BETABIOPTAL 1.3mg / 2.5mg / g ophthalmic gel medication leaflet

S01CA05 betamethasone + chloramphenicol • Sensory organs | Antiinflammatory agents and antiinfectives in combination | Corticosteroids and antiinfectives in combination

The combination of betamethasone and chloramphenicol is used to treat inflammatory skin infections caused by susceptible bacteria. Betamethasone is a potent corticosteroid that reduces inflammation, itching, and redness, while chloramphenicol is a broad-spectrum antibiotic that fights bacterial infections. This combination is indicated for conditions such as infected dermatitis, superinfected eczema, or other bacterial dermatoses.

The medication is available as a cream or ointment and is applied topically to the affected area, usually 1-2 times daily, as directed by a doctor. It is important to avoid using it on broken skin, the face, or sensitive areas unless specifically advised by a doctor.

Side effects may include local irritation, burning sensation, dryness, or, in rare cases, allergic reactions. Prolonged or excessive use of the corticosteroid may lead to skin thinning, stretch marks, or systemic absorption, potentially causing systemic side effects.

This combination is contraindicated in viral, fungal, or tuberculous skin infections, as well as in cases of hypersensitivity to any of the components. Use during pregnancy or breastfeeding should be done with caution and only under medical advice. Patients must strictly follow their doctor’s instructions to avoid adverse effects and ensure the effectiveness of the treatment.

General data about BETABIOPTAL 1.3mg / 2.5mg / g

Substance: betamethasone + chloramphenicol

Date of last drug list: 01-06-2025

Commercial code: W60088001

Concentration: 1.3mg / 2.5mg / g

Pharmaceutical form: ophthalmic gel

Quantity: 1

Product type: generic

Price: 71.60 RON

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

Marketing authorisation

Manufacturer: FARMILA-THEA FARMACEUTICI S.P.A. - ITALIA

Holder: THEA FARMA S.P.A. - ITALIA

Number: 12728/2019/01

Shelf life: 2 years-after packing for marketing;after the first opening-4 weeks

Pharmaceutical forms available for betamethasone + chloramphenicol

Concentrations available for betamethasone + chloramphenicol

1.3mg/2.5mg/g, 2mg/5mg/ml, 2mg/g+5mg/g

Compensation lists for BETABIOPTAL 1.3mg / 2.5mg / g THEA

A - Sublist A with 90% discount from the reference price

Price

Copayment

Patient

71.60 RON

45.09 RON

26.51 RON