Medicinal Products

DUALKOPT 20 mg / ml + 5 mg / ml

Generic drug of the therapeutic class: Ophthalmology
active ingredients: Dorzolamide + Timolol
laboratory: Thea

Eye drops in solution
box of 1 multidose bottle of 10 ml
All forms

Indication

DUALKOPT 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 DUALKOPT 20 mg / ml + 5 mg / ml eye drops in solution box of 1 multidose vial of 10 ml

DUALKOPT 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.

Against indications

DUALKOPT is contraindicated in patients with:

· Hypersensitivity to one or both of the active ingredients or to any of the excipients listed under Composition,

· Reactive airway disease including asthma or history of asthma, or severe chronic obstructive pulmonary disease,

· Sinus bradycardia, sinus disease, sinoatrial block, second or third degree atrioventricular block not controlled by a pacemaker, patent 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.

Dualkopt side effects

In a clinical study, with the reference specialty based on dorzolamide / timolol (formulation without preservative), the reported adverse effects were consistent with those previously reported with the reference specialty based on dorzolamide / timolol multidose (formulation with preservative), dorzolamide hydrochloride and / or timolol maleate.

In clinical studies, 1, 035 patients were treated with the reference medicine dorzolamide / timolol (preservative formulation). Approximately 2.4% of them discontinued treatment with the dorzolamide / timolol maleate (preservative formulation) reference drug 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).

The reference specialty based on dorzolamide / timolol (preservative-free formulation) has shown a similar safety profile to that based on dorzolamide / timolol multidose (formulation with preservative) in a comparative double-blind clinical study. in multiple doses.

Timolol passes into the general circulation. This can induce the same types of adverse effects as those occurring after systemic administration of beta-blockers. The incidence of systemic adverse events after ophthalmic instillation is lower than after systemic administration.

The following undesirable effects have been reported with the reference medicine dorzolamide / timolol (preservative-free formulation) or one of its components either in clinical studies or since the time of marketing:

Adverse reactions are categorized by frequency as follows: Very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), and rare (≥ 1/10 000, <1/1 000), not known (can not be estimated from the available data).

Classes of organ systems

(MedDRA)

Formula

Very common

Frequent

Rare

Rare

Undetermined**

Immune system disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

signs and symptoms of allergic reactions, including angioedema, urticaria, pruritus, rash, anaphylaxis

Timolol maleate, solution eye drops

signs and symptoms of allergic reactions, including angioedema, urticaria, local and general rash, anaphylaxis

pruritus

Metabolism and nutrition disorders

Timolol maleate, solution eye drops

hypoglycemia

Psychiatric disorders

Timolol maleate, solution eye drops

depression*

insomnia *, nightmares *, memory loss

Nervous system disorders

Dorzolamide hydrochloride, solution eye drops

headache *

dizziness *, paresthesia *

Timolol maleate, solution eye drops

headache *

dizziness *, syncope *

paresthesia *, worsening signs and symptoms of myasthenia gravis, decreased libido *, cerebrovascular accident *, cerebral ischemia

Eye disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

burns and tingling

conjunctival hyperemia, blurred vision, corneal erosion, itchy eyes, watery eyes

Dorzolamide hydrochloride, solution eye drops

eyelid inflammation *, palpebral irritation *

iridocyclitis *

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

Timolol maleate, solution eye drops

signs and symptoms of eye irritation including blepharitis *, keratitis *, corneal hypoaesthesia and dry eye *,

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

ptosis, diplopia, choroidal detachment (after filtering surgery) * (see Warnings and precautions for use special warnings and precautions for use)

itching, tearing, redness, blurred vision, corneal erosion

Affections of the ear and labyrinth

Timolol maleate, solution eye drops

tinnitus *

Heart conditions

Timolol maleate, solution eye drops

bradycardia

chest pain *, palpitations *, edema *, arrhythmia *, congestive heart failure *, cardiac arrest *, heart block

atrioventricular block, heart failure

Vascular disorders

Timolol maleate, solution eye drops

hypotension *, claudication, Raynaud's phenomenon *, coldness of the extremities *

Respiratory, thoracic and mediastinal disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

sinusitis

shortness of breath, respiratory failure, rhinitis, rarely bronchospasm

Dorzolamide hydrochloride, solution eye drops

epistaxis*

Timolol maleate, solution eye drops

dyspnea*

bronchospasm (especially in patients with pre-existing bronchospastic disease) *, respiratory failure, cough *

Gastrointestinal disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

dysgeusia

Dorzolamide hydrochloride, solution eye drops

nausea *

throat irritation, dry mouth *

Timolol maleate, solution eye drops

nausea *, dyspepsia *

diarrhea, dry mouth *,

dysgeusia, abdominal pain, vomiting

Skin and subcutaneous tissue disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Dorzolamide hydrochloride, solution eye drops

eruption*

Timolol maleate, solution eye drops

alopecia *, psoriasiform rash or worsening of psoriasis *,

skin rash

Musculoskeletal and systemic disorders

Timolol maleate, solution eye drops

Systemic lupus erythematosus

myalgia

Renal and urinary disorders

Reference specialty based on dorzolamide / timolol formulation without preservative

urinary lithiasis

Disorders of reproductive organs and breast

Timolol maleate, solution eye drops

Peyronie's disease *, decreased libido

sexual dysfunction

General disorders and administration site conditions

Dorzolamide hydrochloride, solution eye drops

asthenia / fatigue *

Timolol maleate, solution eye drops

asthenia / fatigue *

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