Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Alcon
BETOPTIC® S Single Dose Ophthalmic suspension SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): BETOPTIC ® S Single Dose Ophthalmic suspension COMPOSITION: Each mL contains betaxolol hydrochloride equivalent to 2,5 mg betaxolol base. PHARMACOLOGICAL CLASSIFICATION: A.15.4 Ophthalmic preparations, other. PHARMACOLOGICAL ACTION: Betaxolol HCl is a cardioselective (beta-1-adrenergic) receptor blocking agent. When instilled in the eye, betaxolol reduces elevated as well as normal intraocular pressure. The mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. The onset of action with betaxolol can generally be noted within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration. A single dose provides a 12 hour reduction in intraocular pressure. Betaxolol does not produce miosis or accommodative spasm. During therapy with betaxolol, no negative effect on the blood supply to the optic nerve has been observed. INDICATIONS: BETOPTIC S Single Dose has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of: 1. Patients with chronic open-angle glaucoma. 2. Patients with elevated intraocular pressure (ocular hypertensive patients). CONTRA-INDICATIONS: Hypersensitivity to any component of this product. BETOPTIC S Single Dose is contra-indicated in patients with sinus bradycardia, an uncorrected greater than first degree atrioventricular block, cardiogenic shock, or patients with cardiac failure unless or until signs of failure are controlled with appropriate medicine. WARNINGS: Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with BETOPTIC S Single Dose should be dis Perskaitykite visą dokumentą