Rozalin (dorzolamide) eye drops solution 20 mg/ml. 5 ml. vial

Description

Rozalin (dorzolamide) eye drops solution 20 mg/ml. 5 ml. vial 

Composition

active substance: dorzolamide in the form of dorzolamide hydrochloride; 1 ml of solution contains dorzolamide – 20 mg in the form of dorzolamide hydrochloride – 22.26 mg;
excipients: mannitol (E 421), sodium citrate, hydroxyethyl cellulose, benzalkonium chloride, sodium hydroxide, water for injections.

Medicinal form

Eye drops, solution.

Main physicochemical properties: slightly opalescent, almost colorless, slightly viscous solution. Color: should not exceed standard B9. Opalescence: should not exceed reference suspension I.

Pharmacotherapeutic group

Carbonic anhydrase inhibitors.
ATX code S01E C03.

Pharmacological properties

Ophthalmic drug, which belongs to the group of antiglaucoma drugs and miotic drugs.
The main active ingredient of the drug – dorzolamide – is a powerful inhibitor of human carbonic anhydrase II. Once applied topically, it effectively reduces intraocular pressure, both associated and non-glaucoma.
Increased intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucoma narrowing of the visual field.
The positive characteristics of dorzolamide include its property, with a decrease in intraocular pressure, not to cause the development of side effects inherent in other miotics, such as night blindness, accommodative spasm, or pupil constriction.
The drug also has no or little effect on blood pressure and / or heart rate.
Unlike oral drugs – carbonic anhydrase inhibitors, in the case of topical application, dorzolamide acts directly in the human eye, while significantly lower concentrations are required, and therefore such use is accompanied by less systemic exposure.

Indications

It is used as a medicine that is used in the treatment of:

• increased intraocular pressure;
• open-angle glaucoma;
• pseudoexfoliative glaucoma;
• other types of secondary open-angle glaucoma.

The main active ingredient of the drug, dorzolamide, has shown its effectiveness both in monotherapy and when used in combination with local beta-blockers. Dorzolamide reduced intraocular pressure throughout the day, and this effect persisted for a significant time.
In terms of its effectiveness, this drug (after long-term monotherapy) showed its similarity with betaxolol and only to some extent lower than timolol.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
In addition, the use of this drug is contraindicated if the patient has:

• severe renal dysfunction;
• hyperchloremic acidosis;
• allergy to sulfa drugs.

Simultaneous use with drugs that inhibit the production of aqueous liquid after filtration measures is not recommended, as this can cause detachment of the choroid.
It is not used in pediatrics.

Application during pregnancy and lactation

This drug is not recommended for use during pregnancy.
If there is a need to use this drug during breastfeeding, then it is better to suspend lactation for this period.

Method of administration and dosage

The drug Rosalin is used 1 drop in each affected eye (in the conjunctival sac), three times a day.

With combined or additional therapy, 1 drop is administered twice a day.

In order for the drug to be better absorbed, you should immediately after instillation, close your eyes, slightly press your eyelids and hold it for a few seconds.

If there is a need to replace another local antiglaucoma drug with dorzolamide, you should suspend treatment with this drug and start using this drug the next day.

If there is a need to use several topical ophthalmic agents, they should be administered at intervals of 10 minutes.
Before introducing the drug into the eye, wash your hands thoroughly and avoid contact of the dropper tip with the eye or skin during instillation.

If these precautions are violated, the drug may be contaminated with foreign bacteria, and the infection may subsequently get into the eyes, which can have dire consequences.

Overdose

Overdose with this drug was observed extremely rarely. In rare cases, overdose has been observed:

• drowsiness (with accidental oral ingestion);
• nausea, dizziness, headache;
• feeling tired;
• atypical dreams;
• dysphagia.

Disorders of the central nervous system, manifestations of asthenia, electrolyte disturbances are also possible.
Symptomatic treatment is recommended. It is necessary to control the content of electrolytes, in particular potassium, in blood plasma, monitor blood pH.

Side effects

Adverse reactions have been observed with this drug:

• headache, paresthesia, dizziness;
• burning and tingling in the eyes when the drug is injected;
• external punctate keratitis, lacrimation, blepharitis, conjunctivitis;
• itchy eyes, irritation of the eye mucosa, blurred vision, iridocyclitis;
• clumping of the eyelids, rapidly passing hyperopia;
• nosebleeds, nausea, bitterness in the mouth, sore throat;
• contact dermatitis, toxic epidermal necrolysis;
• urolithiasis disease;
• asthenia, fatigue;
• hives, itching, rash, shortness of breath;
• angioedema, bronchospasm.

If you experience any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.