Cosopt

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Dorzolamide hydrochloride 22.26 mg/mL equivalent to 20 mg/mL Dorzolamide free base; Timolol maleate 6.83 mg/mL equivalent to 5 mg/mL Timolol free base

Disponibbli minn:

Mundipharma New Zealand Ltd

INN (Isem Internazzjonali):

Dorzolamide hydrochloride 22.26 mg/mL (equivalent to 20 mg/mL Dorzolamide free base)

Dożaġġ:

20mg/mL, 5mg/mL

Għamla farmaċewtika:

Eye drops, solution

Kompożizzjoni:

Active: Dorzolamide hydrochloride 22.26 mg/mL equivalent to 20 mg/mL Dorzolamide free base Timolol maleate 6.83 mg/mL equivalent to 5 mg/mL Timolol free base Excipient: Benzalkonium chloride Hyetellose Mannitol Sodium citrate Sodium hydroxide Water for injection

Unitajiet fil-pakkett:

Bottle, plastic, 'professional sample pack', 5 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

F.I.S. Fabbrica Italiana Sintetici SpA

Indikazzjonijiet terapewtiċi:

COSOPT is indicated for the treatment of elevated intraocular pressure (IOP) in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma · or other secondary open-angle glaucoma's and who are: · insufficiently responsive to topical beta blocker monotherapy · currently receiving concomitant antiglaucoma therapies such as dorzolamide HCl and timolol maleate

Sommarju tal-prodott:

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

Data ta 'l-awtorizzazzjoni:

1997-07-04

Karatteristiċi tal-prodott

NAME OF MEDICINE 
COSOPT
®

_dorzolamide hydrochloride and timolol maleate _
20 mg/5 mg ophthalmic solution 
PRESENTATION 
A clear, colourless to
nearly colourless, slightly viscous solution available in a
translucent 
plastic dispensing bottle (Occumeter) with a yellow cap. 
Each mL contains 20 mg of 
dorzolamide (22.26 mg dorzolamide HCl) and 5
mg of timolol (6.83 mg of timolol maleate). 

THERAPEUTIC CLASS 
COSOPT Ophthalmic Solution (dorzolamide hydrochloride and
timolol maleate, MSD) is 
the first combination of a topical carbonic anhydrase
inhibitor and a topical beta-adrenergic 
receptor blocking agent. 

INDICATIONS 
COSOPT is indicated for the treatment of elevated
intraocular pressure (IOP) in patients 
with: 
•

ocular hypertension 
•

open-angle glaucoma 
•

pseudoexfoliative glaucoma 
•

or other secondary open-angle glaucoma’s 

and who are: 
•

insufficiently responsive to topical beta blocker monotherapy 
•

currently receiving concomitant antiglaucoma therapies such
as dorzolamide HCI and 
timolol maleate 

DOSAGE AND ADMINISTRATION 
The dose is one drop of COSOPT in the affected eye(s) two
times daily.  When 
substituting COSOPT for another ophthalmic antiglaucoma
agent(s), discontinue the other 
agent(s) after proper dosing on
one day, and start COSOPT on the next day. 

If
another topical ophthalmic agent is being used, COSOPT and the other agent should
be 
administered at least ten minutes apart. 

Safety and efficacy in paediatric patients below the age of 2
years have not been 
established.  (For information regarding use in
paediatric patients ≥2 years of age see 
Warnings and Precautions, _Paediatric Use_). 

CONTRAINDICATIONS 
COSOPT is contraindicated in patients with: 
•

reactive airway disease, bronchial asthma
or other obstructive lung disorders