Avazir 0.3% Sterile ophthalmic solution 10 ml

Avazir 0.3% Sterile ophthalmic solution 10 ml

Composition:

Each 1 ml of solution contains:

Tobramycin 3 mg (0.3%)

Benzalkonium chloride 0.01% (as preservative)

Inactive ingredients: Polysorbate 80, sodium chloride, boric acid, sodium sulfate, sodium hydroxide, water for injection.

Description:

Avazir (tobramycin 0.3%) is a sterile ophthalmic solution intended for topical treatment of external eye infections caused by susceptible bacteria. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide range of gram-positive and gram-negative pathogens. The solution has a pH range between 7 and 8.

Indications for Use:

Indicated for the treatment of external infections of the eye and its adnexa caused by susceptible microorganisms. Clinical studies support its safety and effectiveness in children.

Dosage:

For mild to moderate infections: instill 1–2 drops into the affected eye(s) every 4 hours.

For severe infections: instill 2 drops hourly until improvement, then reduce dosage before discontinuation.

Method of Use:

Turn the cap clockwise to pierce the dropper.

Then turn counter-clockwise to remove the cap.

Invert the bottle and gently press to release one drop.

Contraindications:

Hypersensitivity to any component of the formulation, including aminoglycosides.

Precautions:

-For topical ophthalmic use only — not for injection.

-Contains benzalkonium chloride, which may discolor soft contact lenses. Remove lenses before use and wait at least 15 minutes before reinsertion.

-Prolonged use may lead to overgrowth of non-susceptible organisms, including fungi.

-Do not touch dropper tip to any surface to avoid contamination.

-Patients with signs of bacterial conjunctivitis should not wear contact lenses.

Side Effects:

Most common reactions: hypersensitivity, localized ocular irritation (itching, swelling, conjunctival redness).

Post-marketing reports include: anaphylactic reactions, Stevens-Johnson syndrome, and erythema multiforme.

Pregnancy and Lactation:

Animal studies showed no harm to the fetus. Use during pregnancy only if clearly needed.

Nursing: Consider the importance of the drug to the mother when deciding to discontinue nursing or the drug.

Storage Conditions:

Store below 30°C. Use within 30 days of opening.

Keep out of reach of children.

Packaging:

Carton box containing a 10 ml plastic bottle with a dropper plus inner leaflet.