Cosopt

/ Rafa

The dose is one drop of COSOPT in the (conjunctival sac of the) affected eye(s) two times daily.
If another topical ophthalmic agent is being used, COSOPT and the other agent should be administered at least ten minutes apart.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Patients should be informed of the correct handling of the bottles.
Method of administration: See prescribing information.
Paediatric population: Efficacy in paediatric patients has not been established.
Safety in paediatric patients below the age of 2 years has not been established.

Indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension, open-angle glaucoma, or other secondary open-angle glaucoma when concomitant therapy is appropriate.

COSOPT is contraindicated in patients with:
– reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
– sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pacemaker, overt cardiac failure, cardiogenic shock.
– severe renal impairment (CrCl < 30 ml/min) or hyperchloraemic acidosis
– hypersensitivity to one or both active substances or to any of the excipients.
The above are based on the components and are not unique to the combination.

Same types of adverse reactions that are attributable to sulfonamides and/or systemic administration of beta-adrenergic blocking agents may occur. At the first sign or symptom of cardiac failure, treatment should be discontinued. Drug may be absorbed systemically. Patients in whom the systemic use of beta-adrenergic receptor blocking agents is contraindicated. Should not be used while wearing lenses. Cardiac failure, chronic obstructive pulmonary disease, patients undergoing elective surgery, diabetic patients, patients suspected of developing thyrotoxicosis, breastfeeding and lactation, pediatrics, patients who are receiving a beta-adrenergic receptor blocking agent orally, cerebrovascular insufficiency, angle-closure glaucoma.
See prescribing information for full details.

Very Common: burning and stinging, dysgeusia.
See prescribing information for full details.

Specific medicine interaction studies have not been performed with COSOPT.
In clinical studies, this medicinal product was used concomitantly with the following systemic medications without evidence of adverse interactions: ACE-inhibitors, calcium channel blockers, diuretics, non-steroidal anti-inflammatory medicines including aspirin, and hormones (e.g., estrogen, insulin, thyroxine).
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, catecholamine-depleting medicines or beta-adrenergic blocking agents, antiarrhythmics (including
amiodarone), digitalis glycosides, parasympathomimetics, guanethidine, narcotics, and monoamine oxidase (MAO) inhibitors.
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Although COSOPT alone has little or no effect on pupil size, mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents.
Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.

Pregnancy: COSOPT should not be used during pregnancy.
Breast-feeding: It is not known whether dorzolamide is excreted in human milk. If treatment with COSOPT is required, then lactation is not recommended.
See prescribing information for full details.

No data are available in humans in regard to overdose by accidental or deliberate ingestion of COSOPT.
Symptoms: There have been reports of inadvertent overdoses with timolol maleate ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. The most common signs and symptoms to be expected with overdoses of dorzolamide are electrolyte imbalance, development of an acidotic state, and possibly central nervous system effects.
Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride. With oral ingestion, somnolence has been reported. With topical application the following have been reported: nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia.
Treatment: Treatment should be symptomatic and supportive. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Studies have shown that timolol does not dialyze readily.

Shelf life: 2 years. COSOPT should be used no longer than 28 days after first opening the container.