Cosopt-S

Cosopt-S

dorzolamide + timolol

Manufacturer:

Santen

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Per mL Dorzolamide HCl 20 mg, timolol maleate 5 mg
Indications/Uses
Elevated IOP in patients w/ open-angle glaucoma or pseudoexfoliative glaucoma when topical β-blocker monotherapy is insufficient.
Dosage/Direction for Use
Instill 1 drop bd in the conjunctival sac of the affected eye(s). Administer at least 10 min apart if using another topical ophth agent.
Contraindications
Hypersensitivity. Patients w/ reactive airway disease, including bronchial asthma or history thereof, 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; severe renal impairment (CrCl <30 mL/min) or hyperchloraemic acidosis.
Special Precautions
CV, pulmonary & other adverse reactions seen w/ systemic β-adrenergic blockers may occur. Patients w/ CV diseases should be watched for signs of CV disease deterioration & of adverse reactions. Reports of resp reactions, including death due to bronchospasm in patients w/ asthma. Adverse reactions found w/ systemic administration of sulfonamides may occur w/ topical administration, including severe reactions eg, SJS & TEN. Discontinue use if signs of serious reactions or hypersensitivity occur. W/draw treatment gradually if discontinuation of ophth timolol is needed in patients w/ CHD. β-blockers may mask signs & symptoms of acute hypoglycaemia; mask signs of hyperthyroidism; induce dryness of eyes; block systemic β-agonist effects eg, of adrenaline; aggravate symptoms of myasthenia gravis. Patients w/ prior history of renal calculi may be at increased risk of urolithiasis while on treatment. Reports of corneal oedema & irreversible corneal decompensation in patients w/ pre-existing chronic corneal defects &/or history of intraocular surgery while using dorzolamide. Reports of choroidal detachment w/ administration of aq suppressant therapies (eg, timolol, acetazolamide) after filtration procedures. Reports of diminished responsiveness to ophth timolol maleate after prolonged therapy. Not studied in patients w/ acute angle-closure glaucoma; patients wearing contact lenses. Use of 2 topical β-adrenergic blockers is not recommended. Use of dorzolamide & oral carbonic anhydrase inhibitors is not recommended. May affect ability to drive &/or operate machinery. Caution in patients w/ 1st degree heart block; severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or Raynaud's syndrome); mild/moderate COPD; labile diabetes & those subject to spontaneous hypoglycaemia; corneal diseases; hepatic impairment. Do not use during pregnancy. Lactation is not recommended if treatment is required. Efficacy in paed patients has not been established. Safety in paed patients <2 yr has not been established.
Adverse Reactions
Cosopt-S: Ocular burning & stinging; dysgeusia. Conjunctival inj, blurred vision, corneal erosion, ocular itching, tearing; sinusitis. Dorzolamide HCl: Headache; eyelid inflammation & irritation; nausea; asthenia/fatigue. Timolol maleate: Headache; signs & symptoms of ocular irritation including blepharitis, keratitis, decreased corneal sensitivity, & dry eyes.
Drug Interactions
Potential additive effects w/ oral Ca channel blockers, catecholamine-depleting medicines or β-adrenergic blockers, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine, narcotics, & MAOIs. Potentiated systemic β-blockade w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Risk of mydriasis w/ adrenaline (epinephrine). Increased hypoglycaemic effect of antidiabetic agents.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Cosopt-S ophth soln
Packing/Price
0.2 mL x 60 × 1's
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