Medicinal Products

DORZOLAMIDE 20 mg / mL

Trusopt Generic Drug
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide
laboratory: EG Labo

Eye drops in solution
Box of 1 bottle of 5 ml
All forms

Indication

DORZOLAMIDE 20 mg / ml eye drops solution is indicated:

· As adjunctive therapy in combination with beta-blocker therapy,

· As monotherapy in patients not responding to beta-blockers or in patients for whom beta-blockers are contraindicated,

In the treatment of elevated intraocular pressure in patients with:

· Ocular hypertension,

· Open-angle glaucoma,

· Pseudo-exfoliative glaucoma.

Dosage DORZOLAMIDE EG 20 mg / ml Eye drops in solution Box of 1 vial of 5 ml

In monotherapy, the dose is one drop of dorzolamide in the conjunctival cul-de-sac of the affected eye (s), three times a day.

In adjunctive therapy in combination with a beta-blocker for ophthalmic use, the dose is one drop of dorzolamide in the conjunctival cul-de-sac of the affected eye (s), twice daily .

If another antiglaucoma treatment is being replaced with dorzolamide, discontinue the other medication after the last dose of the day at the appropriate dose and start dorzolamide the next day.

Concomitant use of multiple eye drops should be administered at least 10 minutes apart.

Patients should be cautioned to wash their hands before use and to avoid contacting the tip of the vial with the eye or surrounding areas.

Patients should also be informed that ophthalmic solutions, if improperly handled, may be contaminated by common bacteria known to cause eye infections. The use of contaminated solutions can cause severe serious injury and loss of vision.

Patients should be informed about the exact handling of the vials.

Manual :

1. Before first use, check that the tamper evident ring at the neck of the vial is not broken. The presence of a space between the stopper and the unopened vial is normal;

2. Remove the cap from the vial.

3. Tilt the head back and gently pull the lower eyelid down to instil drops between the eyelid and the eye.

4. Invert the bottle and squeeze gently between your thumb and forefinger until only one drop falls into the eye as directed by your doctor. Do not touch the eye or eyelid with the tip of the vial.

5. Repeat steps 2 and 3 for the other eye if your doctor has prescribed it.

6. Replace the cap and close the bottle immediately after use.

In children:

In children, limited clinical data are available after administration of dorzolamide three times daily (for further information see section 5.1 ).

Against indications

Hypersensitivity to this active substance or to any of the excipients.

Dorzolamide has not been studied in patients with severe renal impairment (creatinine clearance <30 ml / min) or hyperchloremic acidosis. Since dorzolamide and its metabolites are mainly excreted by the kidney, dorzolamide is therefore contraindicated in such patients.

Adverse effects Dorzolamide EG

Dorzolamide has been evaluated in controlled and uncontrolled clinical studies in more than 1400 subjects. In long-term studies involving 1108 patients treated with DORZOLAMIDE 20 mg / ml, eye drops in solution, monotherapy or adjunctive therapy with a beta-blocker for ophthalmic use, the most common cause of treatment discontinuation with dorzolamide was ocular adverse effects attributed to the drug (about 3% of patients), mainly conjunctivitis and palpebral reactions.

The following side effects have been reported either in clinical studies or since marketing.

The frequency of adverse reactions listed below is defined according to the following convention:

Very common: (≥1 / 10) (³ 1/10);

Frequent: (³ 1/100 to <1/10);

Uncommon: (1/1000 to <1/100);

Rare: (1/10 000 to <1/1000).

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data).

Within each frequency group, adverse effects are presented in order of decreasing severity.

Nervous system disorders and psychiatric disorders:

Frequent:

headaches

Rare:

dizziness, paresthesia

Eye disorders:

Very common:

burns and tingling

Frequent:

superficial punctate keratitis, conjunctivitis, tearing, blurred vision, eyelid inflammation, itchy eyes, eyelid irritation.

Uncommon :

iridocyclitis

Rare:

corneal edema, choroidal detachment after filtering surgery, ocular hypotonia, irritation including redness, pain, palpebral crustal lesions, transient myopia (which disappeared upon discontinuation of treatment)

Respiratory, thoracic and mediastinal disorders:

Rare :

epistaxis

Gastrointestinal disorders:

Frequent:

nausea, bitter taste

Rare:

throat irritation, dry mouth

Renal disorders:

Rare:

urinary lithiasis

Skin and subcutaneous tissue disorders:

Rare:

contact dermatitis.

General disorders and accidents related to the site of administration

Frequent:

asthenia / fatigue

Rare:

Hypersensitivity : systemic allergic reactions including angioedema, urticaria and pruritus, rash, difficulty breathing, rarely bronchospasm and signs and symptoms of local reactions (palpebral reactions).

Biological examinations:

No clinically significant hydroelectrolytic disorder has been reported with dorzolamide.

In children: see section 5.1 Pharmacodynamic properties

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