Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Alcon
BETOPTIC® Ophthalmic Solution SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): BETOPTIC ® Ophthalmic Solution COMPOSITION: Contains 5,6 mg betaxolol hydrochloride equivalent to 5 mg betaxolol per mL preserved with 0,01% benzalkonium chloride. 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, BETOPTIC 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 BETOPTICcan 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: BETOPTIC 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: BETOPTIChas 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 is contra-indicated in patients with sinus bradycardia greater than a first degree 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 should be discontinued at the first signs of cardiac failure. Ocular: In patients wit Perskaitykite visą dokumentą