Product Details
Gatifloxacin 0.3% & Benzalkonium Chloride 0.005% Eye Drops 10 ML
10 ML
Product Description :
GATIFLOXACIN 0.3% & BENZALKONIUM CHLORIDE 0.005% EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Gatifloxacin 3 mg (0.3% w/v).
• Benzalkonium Chloride 0.05 mg (0.005% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile, clear ophthalmic solution for topical ocular administration.
3. THERAPEUTIC CLASS
Ophthalmic Antibacterial – Fluoroquinolone Antibiotic.
4. INDICATIONS
Gatifloxacin Eye Drops are indicated for the treatment of susceptible superficial bacterial infections of the eye, including:
• Bacterial conjunctivitis.
• Bacterial keratitis, where appropriate.
• Other superficial ocular infections caused by susceptible microorganisms.
Treatment should be guided by the clinical diagnosis, susceptibility of the causative organism and applicable ophthalmic antimicrobial guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to gatifloxacin, other quinolone/fluoroquinolone antibiotics, benzalkonium chloride, or any component of the formulation.
6. DRUG INTERACTIONS
• Clinically significant drug interactions are unlikely following topical ocular administration.
• Other ophthalmic preparations should generally be administered with an appropriate interval between applications.
The treating physician or pharmacist should review all concomitant medications before use.
7. ADMINISTRATION
For topical ophthalmic use only. Instill the prescribed number of drops into the affected eye(s) according to the approved product information. Do not touch the dropper tip to the eye or surrounding surfaces. If using other ophthalmic preparations, separate administration by an appropriate interval.
8. STORAGE
Store according to the storage conditions stated on the approved product label. Protect from excessive heat, moisture and light. Keep the container tightly closed when not in use. Do not use if the solution shows visible particles, precipitation or unexpected discoloration.
Market : international export
Private Label : Available
Registration Support : Available
Regulatory documents : Available on request