Product Details
Dorzolamide Hydrochloride 2% & Benzalkonium Chloride 0.015% Eye Drops 10 ML
10 ML
Product Description :
DORZOLAMIDE HYDROCHLORIDE 2% & BENZALKONIUM CHLORIDE 0.015% EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Dorzolamide Hydrochloride equivalent to Dorzolamide 20 mg (2% w/v).
• Benzalkonium Chloride 0.15 mg (0.015% 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 Antiglaucoma – Carbonic Anhydrase Inhibitor.
4. INDICATIONS
Dorzolamide Hydrochloride Eye Drops are indicated for the reduction of elevated intraocular pressure in patients with:
• Ocular hypertension.
• Open-angle glaucoma.
• Other conditions associated with elevated intraocular pressure where topical carbonic anhydrase inhibitor therapy is clinically appropriate.
Dorzolamide reduces the formation of aqueous humor by inhibiting carbonic anhydrase in the ciliary processes of the eye, thereby reducing intraocular pressure.
5. CONTRAINDICATIONS
• Hypersensitivity to dorzolamide, sulfonamide derivatives, benzalkonium chloride, or any component of the formulation.
• Severe renal impairment or hyperchloremic acidosis, where clinically contraindicated.
6. DRUG INTERACTIONS
• Concomitant use with oral carbonic anhydrase inhibitors may increase the potential for additive pharmacological 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. 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