Land: Israel
Språk: engelsk
Kilde: Ministry of Health
SPIRONOLACTONE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
C03DA01
COATED TABLETS
SPIRONOLACTONE 25 MG
PER OS
Required
PFIZER INC, USA
SPIRONOLACTONE
SPIRONOLACTONE
Congestive heart failure, cirrhotic ascites.
2022-07-31
.مقافتت دق كتلاحف ،يغبني امم ركبأ ءاودلا لوانت نع تفقوت اذإ .نسحتب رعشت يئاودلا رادقملا نم دكأتلاو ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودلأا لوانت زوجي لا .اهيلا ةجاحب تنك اذإ ةيبطلا تاراظنلا عض .ءاود اهيف لوانتت ةرم لك يف .يلديصلا وأ بيبطلا رشتسإ ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ . ةيبناجلا ضارعلأا لا .نيلمعتسملا ضعب دنع ةيبناج ً اضارعأ ببسي دق نوتكادلأ لامعتسإ نإ ،ءاود لكب امك .اهنم ً ايأ يناعت لاأ زئاجلا نم .ةيبناجلا ضارعلأا ةمئاق نم شهدنت دعب ةيلاتلا ةيبناجلا ضارعلأا ىدحإ نم يناعت تنك اذإ بيبطلا ىلإ ً لااح هجوتلا بجي :ةريطخ نوكت دق ضارعلأا نإف ،ةردان ضارعلأا هذه نأ نم مغرلا ىلع .ءاودلا لوانت • رمحأ رشتنم حفط ،مسجلا يقاب يفو نيتفشلا لوح نم دلجلا يف تلاصيوح روهظو ةكح (نوسنوج - سنڤيتس ةمزلاتم) تلاصيوح لكشتو يجسفنب وأ • رشقت) مسجلا لماك يف ،دلجلا نم ىلفسلا تاقبطلا نع دلجلل ةيولعلا ةقبطلا لاصفنإ (toxic epidermal necrolysis ،يممستلا ةيورشبلا ةتومتملا ةجسنلأا • يئاود لعافت -ةروطخ رثكأ ةلاحل اضارعأ نوكت دق يتلا) خافتنإو ةنوخس ،يدلج حفط ،ةيزاهجلا ضارعلأاو تاضمحلا ةرثك عم .(Drug Reaction with Eosinophilia and Systemic Symptoms • (ناقري) رفصلأاب نينيعلاو دلجلا نولت • دبكلا فئاظوب ءاودلا رضي دق • نادقف) للش ،زخوب روعش ،ةايحلا ىلع ً ارطخ لكشي دق يذ Les hele dokumentet
Aldactone 25mg, LPD, CC 270222 2021-0073945 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aldactone ® 25mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 25mg spironolactone For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Aldactone 25mg tablets are round buff, film coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Congestive heart failure • Cirrhotic ascites 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration of Aldactone once daily with a meal is recommended. Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available (see sections 5.1 and 5.2). POSOLOGY ADULTS CONGESTIVE CARDIAC FAILURE WITH OEDEMA For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg to 200 mg daily. Maintenance dose should be individually determined. SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS III-IV) Based on the Randomized Aldactone Evaluation Study (RALES: see also section 5.1), treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day. See section 4.4 for advice on monitoring serum potassium and serum creatinine. HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA Aldactone 25mg, LPD, CC 270222 2021-0073945 Page 2 of 8 If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio is less than 1.0, 200 mg/day to 400 mg/day. Maintenance dosage should be individually determined. ELDERLY It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should b Les hele dokumentet