Medicinal Products

DORZOLAMIDE ACTAVIS 2% 20 mg / mL

Trusopt Generic Drug
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide
laboratory: Actavis Group Ptc Ehf

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

Indication

DORZOLAMIDE ACTAVIS 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 ACTAVIS 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 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 severe serious injury and loss of vision.

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

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.

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 Actavis 2%

DORZOLAMIDE ACTAVIS has been evaluated in controlled and uncontrolled clinical studies in more than 1400 subjects. In long-term studies of 1108 patients treated with DORZOLAMIDE ACTAVIS alone or in combination with an ophthalmic beta-blocker, the most common cause of withdrawal from treatment with DORZOLAMIDE ACTAVIS was ocular adverse drug effects. (about 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 and <1/10), Uncommon (≥1 / 1000 and <1/100), Rare (≥1 / 10, 000 and <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, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary 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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