معلومات المريض
کار دورا® (کار دور۔ا) (اقراص ميسيلات دوکسازوسین)
ما هو کاردورا؟
کاردورا هو دواء لا يصرف إلا بوصفة طبية يحتوي على ميسيلات دركسازوسين وينتمي إلى فئة من الأدوية تدعى "حاصرات مستقبلات ألفا"
يستخدم كاردورا لعلاج
اعراض فرط التنسج البروستاتي الحميد (BPH)
ضغط الدم المرتفع (ارتفاع ضغط الدم) ليس معروفا إذا ما كان كار دورا آمنا وفعالا في الأطفال أم لا
من الذي ينبغي عليه عدم تناول کاردورا؟
لا تتناول کاردورا إذا كنت
• تعاني من الحساسية تجاه دوکسازوسين أو الكينازولينات الأخرى، أو تجاه أي من مكونات کاردورا. راجع الجزء الأخير من نشرة معلومات المريض هذه للاطلاع على قائمة كاملة بمكونات کاردورا.
ما الذي ينبغي أن أخبر به مقدم الرعاية الصحية الخاص بي قبل تناول کاردورا؟
قبل تناول كاربورا، أطلع مقدم الرعاية الصحية الخاص بك على جميع الحالات الطبية التي تعاني منها، بما في ذلك إذا
• كنت قد عانيت من ضغط الدم المنخفض، خاصة بعد تناول دواء آخر. تشمل علامات ضغط الدم المنخفض الإغماء والدوار والدوخة و كان من المزمع خضوعك لعملية جراحية في العين
• كنت تعاني من سرطان البروستاتا أو لديك تاريخ للإصابة بسرطان البروستاتا. يمكن أن يقوم مقدم الرعاية الصحية الخاص بك بإخضاعك التحرص خاصة بسرطان البروستاتا قبل أن تبدأ في تناول کار دورا وأثناء تناولك له
• كنت تعاني من مشكلات في الكبد
كنت حاملا أو تخططين للحمل. ليس معروفا إذا ما كان كار دورا سيضر يجنينك أم لا
كنت ترضعين رضاعة طبيعية أو تخططين لذلك ليس معروفا إذا ما كان کاردورا يفرز في لين الثدي ام لا. تحدثي إلى مقدم الرعاية الصحية الخاص بك بشأن أفضل طريقة لإرضاع طفلك إذا كنت تتناولي كار دورا
أخبر مقدم الرعاية الصحية الخاص بك بجميع الأدوية التي تتناولها، بما في ذلك الأدوية والفيتامينات والمكملات العشبية، سواء التي صرف بوصفة طبية ار التي تصرف بدون وصفة طبية قد يؤثر کاردورا على طريقة عمل الأدوية الأخرى كما قد تؤثر الأدوية الأخرى على طريقة عمل كلراعي لثارا چلیږية
اخبر مقدم الرعاية الصحية الخاص بك خاصة إذا كنت تتناول
أدوية أخرى لعلاج ضغط الدم المرتفع تستخدم لعلاج الخلل الوظيفي في الانتصاب (ED) تدعى مثبطات إنزيم فوسفودایستراز من النوع الخامس (5-PDE). يمكن أن يؤدي استخدام کاردورا بالتزامن مع مثبطات إنزيم فوسفودايستراز من النوع الخامس إلى هبوط في ضغط الدم أو الإغماء اعرف الأدوية التي تتناولها، واحتفظ بقائمة بها لتعرضها على مقدم الرعاية الصحية الخاص بك والصيدلي الذي تتعامل معه عند تلقيك دواء جديدا
كيف ينبغي على تناول کاردورا؟ :
تناول کار دورا تماما مثلما يخبرك مقدم الرعاية الصحية الخاص بك. و سيخبرك بقلم الرعاية الصحية الخاص بك بكمية كاردورا التي ينبغي
عليك تناولها ومتي ينبغي عليك تناولها و يمكن ان يحتاج مقدم الرعاية الصحية الخاص بك إلى تغيير جرعتك من | کار دورا إلى أن تصبح الجرعة ملائمة لك
ما الذي ينبغي علي أن أتجنبه أثناء تناول کاردورا؟ لا تقم بالقيادة أو أداء أي مهام خطيرة قبل مضي 24 ساعة على الأقل على تناولك لكارتورا إذا كنت تتناول ، اول جرعة لك من کار دررا و كار دورا لأول مرة بعد أن قام مقدم الرعاية الصحية الخاص بك بزيادة جرعتك من کاردورا و کاردورا لأول مرة بعد أي فترات توقف (انقطاع) عن علاجك بكار دورا
ما هي الآثار الجانبية المحتملة لكاردورا؟
يمكن أن يسبب كار دورا آثارا | جانبية خطيرة، بما في ذلك :
الهبوط المفاجئ في ضغط الدم، خاصة عند بدء العلاج لأول مرة أو عند وجود زيادة في حجر عثك من کار دورا، وهو شائع ولكن يمكن أن يكون خطيرا أيضا يمكن أن يسبب هذا تعرضك للإغماء أو شعورك بالدوار او الدوخة يمكن أن يزداد خطر تعرضك لهذه المشكلة إذا كنت تتناول کاردورا مع أدوية معينة أخرى تخفض ضغط دمك، بما في ذلك مثبطات إنزيم فوسفودایئراز من النوع الخامس يمكن أن يقوم مقدم الرعاية الصحية الخاص بك بمراقبة مستويات ضغط دمك أثناء تناولك لكار دورا۔ انظر أسم "ما الذي ينبغي علي أن أتجنبه أثناء تناول کاردررا؟"
مشکلات في العين أثناء جراحة تصحيح إعتام عدسة العين. يمكن أن تحدث حالة تسمى متلازمة أين القزحية الجراحي (IFIS) أثناء جراحة تصحيح إعتام عدسة العين إذا كنت تتناول او قد تناولت حاصرات مستقبلات الفا مثل کاردررا. إذا كنت تحتاج الى الخضوع لجراحة تصحيح اعتام عدسة العين، فاحرص على اخبار مقدم الرعاية الصحية الخاص بك إذا كنت تتناول أو قد تناولت کار دررا د انتصابا مستمرا مولنا يمكن ان يمش کار شورا انتصابا مؤلما (الفات
لا يمكن إزالته بواسطة ممارسة الجنس في حالة حدوث هذا، اس للحصول على المساعدة الطبية على الفور. إذا لم تتم معالجة الفساح، نت لا تكون قادرا على تحقيق انتصاب في المستقبل.
الآثار الجانبية الأكثر شيوعا لكاردررا
هي:
الضعف أو نقص الطاقة (الوهن)
الدوار
أخبر مقدم الرعاية الصحية الخاص بك إذا أصيت باي آثار جانبية تسبب لك الانزعاج او لا تزول هذه ليست كل الآثار الجانبية المحتملة لكاردورا المزيد من المعلومات، اسال مقدم الرعاية الصحية او الصيدلي الخاص بك اتصل بطبيبك للحصول على المشورة الطبية حول الآثار الجانبية
معلومات عامة حول الاستخدام الأمن والفعال لكاردررا ؟في بعض الأحيان توصف الأدوية لأغراض غير تلك الواردة بقشرة معلومات المريض. لا تستخدم كار دورا لحالة لم يوصف لها. لا تقم بإعطاء كاردورا لاشخاص آخرين حتى إذا كانوا يعانون من نفس الأعراض التي تعاني منها. فقد يضرهم ذلك توجز نشرة معلومات المريض هذه اهم المعلومات بخصوص کار دورا. لمزيد من المعلومات، اسال مقدم الرعاية الصحية الخاص بك. يمكنك أن تطلب من مقدم الرعاية الصحية الخاص بك اور الصيدلي إطلاعك على المعلومات الموجهة إلى متخصصي الرعاية الصحية
ما هي مكونات کاردورا؟المكون الفعال ميسيلات دوکسازوسين المكونات غير الفعالة سليولوز بلوري مكرري، ولاكتوز احادي الهيدرات ، وجليكولات نشا الصوديوم، وستيارات المغنيسيوم، وكبريتات لوريل الصوديوم
ظروف التخزينيخزن في درجة حرارة لا تتعدي 30 درجة مئوية في مكان جاف. مالك حق التسويق:
Cardura 1 mg: Pfizer Limited UK a subsidiary of Pfizer Inc. USA Cardura 4 mg: Pfizer Corporation Austria GmbH a subsidiary of Pfizer Inc. USA
الشركة المصنعة و المعبئة :Pfizer Egypt
توزيع:Pfizer Egypt
تاريخ المراجعة: يونيو/حزيران 2016
للإبلاغ عن اي اثر جانبي:
مصر: مركز اليقظة الدوائية، شركة Pfizer للمنتجات الدوائية
EGY.AEReporting@pfizer.com
مركز اليقظة الدوائية المصري (EPVC)، الإدارة المركزية للشئون الصيدلية (CAPA)
PV.Center@Eda mohealth.gov.eg
إن هذا دواء- الدواء مستحضر يؤثر على صحتك واستهلاكه خلافا للتعليمات يعرضك للخطر
- اتبع بدقة وصفة الطبيب وطريقة الاستخدام وتعليمات الصيدلي الذي قام بصرف الدواء
- الطبيب والصيدلي خبيران في الأدوية وفوائدها ومخاطرها
- لا تقطع فترة العلاج المرصوفة لك من تلقاء نفسك
- لا تكرر صرف نفس الدواء دون استشارة طبيبك احتفظ بجميع الأدوية بعيدا عن متناول ومرای الأطفال مجلس وزراء الصحة العرب اتحاد الصيادلة العرب
صور نشرة كاردورا لعلاج ضغط الدم المرتفع Cardura
صور نشرة كاردورا بالانجليزية لعلاج ضغط الدم المرتفع Cardura
نشرة كاردورا بالانجليزية لعلاج ضغط الدم المرتفع Cardura
CARDURA fizer
Pazer
Doxazosin mesylate 1 mg and 4 mg Tablets
KARY OF PRODUCT CHARACTERISTICS LAGITN OF PRESCRIBING
muy cocer (51) RMATION
skor lemoperative Floppy Iris Syndrome bighlights do not include the
during cart wurgery (5.2) mation sueded to CARDURA les Search for the presence of prostate cancer prior Toetvety. See prescribing lafurmation to trestmeat for BPH and regular interval RDURA
terwards (5.3) DURA (doxnesia masylate) tablets, for
ADVERSE REACTIONS
The most commonly reported adverse reactions U.S. Approval: 1990
from clinical trials and Fugue, malaise. INDICATIONS AND USAGE hypotension, and duzine (61) DURAI n alpha adrentryle antagonist ed for
To report SUSPECTED ADVERSE ons and symptoms of Benign Prostatic REACTIONS, contact tur, Inc. at perplazis (PH)
1-800-434-1985 or FDA at 1-800-FDA:1088 or aiment of Hypertension
wwwfepowmedwatch.
DOSAGE AND ADMINISTRATION the treatment of BPIL fitime therapy 1
once daily Dose maybe titrated at 1 to 2 reek intervals, up to my goce daily.(2.2) or the traitement hypertensioInitiate therapy
1 mg once daily Dose may be tried coded up to 16 my quee daily (233)
DRUG INTERACTIONS a Strong cytochrome P450 (CYP) JA inhibitors
may increase exposure to desazoxía and increased risk of hypotension. (7.1) Concomitant administration of CARDURA with a phosphodiesterse (PDE 5) inhibitor can result in additive blood pressure lowering effects wid symptomatic hypotensio (72)
DOSAGE. FORMS AND STRENGTHS Tablots: 1 mg 4 mg
USE IN SPECIFIC POPULATIONS Hepatis Impiant: Monitor for hypownsion (8.6 12 )
CONTRAINDICATIONSHypersensitivity to donatos, other putostolines, or any other ingredienst in CARDURA (5)
See 17 for PATIENT COUNSELING INFORMATION IN FDA-approved patient labeling
Revised: 6/2016
-WARNINGS AND PRECAUTIONSPostural hypotension with or without syncope
LL PRESCRIBING INFORMATION: ONTENTS INDICATIONS AND USAGE LT Benign Prostatic Hyperplasia (BPH) 1 2 Hypertension DOSAGE AND ADMINISTRATION 2.) Dosing Information 22 Benign Protatie Hyperplasia 23 Hypertension DOSAGE FORMS AND STRENGTRS CONTRAINDICATIONS WARNINGS AND PRECAUTIONS 31 Postural Hypotension 5.2 Cataract Surgery $3 Prostate Cancer
54 Prapista GADVERSE REACTIONS
6 1 Clinical Trials Experience 62 Postmarketing Experience 7 DRUG INTERACTIONS 71 CYT JA Inhibitors
72 Phosphodiestese-5 (PDE-S) Inhibitor SUSE IN SPECIFIC POPULATIONS
* Pregnancy
8.2 Laciation 8.4 Pediatric Use RS Geriate Use
8.6 Hepatic impatient 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12 2 Pharmacodynamics
12.3 Pharmacokinetica 13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis, Mutagenesis Impairment of Fertility
13 2 Animal Toxicology and Pharoscolop 14 CLINICAL STUDIES
141 Beign Prontatic Hyperplasia (BPH)
14 2 Hypertension 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing information are not listed
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 11 Beniga Prostatic Hyperplasia (PH) CARDURA 1 indicated for the treatment of the signs and symptoms of BPR 1.2 Hypertensien CARDURA U indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of tatal and nonfatal cardiovascular events, primarily strokes and myocardial tofarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the drug Control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate, lipid control diabetes management, antithrombotic therapy, smoking countion exercise, sud limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint Natronal Committee on Prevention, Detection Evaluation, and Treatinent of High Blood Pressure (JNC) Numerous antihypertensive drugs from a variety of pharmacolagic classes and with different mechanisms of action, have been shown in mindomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, dat is largely responsible for those benefits. The largest and most consistent cardiovasculit outcome beneft has been a reduction in the risk of stroke, hus reduction in myocardial infarction and cardiovascular mortality also have been seen regularly Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg u greater at higher blood pressures, so that even modest reductions of severe lypertension can provide substantial benefit Relative risk reduction from blood presvure reduction is similar ucros populations with varying absolute nok, so the absolute benefit is greater in patients who are a higher risk independent of their hypertension (for cumple patients with diabetes or hyperlipidemia), and sach patients would be expected to bencit from more aggressive treatment to a lower blood pressure goal Some antihypertensive drugs have smaller blood pressure effects fa monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (es, on angina, heart failure, or diabetic dey disease) These considerations may guide selection of therapy CARDURAN be used alone or in combination with other antihypertensives 2 DOSAGE AND ADMINISTRATION 11 Dosing Information Following the initial dose and with each dose increase of CARDURA mmitor blond pressure for at least 6 bour following administrsbon. IT CARDURA administration is discontinued for several days, thepy should be restarted using the initial dosing regimen. 2.2 Benign Prestatie Hyperplasia The recommended initial dosage of CARDURA Im giver daily either in the moming or evening Depending on the individual patient's rodynamics and BPR symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg and thereafter to 4 mg an mg once daily The maximum recommended dose for BPH.8 mg once daily Routinely monitor blood pressure in these patients 2.3 Hypertension The initial dosage of CARDURAK mg given once daily Daily dosage may be doubled up 16 mg once daily, a needed to achieve the desired reduction in blood pressure,
3 DOSAGE FORMS AND STRENGTHS Tablet 1 mg and, 4 mg 4 CONTRAINDICATIONS The use of CARDURA is contraindicated in patients with hypersensitivity to dokazinot quinazolines (4-8 prazosin, ter zotin), or any of its components 5 WARNINGS AND PRECAUTIONS 5.1 Postural Hypotension Postural hypotension with or without symptoms (eg, dizziness) may develop within a few hours follow administration of CARDURA. However, infrequently, symptomatic protunel hypotension has also be reported later than a few hours after doing. As with other apba-blockers, there is a potential for at especially after the initial dose or after an increase in donge strength. Advise patient how to symptoms resulting from postural hypoon and what measures to take should be develop Concomitant administration of CARDURA with PDE5 inhibitor can rest in additive blood pre lowering effects and symptomatic hypotension 5.2 Catarset Surgery Intraoperative Floppy Irix Syndrome (UFIS) has been observed during cant surgery in some patient or previously treated with alpha, blockers. This variant of small pupil syndrome is charactered by combination of a thecidinis that willows in response to intraoperative irrigation current program intraoperative miosis despite preoperative dilation with standard mydriatic drug and potential prolap the inis toward the phacoemulsification incins. The intrycon should be prepared for pus modifications to their surgical technique, much the wilization of int hooks ini dilatating viscoelatie pubstances. There does not appear to be a benefit of stopping alpha, blocker therapy pri
urgery $3 Peale Cancer Carcoma of the prostate many of the symptom sociind with BPH od the two i frequently co-cu Curioms of the proteshed there be ruled out prior to com i ng the with CADURA for the rest of BPM SA Priapismo Alpha, mais including d i have been
with prima p er tid for brown and relieved by
mouse o r bat) This donc per potence if not promptly treated
GADVERSE REACTIONS 61 Chical Therace Be i ntel le we conected and widely varying conditions were contr o cal wials of a dog h e directly
in the basicalls of another not reflect the two obvod price Benige PuthperplasPH The side of advene ema ben
s
rom wide inicial The medence to presented below (Table 2) are donm ad data from placebo male involve dailymotion CALDURA dost of tolong in hypertensive Smug in mortives Advertis ing more than 1more frequently in BPR W CARDURA Y planchore d in the
19 More Frequently BPR Patients Treated with
Table 1. Adverse Reactions Decurri Cardura Verres cabo
RODYMIEM NERVOUS SY TEMI DI CALDERS
CARDLAC DISORDERS Wyption REATIKATOHY, TROLLACK AND MEDIANTIRAL DISORDERS
CASTROINTESTINAL DISORDERS
UDYM
GENERAL DISORDERS AND ADMINISTRATION STIE CONDITIONS
O
includes vertiyo Other advertention securring lees than I toore frequently in BPI patients treated with CARDURA
placebo bu planbly related to CARDURA include palpitation
CARDURA has been administered to spraumately 4000 hypertensive patients in clinical trials, of whom 1679 were locluded in the hypertension clinical development program. In placebo-controlled studies adverse eve occurred in 9 and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 29 af patients in each group Adverse reactions occurring more than 1% more frequently in hyperten patients treated with CARDURA placeho are urm e d in Table 1. Postunetfects and edem appeared to be done related The presence les presented below are based on combined data from placebo-controlled medica involstag once-daily administration of doutrotina dosarunglog from to to me
Table 2. Adhere Reactions Occurring more than 1% More Frequently in Hypertensive Patients Treated with Cardura versus Placebo
BODY SYSTEM
Cardena
Pacche
IN-339 NERVOUS SYSTEM DISORDERS Dizzines
39 Sociolenc RESPIRATORY, THORACIC AND MEDIANTINAL DISORDERS Rhin
IN RENAEANDURINARY DISORDERS Focus
235 REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fate/Mulus
Other udven reactions occurrin less than 1% more frequently in hypertensive patient cated with CARDURA V placebo hut plusibly related to CARDURA UE inchide vartijo, hypotension, hot flusher spistatis ad oedem CARDURA has been sociated with decreases in white blood cell counts Lebaraton changer ouredin dincat sedes Leaker /Neutronis. Decreases in men white blood cell (WBC) and mean neutrophil count were observed in controlled clinical trials of hypertensive patients receiving CARDURA. In cases where follow-up w brailable. WBC and neutrophil counts returned to normal after discontinuation of CARDURA No patients became symptomatic as a result of the low WBC or neutrophil cousta. 62 Postmarketing Experience The following adverse reaction bave been identified during post-approval use of CARDURA. Hecause the reactions are reported volontarily from a population of uncertain size, it is not always possible to relebly estimate their frequency or establish a cual relationship to drug exposure la posuiting expenonce the following addibonal advente reactions have been reported Bleo and Lymphanc vitlent Duorders: leukupenia thrombocytopenia, Immune Si Dirender allergic react Nervous System Diadors hypoesthesia
Duelers Intoperative Floppy Iris Syndrome te Wurnitgrand precaution 3.0 Cardiac Disordene hradycardia Raptutory: Thonucle and Mediastinal Duorders: bronchospam anavated. Gastroestinal Dironder voruting. Hepatobillary Duarders cholestas, bepatitu cholertatic, Sein and Subcutaneous True Diorders urticarias Mwculoskeletal and Connecthe Time Disorders muscle cramps, muscle weakness, Renal and Urinary Disorder hematuria, micution disorder, mleturition frequency, nocturia, Reproducte System anal Bart Duorders rynecomastia, priapism. 7 DRUG INTERACTIONS 7.1. CYP 3A Inhibitors to witro studier suggest that doxazon ka substrate of CYP3A4 Strong CYPJA inhibitors may increas exposure to donazoxin, Monitor blood presure and for symptoms of hypotension when CARDURA is used coticomitantly with strong CYP3A inhibitors (ree Clinical Pharmacolog (123) 72 Phosphodiesterase-5 (PDE-S) inhibitors Concomitant administration of CARDURA with a phosphodiesters-5 (PDE5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for aymptoms of bypotension (sve Warnings and Precaution (5. D. * USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The limited available data with CARDURA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscamage. However, untreated hypertension during pregnancy can result in increased matemal naks free Clinical Considerations). In animal reproduction studies, no adverse developmental effects were observed when doxazosin ww orally administered to pregnant rabbits and ruts during the period of organogenesis at doses of up to 47 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC expares with a 12 me day therapeutic dose). A dosage regimen of 82 mpkg/day in the rabbit was Asociated with reduced fetal survival free Dara) The estimated background risk of major birth defects and miscarriage for the indicated population is unknown in the US general population, the estimated background risk of major birth defects and miscamage in clinically recognized pregnancies is 2-4% and 15-20%, respectively Clinical Considerations Dunase rociated maternal and/or embofetal risk Hypertension in pregnancy increases the maternal risk fur pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarem section, and post-partum hemorrhage) Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine deuth Data Animal Data Radioactivity was found to cross the placenta followiny oral administration of labelled doxazostato pregnant raus Studies in pregnant rabbits and rais a daily eral doses of up to 41 und 20 mg/kg. respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 any day therapeutic dose), have revealed mo evidence of adverse developmental effects. A douage regimen of 3 mpkg/day in the rabbit was associated with reduced fcial survival. In peri- and postnatal stadies in rats postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazon (about times human Aue exposure with a 12 mg/day therapeutic dove) was delayed, us evidenced by slower body weight gain and slightly Ister appearance of anatomical features and reflect 8.2 Lactation Risk Summary There is limited information on the presence of CARDURA in human milks Duta) There is no information on the effects of CARDURA on the breastfeed infunt or the effects on milk production
present in human milk, which resulted in an infant done of A single cwe study reports that CARDURA less than 1% of the maternal weight-adjusted dosage and a milk pluma ratio of 0.1. However, these data are insuficient to confirm the presence of CARDURA in human milk 84 Pediatric Use The safety and effectiveness of CARDURA have not been established in children. 35 Geriatric Use Benign Prostatic Hyperplasia (BPH) The safety and effectiveness profile orCARDURA was similar in the elderly (age 2 65 years) and younger (age 65 years) patients Hypertension Clinical studies of CARDURA did not include sufficient number of subjects aged 65 and over to determine whether they respond differently free younger subjects Other reported clinical experience has not identified differences in responset berpen the elderly and younger patien In general dose selection for an ederly patient should be cautious, wally marting at the low end of the doring range, retecting the greater frequency of decreased bepahia tenal or cardiac function, and of concomitant lese or other drug therapy 1.6 Hepatie Impairment CARDURA Cuentively metibolized in the liver Hepatic impairment is expected to increase exposure to
) is not doxazorin Use of CARDURA in patients with severe bepatic impairment (Child-Pugh C recommended. Monitor blood prestare and for symptoms of hypotention in patients with lenser degree of hepatic impairment (Child-Pugh Class A ad B) per Chitical Pharmacology (1272 10 OVERDOSAGE Experience with CARDURA Overdosage is limited Two adolescents who each intentionally infested 40
stric love with activated charcoal my CARDURA with diclofenac or cetaminophim, were treated with
d with and made full recoveries. Anyour old child who accidently injected 4 ing CARDURA war
during the bour energy on obarvation period. A atri lavage and remained normale
was roported to have her month-old child decidentally Pocevved a crushed 1 mg tables of CARDURA drwy A 12-year-old female wis chronie real failurt, pilepay, and depression intentionally insed
mendeath was 80 mg CARDURA (blood level-09 pm moral values in typernah attributed to pred mal t multing from hypotension. A 19. your old facade sto ingested 70 mg
ad CARDURA Sehil sa Dalmase (fursaepur) developed hypotetion which responded to thegy
The next likely misis of The LDy of deas. is greater than 1000 mg kg in mice and
n ice of the Al
treatment would be werdege wat he hypomin, fue which the
ichsd depois highly protein been dialys Wooldsobe 11 DESCRIPTION
of
the e que CARDURAS ( d
compound that one
of dom es 1.- 47 soby f reerse report the chesscale
hyperzse l l
al The dimethoxy quinnyl) 43,4-esco
CH 0,
eur weight AR pical formule for detto hus the following structure
Doyance
CARDURA ( mer wighly solutie a metal
l ocidit, soluble is diedyomuamike ) is freely souble indime
v 25°C),
by s
moned
e and a
Timore than 1% Mere Frequently in HP Patients Treated with
Table 1 Ad Reactions Ou Curdereru Placebo
BODY SYST
ENERYOLISTITEM DISORDERS
NO
TS
ALLHAC DISORDERS
RESPIRATORY. THORACIC AND MEDIATINAL DISORDERS
12 GASTROINTESTINAL DISOR
07 CENEILL DINORDERS AND ADMINISTRATIONE CONDITIONS
10
Hecludes vertigo Other s ense ctions occurn less than 1% more frequently in DPH patients treated with CARDURA Ys placebo but pluusibly related to CARDURA che pulpitation Hyper CARDURA has been administered to approximately 4000 hypertensive patients in clinical trials, of whom 1679 were oluded in the hyperten clinical development program. In placebo-controlled studies adverse event occurred in 19% and 40% of patients in the daxazosin and placebo groups respectively, and led to discontinuation in 2% of patients in each roup Aive action Occurring more than 1% more frequently to hypertensive patiests treated with CARDURA va placeho are summzed in Table 1 Postural efects and oder appeared to be dose-related The prevalence rates presented below are based on combined data from placebo-controlled studies involving door daily administration of destinat doses ranging from 1 10 16 mg
Table 2 Adverse Reaction Occurring more than 1% More Frequratly in Hypertensive Patients Treated with Cardura versus Placebo
BODY SYSTEM
Cardura
cubo
139 NERVOUS SYSTEM DISORDERS Durine
1995 Samole RESPIRATORY THORACIC AND MEDIASTINAL DISORDERS
131 RENAL AND URINARY DISORDERS Poly
12
IO REPRODUCTIVE SYSTEM AND BREAST DISORDERS
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FM
125
IAN
m
Other advenie reactions occurring less than 1% more frequently in bypereure patients treated with CARDURA placebo but plausibly related to CARDURA use include vertigo, hypotension, hot flushes epties and cedens CARDURA has been sociated with decreases in white blood cell counts Laboratory chanyatoked in clinical tudiet Leukopis Neutrop . Dette in mean white blood cell (WBC) and mean neutrophil count were observed in controlled climcal trials of hypertensive patients reiving CARDURA In cases where follow-up was available, WHC and noutrophil counts returned to normal ser discontinuation of CARDURA No patients became symptomatic as a result of the low WBC of neutrophil counts 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CARDURA Because these reachons are reported voluntarily from a population of uncertain its not always possible to reliably estimate their frequency of establish c al relationship to drug exposure In post-marketing experience the following additional advenerations have been reported Blood and Lymphatic System Disorders leukopenia, thrombocytopenia Immune System Duerders clergic reaction Nervous Systen Dordre hypoest Eye Duardere Intraoperative Floppy Ins Syndrome free Harring and protution (50) Cardiac Disorders: bradycards, Respiratory Thoracic and Mediastinal Disorders bronchospasm aggravated Garrottal Disorders vomiting Hepatobillary Disorders cholestasis, hepatitis cholestatic Shin and Subcutaneo True Duerdere urtican Musculoskeletal and Connect There Doarders muscle crap, misele weakness Ronald Urinary Disorders hematuri, mitunition disorder, mictation frequency, nocturia, Reproductive System and Brrut Doarders kynecomasti, pinapisan. 7 DRUG INTERACTIONS 1.1. СУР ЗА Inhibian Intro Studies suggest that dorizon is a subtrite of CYP3A4 Strong CYP3A inhibitors may increase esporte todoxazosin. Monitor blood pressure and for symptoms of hypotension when CARDURA is used concomitantly with strong CYP3A inhibitors (see Clinical Pharmacology (125) 72 Phosphodiesters-5 (PDE-5) Inhibitors Concomitant administration of CARDURA with a phosphodiesters-5 (PDE-S) inhibitor can result in additive blood pressure lowering effects and symptomatic bypotension Monitor blood pressure and for symptoms of hypotension (see Waming and Proct (51) # USE IN SPECIFIC POPULATIONS 8.1 Present Risk Summary The limited available data with CARDURA in prenant women are not sufficient to informa drugociated ruk for major burtu defects and misc e. However, untreated by tension dung pregnancy can result in increased material maks free Clinical Consideration) Inmul reproduction studies no adverse developmental effects were observed when dort was orally administered to pregnant rabbits and rats during the penod of organogenesis doses of up to 41 and 20 m kg. respectively (exposures in rabbits and rats were 10 and 4 times, respectively the human AUC exposure with a 12 mg day therapeutic done) A dosage regimen of 2 mg kg/day in the rabbit was associated with reduced fetal survival e Data The estimated background nak of major birth defects and miscarriage for the indicated population is unknown in the US g eral population, the estimated background risk of major birth defects and
e in clinically recognized pregnancies is 2-4% and 15-20% respectively Chmical Consideration Dressecite maternal and archyvjetari Hypertension in pregnancy increases the maternal risk for pre-eclampsia prestational diabetes, premature delivery, and delivery complications (eg ned for a chion, and post purtam hemory ). Hypertension increases the fetal ak for intrauterine growth restriction and intrauterine death Data Animal Dan Radioactivity was found to cross the placenta following oral administration of labelled Sorronto pregnant Studies in pregnant rabbitts and rats at daily oral dose of up to 41 und 20 mg kg respectively
plasma drug concentratio of 10 und 4 times, respectively the human AUC posures with a 12 mg day theneutie donc) hay revealed no evidence of adverse developmental effects A dosaye regimen of 2 mg/kg/day in the rabbit was noted with reduced final survival in port and postal studies in a postnatal development acades of 4 or 50 kg/day of deursin but mos un ALL export with a 12 mg/day therapeutic dose) w delayed, as evidenced by lower body weight gain and Slighy later appen of anatomical features and reflexes
a Lactation Bisk SUTID There is limited information on the presence of CARDURA in human milks Data Thered to information on the effects of CARDURA on the hosted infant or the electo milk production Data A single che study reports that CARDURA is present in human milk which resulted in an infant dose of less than 1% of the matemal weight adjusted dosage and a milk plama ratio of However, boe data are insufficient to contrm the presence of CARDURA in human milk .4 Pediatric Use The safesy and stectiveness of CARDURA have not been established in children K3 Geriatrie Use Benign Prestatie Hyperplasia (BPH The safety and effect profile of CARDURA similar in the elderly e 2 65 yen) nd younger que 65 yeurs) patients Hasion Clinical studies of CARDURA did not include sufficient numbers of tee 65 and over to determine whether they repond differ from younger subjects Other reported clinical experience not identified difference is responses between the elderly and younger p enis In general doxe selection for elderly patient should be co l iy marting the lowed of the dering range relecting the re q uesy of decreased bebis salotoude function and of concomitan disease or other are they
& Hepatie Impairment CARDURA I C avely metabolized in the livet Hepatimpament in respected to incresp
e CARDURA photo with were hepate impart (Child-Pugh Chat recor d Mont blood press and for symptoms of hypotension in with a degree of hepati pirment (Child-Pugh Clau A d i Cical Pharma (123) 10 OVERDOSAGE Experience with CARDURA douage is limited the deceat whacach intentionally 40 mg CARDURA with diclofenac of acetaminophen were treated thi s wit h
and made full recov . Awer child who secently upd CARDURA Wor th He live and remained more durmgebuergy room obratio penal
month old child accidentally reweldsbedim o CARDURA soported to the dwy 32 year old female with chronic l e up and decim al
60 CARDURA (blood level-09 el malestin dyper 0 2 mmL dan n ed to almal selare from type A your c ale when CARDURA
D A (una ) developed by which responded Bud py TLD of d
a n 1000 meter. The mostly werd
het for which the same wel he t oud
d
11 DESCRITION CARDURA (
desses by of alpha-drew duethoxy qurol -014-
he w for
The the
that secara m e of l ewesperate
The SACHS
CARDURAS
كلمات دليلة
كاردورا للاثاث , كاردورا للنساء , كاردورا والتهاب البروستاتا , كاردورا xl , كاردورا 1 مجم , كاردورا والانتصاب , كاردورا واحتقان البروستاتا , كاردورا وضعف الانتصاب , كاردورا اقراص , فيما يستخدم كاردورا , ماذا يعالج كاردورا , كاردورا وتامسولين , كاردورا والضغط , كاردورا وضغط الدم , كاردورا والامساك , كاردورا والحمل , دواء كاردورا والجنس , دار داركم , كاردورا ما هو , نشرة كاردورا , مفعول كاردورا , اضرار كاردورا , كاردورا 1 مج , كاردورا 1 مجم أقراص , تجربتي مع كاردورا , مكونات كاردورا , كاردورا لعلاج الضغط , كاردورا للبروستاتا , حبوب كاردورا للبروستاتا , الاثار الجانبيه لكاردورا , الاعراض الجانبيه لكاردورا , قرص كاردورا , كاردورا فارماسيا , فوائد كاردورا , سعر كاردورا في مصر , كاردورا لعلاج البروستاتا , كاردورا 2 مجم , كاردورا علاج , cardura عربي , سعر كاردورا 4 , cardura سعر , كم سعر كاردورا , كاردورا حب , سعر حبوب كاردورا , تاثير كاردورا , cardura ترجمة , كاردورا بروستاتا , كاردورا بلس , بديل كاردورا , برشام كاردورا , بدائل كاردورا , سعر برشام كاردورا , cardura 0.4 mg , cardura 04 , cardura 1 mg سعر , cardura 10 mg , cardura 1 mg tablet , cardura 1 mg side effects , cardura 1 , cardura 1 mg uses , كاردورا 1 , كاردورا 2 مج , cardura 2 mg , cardura 2 mg tablet , cardura 2 mg uses , cardura 2 mg side effects , cardura 2 mg دواء , cardura 2 mg tab , cardura 2 mg doxazosin , cardura 2 mg indication , كاردورا 2 , cardura 3 mg , cardura 30cpr div 2 mg , cardura 4 mg tablet , cardura 4 mg tab , cardura 4mg side effects , cardura 4 mg price , cardura 40 mg , cardura 4 mg doxazosin , cardura 4 , cardura 4 mg xl , cardura 4 mg fiyatı , cardura 4 mg 20 tablet , كاردورا 4 ملغ , cardura 5mg , cardura 5mg xl , cardura 50 mg , cardura 5 , cardura 6 mg , cardura 600 mg , cardura 8 mg , cardura 8 mg side effects , cardura 8mg xl , cardura 8 , cardura 8 mg tablet , cardura 8 xl , cardura 8 mg fiyat , cardura 8 mg yan etkileri , cardura 8 mg ne ilacı , cardura 8 mg ne işe yarar ,
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