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Indications

COSOPT is indicated for the reduction of elevated intraocular pressure (IOP) 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). The IOP-lowering effect of COSOPT bid was slightly less than that seen with the concomitant administration of 0.5% timolol bid and 2.0% dorzolamide tid.

Contraindications

COSOPT is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second- or third-degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Warnings

COSOPT contains dorzolamide, a sulfonamide, and timolol maleate, a beta-adrenergic blocking agent; and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides and/or systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate.

Precautions

The concomitant use of two topical beta-adrenergic blocking agents (eg, COSOPT and timolol maleate) is not recommended.

Patients should be advised that COSOPT contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes after administration of COSOPT.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

There are no adequate and well-controlled studies in pregnant women. COSOPT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

COSOPT is not recommended in patients with severe renal impairment and should be used with caution in patients with hepatic impairment.

Adverse Events

In clinical trials with COSOPT, the most frequently reported adverse events were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging in up to 30% of patients. Conjunctival hyperemia, blurred vision, superficial punctate keratitis, or eye itching were reported in 5% to 15% of patients. A comprehensive list of adverse events observed in clinical studies and postmarketing surveillance is included in the Prescribing Information. Also see the Patient Product Information for patient information on COSOPT.