Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION, STERILE
**DOSAGE AND ADMINISTRATION** Posology Recommended therapy is one eye drop in the conjunctival sac of the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Tapcom-S is a preservative free sterile solution packaged in a single-dose container. For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use.
OPHTHALMIC
Medical Information
**INDICATIONS** Reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops.
**CONTRAINDICATIONS (This product is contraindicated in the following patients.)** Hypersensitivity to the active substances or to any of the excipients listed in PHARMACEUTICAL PARTICULARS, 1. List of excipients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock. Patients with combination with products containing omidenepag isopropyl.
S01ED51
timolol, combinations
Manufacturer Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Laboratoire Unither
Active Ingredients
Documents
Package Inserts
Tapcom-S_ PI.pdf
Approved: December 13, 2022