R-dorza eye drops 20mg/ml 5ml №1

Name:
R-dorza. Release form Drops. MNN Dorzolamide. FTH Antiglaucoma agent; carbonic anhydrase inhibitor.
Description:
Transparent, almost colorless, slightly viscous solution Composition 1 ml of the drug contains: active substance: dorzolamide (in the form of dorzolamide hydrochloride) – 20 mg; excipients: hydroxyethylcellulose, mannitol, citric acid monohydrate, sodium hydroxide, benzalkonium chloride, water for injection. Pharmacotherapeutic groupMeans used in ophthalmology. Medicines for the treatment of glaucoma and myotics. ATX code: S01EC03. Pharmacological properties Pharmacodynamics The active ingredient of R-Dorza is dorzolamide, which is a carbonic anhydrase inhibitor. Inhibition of carbonic anhydrase in the ciliary body of the eye leads to a decrease in the secretion of intraocular fluid. When applied topically in the form of 2% eye drops, dorzolamide reduces elevated intraocular pressure, which is a leading risk factor in the pathogenesis of optic nerve damage and glaucomatous visual impairment (loss of visual fields). Pharmacokinetics Distribution When applied topically, dorzolamide enters the systemic circulation. With prolonged use, dorzolamide selectively accumulates in erythrocytes as a result of selective binding to carbonic anhydrase II, while the concentration of free dorzolamide in plasma remains extremely low. Dorzolamide forms the only metabolite, to a lesser extent than dorzolamide, which inhibits the enzyme carbonic anhydrase II, as well as the enzyme carbonic anhydrase I. The metabolite accumulates in erythrocytes, binding mainly to carbonic anhydrase I. Dorzolamide moderately binds to plasma proteins (about 33%). Metabolism and excretion Dorzolamide and its metabolite are excreted predominantly unchanged via the kidneys. After the end of treatment, dorzolamide is eliminated from erythrocytes non-linearly, which leads to a rapid decrease in the concentration of the drug at the initial stage, followed by a slow elimination with a half-life of about 4 months. Indications for use – increased intraocular pressure, including in patients with open-angle glaucoma. Method of application and dosage R-Dorza is indicated for topical use only. When R-Dorza monotherapy is prescribed 1 drop in the affected eye 3 times a day. In combination with β-blockers for topical application, R-Dorza is prescribed 1 drop in the affected eye 2 times a day. With the simultaneous use of other local ophthalmic agents, the interval between injections should be at least 10 minutes. When switching from treatment with another ophthalmic agent to R-Dorza, this drug is canceled after the usual daily dosage and treatment with R-Dorza is started the next day. Patients with impaired liver function: no studies have been conducted on the use of the drug (should be used with caution). Patients with impaired renal function: no studies have been conducted in patients with CC < 30 ml / min; use in this category of patients is not recommended. Elderly patients: no features of the use of the drug have been identified. Side effects In clinical studies: the most common side effects were burning, tingling or discomfort immediately after use (in about a third of patients). Approximately a quarter of patients noted bitterness in the mouth immediately after application. Superficial punctate keratitis was observed in 10% to 15% of cases, symptoms of ocular allergic reactions in about 10% of patients. Approximately 1% to 5% of patients have been found to have conjunctivitis and eyelid reactions, blurred vision, red eyes, watery eyes, dry eyes, and photophobia. Other ophthalmic and systemic reactions have been observed infrequently, including headache, nausea, asthenia/fatigue, and, rarely, skin rashes, urolithiasis, inflammation of the iris and ciliary body. In the course of post-registration studies (it is not always possible to establish the frequency and relationship with the use of the drug): symptoms of systemic allergic reactions, including angioedema, bronchospasm, itching, urticaria; Stevens-Johnson syndrome and toxic epidermal necrolysis; dizziness, paresthesia; eye pain, transient myopia, choroidal postoperative detachment, crusting of the eyelids; shortness of breath, contact dermatitis, epistaxis, dry mouth and throat irritation. If the listed adverse reactions occur, as well as reactions not listed in the instructions for use, you should consult a doctor. Contraindications Hypersensitivity to the components of the drug; severe renal failure (creatinine clearance less than 30 ml / min); hyperchloremic acidosis. Precautions Local side effects have been reported with prolonged use of dorzolamide eye drops, mainly conjunctivitis and eyelid reactions; many of them had clinical manifestations and an allergic course and disappeared after drug withdrawal. If such reactions or hypersensitivity reactions occur, the drug should be discontinued and consult a doctor. Benzalkonium chloride, which is part of R-Dorza, can cause eye irritation. Contact with soft contact lenses should be avoided (they must be removed before instillation and installed at least 15 minutes after). Benzalkonium chloride may discolour soft contact lenses. Treatment of patients with angle-closure glaucoma requires therapeutic intervention in addition to the prescription of drugs that reduce intraocular pressure. Dorzolamide has not been studied in patients with acute angle-closure glaucoma. The simultaneous appointment of dorzolamide and oral is not recommended. carbonic anhydrase inhibitors. Dorzolamide should be used with caution in patients with low endothelial cell counts due to an increased risk of corneal edema. With prolonged use of the drug, bacterial keratitis associated with contamination of the container may occur. Dorzolamide is a sulfanilamide and, despite topical application, is subject to systemic absorption. With topical application of dorzolamide, side effects characteristic of the systemic use of sulfonamides may occur. Rare cases of death associated with serious adverse reactions to sulfonamides have been recorded, including Stevens-Johnson syndrome, toxic epidermal necrolysis, transient liver necrosis, agranulocytosis, aplastic anemia and other persistent pathological changes in the cellular composition of the blood. Hypersensitivity may occur in the case of repeated use of sulfonamides, regardless of the method of application. In case of serious side effects or hypersensitivity, it is necessary to stop using the drug. Influence on the ability to drive vehicles and work with mechanisms In view of the fact that dorzolamide can cause dizziness and blurred vision, during the period of treatment, especially at the beginning, potentially hazardous activities associated with the need for concentration and increased speed of psychomotor reactions should be avoided. Application during pregnancy and lactation When studying the effect of dorzolamide at a dose of 2.5 mg / kg / day orally in rabbits, malformations of the vertebral bodies were detected. These malformations have been noted at doses that cause metabolic acidosis with decreased uterine weight gain and decreased fetal weight. At doses of 1 mg/kg/day orally, no malformations associated with the use of dorzolamide have been identified. These doses resulted in plasma Cmax in rabbits that were 37 and 15 times, respectively, the lower levels in human plasma for ophthalmic use. Sufficient and appropriately controlled studies of the use of R-Dorz in pregnant women have not been conducted. R-Dorza can be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus. When studying the effect of dorzolamide in lactating rats, a decrease in weight gain in offspring from 5% to 7% was noted at a dose of 7.5 mg/kg/day orally during the lactation period. A slight delay in postnatal development (eruption of the incisors, formation of the vagina, opening of the eyes) was noted, which is a consequence of the lower weight of the fetus. This dose resulted in a plasma Cmax in rats that was 52 times the lower detection limit in human plasma in ophthalmic use. There are no data on the allocation of dorzolamide with breast milk. Due to the fact that many drugs are excreted in breast milk, and due to potentially serious adverse reactions in breastfed infants, the decision to discontinue the use of R-Dorza or stop lactation should be made on a case-by-case basis, taking into account the need women in medicine. Pediatric Use The safety and efficacy of dorzolamide in children was demonstrated in a 3-month, multicentre, double-blind, controlled trial. Overdose Possible electrolyte imbalance, development of acidosis, disorders of the central nervous system. Electrolyte levels (especially potassium) and blood pH need to be monitored. Treatment: symptomatic. In case of accidental or intentional overdose, you should consult a doctor. Interaction with other drugs Dorzolamide potentiates the effect of other antiglaucoma drugs Acetazolamide when taken orally increases the risk of developing systemic side effects of R-Dorza. The effect of acetylcholinesterase inhibitors such as physiostigmine, galantamine, neostigmine, or pyridostigmine (often used in myasthenia gravis) can be reduced by dorzolamide. When combined with diuretics, a significant loss of potassium is possible. Administration concomitantly with phenytoin may exacerbate osteoporosis. There is a potential risk of an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving oral carbonic anhydrase inhibitors and dorzolamide eye drops. The combined use of R-Dorz and oral carbonic anhydrase inhibitors is not recommended. Although acid-base and electrolyte disturbances were not observed in clinical studies with dorzolamide ophthalmic solutions, these disturbances were noted in studies of oral carbonic anhydrase inhibitors and were, in some cases, the result of drug interactions (for example, toxicity resulting from high-dose therapy). salicylates). The potential for this type of interaction must be taken into account. Storage conditionsKeep in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children! After opening the vial, use within 28 days. Shelf life 3 years. Do not use after the expiry date stated on the package. Release conditions Released by doctor's prescription. Upakovka5 ml of the drug in a white polyethylene bottle. The vial is sealed with a white dropper tip, a white screw cap and a film ring to control the first opening of the vial. 1 bottle with leaflet in a cardboard pack. Buy R-dorza eye drops 20mg/ml 5ml №1 Price for R-dorza eye drops 20mg/ml 5ml №1