Universal reference book for medicines
Product name: DORZOPT (DORZOPT)

Active substance: dorzolamide

Type: Anti-glaucoma preparation is a local inhibitor of carbonic anhydrase

Manufacturer: SC ROMPHARM Company (Romania)
Composition, form of production and packaging

Eye drops 2% clear, colorless.

1 ml

dorzolamide (in the form of hydrochloride) 20 mg

Excipients: gietelloza - 1 mg, mannitol - 20 mg, citric acid monohydrate - 4 mg, sodium hydroxide - 2.4 mg, benzalkonium chloride - 0.1 mg, purified water - up to 1 ml.

5 ml - polymeric bottles with a stopper-dropper (1) - packs cardboard.

5 ml - polymer bottles with a stopper-dropper (3) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Antiglaucoma preparation, a local inhibitor of carbonic anhydrase.
Reduces the secretion of intraocular fluid, slowing the formation of hydrocarbonate, followed by a decrease in the transfer of sodium and water. Does not cause a spasm of accommodation, miosis, gemeralopia.
PHARMACOKINETICS

Suction

It penetrates the eye mainly through the cornea (to a lesser extent through the sclera or limbus).
Systemic absorption is low. After entering the blood quickly penetrates into the red blood cells containing a significant amount of carbonic anhydrase II.
Distribution and Metabolism

Binding to plasma proteins - 33%.
It is transformed into an N-desethylated metabolite, less active with respect to carbonic anhydrase II, but capable of blocking carbonic anhydrase I. For long-term use, it accumulates in red blood cells.
Excretion

It is excreted by the kidneys in the unmodified form and in the form of metabolites.
After cancellation, the rapid phase of withdrawal is replaced by a slow one, caused by the gradual release of the drug from erythrocytes, with T 1/2 about 4 months.
INDICATIONS

- open-angle (including secondary) glaucoma;

- pseudoexfoliation glaucoma;

ophthalmic hypertension.

DOSING MODE

Instilled in 1 drop in the conjunctival sac of the affected eye 3 times / day.
In combination with beta-blockers for topical administration - 1 drop 2 times / day.
If several local ophthalmic preparations are used in the treatment, they are administered at an interval of 10 minutes.

SIDE EFFECT

Local reactions: burning, paresthesia, itching in the eyes, lacrimation, blurred vision, irritation and edema of the eyelids, conjunctivitis, superficial pinpoint keratitis, blepharitis, photophobia;
rarely - iridocyclitis, increased corneal thickness, allergic reactions, eye hypotension, retinal detachment in patients after antiglaucomatous surgeries.
Systemic reactions: bitter taste in the mouth, nausea, headache, asthenia, nephrourolythiasis, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), agranulocytosis, aplastic anemia, skin rashes.

CONTRAINDICATIONS

- chronic renal failure (CC less than 30 ml / min);

- hyperchloremic acidosis;

- children and adolescence under 18;

- Pregnancy;

- the period of lactation (breastfeeding);

- simultaneous oral administration of inhibitors of carbonic anhydrase;

- Hypersensitivity to any component of the drug.

With caution appoint a drug for diabetes, liver failure, corneal diseases, use in patients after antiglaukomatoznyh operations (risk of eye hypotension, retinal detachment).

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in chronic renal failure (creatinine clearance less than 30 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint a drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated use of the drug in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

In elderly patients, sensitivity to dorsolimide may increase, so this category of patients may require a dose reduction.

SPECIAL INSTRUCTIONS

The preservative of benzalkonium chloride contained in the preparation can be adsorbed by soft contact lenses, causing eye irritation and toxic effects.
The drug is used only after removal of contact lenses. Install contact lenses should be no earlier than 15 minutes after instillation.
It is necessary to control the content of potassium, electrolytes in the blood serum and its pH.

In elderly patients, sensitivity to dorsolimide may increase, so this category of patients may require a dose reduction.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

Symptoms: violation of water-electrolyte metabolism, acidosis, violations of the central nervous system.

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

Anti-glaucoma drugs (beta-adrenoblockers, pilocarpine, dipivefrin, carbachol) enhance the action of dorzolamide.

With simultaneous use with acetazolamide, the risk of systemic side effects increases.

It is possible to increase toxicity when taking large doses of acetylsalicylic acid.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children, at a temperature of no higher than 25 В° C.
Shelf life - 2 years.
After opening, the vial should be stored for no more than 4 weeks.

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