Cosopt/Cosopt-S

Cosopt/Cosopt-S

dorzolamide + timolol

Manufacturer:

Santen

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Per mL Dorzolamide HCl 20 mg, timolol maleate 5 mg
Indications/Uses
Elevated IOP in patients w/ ocular HTN, open-angle glaucoma, pseudoexfoliative glaucoma or other secondary open-angle glaucoma when concomitant therapy is appropriate.
Dosage/Direction for Use
1 drop in the affected eye(s) bid. Administer at least 10 min apart if another topical ophth agent is being used.
Contraindications
Hypersensitivity. Patients w/ reactive airway disease, including bronchial asthma or history of bronchial asthma, or severe COPD; sinus bradycardia, sick sinus syndrome, SA block, 2nd- or 3rd-degree AV block not controlled w/ pacemaker, overt cardiac failure, cardiogenic shock. Cosopt-S: Patients w/ hyperchloraemic acidosis. Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Discontinue use if signs of serious reactions or hypersensitivity occur. Consider to discontinue use if local ocular adverse effects occur. Reduced systemic absorption when using nasolacrimal occlusion or closing the eyelids for 2 min. Report of resp reactions including death due to bronchospasm in patients w/ asthma; choroidal detachment after filtration procedures. May mask signs of hyperthyroidism. Patients w/ 1st degree heart block; severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or syndrome); mild/moderate COPD; history of atopy or of severe anaphylactic reaction to a variety of allergens; subject to spontaneous hypoglycaemia or w/ labile diabetes; acute angle-closure glaucoma; low endothelial cell counts. Gradually w/draw therapy. Not recommended to be used w/ another topical β-adrenergic blocking agent; oral carbonic anhydrase inhibitors. Observe response in patients already receiving systemic β-blocking agent. Possible side effects (eg, blurred vision) may affect some patients' ability to drive &/or operate machinery. Hepatic impairment. Childn <2 yr. Cosopt: Adequately control cardiac failure prior to therapy. Watch for signs of deterioration of CV disease & check for pulse rates in patients w/ history of CV disease including cardiac failure. W/drawal prior to major surgery. Contains benzalkonium Cl; not to be administered in patients while wearing contact lenses. Not recommended in severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Cosopt-S: May induce dryness of eyes. May aggravate symptoms of myasthenia gravis. May increase risk of urolithiasis in patients w/ prior history of renal calculi. Diminished responsiveness to ophth timolol maleate after prolonged therapy in some patients. Patients w/ corneal diseases. Assess therapy in patients w/ CV diseases (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension. Watch for signs of deterioration of CV diseases & of adverse reactions. Patients wearing contact lenses. May block systemic β-agonist effects of adrenaline. Not to be used during pregnancy. Not recommended during lactation.
Adverse Reactions
Cosopt: Ocular burning or stinging, taste perversion, corneal erosion, conjunctival infection, blurred vision, tearing & ocular itching. Dyspnea, resp failure, contact dermatitis, bradycardia, heart block, choroidal detachment following filtration surgery, nausea, SJS & TEN. Cosopt-S: Ocular burning & stinging; dysgeusia. Sinusitis. Headache; conjunctival infection, blurred vision, corneal erosion, ocular itching, tearing; sinusitis.
Drug Interactions
Potential additive effects resulting in hypotension &/or marked bradycardia w/ oral Ca channel blockers, catecholamine-depleting medicines or β-adrenergic blocking agents, antiarrhythmics (including amiodarone), parasympathomimetics. Potentiated systemic β-blockade (eg, decreased heart rate, depression) w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine) & timolol. May exacerbate rebound HTN following clonidine w/drawal. Cosopt: Potential drug interactions (eg, toxicity associated w/ high-dose salicylate therapy). Cosopt-S: Potential additive effects resulting in hypotension &/or marked bradycardia w/ digitalis glycosides, guanethidine, narcotics & MAO inhibitors. Occasional report of mydriasis w/ epinephrine. May increase hypoglycaemic effect of antidiabetic agents. Concomitant use w/ omidenepag isopropyl.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
S01EC03 - dorzolamide ; Belongs to the class of carbonic anhydrase inhibitors. Used in the treatment of glaucoma.
Presentation/Packing
Form
Cosopt-S ophth soln
Packing/Price
0.2 mL x 60 × 1's
Form
Cosopt ophth soln
Packing/Price
5 mL x 1's
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