Timoptol

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Timolol maleate 3.42 mg/mL equivalent to 2.5 mg/mL timolol

Disponible desde:

Mundipharma New Zealand Ltd

Designación común internacional (DCI):

Timolol maleate 3.42 mg/mL (=2.5 mg/mL timolol)

Dosis:

0.25 %

formulario farmacéutico:

Eye drops, solution

Composición:

Active: Timolol maleate 3.42 mg/mL equivalent to 2.5 mg/mL timolol Excipient: Benzalkonium chloride as 17% solution Dibasic sodium phosphate Monobasic sodium phosphate dihydrate Sodium hydroxide as 1N solution to pH 6.8-7.0 Water for injection

Unidades en paquete:

Bottle, plastic, 5mL sample pack, 5 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Fareva La Vallee

Resumen del producto:

Package - Contents - Shelf Life: Bottle, plastic, 5mL sample pack - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, Occumeter Plus- HDPE(Lupolen) - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light

Fecha de autorización:

1978-11-16

Ficha técnica

NAME OF MEDICINE 
TIMOPTOL
®

_timolol maleate  _
0.25% and 0.5% w/v Ophthalmic Solution  
PRESENTATION 
0.25%:  A clear colourless to light yellow solution available
in a translucent plastic 
dispensing bottle (ocumeter) with a pink cap
(contains 2.5mg timolol/ml). 

0.5%:  A clear colourless to light yellow solution available in
a translucent plastic 
dispensing bottle (ocumeter) with a mauve cap
(contains 5mg timolol/ml). 

THERAPEUTIC CLASS 
Timolol maleate is a non-selective
beta-adrenergic receptor blocking agent. 

INDICATIONS 
TIMOPTOL is indicated for the reduction of elevated
intraocular pressure.  In clinical trials 
it has been shown to reduce intraocular pressure in
patients with: 

•

ocular hypertension 
•

chronic open-angle glaucoma 
•

Aphakic glaucoma 
•

some forms of secondary glaucoma 
•

narrow angles and a
history of spontaneous or iatrogenically induced narrow-angle 
closure in the opposite eye in whom reduction
of intraocular pressure is necessary (see 
Warnings and Precautions) 

TIMOPTOL is also indicated as concomitant therapy in
patients with paediatric glaucoma, 
who are inadequately controlled, with other antiglaucoma therapy. 

DOSAGE AND ADMINISTRATION 
The usual starting dose is one drop of 0.25 percent TIMOPTOL in
the affected eye(s) 
twice a day.  If the clinical response is not adequate, the
dosage may be changed to one 
drop of 0.5 percent solution in the affected eye(s) twice a day. 

For a small proportion of patient’s one drop of 0.1
percent TIMOPTOL in the affected 
eye(s) twice a day may be satisfactory. 
If the clinical response is not adequate with 0.1 
percent solution, the dosage should be increased to one drop
of 0.25 percent in the 
affected eye(s) twice a day. 

If needed, concomitant therapy with
other agent(s) for lowering intraocular pressure may 
be given with TIMOPTO