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Revisión médica por Kovalenko Svetlana Olegovna Última actualización de farmacia el 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 is contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
Do not co-administer aliskiren with Trandolapril Genera in patients with diabetes (see DRUG INTERACTIONS).
Trandolapril Genera is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Trandolapril Genera within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS).
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.
La experiencia de seguridad en ensayos controlados con placebo en EE. UU. Incluyó 1069 pacientes hipertensos, de los cuales 832 recibieron Grandolapril Genera. Casi 200 pacientes hipertensos recibieron Trandolapril Genera durante más de un año en ensayos abiertos. En ensayos controlados, los retiros por eventos adversos fueron 2.1% con placebo y 1.4% con los géneros de Trandolapril. Los eventos adversos considerados al menos posiblemente relacionados con el tratamiento que ocurre en el 1% de los pacientes tratados con Trandolapril Genera y más comunes en los géneros de Trandolapril que el placebo, agrupados para todas las dosis, se muestran a continuación, junto con la frecuencia de interrupción del tratamiento debido a estos eventos.
EVENTOS ADVERSOS EN LAS PRUEBAS DE HIPERTENSIÓN CONTROLADAS DE PLACEBO
Ocurriendo al 1% o más | ||
Grandolapril Genera (N = 832)% Incidencia (% Discontinuación) | PLACEBO (N = 237)% Incidencia (% Discontinuación) | |
Tos | 1.9 (0.1) | 0.4 (0.4) |
Mareo | 1.3 (0.2) | 0.4 (0.4) |
Diarrea | 1.0 (0.0) | 0.4 (0.0) |
Se observaron dolor de cabeza y fatiga en más del 1% de los pacientes tratados con Trandolapril Genera, pero se observaron con mayor frecuencia con placebo. Los eventos adversos generalmente no fueron persistentes o difíciles de manejar.
Disfunción ventricular izquierda después del infarto de miocardio
A continuación se muestran las reacciones adversas relacionadas con los géneros de Trandolapril que ocurren a una tasa mayor que la observada en pacientes tratados con placebo con disfunción ventricular izquierda. Las incidencias representan las experiencias del estudio TRACE. El tiempo de seguimiento fue de entre 24 y 50 meses para este estudio.
Porcentaje de pacientes con eventos adversos mayores que el placebo
Estudio de mortalidad controlado por placebo (TRACE) | ||
Evento adverso | Trandolapril N = 876 | Placebo N = 873 |
Tos | 35 | 22 |
Mareo | 23 | 17 |
Hipotensión | 11 | 6.8 |
Ácido úrico sérico elevado | 15 | 13 |
BUN elevado | 9.0 | 7.6 |
PICA o CABG | 7.3 | 6.1 |
Dispepsia | 6.4 | 6.0 |
Síncope | 5.9 | 3.3 |
Hipercalemia | 5.3 | 2.8 |
Bradicardia | 4.7 | 4.4 |
Hipocalcemia | 4.7 | 3.9 |
Mialgia | 4.7 | 3.1 |
Creatinina elevada | 4.7 | 2.4 |
Gastritis | 4.2 | 3.6 |
Choque cardiogénico | 3.8 | <2 |
Claudicación intermitente | 3.8 | <2 |
Carrera | 3.3 | 3.2 |
Astenia | 3.3 | 2.6 |
Experiencias adversas clínicas posiblemente o probablemente relacionadas o de relación incierta con la terapia que ocurre en 0.3% a 1.0% (excepto como se señaló) de los pacientes tratados con Trandolapril Genera (con o sin antagonista concomitante de iones de calcio o diurético) en ensayos controlados o no controlados (N = 1134) y menos frecuente, Los eventos clínicamente significativos observados en ensayos clínicos o experiencia posterior a la comercialización incluyen (listado por sistema corporal):
Función general del cuerpo
Dolor en el pecho.
Cardiovascular
Bloque de primer grado AV, bradicardia, edema, enrojecimiento y palpitaciones.
Sistema nervioso central
Somnolencia, insomnio, parestesia, vértigo.
Dermatológico
Prurito, erupción cutánea, pemphigus.
Ojo, Oído, Nariz, Garganta
Epistaxis, inflamación de la garganta, infección del tracto respiratorio superior.
Estados emocionales, mentales, sexuales
Ansiedad, impotencia, disminución de la libido.
Gastrointestinal
Distensión abdominal, dolor / calambres abdominales, estreñimiento, dispepsia, diarrea, vómitos, náuseas.
Hemopoyético
Disminución de leucocitos, disminución de neutrófilos.
Metabolismo y endocrino
Aumento de las enzimas hepáticas, incluido el SGPT (ALT).
Sistema musculoesquelético
Dolor por extremidades, calambres musculares, gota.
Pulmonar
Disnea.
Postmarketing
Se identificaron las siguientes reacciones adversas durante el uso posterior a la aprobación de los géneros de Trandolapril. Debido a que estas reacciones se informan voluntariamente de una población de tamaño incierto, no siempre es posible estimar de manera confiable su frecuencia o establecer una relación causal con la exposición a drogas.
Función general del cuerpo
Malestar, fiebre.
Cardiovascular
Infarto de miocardio, isquemia miocárdica, angina de pecho, insuficiencia cardíaca, taquicardia ventricular, taquicardia, ataque isquémico transitorio, arritmia.
Sistema nervioso central
Hemorragia cerebral.
Dermatológico
Alopecia, sudoración, síndrome de Stevens-Johnson y necrólisis epidérmica tóxica.
Estados emocionales, mentales, sexuales
Alucinación, depresión.
Gastrointestinal
Boca seca, pancreatitis, ictericia y hepatitis.
Hemopoyético
Agranulocitosis, pancitopenia.
Metabolismo y endocrino
Aumento de SGOT (AST).
Pulmonar
Bronquitis.
Renal y Urinario
Insuficiencia renal.
Hallazgos de pruebas de laboratorio clínico
Hematología
Trombocitopenia.
Electrolitos Suero
Hipotremia.
Creatinina y nitrógeno de la urea en sangre
Los aumentos en los niveles de creatinina ocurrieron en el 1.1% de los pacientes que recibieron los géneros de Trandolapril solo y el 7.3% de los pacientes tratados con los géneros de Trandolapril, un antagonista de los iones de calcio y un diurético. Los aumentos en los niveles de nitrógeno ureico en sangre ocurrieron en el 0.6% de los pacientes que recibieron los géneros de Trandolapril solo y el 1.4% de los pacientes que recibieron los géneros de Trandolapril, un antagonista de los iones de calcio y un diurético. Ninguno de estos aumentos requirió la interrupción del tratamiento. Es más probable que ocurran aumentos en estos valores de laboratorio en pacientes con insuficiencia renal o aquellos pretratados con un diurético y, según la experiencia con otros inhibidores de la ECA, sería especialmente probable en pacientes con estenosis de la arteria renal. (ver PRECAUCIONES y ADVERTENCIAS.)
Pruebas de función hepática
La elevación ocasional de las transaminasas a una tasa de 3 veces normales superiores ocurrió en el 0.8% de los pacientes y el aumento persistente de la bilirrubina ocurrió en el 0.2% de los pacientes. La interrupción de las enzimas hepáticas elevadas ocurrió en el 0.2% de los pacientes.
Otro
Otra experiencia adversa potencialmente importante, la neumonitis eosinofílica, se ha atribuido a otros inhibidores de la ECA.
No hay datos disponibles con respecto a la sobredosis en humanos. La DL50 oral de trandolapril en ratones fue de 4875 mg / Kg en machos y 3990 mg / Kg en hembras. En ratas, una dosis oral de 5000 mg / Kg causó baja mortalidad (1 macho de 5; 0 hembras). En perros, una dosis oral de 1000 mg / Kg no causó mortalidad y no se observaron signos clínicos anormales. En humanos, la manifestación clínica más probable serían los síntomas atribuibles a la hipotensión severa. Los síntomas también esperados con los inhibidores de la ECA son hipotensión, hipercalemia e insuficiencia renal.
Las determinaciones de laboratorio de los niveles séricos de trandolapril y sus metabolitos no están ampliamente disponibles, y tales determinaciones no tienen, en ningún caso, un papel establecido en el tratamiento de la sobredosis de trandolapril. No hay datos disponibles que sugieran maniobras fisiológicas (p. Ej., las maniobras para cambiar el pH de la orina) podrían acelerar la eliminación de trandolapril y sus metabolitos. El trandolaprilato se elimina por hemodiálisis. La angiotensina II presumiblemente podría servir como un antídoto antagonista específico en el contexto de la sobredosis de trandolapril, pero la angiotensina II esencialmente no está disponible fuera de las instalaciones de investigación dispersas. Debido a que el efecto hipotensor de trandolapril se logra a través de la vasodilatación y la hipovolemia efectiva, es razonable tratar la sobredosis de trandolapril mediante la infusión de solución salina normal.
However, we will provide data for each active ingredient