Composition

Each 1 ml contains:
Dorzolamide (as hydrochloride) ................................................. 20 mg
Timolol (as maleate) ....................................................................... 5 mg
Preservative:
Benzalkonium chloride .......................................................... 0.075 mg

Therapeutic Indications

Treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage and Administration

One drop is instilled into the affected eye(s) two times daily.

Contraindications

Hypersensitivity to any component of the product.
Chronic angle-closure glaucoma.
Bronchial asthma or a history of bronchial asthma.
Chronic obstructive pulmonary disease.
Sinus bradycardia.
Overt cardiac failure.
Second or third degree atrioventricular block.
Cardiogenic shock.
Hypotension.
Severe renal impairment.

Drug Interactions

The systemic effect of Episopt (beta-adrenergic blocking agent) may be additive with those of other oral carbonic anhydrase inhibitors.
There is potential additive effects of beta-blockade, both systemic and on intraocular pressure, in patients receiving oral beta-adrenergic blocking agents and Episopt.
Co-administration of Episopt and calcium antagonists or digitalis may have additive effects in prolonging atrioventricular conduction time.
Co-administration of Episopt and catecholamine-depleting drugs such as reserpine, may result in possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension; so patients should be monitored closely.
Concomitant administration of Episopt with quinidine decreases heart rate.

Warnings and Precautions

Episopt should be used with caution in patients with hepatic impairment.
Because of the dorzolamide (sulphonamide) component, signs of hypersensitivity may occur; and in this case patients should discontinue the use of the product.
Because of the timolol component (a beta-blocker), cardiac failure should be watched for and pulse rates should be checked.
Patients should be instructed that:
If they develop any ocular reactions, they should discontinue use.
If they have ocular surgery or develop an intercurrent ocular condition, they should consult the physician.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart.
Contact lenses should be removed prior to administration of Episopt. Lenses may be reinserted 15 minutes following administration of the solution.
They should avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid bacterial contamination.