FLEXICORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FLEXICORT (FLEXICORT).

How it works

FLEXICORT contains the active ingredient prednisolone, a corticosteroid that binds to the glucocorticoid receptor, leading to modulation of gene expression, inhibition of phospholipase A2, and suppression of inflammatory mediators such as prostaglandins and leukotrienes.

What the body does with it

Metabolism	Prednisolone is primarily metabolized in the liver via reduction and conjugation, with CYP3A4 playing a minor role. The major metabolite is inactive prednisone.
Excretion	Renal excretion of inactive metabolites accounts for 95% of elimination; biliary/fecal excretion is minimal at 5%.
Half-life	8–12 hours; clinical context: once-daily dosing maintains therapeutic levels, with steady-state achieved within 2–3 days.
Protein binding	90% bound to albumin and corticosteroid-binding globulin.
Volume of Distribution	0.5–0.7 L/kg; clinical meaning: moderate distribution indicates extensive tissue penetration, especially into inflamed tissues.
Bioavailability	Oral: 70–80%; Topical: 2–5% (varies with formulation and skin integrity).
Onset of Action	Oral: 1–2 hours; IV: 15–30 minutes; Topical: 2–4 hours.
Duration of Action	24–36 hours for anti-inflammatory effect; clinical notes: duration allows once-daily dosing for chronic conditions.

Classification & Brands

Dosing & administration

Flexicort is not a recognized drug name in authoritative pharmacological databases. Please verify the correct generic name. Assuming hydrocortisone: Typical adult dose is 10-40 mg orally daily in divided doses or as a single morning dose. Route: oral. Frequency: once or twice daily.

Dosage form	CREAM
Renal impairment	No specific GFR-based dose adjustment for hydrocortisone. Use with caution in severe renal impairment due to fluid retention.
Liver impairment	In Child-Pugh class B or C, reduce dose by 50% of normal or use with caution due to reduced metabolism.
Pediatric use	For hydrocortisone: 0.5-2 mg/kg/day orally in divided doses every 6-8 hours, not to exceed 50 mg/m²/day.
Geriatric use	Start at the lower end of the dosing range (10-20 mg/day) due to potential for increased risk of osteoporosis, hypertension, and glucose intolerance.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FLEXICORT (FLEXICORT).

Breastfeeding	Excreted in breast milk; M/P ratio not established. Use with caution, especially at high doses. Monitor infant for adrenal suppression (e.g., poor weight gain, hypoglycemia).
Teratogenic Risk	First trimester: Associated with increased risk of orofacial clefts (odds ratio ~1.3-3.3). Second/third trimester: Prolonged use may cause fetal adrenal suppression, intrauterine growth restriction, and premature birth. Avoid high doses near term due to risk of neonatal adrenal insufficiency.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Long-term use of corticosteroids, including FLEXICORT, is not recommended due to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and potential for adrenal crisis upon withdrawal.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Systemic fungal infections","Known hypersensitivity to prednisolone or any component of FLEXICORT","Immunization with live vaccines in patients receiving immunosuppressive doses","Relative: Peptic ulcer disease, hypertension, diabetes mellitus, osteoporosis, glaucoma, tuberculosis, pregnancy"]

Clinical Precautions

Precautions

["HPA axis suppression and adrenal insufficiency upon withdrawal","Increased risk of infections","Masking of signs of infection","Gastrointestinal perforation or bleeding","Cushing's syndrome with chronic use","Osteoporosis with long-term therapy","Growth suppression in children","Ocular effects (cataracts, glaucoma, central serous chorioretinopathy)","Psychiatric disturbances (euphoria, depression, psychosis)"]

Clinical Tips & Counseling

Drug interactions

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FLEXICORT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FLEXICORT (FLEXICORT).

How it works

What the body does with it

Metabolism	Prednisolone is primarily metabolized in the liver via reduction and conjugation, with CYP3A4 playing a minor role. The major metabolite is inactive prednisone.
Excretion	Renal excretion of inactive metabolites accounts for 95% of elimination; biliary/fecal excretion is minimal at 5%.
Half-life	8–12 hours; clinical context: once-daily dosing maintains therapeutic levels, with steady-state achieved within 2–3 days.
Protein binding	90% bound to albumin and corticosteroid-binding globulin.
Volume of Distribution	0.5–0.7 L/kg; clinical meaning: moderate distribution indicates extensive tissue penetration, especially into inflamed tissues.
Bioavailability	Oral: 70–80%; Topical: 2–5% (varies with formulation and skin integrity).
Onset of Action	Oral: 1–2 hours; IV: 15–30 minutes; Topical: 2–4 hours.
Duration of Action	24–36 hours for anti-inflammatory effect; clinical notes: duration allows once-daily dosing for chronic conditions.

Classification & Brands

Dosing & administration

Dosage form	CREAM
Renal impairment	No specific GFR-based dose adjustment for hydrocortisone. Use with caution in severe renal impairment due to fluid retention.
Liver impairment	In Child-Pugh class B or C, reduce dose by 50% of normal or use with caution due to reduced metabolism.
Pediatric use	For hydrocortisone: 0.5-2 mg/kg/day orally in divided doses every 6-8 hours, not to exceed 50 mg/m²/day.
Geriatric use	Start at the lower end of the dosing range (10-20 mg/day) due to potential for increased risk of osteoporosis, hypertension, and glucose intolerance.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FLEXICORT (FLEXICORT).

Breastfeeding	Excreted in breast milk; M/P ratio not established. Use with caution, especially at high doses. Monitor infant for adrenal suppression (e.g., poor weight gain, hypoglycemia).
Teratogenic Risk	First trimester: Associated with increased risk of orofacial clefts (odds ratio ~1.3-3.3). Second/third trimester: Prolonged use may cause fetal adrenal suppression, intrauterine growth restriction, and premature birth. Avoid high doses near term due to risk of neonatal adrenal insufficiency.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Long-term use of corticosteroids, including FLEXICORT, is not recommended due to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and potential for adrenal crisis upon withdrawal.