DORSUN T - Dorzolamide Hydrochloride & Timolol Maleate Ophthalmic Solution

Composition   Dorzolamide Hydrochloride USP   Equivalent to Dorzolamide 2.0% w/v Timolol Maleate IP   Equivalent to Timolol Base 0.5% w/v Benzalkonium chloride IP 0.01% w/v Sterile Aqueous Base q.s. Dosage Form Ophthalmic Solution (Eye Drops) Category Anti Glaucoma Description Dorsun-T is comprised of two components: dorzolamide hydrochloride and timolol maleate. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma, by reducing aqueous humor secretion. Pharmacology – Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase II. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. Timolol maleate is a beta 1 and beta 2 (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. The combined effect of these two agents administered as a fixed dose combination b.i.d. results in additional intraocular pressure reduction compared to either component administered alone. Indications Dorsun-T is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). Dosage The dose is one drop of Dorsun-T in the affected eye(s) two times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Contraindications Dorsun-T is contraindicated in patients with 1. Bronchial asthma; 2. A history of bronchial asthma; 3. Severe chronic obstructive pulmonary disease; 4. Sinus bradycardia; 5. Second or third degree atrioentricular block; 6. Overt cardiac failure; 7. Cardiogenic shock; 8. Hypersensitivity to any component of this product. Precautions Pregnanacy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Dorsun-T should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation It is not known whether dorzolamide is excreted in human milk. Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Dorsun-T in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. Storage Store in a cool dark place, protect from light. Presentation Dorsun-T Eye Drops: Available in 5 ml vial.