Medicinal Products

DORZOLAMIDE TEVA 2% 20 mg / mL

Trusopt Generic Drug
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide
laboratory: Teva Sante

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

Indication

This drug is indicated: 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 TEVA 2% 20 mg / ml Eye drops in solution Box of 1 Bottle 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.

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 advised to wash their hands before use and 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 serious eye damage and decreased vision.

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

Manual

1. Before using the eye drops for the first time, make sure the safety tab is not torn.

2. To open the bottle, unscrew the cap.

3. Tilt your head back and gently pull your lower eyelid down to form a pocket between your eyelid and your eye.

4. Turn the vial upside down and lightly press on the sides of the vial until only one drop falls into the eye, as directed by your doctor. DO NOT TOUCH EYE OR EYE WITH BOTTLE BIT.

5. Repeat steps 3 & 4 for the other eye if your doctor has prescribed it.

6. Screw in the cap until it touches the bottle firmly.

7. The tip is designed to deliver a pre-calibrated drop; therefore, do not enlarge the tip hole.

Against indications

Hypersensitivity to the 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 in patients with hyperchloremic acidosis. Since dorzolamide and its metabolites are mainly excreted by the kidney, dorzolamide is therefore contraindicated in these patients.

Adverse effects Dorzolamide Teva 2%

Dorzolamide 2%, eye drops in solution, has been evaluated in controlled and uncontrolled clinical studies in more than 1, 400 subjects. In long-term studies of 1, 108 patients treated with dorzolamide monotherapy, the most common cause of treatment discontinuation was drug-related ocular adverse events (approximately 3% of patients), mainly conjunctivitis and palpebral reactions.

The following side effects have been reported either in the clinical studies or since the placing on the market:

Very common (≥ 1/10) frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000)

Nervous system disorders

Frequent : headache.

Rare : dizziness, paresthesia.

Eye disorders

Very common : burns and tingling.

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

Uncommon : iridocyclitis

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

Respiratory, thoracic and mediastinal disorders

Rare : epistaxis

Gastrointestinal disorders

Common : nausea, bitter taste

Rare : throat irritation, dry mouth

Skin and subcutaneous tissue disorders

Rare : contact dermatitis

Renal and urinary disorders

Rare : urolithiasis

General disorders and administration site conditions

Frequent : asthenia / fatigue

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

Biological examinations

No clinically significant hydroelectrolytic disorder has been reported with dorzolamide.

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