized and excreted as inactive metabolites.
Half-life	Terminal elimination half-life is 3.5 hours (range 2.5–4.5 hours) in adults with normal renal function; prolonged to up to 10–15 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	90–95% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	1.5 L/kg (range 1.2–1.8 L/kg); indicates extensive extravascular distribution and tissue binding.
Bioavailability	Oral: 85–95% (well absorbed; minimal first-pass metabolism); Intramuscular: 90–100%; Rectal: 60–70%.
Onset of Action	Oral: 30–60 minutes (peak effect at 1–2 hours); Intravenous: <5 minutes (peak effect at 15–30 minutes); Intramuscular: 10–20 minutes.
Duration of Action	Clinical duration: 4–6 hours for oral and IV routes; up to 8 hours with high doses. Duration is dose-dependent and prolonged in hepatic impairment due to reduced clearance.

Classification & Brands

Dosing & administration

Prednisone 5-60 mg orally once daily; initial dose 5-15 mg daily; for acute conditions, up to 60 mg daily tapered over 2-3 weeks.

Dosage form	TABLET
Renal impairment	No adjustment required for mild to moderate renal impairment. For severe renal impairment (GFR <30 mL/min): use with caution and monitor for fluid retention. No specific dose adjustment guidelines.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% due to impaired corticosteroid metabolism. Child-Pugh C: avoid or use with extreme caution; consider alternative glucocorticoid.
Pediatric use	Oral: 0.1-2 mg/kg/day in divided doses every 6-12 hours; typical starting dose 1-2 mg/kg/day for anti-inflammatory effect; maximum 60 mg/day. For asthma: 1-2 mg/kg/day for 3-5 days.
Geriatric use	Elderly patients: initiate at lower end of dosing range (5-10 mg/day) due to increased risk of osteoporosis, hypertension, and diabetes; taper slowly; monitor for glucose intolerance, fluid retention, and adrenal suppression.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PARACORT (PARACORT).

Breastfeeding	Enters breast milk; M/P ratio approximately 0.3. Low doses (≤20 mg/day prednisone equivalent) considered compatible. High doses may cause infant adrenal suppression; monitor infant growth. Avoid breastfeeding within 4 hours of dose.
Teratogenic Risk	First trimester: Increased risk of orofacial clefts (odds ratio 1.3–3.4) and cardiovascular defects (odds ratio 1.5–2.0). Second/third trimesters: Risk of intrauterine growth restriction, preterm birth, and adrenal suppression in the neonate. Chronic use: Increased risk of premature rupture of membranes.

Warnings & precautions

■ FDA Black Box Warning

None FDA-approved. However, long-term use may suppress hypothalamic-pituitary-adrenal (HPA) axis and increase infection risk.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Systemic fungal infections","Hypersensitivity to paracort or any component","Use of live vaccines"]