Product Details
Dorzolamide Hydrochloride 2%, Timolol Maleate 0.5% & Benzalkonium Chloride Solution 0.015 Eye Drops 10 ML
10 ML
Product Description :
DORZOLAMIDE HYDROCHLORIDE 2% + TIMOLOL MALEATE 0.5% & 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).
• Timolol Maleate equivalent to Timolol 5 mg (0.5% 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 and Beta-Adrenergic Blocking Agent Combination.
4. INDICATIONS
Dorzolamide Hydrochloride and Timolol Maleate 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 combination therapy is clinically appropriate.
Dorzolamide reduces aqueous humor production through inhibition of carbonic anhydrase, while timolol reduces aqueous humor production through beta-adrenergic receptor blockade.
5. CONTRAINDICATIONS
• Hypersensitivity to dorzolamide, timolol, sulfonamide derivatives, benzalkonium chloride, or any component of the formulation.
• Bronchial asthma or a history of bronchial asthma.
• Severe chronic obstructive pulmonary disease.
• Sinus bradycardia.
• Second- or third-degree atrioventricular block.
• Overt cardiac failure or cardiogenic shock.
• Severe renal impairment or hyperchloremic acidosis, where clinically contraindicated.
6. DRUG INTERACTIONS
• Concomitant use with systemic beta-blockers may result in additive beta-blockade.
• Concomitant use with calcium-channel blockers, catecholamine-depleting medicines, or other medicines affecting cardiac conduction may increase the risk of cardiovascular effects.
• Concomitant use with other carbonic anhydrase inhibitors may increase the potential for additive 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