Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BRIMONIDINE TARTRATE
Allergan Malaysia Sdn Bhd
BRIMONIDINE TARTRATE
5ml mL
ALLERGAN PHARMACEUTICALS IRELAND
ALPHAGAN ® EYE DROPS brimonidine tartrate (0.2% w/v) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What ALPHAGAN ® is used for 2. How ALPHAGAN ® works 3. Before you use ALPHAGAN ® 4. How to use ALPHAGAN ® 5. While you are using it 6. Side effects 7. Storage and Disposal of ALPHAGAN ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What ALPHAGAN ® is used for ALPHAGAN ® is used to lower pressure in the eye of people with glaucoma or high pressure in the eye. How ALPHAGAN ® works ALPHAGAN ® is an eye drop solution that reduces the amount of fluid produced in the eye and increases the amount of fluid flowing out of the eye. This reduces the pressure inside the eye. Before you use ALPHAGAN ® - When you must not use it Do not use ALPHAGAN ® : - If you are allergic (hypersensitive to brimonidine tartrate, or any of the other ingredients of ALPHAGAN ® . (for a full list of ingredients, see section “PRODUCT DESCRIPTION”). - If you are taking monoamine oxidase antidepressant medication (MAO) - For neonates and infants (children under the age of 2 years) If you are not sure whether you should start using ALPHAGAN ® , talk to your doctor. - Pregnancy and lactation Discuss with your doctor the possible risks and benefits of using ALPHAGAN ® during pregnancy. Discuss with your doctor the possible risks and benefits of using ALPHAGAN ® when breast-feeding. - Children The safe and effective use of ALPHAGAN ® in children under the age of 2 has not been established. In children 2 years of age and above, especially those weighing ≤ 20kg, ALPHAGAN ® should be used with caution and closely monitored due to the high incidence and severity of sleepiness. - Before you start use it Tell your doctor if: 1. You have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes. 2. You have or have had any medical conditions, especially the following: - Liver or kidney disease - Severe heart or blood vess Les hele dokumentet
ALPHAGAN ® Brimonidine tartrate ophthalmic solution 0.2% DESCRIPTION Each mL contains: brimonidine tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base) with: benzalkonium chloride 0.05 mg, polyvinyl alcohol 14 mg; sodium chloride; sodium citrate; citric acid and purified water. CLINICAL PHARMACOLOGY ALPHAGAN ® is a relatively selective alpha- 2 adrenergic agonist. It has a peak ocular hypotensive effect occurring at two hours post -dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a system ic half -life of approximately 3 hours. In humans, system ic metabolism of brimonidine is extensive. It is metabolized primarily by the liver. Urinary excretion is the major route of elimination of the drug and its metabolites. Approximately 87% of an orally -administered radioactive dose was eliminated within 120 hours, with 74% found in the urine. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. ALPHAGAN ® has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters. In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of ALPHAGAN ® was approximately 4 -6 mm Hg compared with approximately 6 mm Hg for timolol. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy. Approximately 20% were discontinued due to adverse experiences. INDICATIONS AND USAGE ALPHAGAN ® is indicated for lowering intraocular pressure in patients with open- angle glaucoma or ocular hypertension. The IOP lowering efficacy of ALPHAGAN ® ophthalmic Les hele dokumentet