DuoTrav Eye Drops, Solution (5mg/40mcg) per mL

3. Indications

DUOTRAV® eye drops contains travoprost, a prostaglandin analogue, and timolol, a non-selective beta-adrenergic receptor blocking agent (beta-blocker).

DUOTRAV eye drops is indicated for the decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers or prostaglandin analogues (see sections 11 and 12 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

5. Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
• Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
• Sinus bradycardia, sick sinus syndrome (including sino-atrial block), second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock.

4. Dosage regimen and administration

Dosage regimen

General target population

Adults

The recommended dosage of DUOTRAV is one drop in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day.

The dosage of DUOTRAV eye drops should not exceed one drop in the affected eye(s) once daily since it has been shown that more frequent administration of prostaglandin analogues may decrease the IOP lowering effect.

If a dose is missed, treatment should be continued with the next dose as normal. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.

When substituting another ophthalmic antiglaucoma medicinal product with DUOTRAV eye drops, the other medicinal product should be discontinued and DUOTRAV eye drops should be started the following day.

Special populations

Pediatric patients (below 18 years)

The use of DUOTRAV eye drops in pediatric patients is currently not recommended. The safety and efficacy of the use of DUOTRAV eye drops in children and adolescents below the age of 18 years have not been established. No data are available.

Geriatric patients (65 years of age and above)

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Hepatic and renal impairment

No studies have been conducted with DUOTRAV eye drops or with timolol 5 mg/mL eye drops in patients with renal or hepatic impairment.

Travoprost alone has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dose adjustment was necessary in these patients.

Patients with hepatic or renal impairment are unlikely to require a dose adjustment with DUOTRAV eye drops.

Method of administration

For ocular use only.

To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye.

When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Patients must be instructed to remove contact lenses prior to application of DUOTRAV eye drops and wait at least 15 minutes before reinsertion.