NEO-HYDELTRASOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NEO-HYDELTRASOL (NEO-HYDELTRASOL).

How it works

Prednisolone, a glucocorticoid, binds to the glucocorticoid receptor, leading to modulation of gene expression and suppression of inflammatory mediators, including cytokines, prostaglandins, and leukotrienes. It also inhibits phospholipase A2 and reduces immune cell activity.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; prednisolone is a metabolite of prednisone. Conjugation with glucuronic acid and sulfate; renal excretion of metabolites.
Excretion	Renal: 50–80% as unchanged drug and metabolites (primarily as glucuronide and sulfate conjugates). Fecal/biliary: minor (<10%).
Half-life	Terminal elimination half-life: 2.5–3.5 hours (adults). Note: The biologic half-life (duration of anti-inflammatory effect) is 18–36 hours due to persistence of glucocorticoid receptor-mediated effects.
Protein binding	70–80% bound to corticosteroid-binding globulin (CBG, transcortin) and albumin.
Volume of Distribution	Vd: 0.4–0.6 L/kg. Indicates moderate extracellular distribution.
Bioavailability	Bioavailability: intravenous 100%; oral 70–90% (peak at 1–2 hours); topical/intra-articular: systemic absorption minimal (if applied to intact skin), but can be significant in denuded areas or with high doses.
Onset of Action	Intravenous: immediate (minutes). Intra-articular: 1–2 days. Oral: 1–2 hours. Topical: variable (hours).
Duration of Action	Duration of clinical effect: 12–36 hours depending on dose and route; intra-articular can last 1–3 weeks. Biologic effects persist longer than plasma levels.

Classification & Brands

Dosing & administration

4-20 mg intramuscularly, intravenously, intra-articularly, or intrasynovially every 12-24 hours; maximum initial dose 40 mg.

Dosage form	OINTMENT
Renal impairment	No dose adjustment required for GFR >30 mL/min; for GFR 10-30 mL/min, use with caution and consider dose reduction by 25%; for GFR <10 mL/min, avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	0.04-0.3 mg/kg/day intramuscularly or intravenously divided every 6-12 hours; not to exceed 2 mg/kg/day.
Geriatric use	Use lowest effective dose; monitor for fluid retention, hypertension, and hyperglycemia; initiate at 4 mg/day and titrate slowly.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for NEO-HYDELTRASOL (NEO-HYDELTRASOL).

Breastfeeding	Enters breast milk; M/P ratio 0.4-1.0. Use caution with high doses; avoid during breastfeeding if possible. Monitor infant for growth and adrenal suppression.
Teratogenic Risk	First trimester: Increased risk of cleft palate (odds ratio 1.3-3.0) with systemic use; risk unclear with topical/ocular use. Second trimester: Possible growth restriction, adrenal suppression. Third trimester: Risk of neonatal adrenal suppression, premature delivery, low birth weight.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

No FDA boxed warning is specified for NEO-HYDELTRASOL; however, corticosteroids as a class may increase risk of fungal infections, and intrathecal administration is contraindicated.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Systemic fungal infections","Hypersensitivity to prednisolone or any component","Intrathecal administration (contraindicated)","Live or live-attenuated vaccine administration","Idiopathic thrombocytopenic purpura (IM route)"]

Clinical Precautions

Precautions

["Immunosuppression and increased susceptibility to infections","Adrenal suppression with prolonged use","Cushing's syndrome","Osteoporosis","Gastrointestinal perforation (especially in patients with diverticulitis or recent GI surgery)","Myopathy","Ocular effects (cataracts, glaucoma)","HPA axis suppression with rapid withdrawal"]

Clinical Tips & Counseling

Drug interactions

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NEO-HYDELTRASOL

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NEO-HYDELTRASOL (NEO-HYDELTRASOL).

How it works

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; prednisolone is a metabolite of prednisone. Conjugation with glucuronic acid and sulfate; renal excretion of metabolites.
Excretion	Renal: 50–80% as unchanged drug and metabolites (primarily as glucuronide and sulfate conjugates). Fecal/biliary: minor (<10%).
Half-life	Terminal elimination half-life: 2.5–3.5 hours (adults). Note: The biologic half-life (duration of anti-inflammatory effect) is 18–36 hours due to persistence of glucocorticoid receptor-mediated effects.
Protein binding	70–80% bound to corticosteroid-binding globulin (CBG, transcortin) and albumin.
Volume of Distribution	Vd: 0.4–0.6 L/kg. Indicates moderate extracellular distribution.
Bioavailability	Bioavailability: intravenous 100%; oral 70–90% (peak at 1–2 hours); topical/intra-articular: systemic absorption minimal (if applied to intact skin), but can be significant in denuded areas or with high doses.
Onset of Action	Intravenous: immediate (minutes). Intra-articular: 1–2 days. Oral: 1–2 hours. Topical: variable (hours).
Duration of Action	Duration of clinical effect: 12–36 hours depending on dose and route; intra-articular can last 1–3 weeks. Biologic effects persist longer than plasma levels.

Classification & Brands

Dosing & administration

4-20 mg intramuscularly, intravenously, intra-articularly, or intrasynovially every 12-24 hours; maximum initial dose 40 mg.

Dosage form	OINTMENT
Renal impairment	No dose adjustment required for GFR >30 mL/min; for GFR 10-30 mL/min, use with caution and consider dose reduction by 25%; for GFR <10 mL/min, avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	0.04-0.3 mg/kg/day intramuscularly or intravenously divided every 6-12 hours; not to exceed 2 mg/kg/day.
Geriatric use	Use lowest effective dose; monitor for fluid retention, hypertension, and hyperglycemia; initiate at 4 mg/day and titrate slowly.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for NEO-HYDELTRASOL (NEO-HYDELTRASOL).

Breastfeeding	Enters breast milk; M/P ratio 0.4-1.0. Use caution with high doses; avoid during breastfeeding if possible. Monitor infant for growth and adrenal suppression.
Teratogenic Risk	First trimester: Increased risk of cleft palate (odds ratio 1.3-3.0) with systemic use; risk unclear with topical/ocular use. Second trimester: Possible growth restriction, adrenal suppression. Third trimester: Risk of neonatal adrenal suppression, premature delivery, low birth weight.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

No FDA boxed warning is specified for NEO-HYDELTRASOL; however, corticosteroids as a class may increase risk of fungal infections, and intrathecal administration is contraindicated.