Product Details
Gatifloxacin Sesquihydrate 0.3% , Ketorolac Tromethamine 0.4% & Benzalkonium Chloride Solution 0.02% Eye Drops 10 ML
10 ML
Product Description :
GATIFLOXACIN SESQUIHYDRATE 0.3% + KETOROLAC TROMETHAMINE 0.4% & BENZALKONIUM CHLORIDE 0.02% EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Gatifloxacin Sesquihydrate equivalent to Gatifloxacin 3 mg (0.3% w/v).
• Ketorolac Tromethamine 4 mg (0.4% w/v).
• Benzalkonium Chloride 0.2 mg (0.02% 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 – Non-Steroidal Anti-Inflammatory Combination.
4. INDICATIONS
Gatifloxacin and Ketorolac Tromethamine Eye Drops are indicated for ocular conditions where antibacterial therapy and reduction of ocular inflammation or pain are clinically appropriate, including:
• Bacterial ocular infections associated with inflammation.
• Ocular inflammation and discomfort where topical antibacterial therapy is appropriate.
• Postoperative ocular conditions where antibacterial and anti-inflammatory therapy is indicated.
Treatment should be guided by the clinical diagnosis, susceptibility of the causative organism and applicable ophthalmic treatment guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to gatifloxacin, other quinolone/fluoroquinolone antibiotics, ketorolac tromethamine, other NSAIDs, benzalkonium chloride, or any component of the formulation.
• Previous serious hypersensitivity reactions to quinolone antibiotics or NSAIDs.
6. DRUG INTERACTIONS
• Concomitant use with other topical ophthalmic NSAIDs may increase the risk of ocular irritation or other ocular effects.
• Concomitant use with topical corticosteroids may increase the potential for delayed corneal healing and other ocular complications.
• Other ophthalmic preparations should generally be administered with an appropriate interval between applications.
The treating physician 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