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THERAPEUTIC CLASSIFICATION:

Anti-glaucoma and miotic preparations, beta-blocking agents, timolol, combinations, ATC code: S01ED51

 

COMPOSITION

TIMOLOL MALEATE (Equivalent to Timolol base 5.00 mg) / DORZOLAMIDE HCl (Equivalent to Dorzolamide base 20.00 mg) 6.83 mg / 22.26 mg per each ml of solution

SOLUTION

 

USES AND ADMINISTRATION

EPISOPT OFTHALMIC DROPS consists of two active ingredients: Dorzolamide hydrochloride and timolol maleate. Each of these two active principles decreases the elevated intraocular pressure by reducing the secretion of aqueous humor, but each of them does so with a different mechanism of action.

 

Dorzolamide hydrochloride is a potent inhibitor of human carbon II anhydrase. The inhibition of carbonic anhydrase in the ciliary processes of the eye diminishes the secretion of aqueous humor, presumably by slowing down the formation of bicarbonate ions, with the consequent reduction in the transport of sodium and fluids. Timolol maleate is a non-selective beta-adrenergic blocker. The combined effect of these two agents results in a greater reduction in intraocular pressure (IOP), compared to the administration of any of the active ingredients separately.

 

After topical administration, it reduces elevated intraocular pressure, associated or not with glaucoma. Elevated intraocular pressure is an important risk factor in the pathogenesis of optic nerve injuries and glaucomatous visual field loss. In addition, it reduces intraocular pressure without the frequent adverse effects of miotics, for example, night blindness, accommodative spasm and pupillary constriction.

 

INDICATIONS:

IOP (intraocular pressure) reduction in patients with open-angle glaucoma or ocular hypertension who respond inadequately to topical β-blockers or ophthalmic prostaglandin analogues.

 

HOW TO USE:

Ophthalmic route The dose is a drop in the conjunctival sac of each affected eye, twice a day, according to medical indication.

If another ophthalmic medication is being used, both medications should be administered at least 10 minutes apart. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before replacing them. Alters the color of the softwoods contact lenses.

 

CONTRAINDICATIONS:

It is contraindicated in patients with:

Reactive disease of the respiratory tract, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.

Sinus bradycardia, sick sinus node syndrome, sinoatrial block, second or third degree uncontrolled atrioventricular block with pacemaker. manifest heart failure, cardiogenic shock.

Severe renal insufficiency (CrCl <30 ml / min) or hyperchloremic acidosis.

Hypersensitivity to one or to the active ingredients, or to any of the excipients.

These contraindications are based on the respective active principles, and are not exclusive to the combination

 

ADVERSE EFFECTS:

In general it is well tolerated. The most frequently reported adverse reactions related to the drug were: burning and ocular pricking pain, taste alterations, corneal erosion, conjunctival hyperemia, blurred vision, lacrimation, ocular itching.