DORZOPT

Active material: Dorzolamid
When ATH: S01EC03
CCF: Antiglaucoma drug – local carbonic anhydrase inhibitor
ICD-10 codes (testimony): H40.0, H40.1, H40.3, H40.4, H40.5
When CSF: 26.01.01.06
Manufacturer: S.C. ROMPHARM Company S.R.L. (Romania)

Pharmaceutical form, composition and packaging

Eye drops 2% clear, Colorless.

1 ml
dorzolamid (the hydrochloride)20 mg

Excipients: gietelloza, mannitol, citric acid monohydrate, Sodium hydroxide, benzalkonium chloride, Purified water.

5 ml – flakonah- polymer (1) – packs cardboard.

 

Pharmacological action

Antiglaucoma drug – local carbonic anhydrase inhibitor. It lowers intraocular fluid secretion, slowing down the formation with the consequent weakening hydrogencarbonate solution and water transport. There is no spasm of accommodation, mioz, day-blindness.

 

Pharmacokinetics

Absorption

It penetrates into the eye through the cornea mainly (to a lesser extent through the sclera or limb). Sistemnaya absorption – low. Once in the blood quickly into the red blood cells, containing a significant amount of carbonic anhydrase II.

Distribution and metabolism

Plasma protein binding – 33%. Transformed into the metabolite N-dezetilirovanny, less active against carbonic anhydrase II, but capable of blocking carbonic anhydrase I. With prolonged use accumulates in erythrocytes.

Deduction

Excreted by the kidneys in an unchanged form and in the form of metabolites. After the abolition of the fast phase is replaced by a slow elimination, due to the gradual release of the drug from erythrocytes, T1/2 about 4 Months.

 

Testimony

- Open- (incl. secondary) glaucoma;

- Psevdoэksfoliativnaya glaucoma;

- Ocular.

 

Dosage regimen

Buried at 1 drop into the conjunctival sac of the affected eye 3 times / day. In combination with beta-blockers for topical application – by 1 drop 2 times / day. If the treatment is applied by several local ophthalmic drugs, they are administered at intervals of 10 m.

 

Side effect

Local reactions: burning, paresthesia, itchy eyes, lacrimation, blurred vision, irritation and swelling of the eyelids, conjunctivitis, superficial punctate keratitis, .Aloe, photophobia; rarely – iridocyclitis, increasing the thickness of the cornea, allergic reactions, hypotension eyes, retinal detachment in patients after operations antiglaukomatoznyh.

Systemic reactions: bitter taste in the mouth, nausea, headache, asthenia, nefrourolitiaz, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), agranulocytosis, aplasticheskaya anemia, skin rashes.

 

Contraindications

- Chronic renal failure (creatinine clearance less than 30 ml / min);

- Hyperchloraemic acidosis;

- Children up to age 18 years;

- Pregnancy;

- Lactation (breast-feeding);

- Simultaneous oral carbonic anhydrase inhibitors;

- Hypersensitivity to any component of the drug.

FROM caution prescribe the drug for patients with diabetes, hepatic insufficiency, Corneal diseases, Use in patients after operations antiglaukomatoznyh (the risk of hypotension eyes, retinal detachment).

 

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

 

Cautions

Preservative benzalkonium chloride, contained in the product, It can be adsorbed soft contact lenses, causing eye irritation and toxic effects. The drug is used only after removal of contact lenses. Wear contact lenses should not earlier, than 15 minutes after instillation.

Necessary to control the content of potassium, serum electrolyte and its pH.

Elderly patients may increase sensitivity to dorzolamide, therefore, these patients may require a dose reduction.

Effects on ability to drive vehicles and management mechanisms

During the period of treatment must be careful when driving and occupation of other potentially hazardous activities, require high concentration and speed of psychomotor reactions.

 

Overdose

Symptoms: disruption of water and electrolyte metabolism, Acidosis, disorders of the central nervous system.

Treatment: symptomatic therapy. It is necessary to control the level of electrolytes (especially potassium) and blood pH.

 

Drug Interactions

Antiglaucoma drugs (beta-blockers, pilocarpine, dypyvefryn, karʙaxol) enhance the effect of dorzolamide.

While the use of acetazolamide increased risk of systemic side effects.

Perhaps increased toxicity at high doses of acetylsalicylic acid.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored in a dry, protected from light, reach of children, at a temperature no higher than 25 ° C. Shelf life – 2 year.

After opening the bottle should be kept no more 4 weeks.

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