Gatistar 0.5% Eye Drops 5 ml

Gatistar 0.5% Eye Drops 5 ml

Composition:

Active Ingredient:
Gatifloxacin 5 mg/ml (a fluoroquinolone antibiotic).
Preservative:
Benzalkonium chloride 0.05 mg/ml.

Product Description:

Gatistar is a broad-spectrum 4th generation fluoroquinolone antibacterial ophthalmic solution.
It acts by inhibiting bacterial DNA gyrase and topoisomerase IV enzymes, which disrupts DNA replication and transcription, leading to bacterial cell death.
It is effective against major Gram-positive and Gram-negative pathogens causing ocular infections, including Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, and Pseudomonas aeruginosa.

Indications for Use:

• Treatment and prevention of infectious and inflammatory eye diseases caused by gatifloxacin-susceptible microorganisms:
  Bacterial conjunctivitis.
  Blepharitis.
  Keratitis.
  Hordeolum (stye).
  Prevention of post-operative and post-traumatic ocular infectious complications.

Method of Administration and Dosage:

• For topical ophthalmic use (instillation into the conjunctival sac):
• Days 1–2 of Treatment: Instill 1–2 drops into the affected eye(s) every 2 hours (up to 8 times daily).
• Days 3–7 of Treatment: Instill 1–2 drops into the affected eye(s) 3–4 times daily.
• Duration of Therapy: Typically 7 days or as directed by a healthcare professional.

Contraindications:

Hypersensitivity to gatifloxacin, other fluoroquinolones, or any excipients (including benzalkonium chloride).
Pediatric populations unless explicitly authorized by relevant clinical guidelines for specific age groups.

Precautions:

• Contains benzalkonium chloride, which may be absorbed by soft contact lenses and cause eye irritation.
• Contact lenses should be removed prior to instillation and reinserted no sooner than 15 minutes post-application.
• Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi.
• Avoid touching the dropper tip to the eyelids, fingers, or any other surface to maintain sterility.

Adverse Reactions / Side Effects:

Ocular Reactions:
Transient burning or stinging, conjunctival hyperemia, irritation, lacrimation, dry eye, eye pain, or eyelid edema.
Systemic Reactions:
Rarely, dysgeusia (taste disturbance) or headache.

Pregnancy and Lactation:

Pregnancy:
Use during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation:
Data on the excretion of topical ophthalmic gatifloxacin into human milk is limited.
Exercise caution when administering to nursing women.

Storage Conditions:

Store at temperatures not exceeding 25°C in a dry, light-protected place.
Do not freeze.
Keep out of reach of children.

Packaging:

5 ml dropper bottle packed in a cardboard box with a patient information leaflet.