국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
allopurinol, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Allopurinol
Tablet
Excipient Ingredients: stearic acid; maize starch; lactose monohydrate; sodium starch glycollate type A; povidone
Oral
200
(S4) Prescription Only Medicine
Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve:,? hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan syndrome, ? glucose 6-phosphatase including glycogen storage disease, ? phosphoribosylpyrophosphate synthetase, ? phosphoribosylpyrophosphate amidotransferase.,Allopurinol is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase.,Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.
Visual Identification: White to off white colored, round biconvex, uncoated tablets with 'AL' & '100' separated by breakline on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-02-22
ALLOPURINOL APOTEX TABLETS _Contains the active ingredient, allopurinol (al-oe-PUR-in-ol)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about allopurinol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor or pharmacist 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 Allopurinol APOTEX Tablets is used to treat: • gouty arthritis or gout • kidney stones • rare conditions where high levels of uric acid occur in the blood (for example, Lesch-Nyhan syndrome). It belongs to a group of medicines called anti-uricaemic agents. This medicine works by reducing the production of uric acid in the body. High levels of uric acid may cause gout attacks or kidney stones. Allopurinol is used to prevent gout attacks, not to treat them once they occur. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine for children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ Do not take this medicine if you have an al 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION – ALLOPURINOL APOTEX (ALLOPURINOL) 1 NAME OF THE MEDICINE Allopurinol 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Allopurinol is a white or off-white, almost odourless powder. It is very slightly soluble in water and in alcohol, and is practically insoluble in chloroform and in ether. It dissolves in dilute solutions of alkali hydroxides. Each allopurinol tablet contains allopurinol as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, povidone, sodium starch glycollate type A, sunset yellow FCF and stearic acid. ALLOPURINOL APOTEX 100 MG TABLETS White to off white, colored round biconvex, uncoated tablets with ‘AL’ & ‘100’ separated by breakline on one side and plain on other side. ALLOPURINOL APOTEX 300 MG TABLETS Peach colored, round, biconvex, uncoated tablets with ‘AL’ & ‘300’ separated by breakline on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. Allopurinol is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. Allopurinol is indicated for the management of recurrent mixed calciu 전체 문서 읽기