Leaflet OPHTAMESONE-N ophthalmic solution


Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: dexamethasone + neomycin (glucocorticoid + aminoglycoside antibiotic)

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.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Ototoxicity
Ototoxicity

This medicine may affect hearing or balance.

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.

Dexamethasone and neomycin are used together in certain medications, particularly in the form of eye drops, ear drops, or ointments, to treat bacterial infections associated with inflammation. This combination is indicated for conditions such as bacterial conjunctivitis, blepharitis, otitis externa, or other inflammatory skin infections.

Dexamethasone is a potent corticosteroid with anti-inflammatory and immunosuppressive properties, which reduces inflammation, swelling, and allergic symptoms associated with infections. Neomycin is a broad-spectrum aminoglycoside antibiotic effective against gram-negative and some gram-positive bacteria, which inhibits bacterial protein synthesis, thereby eliminating the infection.

While this combination is effective, its use requires caution. Dexamethasone, if used long-term, can lead to systemic side effects such as suppression of the hypothalamic-pituitary-adrenal axis, tissue thinning, or an increased risk of secondary infections. Neomycin may cause allergic reactions or, in rare cases, ototoxicity (hearing damage) or nephrotoxicity, especially if used on large areas or for prolonged periods.

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 use in cases of viral or fungal infections, as corticosteroids may worsen these infections. If severe side effects or persistent symptoms occur, immediate medical attention is necessary.

General data about OPHTAMESONE-N

  • Substance: dexamethasone + neomycin
  • Date of last drug list: 01-07-2013
  • Commercial code: W02232001
  • Pharmaceutical form: ophthalmic solution
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Pharmaceutical forms available for dexamethasone + neomycin