Cosopt/Cosopt-S Adverse Reactions

Cosopt: In clinical studies, DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) was generally well tolerated; no adverse experiences peculiar to this combination drug have been observed. Adverse experiences have been limited to those that were reported previously with dorzolamide hydrochloride and/or timolol maleate. In general, common adverse experiences were mild and did not cause discontinuation.
During clinical studies, 1035 patients were treated with DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT). Approximately 2.4% of all patients discontinued therapy with DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) because of local ocular adverse reactions. Approximately 1.2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity. The most frequently reported drug-related adverse effects were: ocular burning and stinging, taste perversion, corneal erosion, conjunctival injection, blurred vision, tearing, and ocular itching. Urolithiasis was reported rarely.
The following adverse reactions have been reported in post-marketing experience: dyspnea, respiratory failure, contact dermatitis, bradycardia, heart block, choroidal detachment following filtration surgery, nausea, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Cosopt-S: In a clinical study for Dorzolamide HCl/Timolol Maleate (Cosopt-S) the observed adverse reactions have been consistent with those that were reported previously with Dorzolamide HCl/Timolol Maleate (Cosopt) preserved formulation, dorzolamide hydrochloride and/or timolol maleate.
During clinical studies, 1,035 patients were treated with Dorzolamide HCl/Timolol Maleate (Cosopt) preserved formulation, approximately 2.4% of all patients discontinued therapy with Dorzolamide HCl/Timolol Maleate (Cosopt) preserved formulation because of local ocular adverse reactions; approximately 1.2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity (such as lid inflammation and conjunctivitis).
Dorzolamide HCl/Timolol Maleate (Cosopt-S) has been shown to have a similar safety profile to Dorzolamide HCl/Timolol Maleate (Cosopt) preserved formulation in a repeat dose double-masked, comparative study.
Like other topically applied ophthalmic medicines, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
The following adverse reactions have been reported with Dorzolamide HCl/Timolol Maleate (Cosopt-S) or one of its components either during clinical trials or during post-marketing experience: [Very Common: (≥1/10), Common: (≥1/100, <1/10), Uncommon: (≥1/1000, <1/100), and Rare: (≥1/10,000, <1/1000), Not known (cannot be estimated from the available data)]. (See Table A and B.)

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