国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
prazosin hydrochloride, Quantity: 1.1 mg (Equivalent: prazosin, Qty 1 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; polysorbate 80
Oral
100 tablets
(S4) Prescription Only Medicine
In patients with hypertension: Prazosin is indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a general treatment programme in conjunction with other antihypertensive agents. Renal blood flow and glomerular filtration rate are not impaired by long term oral administration. Prazosin can be used with safety in hypertensive patients with impaired renal function. In patients with congestive heart failure: Prazosin is indicated in the treatment of severe refractory congestive heart failure. Prazosin may be added to the therapeutic regimen in those patients who have become refractory to conventional therapy with cardiac glycosides and diuretics. In patients with Raynaud's Phenomenon and Raynaud's Disease: Prazosin is indicated in the treatment of Raynaud's phenomenon and Raynaud's disease. Benign Prostatic Hyperplasia: Prazosin is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia in patients awaiting prostatic surgery.
Visual Identification: Capsule-shaped, white, flat-faced bevelled-edged tablets, scored and engraved "APO P1" on one side, the other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2000-06-19
APO- PRAZOSIN TABLETS _Contains the active ingredient, prazosin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Prazosin. It contains the active ingredient, prazosin (as prazosin hydrochloride). It is used to treat: • high blood pressure (hypertension) • prostate problems, such as benign prostatic hyperplasia (BPH) in men waiting for prostate surgery • Raynaud's disease, where the fingers become white and very painful when cold • certain types of heart failure Prazosin belongs to a group of medicines called alpha blockers. It works by relaxing the muscles in the walls of blood vessels and making it easier for blood to flow. They also relax the muscles in the prostate gland and increase the flow of urine. When used to treat high blood pressure or heart failure, prazosin is often used together with other medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription There is no known evidence to show that this medicine is addictive. There is not enough information to recommend the use of this medicine in children under the age of 12 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • PRAZOSIN • RELATED MEDICINES CALLED QUINAZOLINES • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some of the 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION APO-PRAZOSIN (PRAZOSIN HYDROCHLORIDE) TABLET 1 NAME OF THE MEDICINE Prazosin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains prazosin hydrochloride equivalent to 1 mg, 2 mg or 5 mg prazosin base. EXCIPIENTS WITH KNOWN EFFECT lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-PRAZOSIN 1 MG TABLETS Capsule-shaped, white, flat-faced, bevelled-edged tablets scored and engraved “APO P1" on one side, other side plain. APO-PRAZOSIN 2 MG TABLETS Round, white, biconvex tablets, scored and engraved “APO” over “P2" on one side, other side plain. APO-PRAZOSIN 5 MG TABLETS Diamond-shaped, white, biconvex tablets, scored and engraved “APO” over “P5" on one side, other side plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IN PATIENTS WITH HYPERTENSION Prazosin is indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a general treatment programme in conjunction with other antihypertensive agents. Renal blood flow and glomerular filtration rate are not impaired by long-term oral administration. Prazosin can be used with safety in hypertensive patients with impaired renal function. IN PATIENTS WITH CONGESTIVE HEART FAILURE Prazosin is indicated in the treatment of severe refractory congestive heart failure. Prazosin may be added to the therapeutic regimen in those patients who have become refractory to conventional therapy with cardiac glycosides and diuretics. IN PATIENTS WITH RAYNAUD'S PHENOMENON & RAYNAUD'S DISEASE Prazosin is indicated in the treatment of Raynaud's phenomenon and Raynaud's disease. 2 BENIGN PROSTATIC HYPERPLASIA Prazosin is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia in patients awaiting prostatic surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL COMMENT There is evidence that patien 阅读完整的文件