Product Details
Itraconazole 1% & Benzalkonium Chloride Solution 0.02% Eye Drops 10 ML
10 ML
Product Description :
ITRACONAZOLE 1% & BENZALKONIUM CHLORIDE 0.02% EYE DROPS – 10 mL
Sterile Ophthalmic Suspension
1. COMPOSITION
Each mL contains:
• Itraconazole 10 mg (1% w/v).
• Benzalkonium Chloride 0.2 mg (0.02% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile ophthalmic suspension for topical ocular administration.
3. THERAPEUTIC CLASS
Ophthalmic Antifungal Agent – Triazole Antifungal.
4. INDICATIONS
Itraconazole Eye Drops are indicated for the treatment of susceptible superficial fungal infections of the eye, where topical antifungal therapy is considered clinically appropriate, including:
• Superficial fungal infections of the cornea.
• Other susceptible superficial ocular fungal infections as determined by the treating ophthalmologist.
Treatment should be guided by the clinical diagnosis and identification or susceptibility of the causative organism where appropriate.
5. CONTRAINDICATIONS
• Hypersensitivity to itraconazole, other azole antifungal agents, benzalkonium chloride, or any component of the formulation.
6. DRUG INTERACTIONS
• Clinically significant systemic drug interactions are unlikely with topical ocular administration; however, caution is appropriate where significant systemic absorption may occur.
• 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. 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