CHLOROMYCETIN HYDROCORTISONE

Clinical safety rating: avoid

CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.

How it works

Chloromycetin (chloramphenicol) is a bacteriostatic antibiotic that inhibits protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation. Hydrocortisone is a corticosteroid that suppresses inflammation by inhibiting phospholipase A2 and reducing prostaglandin and leukotriene synthesis.

What the body does with it

Metabolism	Chloramphenicol is metabolized primarily in the liver by glucuronidation via UDP-glucuronosyltransferases (UGTs) and also undergoes reduction to inactive metabolites. Hydrocortisone is metabolized in the liver via reduction and conjugation.
Excretion	Renal: ~80-90% of chloramphenicol as inactive metabolites (glucuronide conjugate) and 5-10% unchanged. Biliary: <3% of unchanged drug. Fecal: minimal.
Half-life	Chloramphenicol: 1.5-4 hours in adults with normal hepatic function; prolonged to 3-7 hours in neonates and up to 15 hours in severe liver disease. Hydrocortisone: 1-2 hours.
Protein binding	Chloramphenicol: ~50-80% bound primarily to albumin. Hydrocortisone: ~90% bound to corticosteroid-binding globulin (CBG) and albumin.
Volume of Distribution	Chloramphenicol: 0.6-1 L/kg, indicating wide distribution including CSF, bile, and aqueous humor. Hydrocortisone: 0.4-0.5 L/kg.
Bioavailability	Chloramphenicol: Oral ~80-90%; ophthalmic drops: negligible systemic absorption (<5%) with typical dosing. Hydrocortisone: Oral ~96%; ophthalmic drops: minimal systemic absorption (<1%).
Onset of Action	Ophthalmic: within 1-2 hours for chloramphenicol; hydrocortisone effects begin within 2-4 hours. Topical (otic): similar ophthalmic onset.
Duration of Action	Chloramphenicol: bacteriostatic levels persist for 6-8 hours after ophthalmic dose; systemic treatment every 6 hours. Hydrocortisone: anti-inflammatory effect lasts 4-8 hours after topical application.

Classification & Brands

Dosing & administration

Apply 1-2 drops or a small amount (approximately 0.5 cm ribbon) into the affected eye(s) every 3-4 hours, or more frequently as needed. For severe infections, may be used every 2 hours. Not to exceed 6 times daily. Otic: Instill 3-4 drops into the affected ear(s) 2-3 times daily.

Dosage form	FOR SUSPENSION
Renal impairment	No dose adjustment required for renal impairment as systemic absorption is minimal following topical ophthalmic or otic use.
Liver impairment	No dose adjustment required for hepatic impairment due to negligible systemic absorption.
Pediatric use	Children ≥2 years: Same as adult dosing. For younger children, use with caution and under medical supervision; dose should be based on severity of infection and body weight, typically 1 drop or small amount applied to affected eye(s) every 4-6 hours.
Geriatric use	Use with caution due to increased risk of adverse effects such as elevated intraocular pressure or cataract formation with prolonged use. No specific dose adjustment, but monitor intraocular pressure and corneal integrity regularly.

Use during pregnancy

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

Clinical note

CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.

FDA category	Positive
Breastfeeding	Chloramphenicol excreted into breast milk; potential for gray baby syndrome or bone marrow suppression in nursing infants; contraindicated. Hydrocortisone: minimal excretion; M/P ratio not reported. Avoid high doses or prolonged use.
Teratogenic Risk	Chloramphenicol crosses the placenta. First trimester: theoretical risk of gray baby syndrome; avoid. Second/third trimesters: associated with gray baby syndrome (cardiovascular collapse, cyanosis, death) in neonates; contraindicated. Hydrocortisone: increased risk of cleft palate (first trimester), fetal adrenal suppression (prolonged use).

Warnings & precautions

■ FDA Black Box Warning

Chloramphenicol is associated with serious and fatal blood dyscrasias (aplastic anemia, bone marrow hypoplasia, thrombocytopenia, granulocytopenia). It should not be used for trivial infections or prophylaxis.

Side Effect Profile

Common Effects	adrenal insufficiency
Serious Effects

Absolute Contraindications

Hypersensitivity to chloramphenicol, hydrocortisone, or any component of the formulation; viral and fungal infections of the eye; history of chloramphenicol-associated blood dyscrasias; neonates and premature infants.

Clinical Precautions

Precautions

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. Caution in patients with prior hypersensitivity reactions. Use with caution in hepatic impairment. Discontinue use if signs of bone marrow suppression occur.

Clinical Tips & Counseling

Drug interactions

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CHLOROMYCETIN HYDROCORTISONE

Clinical safety rating: avoid

CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.

How it works

What the body does with it

Metabolism	Chloramphenicol is metabolized primarily in the liver by glucuronidation via UDP-glucuronosyltransferases (UGTs) and also undergoes reduction to inactive metabolites. Hydrocortisone is metabolized in the liver via reduction and conjugation.
Excretion	Renal: ~80-90% of chloramphenicol as inactive metabolites (glucuronide conjugate) and 5-10% unchanged. Biliary: <3% of unchanged drug. Fecal: minimal.
Half-life	Chloramphenicol: 1.5-4 hours in adults with normal hepatic function; prolonged to 3-7 hours in neonates and up to 15 hours in severe liver disease. Hydrocortisone: 1-2 hours.
Protein binding	Chloramphenicol: ~50-80% bound primarily to albumin. Hydrocortisone: ~90% bound to corticosteroid-binding globulin (CBG) and albumin.
Volume of Distribution	Chloramphenicol: 0.6-1 L/kg, indicating wide distribution including CSF, bile, and aqueous humor. Hydrocortisone: 0.4-0.5 L/kg.
Bioavailability	Chloramphenicol: Oral ~80-90%; ophthalmic drops: negligible systemic absorption (<5%) with typical dosing. Hydrocortisone: Oral ~96%; ophthalmic drops: minimal systemic absorption (<1%).
Onset of Action	Ophthalmic: within 1-2 hours for chloramphenicol; hydrocortisone effects begin within 2-4 hours. Topical (otic): similar ophthalmic onset.
Duration of Action	Chloramphenicol: bacteriostatic levels persist for 6-8 hours after ophthalmic dose; systemic treatment every 6 hours. Hydrocortisone: anti-inflammatory effect lasts 4-8 hours after topical application.

Classification & Brands

Dosing & administration

Dosage form	FOR SUSPENSION
Renal impairment	No dose adjustment required for renal impairment as systemic absorption is minimal following topical ophthalmic or otic use.
Liver impairment	No dose adjustment required for hepatic impairment due to negligible systemic absorption.
Pediatric use	Children ≥2 years: Same as adult dosing. For younger children, use with caution and under medical supervision; dose should be based on severity of infection and body weight, typically 1 drop or small amount applied to affected eye(s) every 4-6 hours.
Geriatric use	Use with caution due to increased risk of adverse effects such as elevated intraocular pressure or cataract formation with prolonged use. No specific dose adjustment, but monitor intraocular pressure and corneal integrity regularly.

Use during pregnancy

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

Clinical note

CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.

FDA category	Positive
Breastfeeding	Chloramphenicol excreted into breast milk; potential for gray baby syndrome or bone marrow suppression in nursing infants; contraindicated. Hydrocortisone: minimal excretion; M/P ratio not reported. Avoid high doses or prolonged use.
Teratogenic Risk	Chloramphenicol crosses the placenta. First trimester: theoretical risk of gray baby syndrome; avoid. Second/third trimesters: associated with gray baby syndrome (cardiovascular collapse, cyanosis, death) in neonates; contraindicated. Hydrocortisone: increased risk of cleft palate (first trimester), fetal adrenal suppression (prolonged use).

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Common Effects	adrenal insufficiency
Serious Effects