Medicinal Products

DORZOLAMIDE MYLAN 2% 20 mg / mL

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

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

Indication

DORZOLAMIDE MYLAN 2%, eye drops in solution is indicated:

· In combination therapy with beta-blockers,

· 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 the following conditions:

o intraocular hypertension,

o open angle glaucoma,

o pseudo-exfoliative glaucoma.

Dosage DORZOLAMIDE MYLAN 2% 20 mg / ml Eye drops in solution Box of 1 vial of 5 ml

As monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye (eye), three times a day.

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

When another ophthalmic antiglaucoma drug is replaced with dorzolamide, the drug should be discontinued after the recommended daily dose and dorzolamide should be started the next day.

If more than one ophthalmic drug is used, medications should be given at least 10 minutes apart.

Patients should be warned that the tip of the dropper bottle should not be placed in contact with the eye or the surrounding area of ​​the eye.

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 subsequent loss of vision.

Patients should be informed of the proper handling of dropper bottles.

Manual :

1. The tamper evident collar at the neck of the vial must not be broken before the first use of the eye drops. A space between the bottle and the stopper is normal on an unopened vial.

2. The vial cap should be removed.

3. The patient should tilt their head back and their lower eyelid should be slightly pulled down to form a small pocket between the eyelid and the eye.

4. Turn the vial upside down and squeeze until only one drop falls into the eye. THE EYE OR EYE SHOULD NOT BE TOUCHED WITH THE DROPPER TIP.

5. Repeat steps 3 & 4 for the other eye if necessary.

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

Pediatric use:

Limited clinical data in pediatric patients are available on dorzolamide administration three times daily (For information on administration to pediatric patients, see section 5.1 ).

Against indications

Hypersensitivity to dorzolamide or 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 contraindicated in such patients.

Adverse effects Dorzolamide Mylan 2%

Dorzolamide has been evaluated in controlled and uncontrolled clinical studies in more than 1400 subjects. In the long-term studies of 1108 patients treated with dorzolamide monotherapy or in combination with ophthalmic beta-blocker therapy, the most common cause of discontinuation of dorzolamide (approximately 3% of patients) was ocular adverse reactions attributed to the drug, mainly conjunctivitis and palpebral reactions.

Adverse reactions reported in more than one case either in clinical studies or since the marketing of dorzolamide are listed below by system organ class and frequency.

Frequencies are defined as follows: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10 000 to <1/1000) and very rare (<1/10 000).

Class of organ systems

Very common

Frequent

Rare

Rare

Nervous system disorders

headaches

Dizziness, paresthesia

Eye disorders

Burn and

tingling

Superficial punctate keratitis, watery eyes, conjunctivitis, eyelid inflammation, eye pruritus, eyelid irritation, blurred vision

Iridocyclitis

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

Respiratory, thoracic and

mediastinal

Epistaxis

Gastrointestinal disorders

Nausea, bitter taste

Irritation of throat, dry mouth

Skin and subcutaneous tissue disorders

Contact dermatitis

Renal and urinary disorders

Urinary lithiasis

General disorders and administration site conditions

Asthenia / fatigue

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

Biological examinations: no clinically significant electrolytic disorder was associated with dorzolamide.

Pediatric patients

See Pharmacodynamic Properties .

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