SOLUTIE AURICULARA CU CLORAMFENICOL SI FLUOCINOLON 5mg / 0.50mg / g ear solution medication leaflet

S02CA05 chloramphenicol + fluocinolone acetonide • Sensory organs | Corticosteroids and antiinfectives in combination

Chloramphenicol and fluocinolone acetonide are used in combination in certain medications, particularly in the form of eye or ear drops, to treat bacterial infections associated with severe inflammation. This combination is indicated for conditions such as bacterial conjunctivitis, blepharitis, keratitis, or otitis externa, where both infection control and inflammation reduction are needed.

Chloramphenicol is a broad-spectrum antibiotic that inhibits bacterial protein synthesis, making it effective against a wide range of gram-positive and gram-negative bacteria. Fluocinolone acetonide is a potent corticosteroid with anti-inflammatory, anti-allergic, and antipruritic properties, which reduces inflammation, swelling, and symptoms associated with infections.

While this combination is effective, its use requires caution. Chloramphenicol may cause rare side effects, such as hypersensitivity reactions or, in very rare cases, bone marrow aplasia (a serious bone marrow condition). Fluocinolone acetonide, if used long-term or in large amounts, can lead to systemic side effects, such as suppression of the hypothalamic-pituitary-adrenal axis, tissue thinning, or an increased risk of secondary infections.

This combination should be used as directed by a doctor, and the duration of treatment should be limited to reduce the risk of side effects. It is important to avoid long-term use or use in cases where the infection is caused by viruses or fungi, as corticosteroids may worsen these infections. If severe side effects or persistent symptoms occur, immediate medical attention is necessary.

General data about SOLUTIE AURICULARA CU CLORAMFENICOL SI FLUOCINOLON 5mg / 0.50mg / g

Substance: chloramphenicol + fluocinolone acetonide

Date of last drug list: 01-01-2025

Commercial code: W10587001

Concentration: 5mg / 0.50mg / g

Pharmaceutical form: ear solution

Quantity: 1

Product type: generic

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: BIOFARM SA - ROMANIA

Holder: BIOFARM SA - ROMANIA

Number: 2904/2002/01

Shelf life: 1 year