DuoTrav Eye Drops Solution (5mg40mcg) per mL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Timolol Maleate 6.8 mg (eqvivalent to 5mg Timolol); Travoprost

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01ED51

Dosage:

5mg/mL

Pharmaceutical form:

SOLUTION, STERILE

Composition:

Timolol Maleate 6.8 mg (eqvivalent to 5mg Timolol) 5mg/mL; Travoprost 40 ug/ml

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

Alcon-Couvreur NV

Authorization status:

ACTIVE

Authorization date:

2009-11-03

Patient Information leaflet

 
1. NAME OF THE MEDICINAL PRODUCT
40 micrograms/ml + 5 mg/ml eye drops, solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 40 micrograms of travoprost and 5 mg of
timolol (as timolol maleate).
Excipient(s) :
Each ml of solution contains polyquaternium-1 (POLYQUAD®) 10
microgram (as a preservative), propylene 
glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 1 mg (see
section 4.4).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in adults, including the elderly population. 
The dose is one drop of DUOTRAV® eye drops 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.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not exceed 
one drop in the affected eye(s) daily.
Special Populations
Hepatic and renal impairment
No studies have been conducted with DUOTRAV® eye drops or with
timolol 5 mg/ml eye drops in patients with 
hepatic or renal impairment.
Travoprost 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 dose
adjustment with DUOTRAV® eye drops 
(see section 5.2).
Paediatric population
The safety and efficacy of DUOTRAV® eye drops in children and
adolescents below the age of 18 years have not 
been established. No data are available ; hence its use is not
recommended in this population.
M

Summary of Product characteristics

1. TRADENAME(S)
DUOTRAV
®
Travoprost 40 µg/mL/Timolol Maleate 5 mg/mL Eye drops, Solution.
2. DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Eye drops, solution.
ACTIVE SUBSTANCE(S)
POLYQUAD-PRESERVED FORMULATION:
One mL of solution contains 40 micrograms of travoprost and 5 mg
of timolol (as timolol maleate).
EXCIPIENTS
POLYQUAD-PRESERVED FORMULATION:
Boric acid, mannitol, polyoxyethylene hydrogenated castor oil 40
(HCO-40), polyquaternium-1 (POLYQUAD), propylene glycol, sodium
chloride, sodium hydroxide and/
or hydrochloric acid (for pH adjustment), and purified water.
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).
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.
Novartis
Page 2
Country Specific Package Insert
25‐Jun‐2020
DUOTRAV

SPECIAL POPULATIONS
PEDIATRIC PATIENTS (BELOW 18 YEARS)
The use of DUOTRAV eye