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| __NOTOC__
| | #REDIRECT [[Trandolapril#Adverse Reactions]] |
| {{Trandolapril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Adverse Reactions==
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| The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received MAVIK. Nearly 200 hypertensive patients received MAVIK for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on MAVIK. Adverse events considered at least possibly related to treatment occurring in 1% of MAVIK-treated patients and more common on MAVIK than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events.
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| [[Headache]] and [[fatigue]] were all seen in more than 1% of MAVIK-treated patients but were more frequently seen on placebo. Adverse events were not usually persistent or difficult to manage.
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| ====Left Ventricular Dysfunction Post Myocardial Infarction====
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| Adverse reactions related to MAVIK occurring at a rate greater than that observed in placebo-treated patients with [[left ventricular dysfunction]], are shown below. The incidences represent the experiences from the TRACE study. The follow-up time was between 24 and 50 months for this study.
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| Clinical adverse experiences possibly or probably related or of uncertain relationship to therapy occurring in 0.3% to 1.0% (except as noted) of the patients treated with MAVIK (with or without concomitant calcium ion antagonist or diuretic) in controlled or uncontrolled trials (N=1134) and less frequent, clinically significant events seen in clinical trials or post-marketing experience include (listed by body system):
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| ====General Body Function====
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| [[Chest pain]].
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| ====Cardiovascular====
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| [[AV first degree block]], [[bradycardia]], [[edema]], [[flushing]], and [[palpitations]].
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| ====Central Nervous System====
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| [[Drowsiness]], [[insomnia]], [[paresthesia]], [[vertigo]].
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| ====Dermatologic====
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| [[Pruritus]], [[rash]], [[pemphigus]].
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| ====Eye, Ear, Nose, Throat====
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| [[Epistaxis]], throat inflammation, [[upper respiratory tract infection]].
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| ====Emotional, Mental, Sexual States====
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| [[Anxiety]], [[impotence]], decreased libido.
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| ====Gastrointestinal====
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| [[Abdominal distention]], [[abdominal pain]]/[[cramps]], [[constipation]], [[dyspepsia]], [[diarrhea]], [[vomiting]], [[nausea]].
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| ====Hemopoietic====
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| Decreased leukocytes, decreased neutrophils.
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| ====Metabolism and Endocrine====
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| Increased liver enzymes including [[SGPT]] (ALT).
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| ====Musculoskeletal System====
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| Extremity pain, muscle cramps, [[gout]].
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| ====Pulmonary====
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| [[Dyspnea]].
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| ====Postmarketing====
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| The following adverse reactions were identified during post approval use of MAVIK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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| ====General Body Function====
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| [[Malaise]], [[fever]].
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| ====Cardiovascular====
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| [[Myocardial infarction]], [[myocardial ischemia]], [[angina pectoris]], [[cardiac failure]], [[ventricular tachycardia]], tachycardia, [[transient ischemic attack]], [[arrhythmia]].
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| ====Central Nervous System====
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| [[Cerebral hemorrhage]].
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| ====Dermatologic====
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| [[Alopecia]], [[sweating]], [[Stevens-Johnson syndrome]] and [[toxic epidermal necrolysis]].
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| ====Emotional, Mental, Sexual States====
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| [[Hallucination]], [[depression]].
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| ====Gastrointestinal====
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| [[Dry mouth]], [[pancreatitis]], [[jaundice]] and [[hepatitis]].
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| ====Hemopoietic====
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| [[Agranulocytosis]], [[pancytopenia]].
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| ====Metabolism and Endocrine====
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| Increased [[SGOT]] (AST).
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| ====Pulmonary====
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| [[Bronchitis]].
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| ====Renal and Urinary====
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| [[Renal failure]].
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| ====Clinical Laboratory Test Findings====
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| ====Hematology====
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| [[Thrombocytopenia]].
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| ====Serum Electrolytes====
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| [[Hyponatremia]].
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| ====Creatinine and Blood Urea Nitrogen====
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| Increases in creatinine levels occurred in 1.1% of patients receiving MAVIK alone and 7.3% of patients treated with MAVIK, a calcium ion antagonist and a diuretic. Increases in [[blood urea nitrogen]] levels occurred in 0.6% of patients receiving MAVIK alone and 1.4% of patients receiving MAVIK, a calcium ion antagonist, and a diuretic. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with [[renal insufficiency]] or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis.
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| ====Liver Function Tests====
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| Occasional elevation of transaminases at the rate of 3X upper normals occurred in 0.8% of patients and persistent increase in [[bilirubin]] occurred in 0.2% of patients. Discontinuation for elevated liver enzymes occurred in 0.2% of patients.
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| ====Other====
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| Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAVIK (TRANDOLAPRIL) TABLET [ABBVIE INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ad67ea2-409c-4f52-a9b8-38216209609a | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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