Product Details
Ketorolac Tromethamine 0.5%, Benzalkonium Chloride 0.02% Eye Drops 10 ML
10 ML
Product Description :
KETOROLAC TROMETHAMINE 0.5% & BENZALKONIUM CHLORIDE 0.02% EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Ketorolac Tromethamine 5 mg (0.5% 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 Non-Steroidal Anti-Inflammatory Drug (NSAID).
4. INDICATIONS
Ketorolac Tromethamine Eye Drops are indicated for the treatment of ocular inflammation and pain, including:
• Relief of ocular itching associated with seasonal allergic conjunctivitis.
• Treatment of postoperative ocular inflammation.
• Temporary relief of ocular pain and discomfort associated with appropriate ophthalmic conditions.
Treatment should be guided by the clinical diagnosis and applicable ophthalmic treatment guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to ketorolac tromethamine, other NSAIDs, benzalkonium chloride, or any component of the formulation.
• Patients with a history of hypersensitivity reactions to aspirin or other NSAIDs should be assessed carefully before use.
6. DRUG INTERACTIONS
• Concomitant use with other topical ophthalmic NSAIDs may increase the risk of ocular irritation or adverse 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