Medicinal Products

DORZOLAMIDE / TIMOLOL SANDOZ 20 mg / 5 mg / mL

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

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

Indication

Dorzolamide / Timolol is indicated for the treatment of high intraocular pressure (IOP) in patients with open-angle glaucoma, or pseudo-exfoliative glaucoma, when ocular beta-blocker monotherapy is insufficient.

Dosage DORZOLAMIDE / TIMOLOL SANDOZ 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 SANDOZ in the conjunctival cul-de-sac of the affected eye (s), twice daily.

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

See section Instructions for use, handling and disposal "Special precautions for disposal and other handling"

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 two years is not established. (For safety information for children ≥ 2 years of age and <6 years of age, see section 5.1 Pharmacodynamic properties ).

Against indications

DORZOLAMIDE / TIMOLOL SANDOZ is contraindicated in patients with:

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

· Reactive airway disease 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 Sandoz

In clinical studies, no specific adverse effects of the fixed combination of dorzolamide and timolol were observed; adverse effects were limited to those previously reported with dorzolamide hydrochloride and / or timolol maleate.

In clinical studies, 1035 patients were treated with the fixed combination of dorzolamide and timolol. Approximately 2.4% of them discontinued fixed-dose combination therapy with dorzolamide and timolol because of ocular adverse events; approximately 1.2% of patients discontinued treatment due to local adverse events suggestive of allergy or hypersensitivity (such as eyelid inflammation and conjunctivitis).

Like other locally applied ophthalmic drugs, timolol may have a systemic passage.

This can cause side effects similar to those seen with systemically administered beta-blockers. The incidence of systemic adverse reactions after local ophthalmic administration is lower than after systemic administration. The listed side effects include reactions seen in the ophthalmic beta-blocker class.

The following undesirable effects have been reported with the fixed combination of dorzolamide and timolol or one of its components either in clinical trials or since marketing:

Very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), and frequency indeterminate (can not be estimated from the available data).

Musculoskeletal and Connective Tissue Disorders

Timolol maleate, eye drops:

Rare: systemic lupus erythematosus.

Nervous system disorders

Dorzolamide hydrochloride, eye drops:

Frequent: headache *.

Rare: dizziness *, paresthesia *.

Timolol maleate, eye drops:

Frequent: headache *.

Uncommon: dizziness *,

Rare: insomnia *, memory loss, paresthesia *, aggravation of signs and symptoms of myasthenia, strokes *.

Psychiatric disorders

Timolol maleate, eye drops:

Uncommon: depression *.

Rare: nightmares *, decreased libido *.

Eye disorders

Very common: burns and tingling.

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

Dorzolamide hydrochloride, 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, eye drops

Common: Signs and symptoms of eye irritation (eg, burning, tingling, itching, watery eyes, redness) including 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 for Use section Special warnings and precautions for use) *.

Ear and ear canal disorders

Timolol maleate, eye drops:

Rare: whistling ear *.

Cardiac disorders

Timolol maleate, eye drops:

Uncommon: bradycardia *, syncope *.

Rare: palpitations *, edema *, arrhythmia *, atrioventricular block *, cardiac arrest *.

Vascular disorders

Rare: hypotension *, chest pain *, congestive heart failure *, cerebral ischemia, claudication, Raynaud's phenomenon *, coldness of the extremities *.

Respiratory, thoracic and mediastinal disorders

Frequent: sinusitis.

Rare: shortness of breath, respiratory failure, rhinitis.

Dorzolamide hydrochloride, eye drops:

Rare: epistaxis *.

Timolol maleate, eye drops:

Uncommon: dyspnea *.

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

Gastrointestinal disorders

Very common: taste alteration.

Dorzolamide hydrochloride, eye drops:

Frequent: nausea *.

Rare: throat irritation, dry mouth *.

Timolol maleate, eye drops:

Uncommon: nausea *, dyspepsia *.

Rare: diarrhea, dry mouth *.

Skin and subcutaneous tissue disorders

Rare: contact dermatitis.

Dorzolamide hydrochloride, eye drops:

Rare: rash *.

Timolol maleate, eye drops:

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

Renal and urinary disorders

Uncommon: urolithiasis.

Disorders of the reproductive organs and breasts

Timolol maleate, eye drops:

Rare: Peyronie's disease *.

General disorders and accidents related to the site of administration

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

Dorzolamide hydrochloride, eye drops:

Frequent: asthenia / fatigue *.

Timolol maleate solution:

Uncommon: asthenia / fatigue *.

* These side effects have also been observed with the fixed combination of dorzolamide and timolol since it was marketed.

Biological examinations

The fixed combination of dorzolamide and timolol has not been associated with clinically significant electrolyte disturbances in clinical studies.

Additional side effects have been reported with ophthalmic beta-blockers and may potentially occur with DORZOLAMIDE / TIMOLOL SANDOZ:

Immune system disorders

Localized and generalized rash

Metabolism and nutrition disorders

Hypoglycemia.

Cardiac disorders

Atrioventricular block, heart failure

Gastrointestinal disorders

Dysgeusia, abdominal pain, vomiting

Skin and subcutaneous tissue disorders

Skin rash.

Musculoskeletal and Connective Tissue Disorders

Myalgia.

Disorders of the reproductive organs and breasts

Sexual disorders.

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