Product Details
Gatifloxacin Sesquihydrate 0.3% , Prednisolone Acetate 1% & Benzalkonium Chloride Solution 0.01% Eye Drops 10 ML
10 ML
Product Description :
GATIFLOXACIN SESQUIHYDRATE 0.3% + PREDNISOLONE ACETATE 1% & BENZALKONIUM CHLORIDE 0.01% EYE DROPS – 10 mL
Sterile Ophthalmic Suspension
1. COMPOSITION
Each mL contains:
• Gatifloxacin Sesquihydrate equivalent to Gatifloxacin 3 mg (0.3% w/v).
• Prednisolone Acetate 10 mg (1% w/v).
• Benzalkonium Chloride 0.1 mg (0.01% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile ophthalmic suspension for topical ocular administration.
3. THERAPEUTIC CLASS
Ophthalmic Antibacterial – Corticosteroid Combination.
4. INDICATIONS
Gatifloxacin and Prednisolone Acetate Eye Drops are indicated for steroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial infection exists, including:
• Inflammatory conditions of the conjunctiva.
• Inflammatory conditions of the eyelids.
• Other steroid-responsive anterior segment inflammatory conditions where antibacterial therapy is appropriate.
Treatment should be guided by the clinical diagnosis, susceptibility of the causative organism and applicable ophthalmic treatment guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to gatifloxacin, prednisolone acetate, other fluoroquinolones, corticosteroids, benzalkonium chloride, or any component of the formulation.
• Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis.
• Fungal diseases of ocular structures.
• Mycobacterial infections of the eye.
6. DRUG INTERACTIONS
• Concomitant use with other ophthalmic corticosteroids may increase the risk of corticosteroid-related ocular effects.
• 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. Shake well before use. 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 suspension shows visible particles, unexpected discoloration or other abnormal changes.
Market : international export
Private Label : Available
Registration Support : Available
Regulatory documents : Available on request