Medicinal Products

DORZOLAMIDE BIOGARAN 2% 20 mg / mL

Trusopt Generic Drug
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide
laboratory: Biogaran

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

Indication

DORZOLAMIDE BIOGARAN is indicated:

· In combination with anti-glaucoma treatment with beta-blocker eye drops,

· 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 BIOGARAN 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.

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 warned that contact should be avoided between the tip of the vial and 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.

Use in children:

In children, limited clinical data are available after administration of dorzolamide three times a day (for more information on the dosage in children see section 5.1 Pharmacodynamic properties ).

Against indications

Dorzolamide is contraindicated in patients with 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 Biogaran 2%

Dorzolamide has been evaluated in controlled and uncontrolled clinical studies in more than 1400 subjects. In long-term studies of 1108 patients treated with dorzolamide monotherapy or in combination with an ophthalmic beta-blocker, the most common cause of treatment discontinuation was ocular adverse drug effects (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), Common (> 1/100, 1/1000, 1/10 000, <1/1000)

Nervous system disorders and psychiatric 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 disorders:

Rare: urolithiasis.

General disorders and accidents related to the site of administration:

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.

In children: see section 5.1 Pharmacodynamic properties .

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