Episopt

Episopt

dorzolamide + timolol

Manufacturer:

Egyptian Int'l Pharma

Distributor:

Vista Pharma

Marketer:

Ambica
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 pseudo-exfoliative glaucoma when topical β-blocker monotherapy is not sufficient.
Dosage/Direction for Use
1 drop in conjunctival sac of the affected eye(s) bid.
Contraindications
Hypersensitivity. 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/ pace-maker, overt cardiac failure, cardiogenic shock. Severe renal impairment (CrCl <30 mL/min) or hyperchloraemic acidosis.
Special Precautions
Patients w/ history of atopy or severe anaphylactic reaction to a variety of allergens. Patients w/ CV diseases (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension therapy w/ β-blockers; 1st degree heart block. Severe peripheral circulatory disturbance/disorders (eg, severe forms of Raynaud's disease/syndrome). Mild/moderate COPD. May mask the signs & symptoms of acute hypoglycemia & hyperthyroidism in patients subjected to spontaneous hypoglycemia or w/ labile diabetes. Patients w/ corneal diseases; may induce dryness of eyes. Choroidal detachment may occur after filtration procedures. Blocks systemic β-agonist effects eg, adrenaline. Discontinue if serious reactions or hypersensitivity occurs. Concomitant use w/ carbonic anhydrase inhibitors; other β-blocking agents is not recommended. W/drawal of therapy in patients w/ CHD should be gradual. May aggravate symptoms of myasthenia gravis. Increased risk of urolithiasis in patients w/ prior history of renal calculi. Patients w/ acute angle closure glaucoma; patients w/ pre-existing chronic corneal defects &/or history of intra-ocular surgery. May discolor soft contact lenses. May affect the ability to drive & use machine. Hepatic impairment. Pregnancy. Do not use during lactation. Childn <2 yr.
Adverse Reactions
Burning & stinging (eye disorder); taste perversion. Headache; conjunctival inj, blurred vision, corneal erosion, ocular itching, tearing; sinusitis. Dorzolamide: eyelid inflammation/irritation; nausea; asthenia/fatigue. Timolol: Signs & symptoms of ocular irritation (eg, burning, stinging, itching, tearing, redness) including blepharitis, keratitis, decreased corneal sensitivity, & dry eyes.
Drug Interactions
Concomitant use w/ adrenaline (epinephrine) may cause mydriasis. May increase hypoglycemic effect of antidiabetic agents. Oral β-adrenergic blocking agents may exacerbate the rebound HTN following the w/drawal of clonidine. Timolol: May potentiate systemic β-blockade w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine); Concomitant use w/ oral Ca channel blockers, β-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides parasympathomimetic, guanethidine may cause additive effects resulting in hypotension &/or marked bradycardia.
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
Episopt ophth soln
Packing/Price
5 mL x 1's
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