Cosopt/Cosopt-S Special Precautions

Cosopt: 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.
Cardio-Respiratory Reactions: Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT). Patients with a history of cardiovascular disease, including cardiac failure, should be watched for signs of deterioration of these diseases, and pulse rates should be checked.
Due to its negative effect on conduction time, beta‑blockers should be given with caution to patients with first degree heart block.
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.
In patients with mild/moderate chronic obstructive pulmonary disease (COPD), DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) should be used with caution, and only if the potential benefit outweighs the potential risk.
Vascular Disorders: Patients with severe peripheral circulatory disturbance/disorders (e.g. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus: Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycemia.
Masking of Thyrotoxicosis: Beta-adrenergic blocking agents may mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.
Surgical Anesthesia: The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
Renal and Hepatic Impairment: DORZOLAMIDE HCl + TIMOLOL MALEATE (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, DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) is not recommended in such patients.
DORZOLAMIDE HCl + TIMOLOL MALEATE (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, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. 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 DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT). If such reactions are observed, discontinuation of treatment with DORZOLAMIDE HCl + TIMOLOL MALEATE (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 DORZOLAMIDE HCl + TIMOLOL MALEATE (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 DORZOLAMIDE HCl + TIMOLOL MALEATE (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. DORZOLAMIDE HCl + TIMOLOL MALEATE (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.
There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) to this group of patients.
Contact Lens Use: DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) contains the preservative benzalkonium chloride, which may be deposited in soft contact lenses; therefore, DORZOLAMIDE HCl + TIMOLOL MALEATE (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.
Cosopt-S: Cardiovascular/Respiratory Reactions: Like other topically applied ophthalmic agents timolol is absorbed systemically. Due to beta- adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see Dosage & Administration.
Cardiac disorders: In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Respiratory disorders: Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.
Dorzolamide HCl/Timolol Maleate (Cosopt-S) should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Hepatic Impairment: This medicinal product has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
Immunology and Hypersensitivity: As with other topically-applied ophthalmic agents, this medicinal product may be absorbed systemically. Dorzolamide contains a sulfonamido group, which also occurs in sulfonamides. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation.
Local ocular adverse effects, similar to those observed with dorzolamide hydrochloride eye drops, have been seen with this medicinal product. If such reactions occur, discontinuation of Dorzolamide HCl/Timolol Maleate (Cosopt-S) should be considered.
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
Concomitant therapy: The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended (see Interactions).
The use of dorzolamide and oral carbonic anhydrase inhibitors is not recommended.
Withdrawal of Therapy: As with systemic beta-blockers, if discontinuation of ophthalmic timolol is needed in patients with coronary heart disease, therapy should be withdrawn gradually.
Additional Effects of Beta-Blockade: Hypoglycaemia/diabetes: Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia.
Beta-blockers may also mask the signs of hyperthyroidism. Abrupt withdrawal of beta-blocker therapy may precipitate a worsening of symptoms.
Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
Surgical anaesthesia: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol.
Therapy with beta-blockers may aggravate symptoms of myasthenia gravis.
Additional Effects of Carbonic Anhydrase Inhibition: Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi. Although no acid-base disturbances have been observed with Dorzolamide HCl/Timolol Maleate (Cosopt) preserved formulation, urolithiasis has been reported infrequently. Because Dorzolamide HCl/Timolol Maleate (Cosopt-S) contains a topical carbonic anhydrase inhibitor that is absorbed systemically, patients with a prior history of renal calculi may be at increased risk of urolithiasis while using this medicinal product.
Other: The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. This medicinal product has not been studied in patients with acute angle-closure glaucoma.
Corneal oedema and irreversible corneal decompensation have been reported in patients with pre- existing chronic corneal defects and/or a history of intraocular surgery while using dorzolamide. There is an increased potential for developing corneal oedema in patients with low endothelial cell counts. Precautions should be used when prescribing Dorzolamide HCl/Timolol Maleate (Cosopt-S) to these groups of patients.
Choroidal detachment has been reported with administration of aqueous suppressant therapies (e.g. timolol, acetazolamide) after filtration procedures.
As with the use of other antiglaucoma medicines, diminished responsiveness to ophthalmic timolol maleate after prolonged therapy has been reported in some patients. However, in clinical studies in which 164 patients have been followed for at least three years, no significant difference in mean intraocular pressure has been observed after initial stabilization.
Contact Lens Use: This medicinal product has not been studied in patients wearing contact lenses.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Possible side effects such as blurred vision may affect some patients' ability to drive and/or operate machinery.
Use in Children: Cosopt: 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 DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT). In those patients DORZOLAMIDE HCl + TIMOLOL MALEATE (COSOPT) was generally well tolerated.