A fixed-dose ophthalmic combination product containing Chloramphenicol, a broad-spectrum bacteriostatic antibiotic, and Hydrocortisone, a low-potency corticosteroid with anti-inflammatory and immunosuppressive properties. Primarily used in the Indian market for the topical treatment of superficial bacterial infections of the eye and ear with associated inflammation. The combination aims to eradicate susceptible pathogens while controlling the inflammatory response, thereby reducing symptoms like redness, swelling, and discomfort.
Adult: Eye: Instill 1-2 drops into the conjunctival sac every 3-6 hours, depending on severity. Ear: Instill 2-3 drops into the affected ear 3-4 times daily.
Note: 1. Wash hands. 2. Tilt head back (eye) or lie on side (ear). 3. Do not let dropper tip touch eye, ear, or any surface. 4. Gently pull lower eyelid down (eye) or pull ear lobe up and back (ear). 5. Instill prescribed drops. 6. Close eye (eye) or keep head tilted (ear) for 1-2 minutes. 7. Apply gentle pressure to the nasolacrimal duct (inner corner of eye) for 1 minute to minimize systemic absorption. 8. Wait at least 5-10 minutes before instilling any other eye drops.
Chloramphenicol binds reversibly to the 50S subunit of the bacterial 70S ribosome, inhibiting peptidyl transferase activity. This blocks peptide bond formation, leading to inhibition of bacterial protein synthesis (bacteriostatic). Hydrocortisone binds to cytoplasmic glucocorticoid receptors, forming a complex that translocates to the nucleus, modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (lipocortin) and inhibition of pro-inflammatory mediators (prostaglandins, leukotrienes, cytokines).
Pregnancy: Category C (US FDA). Hydrocortisone and Chloramphenicol cross the placenta. Topical use should be avoided unless the potential benefit justifies the potential risk to the fetus. Systemic absorption can occur. Not recommended in first trimester.
Driving: May cause temporary blurred vision after instillation. Patients should not drive or operate machinery until vision clears.
| Erythromycin, Clindamycin | Potential antagonism as both inhibit protein synthesis at similar sites; avoid concurrent use. | Moderate |
| Oral Anticoagulants (Warfarin) | Chloramphenicol may inhibit metabolism, increasing anticoagulant effect and risk of bleeding. | Major |
| Phenytoin, Phenobarbital | Chloramphenicol may increase their serum levels, leading to toxicity. | Major |
| Sulfonylureas (e.g., Glimepiride) | Chloramphenicol may potentiate hypoglycemic effect. | Moderate |
| Other Topical Ophthalmic Steroids | Additive risk of steroid-related side effects (glaucoma, cataract). | Moderate |
Same composition (Chloramphenicol (10mg) + Hydrocortisone (5mg)), different brands: