Medicinal Products

DUOTRAV 40 μg / 5 mg / mL

Generic drug of the therapeutic class: Ophthalmology
active ingredients: Travoprost, Timolol
Lab: Alcon Labo (UK) Ltd

Eye drops in solution
Case of 1 bottle of 2.5 ml
All forms

Indication

Reduced intraocular pressure (IOP) in adult patients with open-angle glaucoma or intraocular hypertonia who have an insufficient response to locally administered beta-blockers or prostaglandin analogues (see section 5.1 ).

Dosage DUOTRAV 40 μg / 5 mg / mL Eye drops in solution Case of 1 vial of 2.5 ml

Dosage.

Use in adults and elderly subjects.

The dosage is one drop of DuoTrav in the conjunctival cul-de-sac of the affected eye (s), once a day, in the morning or evening. It must be administered every day at the same time.

If an instillation is missed, treatment should be continued with the following instillation. The dosage should not exceed one drop per day in the affected eye (s).

Special populations.

Hepatic and renal insufficiency

No studies have been performed with DuoTrav or timolol 5 mg / ml eye drops in patients with hepatic or renal impairment.

Travoprost has been studied in patients with moderate to severe hepatic insufficiency and in those with moderate to severe renal impairment (creatinine clearance up to 14 ml / min). No dosage adjustment is necessary in these patients. Patients with impaired hepatic or renal function do not require dosage adjustment with DuoTrav (see section Pharmacokinetic properties ).

Pediatric population

The safety and effectiveness of DuoTrav in children and adolescents under 18 years of age have not been established. No data available.

Administration mode .

Eye track.

The patient must remove the protective bag just before the first use. To avoid contamination of the dropper tip and solution, care should be taken not to touch the eyelids, adjacent surfaces or other surfaces with the dropper tip of the vial.

Nasolacrimal occlusion or soft closure of the eyelids after administration is recommended. This can reduce the systemic absorption of ocular treatments and lead to a decrease in systemic adverse reactions.

If multiple eye drops are used, instillations should be spaced at least 5 minutes apart (see section Interactions with other medicinal products and other forms of interaction ).

If another ophthalmic antiglaucoma drug is being replaced with DuoTrav, discontinue the other drug and start DuoTrav the next day.

Patients should remove their contact lenses before instillation of DuoTrav and wait 15 minutes after instillation before contact lenses.

Against indications

Hypersensitivity to the active substances or to any of the excipients.

Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.

Sinus bradycardia, second or third degree atrioventricular block, confirmed heart failure or cardiogenic shock.

Severe allergic rhinitis and bronchial hyperreactivity; corneal dystrophies; hypersensitivity to other beta-blockers.

Duotrav side effects

In clinical studies involving 938 patients, DuoTrav (preserved with benzalkonium chloride) was administered once daily. The most common treatment-related adverse event was ocular hyperaemia (15.0%). Most patients with hyperemia (96%) did not stop treatment for this reason.

The adverse reactions identified in the table below have been observed in clinical or post-marketing trials. They are presented by organ system class and listed below as follows: very common (≥1 / 10), frequent (≥1 / 100 to <1/10), infrequent (≥1 / 1, 000 to <1/100), rare (≥1 / 10, 000 to <1 / 1, 000), very rare (<1 / 10, 000), or indeterminate frequency (can not be estimated based on available data). Within each group frequency, adverse effects are presented in descending order of severity.

DuoTrav (preserved with benzalkonium chloride)

Class of organ system

Frequency

Side effects

Psychiatric disorders

Frequency Indeterminate

nervousness.
depression.

Nervous system disorders

frequently

dizziness, headache.

indeterminate

cerebrovascular accident, syncope, paresthesia.

Eye disorders

Very frequent

ocular discomfort, ocular hyperemia.

frequently

punctate keratitis, anterior chamber inflammation (cellular and Protein Tyndall effect), eye pain, photophobia, eye swelling, conjunctival haemorrhage, reduced visual acuity, visual disturbance, blurred vision, dry eye, eye pruritus, conjunctivitis, increased tearing, erythema eyelids, blepharitis, asthenopia, eyelash growth.

Infrequent

corneal erosion, keratitis, ocular allergy, conjunctival edema, eyelid edema.

Rare

iritis.

indeterminate

macular edema, ptosis of the eyelids, corneal affection.

Heart conditions

frequently

irregular heartbeat, decreased heart rate.

Uncommon

arrhythmia.

indeterminate

heart failure, tachycardia.

Vascular disorders

frequently

increase in blood pressure, decrease in blood pressure.

Respiratory, thoracic disorders

frequent

bronchospasm.

and mediastinal

Infrequent

dyspnoea, cough, oropharyngeal pain, throat irritation, nasal discomfort, nasopharyngitis.

indeterminate

asthma.

Hepatobiliary disorders

Infrequent

increased alanine aminotransferases, increased aspartate aminotransferases.

Skin and tissue disorders

frequently

hives, hyperpigmentation of the skin (periocular).

subcutaneous

Uncommon

contact dermatitis.

Rare

alopecia.

indeterminate

skin rash.

Musculoskeletal and systemic disorders

frequently

extremity pain

Renal and urinary disorders

Uncommon

chromaturia.

General disorders and administration site conditions

Uncommon

thirst.

indeterminate

chest pain.

In 3 clinical studies conducted for the development of DuoTrav (preserved with polyquaternium-1), 372 patients / subjects were treated over a period of up to 12 months. The most commonly reported adverse event related to DuoTrav (preserved with polyquaternium-1) was ocular hyperemia (11.8%) including ocular or conjunctival hyperemia. In most patients with hyperemia (91%), treatment was not discontinued for this reason.

The side effects listed below have been reported in clinical trials.

DuoTrav (preserved with polyquaternium-1)

Class of organ systems

Frequency

Side effects

Immune system disorders

Infrequent

hypersensitivity

Nervous system disorders

Infrequent

headache

Eye disorders

frequently

eye pain, eye discomfort, dry eye, eye pruritus, ocular hyperemia

Infrequent

punctate keratitis, iritis, photophobia, blurred vision, conjunctivitis, meibomite, crusts on the edge of the eyelid, asthenopia, increased tearing, eyelash growth.

Heart conditions

Infrequent

bradycardia

Vascular disorders

Infrequent

hypotension

Skin and subcutaneous tissue disorders

Infrequent

cutaneous dyschromia, abnormal hair growth

General disorders and administration site conditions

Infrequent

tired

exams

Infrequent

decreased heart rate

Additional side effects that have been observed with any of the active ingredients and may possibly occur with DuoTrav:

travoprost

Ocular disorders: uveitis, conjunctival affection, conjunctival follicles, hyperpigmentation of the iris.

Skin and subcutaneous tissue disorders: Skin exfoliation.

timolol

Metabolism and nutrition disorders: hypoglycaemia.

Nervous system disorders: cerebral ischemia, myasthenia gravis.

Eye disorders: diplopia.

Cardiac disorders: cardiac arrest, atrioventricular block, palpitations.

Respiratory, thoracic and mediastinal disorders: respiratory failure, nasal congestion.

Gastrointestinal disorders: diarrhea, nausea.

General disorders and administration site abnormality: asthenia.

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