Regulatory Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SOLUTION
**IV. 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. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in an increase in local activity.
OPHTHALMIC
Medical Information
**III. INDICATIONS** COSOPT is indicated in the treatment of elevated IOP in patients with ocular hypertension, open-angle glaucoma, pseudoexfoliative glaucoma or other secondary open-angle glaucomas when concomitant therapy is appropriate.
**V. CONTRAINDICATIONS** 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<30mL/min) or hyperchloraemic acidosis - hypersensitivity to any component of this product The above are based on the components and are not unique to the combination.
S01ED51
timolol, combinations
Manufacturer Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Santen Pharmaceutical Co., Ltd. Noto Plant
Active Ingredients
Documents
Package Inserts
Cosopt Ophthalmic Solution PI.pdf
Approved: March 3, 2022