Treatment of increased intraocular pressure in patients with: ocular hypertension, open-angle glaucoma, capillary glaucoma. In adjunctive therapy with beta-blockers. Monotherapy in patients not responding to beta-blockers or in patients in which beta-blockers are contraindicated.
Composition:
1 ml of solution contains 20 mg of dorzolamide in the form of hydrochloride.
Action:
A strong carbonic anhydrase II inhibitor for topical administration. Inhibition of carbonic anhydrase in the ciliary processes of the eye reduces the amount of aqueous humor released. This leads to a reduction in intraocular pressure. After topical ocular administration, dorzolamide reduces elevated intraocular pressure, regardless of whether it is associated with glaucoma or not. After topical application, dorzolamide passes into the systemic circulation. The drug and its metabolite (N-deethyl-dorzolamide) accumulate in erythrocytes. Dorzolamide is moderately bound to plasma proteins (approximately 33%). It is excreted mainly in unchanged form in the urine.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Severe renal failure (creatinine clearance below 30 ml / min). Hyperlloric acidosis.
Precautions:
Use with caution in patients with hepatic impairment (no study). There are no studies on the use of the drug in patients with acute angle-closure glaucoma. Dorzolamide contains a sulphonamide group and, despite local application, absorbs into the systemic circulation - the same types of side effects may be attributed to sulfonamides. Patients with a history of renal calculi may be at increased risk of urolithiasis during treatment with dorzolamide. Co-administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. Patients with previous chronic corneal defects and / or ophthalmologic surgery using dorzolamide have reported corneal edema and irreversible corneal damage - the drug should be used with caution in this group of patients. During the use of drugs that inhibit the production of aqueous humor after filtration, cases of choroidal detachment with a decrease in intraocular pressure have been reported. Dorzolamide has not been studied in patients less than 36 weeks of fetal age and less than 1 week of age. In patients with significant immaturity of the renal tubules, dorzolamide may be given only after careful consideration of the benefit / risk ratio, due to the potential risk of metabolic acidosis.
Pregnancy and lactation:
The drug should not be used during pregnancy. It is not known whether dorzolamide is excreted in human milk - breast-feeding is not recommended.
Side effects:
Very often: burning and pricking. Common: headache, superficial punctate keratitis, lacrimation, conjunctivitis, blepharitis, pruritus of the eyes, eyelid irritation, blurred vision, nausea, bitter taste in the mouth, asthenia / fatigue. Uncommon: inflammation of the iris and ciliary body. Rarely: dizziness, paresthesia, irritation including redness, pain, scabbing on the eyelids, transient myopia (receding after discontinuation of treatment), corneal edema, intraocular hypotension, choroidal detachment after filtration, nosebleeds, throat irritation, dryness in the mouth, contact dermatitis, Stevens-Johnson syndrome, toxic skin necrosis, urolithiasis, hypersensitivity - subjective and objective symptoms of local reactions (eyelid responses) and general allergic reactions including angioneurotic edema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm. Children: the majority of adverse reactions were local; non-serious eye effects such as stinging and prickling eye pain, pain at the instillation site, and eye pain were observed in 26% (20% in the dorzolamide monotherapy group) in children. In a small percentage of patients <4%, swelling or occlusion of the cornea was observed.Metabolic acidosis has been observed in post-marketing experience in very young patients, especially hypoplasia / renal dysfunction.
Dosage:
Adults. In monotherapy: 1 drop to the affected eye (eyes) 3 times a day. In adjunctive therapy, together with an ophthalmic beta-blocker: 1 drop into the affected eye (eyes) twice a day. When using several topical ophthalmic medications, a minimum of 10 minutes should be allowed between the instillation of subsequent medications. Children: Clinical data on the use of dorzolamide 3 times a day are limited in children.
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