Leaflet OPHTASONE ophthalmic drops solution

Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: gentamicin + betamethasone (aminoglycoside antibiotic + glucocorticoid)

ATC: S01CA05 (Sensory organs | Antiinflammatory agents and antiinfectives in combination | Corticosteroids and antiinfectives in combination)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

The combination of gentamicin and betamethasone is used to treat skin or inflammatory infections caused by susceptible bacteria and requiring inflammation reduction. It is commonly available as creams, ointments, or drops (ophthalmic or otic), depending on the location of the condition.

- Gentamicin is an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, providing a bactericidal effect against gram-negative and some gram-positive bacteria.
- Betamethasone is a potent corticosteroid that reduces inflammation, itching, and redness by suppressing the body's inflammatory and immune response.

This combination is indicated for conditions such as infected dermatitis, infected eczema, otitis externa, or bacterial conjunctivitis associated with severe inflammation.

Side effects may include local irritation, burning sensation, dryness, or allergic reactions. Prolonged use of corticosteroids can lead to skin thinning, stretch marks, or secondary infections. When used near the eyes, there is a risk of increased intraocular pressure or cataract development.

Patients should strictly follow their doctor’s instructions regarding the duration and method of application. It is important not to use this combination long-term or on large areas of skin without medical supervision, as it may increase the risk of systemic side effects.

General data about OPHTASONE

  • Substance: gentamicin + betamethasone
  • Date of latest medicines list: 01-07-2013
  • Product code: W02233001
  • Pharmaceutical form: ophthalmic drops solution
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.