Medicinal Products

DORZOLAMIDE / TIMOLOL TEVA 20 mg / 5 mg / mL

Generic drug of Cosopt 20 MG / ML + 5 MG / ML
Therapeutic class: Ophthalmology
active ingredients: Dorzolamide, Timolol
laboratory: Teva Sante

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

Indication

DORZOLAMIDE / TIMOLOL TEVA is indicated for the treatment of high intraocular pressure (IOP) in patients with open-angle glaucoma, or pseudoexfoliative glaucoma, when ocular beta-blocker monotherapy is insufficient .

Dosage DORZOLAMIDE / TIMOLOL TEVA 20 mg / 5 mg / mL Eye drops in solution Box of 1 dropper bottle of 5 ml

The dose is one drop of DORZOLAMIDE / TIMOLOL TEVA in the conjunctival sac of the affected eye (s), twice daily.

When used concomitantly with another eye drop, DORZOLAMIDE / TIMOLOL TEVA and the other eye drops should be administered at least 10 minutes apart.

Patients should be advised to wash their hands before using eye drops 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 subsequently loss of vision.

Manual

1. Before using this eye drop 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. Tip the vial and gently squeeze 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 4 and 5 for the other eye if your doctor has prescribed it.

6. Screw the cap back in until it is firmly in contact with the bottle.

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

Systemic passage may be reduced by nasolacrimal occlusion or eyelid closure for 2 minutes. This method can help reduce systemic side effects and increase local efficiency

Use in children

Efficacy has not been established in children.

Tolerance in children under 2 years of age has not been established (see section 5.1 Pharmacodynamic properties for more information on safety in children over 2 years of age and under 6 years of age).

Against indications

DORZOLAMIDE / TIMOLOL TEVA is contraindicated in patients with:

· Hypersensitivity to one or both of the active ingredients or to any of the excipients.

· A condition associated with bronchial hyperreactivity including asthma or a history of asthma, or severe chronic obstructive pulmonary disease.

· Sinus bradycardia, sinus dysfunction syndrome, sinoatrial block, second or third degree non-pacemaker controlled atrioventricular block, confirmed heart failure, cardiogenic shock.

· Severe renal insufficiency (CrCl <30 ml / min) or hyperchloremic acidosis.

The above contraindications come from those of each of the constituents and are not only specific to the association.

Adverse effects Dorzolamide / Timolol Teva

In clinical studies, no specific adverse effects of the combination dorzolamide / timolol were observed; adverse effects were limited to those previously reported with dorzolamide hydrochloride and / or timolol maleate. Like other locally applied ophthalmic drugs, timolol is absorbed into the systemic circulation, which may cause similar adverse effects to those seen with systemic beta-blockers. The incidence of systemic adverse reactions after topical ophthalmic administration is lower than that after systemic administration. The reported adverse reactions include reactions seen with drugs belonging to the class of ophthalmic beta-blockers.

In clinical studies, 1, 035 patients were treated with dorzolamide / timolol. Approximately 2.4% of them discontinued dorzolamide / timolol combination therapy due to ocular adverse events and approximately 1.2% of patients discontinued treatment due to local adverse events suggestive of allergy or hypersensitivity (such as eyelid inflammation and conjunctivitis).

The following undesirable effects have been reported with the combination dorzolamide / timolol or any of its components either in clinical trials or since market introduction:

[Very common (≥1 / 10), common (≥1 / 100 and <1/10), uncommon (≥1 / 1, 000 and <1/100), and rare (≥1 / 10, 000 and 1/1000), frequency not known (can not be estimated from the available data)]

Immune system disorders

Dorzolamide / Timolol

Rare: signs and symptoms of systemic allergic reactions including angioedema, urticaria, pruritus, rash, anaphylaxis, rarely bronchospasm

Ophthalmic solution of timolol maleate

Not known: systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction

Metabolism and nutrition disorders

Ophthalmic solution of timolol maleate

Not known: hypoglycaemia.

Psychiatric disorders

Timolol maleate, solution eye drops

Uncommon: depression *.

Rare: insomnia *, nightmares *, memory loss.

Nervous system disorders

Dorzolamide hydrochloride, solution eye drops

Frequent: headache *.

Rare: dizziness *, paresthesia *.

Timolol maleate, solution eye drops

Frequent: headache *.

Uncommon: dizziness *, syncope

Rare: paresthesia *, worsening signs and symptoms of myasthenia gravis, decreased libido *, cerebrovascular accidents *, cerebral ischemia.

Eye disorders

Dorzolamide / Timolol

Very common: burns and tingling.

Common: conjunctival hyperemia, blurred vision, corneal erosion, itchy eyes, watery eyes.

Dorzolamide hydrochloride, solution eye drops

Frequent: palpebral inflammation *, eyelid irritation *.

Uncommon: iridocyclitis *.

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

Timolol maleate, solution eye drops

Common: signs and symptoms of eye irritation (eg, burning, tingling, itching, watery eyes, redness *) blepharitis *, keratitis *, hypoesthesia and dry eye *

Uncommon: visual disturbances including changes in refraction (sometimes due to discontinuation of miotics) *.

Rare: ptosis, diplopia, choroidal detachment (after surgical treatment) * (see Warnings and Precautions section ).

Unknown frequency: blurred vision, erosion of the cornea.

Ear and ear canal disorders

Timolol maleate, solution eye drops

Rare: ear whistles *.

Cardiac and vascular disorders

Timolol maleate, solution eye drops

Uncommon: bradycardia *.

Rare: hypotension *, chest pain *, palpitations *, edema *, arrhythmia *, congestive heart failure *, atrioventricular block *, cardiac arrest *, claudication, Raynaud's phenomenon *, coldness of the extremities.

Unknown frequency: heart failure.

Respiratory, thoracic and mediastinal disorders

Dorzolamide / Timolol

Frequent: sinusitis.

Rare: shortness of breath, respiratory failure, rhinitis.

Dorzolamide hydrochloride, solution eye drops

Rare: epistaxis *.

Timolol maleate, solution eye drops

Uncommon: dyspnea *.

Rare: bronchospasm (especially in patients with pre-existing bronchospastic disease) *, cough *.

Gastrointestinal disorders

Dorzolamide / Timolol :

Very common: taste alteration.

Dorzolamide hydrochloride, solution eye drops

Frequent: nausea *.

Rare: throat irritation, dry mouth *.

Timolol maleate, solution eye drops

Uncommon: nausea *, dyspepsia *.

Rare: diarrhea, dry mouth *.

Unknown frequency: dysgeusia, abdominal pain, vomiting.

Skin and subcutaneous tissue disorders

Dorzolamide / Timolol

Rare: contact dermatitis.

Dorzolamide hydrochloride, solution eye drops

Rare: rash *.

Timolol maleate, solution eye drops

Rare: alopecia *, psoriasiform rash or worsening of psoriasis *.

Unknown frequency: rash.

Musculoskeletal and systemic disorders

Eye drops in solution of timolol maleate

Unknown frequency: myalgia.

Renal and urinary disorders

Dorzolamide / Timolol

Uncommon: urolithiasis.

Disorders of the reproductive organs and breasts

Timolol maleate, solution eye drops

Rare: Peyronie's disease *.

Unknown frequency: sexual dysfunction, decreased libido.

General disorders and accidents related to the site of administration

Dorzolamide hydrochloride, solution eye drops

Frequent: asthenia / fatigue *.

Timolol maleate, solution eye drops

Uncommon: asthenia / fatigue *.

* These side effects have also been observed with the combination Dorzolamide / Timolol since it was marketed.

Biological examinations

The combination dorzolamide / timolol has not been associated with electrolyte disturbances in clinical studies.

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