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Kovalenko Svetlana Olegovna tarafından tıbbi olarak gözden geçirilmiştir, Eczane Son güncelleme: 25.03.2022
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Hypertension
Trandolapril Genera is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.
Heart Failure Post Myocardial Infarction Or Left-Ventricular Dysfunction Post Myocardial Infarction
Trandolapril Genera is indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY -Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial).
Hypertension
The recommended initial dosage of Trandolapril Genera for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg.
Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with Trandolapril Genera monotherapy, a diuretic may be added.
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of Trandolapril Genera. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with Trandolapril Genera. (see WARNINGS.) Then, if blood pressure is not controlled with Trandolapril Genera alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg Trandolapril Genera should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response. (see WARNINGS, PRECAUTIONS and DRUG INTERACTIONS.)
Concomitant administration of Trandolapril Genera with potassium supplements, potassium salt substitutes, or potassium sparing diuretics can lead to increases of serum potassium. (see PRECAUTIONS.)
Heart Failure Post Myocardial Infarction Or Left-Ventricular Dysfunction Post Myocardial Infarction
The recommended starting dose is 1 mg, once daily. Following the initial dose, all patients should be titrated (as tolerated) toward a target dose of 4 mg, once daily. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose.
Dosage Adjustment In Renal Impairment Or Hepatic Cirrhosis
For patients with a creatinine clearance < 30 mL/min. or with hepatic cirrhosis, the recommended starting dose, based on clinical and pharmacokinetic data, is 0.5 mg daily. Patients should subsequently have their dosage titrated (as described above) to the optimal response.
Trandolapril Genera, bu ürüne aşırı duyarlı olan hastalarda, kalıtsal / idiyopatik anjiyoödem hastalarında ve bir ACE inhibitörü ile önceki tedaviye bağlı anjiyoödem öyküsü olan hastalarda kontrendikedir.
Diyabetli hastalarda aliskireni Trandolapril Genera ile birlikte uygulamayın (bkz İLAÇ ETKİLEŞİMLERİ).
Trandolapril Genera, bir neprilizin inhibitörü (örn., sakubitril). Bir neprilizin inhibitörü olan sakubitril / valsartan'a geçtikten sonra 36 saat içinde Trandolapril Genera uygulamayın (bkz UYARILAR).
WARNINGS
Anaphylactoid And Possibly Related Reactions
Presumably because angiotensin converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors, including Trandolapril Genera, may be subject to a variety of adverse reactions, some of them serious.
Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions did not occur when ACE inhibitors were temporarily withheld, but they reappeared when the ACE inhibitors were inadvertently readministered.
Anaphylactoid Reactions During Membrane Exposure
Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Head And Neck Angioedema
In controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients.
Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including Trandolapril Genera. Symptoms suggestive of angioedema or facial edema occurred in 0.13% of Trandolapril Genera-treated patients. Two of the four cases were life-threatening and resolved without treatment or with medication (corticosteroids). Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, treatment with Trandolapril Genera should be discontinued immediately, the patient treated in accordance with accepted medical care and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including but not limited to subcutaneous epinephrine solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered. (see PATIENT INFORMATION and ADVERSE REACTIONS.)
Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) or a neprilysin inhibitor (e.g., sacubitril) may be at increased risk for angioedema.
Intestinal Angioedema
Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Hypotension
Trandolapril Genera can cause symptomatic hypotension. Like other ACE inhibitors, Trandolapril Genera has only rarely been associated with symptomatic hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been salt-or volume-depleted as a result of prolonged treatment with diuretics, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume and/or salt depletion should be corrected before initiating treatment with Trandolapril Genera. (see DRUG INTERACTIONS and ADVERSE REACTIONS.) In controlled and uncontrolled studies, hypotension was reported as an adverse event in 0.6% of patients and led to discontinuations in 0.1% of patients.
In patients with concomitant congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia, and rarely, with acute renal failure and death. In such patients, Trandolapril Genera therapy should be started at the recommended dose under close medical supervision. These patients should be followed closely during the first 2 weeks of treatment and, thereafter, whenever the dosage of Trandolapril Genera or diuretic is increased. (see DOSAGE AND ADMINISTRATION.) Care in avoiding hypotension should also be taken in patients with ischemic heart disease, aortic stenosis, or cerebrovascular disease.
If symptomatic hypotension occurs, the patient should be placed in the supine position and, if necessary, normal saline may be administered intravenously. A transient hypotensive response is not a contraindication to further doses; however, lower doses of Trandolapril Genera or reduced concomitant diuretic therapy should be considered.
Neutropenia/Agranulocytosis
Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Available data from clinical trials of trandolapril are insufficient to show that trandolapril does not cause agranulocytosis at similar rates. As with other ACE inhibitors, periodic monitoring of white blood cell counts in patients with collagen-vascular disease and/or renal disease should be considered.
Hepatic Failure
ACE inhibitors rarely have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice should discontinue the ACE inhibitor and receive appropriate medical follow-up.
Fetal Toxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Trandolapril Genera as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the reninangiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Trandolapril Genera, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Trandolapril Genera for hypotension, oliguria, and hyperkalemia (See PRECAUTIONS, Pediatric Use).
Doses of 0.8 mg/kg/day (9.4 mg/m²/day) in rabbits, 1000 mg/kg/day (7000 mg/m²/day) in rats, and 25 mg/kg/day (295 mg/m²/day) in cynomolgus monkeys did not produce teratogenic effects. These doses represent 10 and 3 times (rabbits), 1250 and 2564 times (rats), and 312 and 108 times (monkeys) the maximum projected human dose of 4 mg based on body-weight and bodysurface-area, respectively assuming a 50 kg woman.
PRECAUTIONS
General
Impaired Renal Function
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Trandolapril Genera (trandolapril), may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.
In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy.
Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when ACE inhibitors have been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of any diuretic and/or the ACE inhibitor may be required. Evaluation of hypertensive patients should always include assessment of renal function. (see DOSAGE AND ADMINISTRATION.)
Hyperkalemia and Potassium-sparing Diuretics
In clinical trials, hyperkalemia (serum potassium > 6.00 mEq/L) occurred in approximately 0.4% of hypertensive patients receiving Trandolapril Genera. In most cases, elevated serum potassium levels were isolated values, which resolved despite continued therapy. None of these patients were discontinued from the trials because of hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with Trandolapril Genera. (see DRUG INTERACTIONS.)
Cough
Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. In controlled trials of trandolapril, cough was present in 2% of trandolapril patients and 0% of patients given placebo. There was no evidence of a relationship to dose.
Surgery/Anesthesia
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Trandolapril Genera will block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
ABD plasebo kontrollü çalışmalarda güvenlik deneyimi, 832'si Trandolapril Genera alan 1069 hipertansif hastayı içeriyordu. Yaklaşık 200 hipertansif hasta açık etiketli çalışmalarda bir yıldan fazla bir süredir Trandolapril Genera aldı. Kontrollü çalışmalarda, advers olaylar için para çekme işlemleri plasebo üzerinde% 2.1 ve Trandolapril Genera'da% 1.4 idi. Trandolapril Genera ile tedavi edilen hastaların% 1'inde meydana gelen ve tüm dozlar için toplanan plasebodan daha yaygın olan tedaviyle en azından muhtemelen ilişkili olduğu düşünülen advers olaylar, bu olaylar nedeniyle tedavinin kesilme sıklığı ile birlikte aşağıda gösterilmiştir. .
PLACEBO KONTROLLÜ HİPERTENSİYON DENEMELERİNDE REKLAM ETKİNLİKLERİ
% 1 veya daha fazla gerçekleşiyor | ||
Trandolapril Genera (N = 832)% İnsidans (% Süreksizlik) | PLACEBO (N = 237)% İnsidans (% Süreksizlik) | |
Öksürük | 1.9 (0.1) | 0.4 (0.4) |
Baş dönmesi | 1.3 (0.2) | 0.4 (0.4) |
İshal | 1.0 (0.0) | 0.4 (0.0) |
Trandolapril Genera ile tedavi edilen hastaların% 1'inden fazlasında baş ağrısı ve yorgunluk görülmüştür, ancak plasebo üzerinde daha sık görülmüştür. Olumsuz olaylar genellikle kalıcı değildi veya yönetilmesi zor değildi.
Miyokard Enfarktüsü Sonrası Sol Ventriküler Disfonksiyon
Sol ventrikül disfonksiyonu olan plasebo ile tedavi edilen hastalarda gözlenenden daha yüksek bir oranda meydana gelen Trandolapril Genera ile ilgili advers reaksiyonlar aşağıda gösterilmiştir. Olaylar TRACE çalışmasının deneyimlerini temsil etmektedir. Bu çalışma için takip süresi 24 ila 50 ay arasındaydı.
Plasebodan Daha Büyük Olumsuz Olayları Olan Hastaların Yüzdesi
Plasebo Kontrollü (TRACE) Ölüm Çalışması | ||
Olumsuz Olay | Trandolapril N = 876 | Plasebo N = 873 |
Öksürük | 35 | 22 |
Baş dönmesi | 23 | 17 |
Hipotansiyon | 11 | 6.8 |
Yüksek serum ürik asit | 15 | 13 |
Yüksek BUN | 9.0 | 7.6 |
PICA veya CABG | 7.3 | 6.1 |
Dispepsi | 6.4 | 6.0 |
Senkop | 5.9 | 3.3 |
Hiperkalemi | 5.3 | 2.8 |
Bradikardi | 4.7 | 4.4 |
Hipokalsemi | 4.7 | 3.9 |
Miyalji | 4.7 | 3.1 |
Yüksek kreatinin | 4.7 | 2.4 |
Gastrit | 4.2 | 3.6 |
Kardiyojenik şok | 3.8 | <2 |
Aralıklı topallama | 3.8 | <2 |
İnme | 3.3 | 3.2 |
Asteni | 3.3 | 2.6 |
% 0.3 ila% 1.0 arasında meydana gelen tedavi ile muhtemelen veya muhtemelen ilişkili veya belirsiz bir ilişki olan klinik advers deneyimler (belirtilenler hariç) Trandolapril Genera ile tedavi edilen hastaların (eşlik eden kalsiyum iyon antagonisti veya diüretik ile veya bunlar olmadan) kontrollü veya kontrolsüz çalışmalarda (N = 1134) ve daha az sıklıkta, klinik çalışmalarda veya pazarlama sonrası deneyimlerde görülen klinik olarak anlamlı olaylar şunları içerir (gövde sistemine göre listelenmiştir):
Genel Vücut Fonksiyonu
Göğüs ağrısı.
Kardiyovasküler
AV birinci derece blok, bradikardi, ödem, kızarma ve çarpıntı.
Merkezi Sinir Sistemi
Uyuşukluk, uykusuzluk, parestezi, baş dönmesi.
Dermatolojik
Kaşıntı, döküntü, pemfigus.
Göz, Kulak, Burun, Boğaz
Epistaksis, boğaz iltihabı, üst solunum yolu enfeksiyonu.
Duygusal, Zihinsel, Cinsel Devletler
Anksiyete, iktidarsızlık, libido azaldı.
Gastrointestinal
Karın distansiyonu, karın ağrısı / krampları, kabızlık, hazımsızlık, ishal, kusma, bulantı.
Hemopoietik
Azalmış lökositler, azalmış nötrofiller.
Metabolizma ve Endokrin
SGPT (ALT) dahil olmak üzere artan karaciğer enzimleri.
Kas-iskelet sistemi
Aşırı ağrı, kas krampları, gut.
Pulmoner
Dispne.
Pazarlama sonrası
Trandolapril Genera'nın onay sonrası kullanımı sırasında aşağıdaki advers reaksiyonlar tespit edilmiştir. Bu reaksiyonlar, belirsiz büyüklükteki bir popülasyondan gönüllü olarak bildirildiğinden, sıklıklarını güvenilir bir şekilde tahmin etmek veya ilaca maruz kalma ile nedensel bir ilişki kurmak her zaman mümkün değildir.
Genel Vücut Fonksiyonu
Malaise, ateş.
Kardiyovasküler
Miyokard enfarktüsü, miyokardiyal iskemi, anjina pektoris, kalp yetmezliği, ventriküler taşikardi, taşikardi, geçici iskemik atak, aritmi.
Merkezi Sinir Sistemi
Serebral kanama.
Dermatolojik
Alopesi, terleme, Stevens-Johnson sendromu ve toksik epidermal nekroliz.
Duygusal, Zihinsel, Cinsel Devletler
Halüsinasyon, depresyon.
Gastrointestinal
Ağız kuruluğu, pankreatit, sarılık ve hepatit.
Hemopoietik
Agranülositoz, pansitopeni.
Metabolizma ve Endokrin
Artan SGOT (AST).
Pulmoner
Bronşit.
Böbrek ve idrar
Böbrek yetmezliği.
Klinik Laboratuvar Test Bulguları
Hematoloji
Trombositopeni.
Serum Elektrolitleri
Hiponatremi.
Kreatinin ve Kan Üre Azot
Kreatinin düzeylerinde artış sadece Trandolapril Genera alan hastaların% 1.1'inde ve kalsiyum iyon antagonisti ve diüretik olan Trandolapril Genera ile tedavi edilen hastaların% 7.3'ünde meydana geldi. Kan üre azot düzeylerinde artış sadece Trandolapril Genera alan hastaların% 0.6'sında ve kalsiyum iyon antagonisti ve diüretik olan Trandolapril Genera alan hastaların% 1.4'ünde meydana geldi. Bu artışların hiçbiri tedavinin kesilmesini gerektirmedi. Bu laboratuvar değerlerinde artışların böbrek yetmezliği olan veya diüretik ile tedavi edilen hastalarda ortaya çıkma olasılığı daha yüksektir ve diğer ACE inhibitörleri ile deneyime dayanarak, özellikle böbrek arter stenozu olan hastalarda muhtemel olması beklenir. (Görmek ÖNLEMLER ve UYARILAR.)
Karaciğer Fonksiyon Testleri
Transaminazların 3X üst normal oranında ara sıra yükselmesi hastaların% 0.8'inde, bilirubinde kalıcı artış hastaların% 0.2'sinde meydana gelmiştir. Yüksek karaciğer enzimleri için kesilme hastaların% 0.2'sinde meydana gelmiştir.
Diğer
Potansiyel olarak önemli bir başka advers deneyim olan eozinofilik pnömonit, diğer ACE inhibitörlerine atfedilmiştir.
İnsanlarda aşırı doz ile ilgili veri mevcut değildir. Farelerde trandolapril oral LD50 erkeklerde 4875 mg / Kg ve kadınlarda 3990 mg / Kg idi. Sıçanlarda, 5000 mg / Kg'lık bir oral doz düşük mortaliteye neden oldu (5 erkekten 1 erkek; 0 kadın). Köpeklerde oral 1000 mg / Kg doz mortaliteye neden olmadı ve anormal klinik belirtiler gözlenmedi. İnsanlarda en olası klinik bulgu, şiddetli hipotansiyona atfedilebilen semptomlar olacaktır. ACE inhibitörleri ile de beklenen semptomlar hipotansiyon, hiperkalemi ve böbrek yetmezliğidir.
Trandolapril ve metabolitlerinin serum seviyelerinin laboratuvar belirlemeleri yaygın olarak mevcut değildir ve bu tür tespitler her durumda trandolapril doz aşımının yönetiminde yerleşik bir role sahip değildir. Fizyolojik manevraların (ör., idrarın pH'ını değiştirmek için manevralar) trandolapril ve metabolitlerinin ortadan kaldırılmasını hızlandırabilir. Trandolaprilat hemodiyaliz ile uzaklaştırılır. Anjiyotensin II muhtemelen trandolapril doz aşımı ortamında spesifik bir antagonist antidot görevi görebilir, ancak anjiyotensin II dağınık araştırma tesislerinin dışında esasen kullanılamaz. Trandolaprilin hipotansif etkisi vazodilatasyon ve etkili hipovolemi ile elde edildiğinden, trandolapril doz aşımının normal salin çözeltisi infüzyonu ile tedavi edilmesi mantıklıdır.
However, we will provide data for each active ingredient