Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Santen OY, Niittyhaankatu 20, FI-33720 Tampere, Finland
COSOPT 20 mg/ml + 5 mg/ml eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous solution with a pH between 5.5 and 5.8 and an osmolarity of 242‒323 mOsM. |
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol.
Excipient with known effect: One ml of eye drops solution contains 0.075 mg benzalkonium chloride and one drop contains about 0.002 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dorzolamide |
Dorzolamide is a potent inhibitor of human carbonic anhydrase II. Following topical ocular administration, dorzolamide reduces elevated intra-ocular pressure, whether or not associated with glaucoma. |
|
| Timolol |
Timolol is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol reduces intra-ocular pressure, whether or not this is associated with glaucoma. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
COSOPT containers contain 5 ml of solution. Two alternate containers may be marketed.
White translucent low-density polyethylene container, a transparent dropper tip and a white cap
or
OCUMETER Plus Ophthalmic Dispenser consisting of a translucent, high-density polyethylene container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2-piece cap assembly. The 2-piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label.
COSOPT is available in the following packaging configurations:
1 × 5 ml (single 5 ml container)
3 × 5 ml (three 5 ml containers)
6 × 5 ml (six 5 ml containers)
Not all pack sizes may be marketed
Santen OY, Niittyhaankatu 20, FI-33720 Tampere, Finland
PA0879/005/001
Date of first authorisation: 14 August 1998.
Date of last renewal: 06 March 2008
| Drug | Countries | |
|---|---|---|
| COSOPT | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa |
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