No information provided.

Cardio-respiratory Reactions

As with other topically-applied ophthalmic agents, this drug may be absorbed systemically. The timolol component is a beta-blocker. Therefore, the same types of adverse reactions found with systemic administration of beta-blockers may occur with topical administration.

Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with COSOPT. In patients with a history of severe cardiac disease, signs of cardiac failure should be watched for and pulse rates should be checked.

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 administration of timolol maleate ophthalmic solution.

Renal and Hepatic Impairment

COSOPT has not been studied in patients with severe renal impairment (CrCl < 30 milliliter/min). Because dorzolamide hydrochloride and its metabolite are excreted predominantly by the kidney, COSOPT is not recommended in such patients.

COSOPT has not been studied in patients with hepatic impairment and therefore should be used with caution in such patients.

Immunology and Hypersensitivity

As with other topically-applied ophthalmic agents, this drug may be absorbed systemically. The dorzolamide component is a sulfonamide. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation.

In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of dorzolamide hydrochloride ophthalmic solution. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. Similar reactions have been reported with COSOPT. If such reactions are observed, discontinuation of treatment with COSOPT should be considered.

While taking β -blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to accidental, diagnostic, or therapeutic repeated challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Concomitant Therapy

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving oral and topical carbonic anhydrase inhibitors concomitantly. The concomitant administration of COSOPT and oral carbonic anhydrase inhibitors has not been studied and is not recommended.

Patients who are already receiving a beta-adrenergic blocking agent systemically and who are given COSOPT should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade. The use of two topical beta- adrenergic blocking agents is not recommended.

Other

The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. COSOPT has not been studied in patients with acute angle-closure glaucoma.

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g., timolol, acetazolamide, dorzolamide) after filtration procedures.

Contact Lens Use

COSOPT contains the preservative benzalkonium chloride, which may be deposited in soft contact lenses; therefore, COSOPT should not be administered while wearing these lenses. The lenses should be removed before application of the drops and not be reinserted earlier than 15 minutes after use.

Pregnancy

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.

Nursing Mothers

It is not known whether dorzolamide hydrochloride is excreted in human milk. Timolol maleate does appear in human milk. Because of the potential for serious adverse reactions on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.The safety and efficacy of 2% dorzolamide hydrochloride ophthalmic solution has been established in a clinical study of children under the age of 6 years. In this study patients under 6 and greater than 2 years of age whose IOP was not controlled with monotherapy received COSOPT. In those patients COSOPT was generally well tolerated.

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