DORSUN - Dorzolamide Hydrochloride Ophthalmic Solution

Composition   Dorzolamide Hydrochloride USP   Equivalent to Dorzolamide 2.0% 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 eye drops contain dorzolamide hydrochloride, a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Pharmacology: Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells (RBCs), but also in other tissues. 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. The result is a reduction in intraocular pressure (IOP). Indications Dorzolamide ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dosage The dose is one drop of Dorsun eye drops in the affected eye(s) three times daily. Dorsun eye drops may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. Contraindications Dorzolamide is contraindicated in patients who are hypersensitive to any component of this product. Precautions Pregnanacy Category C There are no adequate and well-controlled studies in pregnant women. Dorsun should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dorzolamide, 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 and effectiveness have been observed between elderly and younger patients. Storage Store in a cool dark place, protect from light. Presentation Dorsun Eye Drops- Container of 5 ml