Avazir 0.3% Sterile ophthalmic solution 10 ml
Orchidia Pharmaceutical Industries
Orchidia Pharmaceutical Industries
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.