Moexipril adverse reactions: Difference between revisions
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==Adverse Reactions== | ==Adverse Reactions== | ||
Moexipril | Moexipril hydrochloride has been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril hydrochloride than patients treated with placebo. | ||
Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with moexipril hydrochloride and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with moexipril hydrochloride were cough (0.7%) and dizziness (0.4%). | |||
All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with | All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with moexipril hydrochloride alone and that were at least as frequent in the moexipril hydrochloride group as in the placebo group are shown in the following table: | ||
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Other adverse | Other adverse events occurring in more than 1% of patients on moexipril that were at least as frequent on placebo include: [[headache]], upper respiratory infection, pain, [[rhinitis]], [[dyspepsia]], [[nausea]], [[peripheral edema]], [[sinusitis]], [[chest pain]], and urinary frequency. [[Angioedema]], [[hypotension]], [[neutropenia]]/[[agranulocytosis]], second and third trimester fetal/neonatal morbidity and mortality, [[hyperkalemia]], and [[cough]]. | ||
Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of moexipril patients or that have been attributed to other ACE inhibitors include the following: | |||
====Cardiovascular==== | ====Cardiovascular==== | ||
==== | Symptomatic [[hypotension]], [[postural hypotension]], or [[syncope]] were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/1254 (0.24%) patients who had received moexipril hydrochloride monotherapy and in 1/344 (0.3%) patients who had received moexipril hydrochloride with hydrochlorothiazide. Other adverse events included [[angina]]/[[myocardial infarction]], [[palpitations]], [[rhythm disturbances]], and [[cerebrovascular accident]]. | ||
====Renal==== | |||
Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving moexipril hydrochloride alone and 2% of patients receiving moexipril hydrochloride with hydrochlorothiazide experienced increases in [[serum creatinine]] to at least 140% of their baseline values. | |||
====Gastrointestinal==== | ====Gastrointestinal==== | ||
==== | [[Abdominal pain]], [[constipation]], [[vomiting]], appetite/weight change, dry mouth, [[pancreatitis]], [[hepatitis]]. | ||
====Respiratory==== | |||
[[Bronchospasm]], [[dyspnea]], [[eosinophilic pneumonitis]]. | |||
====Urogenital==== | |||
[[Renal insufficiency]], [[oliguria]]. | |||
====Dermatologic==== | |||
Apparent hypersensitivity reactions manifested by [[urticaria]], [[rash]], [[pemphigus]], [[pruritus]], [[photosensitivity]], [[alopecia]]. | |||
====Neurological and Psychiatric==== | |||
[[Drowsiness]], [[sleep disturbances]], [[nervousness]], [[mood changes]], [[anxiety]]. | |||
====Other==== | |||
[[Angioedema]] , taste disturbances, [[tinnitus]], sweating, [[malaise]], [[arthralgia]], [[hemolytic anemia]]. | |||
==== | ====Clinical Laboratory Test Findings==== | ||
==== | ====Serum Electrolytes==== | ||
[[Hyperkalemia]] , [[hyponatremia]]. | |||
==== | ====Creatinine and Blood Urea Nitrogen==== | ||
As with other ACE inhibitors, minor increases in blood urea nitrogen or [[serum creatinine]], reversible upon discontinuation of therapy, were observed in approximately 1% of patients with essential hypertension who were treated with moexipril hydrochloride. Increases are more likely to occur in patients receiving concomitant diuretics and in patients with compromised renal function. | |||
====Other==== | ====Other==== | ||
Clinically important changes in standard laboratory tests were rarely associated with moexipril hydrochloride administration. | |||
Elevations of liver enzymes and uric acid have been reported. In trials, less than 1% of moexipril-treated patients discontinued moexipril hydrochloride treatment because of laboratory abnormalities. The incidence of abnormal laboratory values with moexipril was similar to that in the placebo-treated group.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MOEXIPRIL HYDROCHLORIDE TABLET [APOTEX CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d18108f5-98ca-1220-d145-bcf4e71ceaee | publisher = | date = | accessdate = }}</ref> | |||
Revision as of 21:44, 14 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2], Amr Marawan, M.D. [3]
Moexipril
Moexipril and Hydrochlorothiazide tablet
Overview
Moexipril tablet is an angiontensin converting enzyme inhibitor drug that is FDA approved for the treatment of hypertension, heart failure, left ventricular dysfunction after myocardial infarction, diabetic nephropathy. Adverse reactions include hypotension, rash, hyperkalemia, disorder of taste, cough. hypotension, rash, hyperkalemia, disorder of taste, cough.
Category
Antihypertensive Agents, Angiotensin Converting Enzyme Inhibitors. Editor-In-Chief: C. Michael Gibson, M.S., M.D. [4]; Associate Editor(s)-in-Chief: Amr Marawan, M.D. [5]
Adverse Reactions
Moexipril hydrochloride has been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril hydrochloride than patients treated with placebo.
Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with moexipril hydrochloride and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with moexipril hydrochloride were cough (0.7%) and dizziness (0.4%).
All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with moexipril hydrochloride alone and that were at least as frequent in the moexipril hydrochloride group as in the placebo group are shown in the following table:
 |
Other adverse events occurring in more than 1% of patients on moexipril that were at least as frequent on placebo include: headache, upper respiratory infection, pain, rhinitis, dyspepsia, nausea, peripheral edema, sinusitis, chest pain, and urinary frequency. Angioedema, hypotension, neutropenia/agranulocytosis, second and third trimester fetal/neonatal morbidity and mortality, hyperkalemia, and cough.
Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of moexipril patients or that have been attributed to other ACE inhibitors include the following:
Cardiovascular
Symptomatic hypotension, postural hypotension, or syncope were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/1254 (0.24%) patients who had received moexipril hydrochloride monotherapy and in 1/344 (0.3%) patients who had received moexipril hydrochloride with hydrochlorothiazide. Other adverse events included angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accident.
Renal
Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving moexipril hydrochloride alone and 2% of patients receiving moexipril hydrochloride with hydrochlorothiazide experienced increases in serum creatinine to at least 140% of their baseline values.
Gastrointestinal
Abdominal pain, constipation, vomiting, appetite/weight change, dry mouth, pancreatitis, hepatitis.
Respiratory
Bronchospasm, dyspnea, eosinophilic pneumonitis.
Urogenital
Renal insufficiency, oliguria.
Dermatologic
Apparent hypersensitivity reactions manifested by urticaria, rash, pemphigus, pruritus, photosensitivity, alopecia.
Neurological and Psychiatric
Drowsiness, sleep disturbances, nervousness, mood changes, anxiety.
Other
Angioedema , taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.
Clinical Laboratory Test Findings
Serum Electrolytes
Creatinine and Blood Urea Nitrogen
As with other ACE inhibitors, minor increases in blood urea nitrogen or serum creatinine, reversible upon discontinuation of therapy, were observed in approximately 1% of patients with essential hypertension who were treated with moexipril hydrochloride. Increases are more likely to occur in patients receiving concomitant diuretics and in patients with compromised renal function.
Other
Clinically important changes in standard laboratory tests were rarely associated with moexipril hydrochloride administration.
Elevations of liver enzymes and uric acid have been reported. In trials, less than 1% of moexipril-treated patients discontinued moexipril hydrochloride treatment because of laboratory abnormalities. The incidence of abnormal laboratory values with moexipril was similar to that in the placebo-treated group.[1]
References
Adapted from the FDA Package Insert.