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| {{DrugProjectFormSinglePage
| | #REDIRECT [[Moexipril Hydrochloride]] |
| |authorTag={{AZ}}, {{AM}}
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| |genericName=Univasc
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
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| |fdaLIADAdult=<h4>Condition 1</h4>
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| * Dosing Information
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| :: (Dosage)
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| |contraindications=Moexipril hydrochloride is contraindicated in patients who are hypersensitive to this product and in patients with a history of [[angioedema]] related to previous treatment with an ACE inhibitor.
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| Do not co-administer [[aliskiren]] with moexipril hydrochloride in patients with [[diabetes]]
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| |clinicalTrials=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.
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| 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%).
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| 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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| [[File:b14.png|800px|thumb]]
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| 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]].
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| 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:
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| ====Cardiovascular====
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| 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]].
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| ====Renal====
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| 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.
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| ====Gastrointestinal====
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| [[Abdominal pain]], [[constipation]], [[vomiting]], appetite/weight change, dry mouth, [[pancreatitis]], [[hepatitis]].
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| ====Respiratory====
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| [[Bronchospasm]], [[dyspnea]], [[eosinophilic pneumonitis]].
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| ====Urogenital====
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| [[Renal insufficiency]], [[oliguria]].
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| ====Dermatologic====
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| Apparent hypersensitivity reactions manifested by [[urticaria]], [[rash]], [[pemphigus]], [[pruritus]], [[photosensitivity]], [[alopecia]].
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| ====Neurological and Psychiatric====
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| [[Drowsiness]], [[sleep disturbances]], [[nervousness]], [[mood changes]], [[anxiety]].
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| ====Other====
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| [[Angioedema]] , taste disturbances, [[tinnitus]], sweating, [[malaise]], [[arthralgia]], [[hemolytic anemia]].
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| ====Clinical Laboratory Test Findings====
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| ====Serum Electrolytes====
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| [[Hyperkalemia]] , [[hyponatremia]].
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| ====Creatinine and Blood Urea Nitrogen====
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| 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.
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| ====Other====
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| Clinically important changes in standard laboratory tests were rarely associated with moexipril hydrochloride administration.
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| 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.
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| |drugInteractions=====Diuretics====
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| Excessive reductions in blood pressure may occur in patients on [[diuretic]] therapy when ACE inhibitors are started. The possibility of [[hypotensive]] effects with moexipril [[hydrochloride]] can be minimized by discontinuing [[diuretic]] therapy for several days or cautiously increasing salt intake before initiation of treatment with moexipril hydrochloride. If this is not possible, the starting dose of moexipril should be reduced.
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| ====Potassium Supplements and Potassium-Sparing Diuretics====
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| Moexipril hydrochloride can increase serum potassium because it decreases [[aldosterone secretion]]. Use of potassium-sparing diuretics ([[spironolactone]], [[triamterene]], [[amiloride]]) or potassium supplements concomitantly with ACE inhibitors can increase the risk of [[hyperkalemia]]. Therefore, if concomitant use of such agents is indicated, they should be given with caution and the patient's serum potassium should be monitored.
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| ====Oral Anticoagulants====
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| Interaction studies with [[warfarin]] failed to identify any clinically important effect on the serum concentrations of the anticoagulant or on its anticoagulant effect.
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| ====Lithium====
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| Increased serum [[lithium]] levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of [[lithium toxicity]] may be increased.
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| ====Gold====
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| Nitritoid reactions (symptoms include [[facial flushing]], [[nausea]], [[vomiting]] and [[hypotension]]) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including moexipril hydrochloride.
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| ====Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)====
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| In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of [[NSAIDS]], including selective COX-2 inhibitors, with ACE inhibitors, including moexipril, may result in deterioration of renal function, including possible [[acute renal failure]]. These effects are usually reversible. Monitor renal function periodically in patients receiving moexipril and NSAID therapy.The antihypertensive effect of ACE inhibitors, including moexipril hydrochloride, may be attenuated by NSAIDS.
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| ====Dual Blockade of the Renin-Angiotensin System (RAS)====
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| Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or [[aliskiren]] is associated with increased risks of [[hypotension]], [[hyperkalemia]], and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on moexipril hydrochloride and other agents that affect the [[RAS]].
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| Do not co-administer [[aliskiren]] with moexipril in patients with diabetes. Avoid use of aliskiren with moexipril hydrochloride in patients with renal impairment (GFR <60 mL/min).
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| ====Other Agents====
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| No clinically important pharmacokinetic interactions occurred when moexipril hydrochloride was administered concomitantly with [[hydrochlorothiazide]], [[digoxin]], or [[cimetidine]].
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| Moexipril hydrochloride has been used in clinical trials concomitantly with calcium-channel-blocking agents, diuretics, H2 blockers, digoxin, oral hypoglycemic agents, and cholesterol-lowering agents. There was no evidence of clinically important adverse interactions.
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| ====Carcinogenesis, Mutagenesis, Impairment of Fertility====
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| No evidence of carcinogenicity was detected in long-term studies in mice and rats at doses up to 14 or 27.3 times the Maximum Recommended Human Dose (MRHD) on a mg/m2 basis.
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| No mutagenicity was detected in the Ames test and microbial reverse mutation assay, with and without metabolic activation, or in an in vivo nucleus anomaly test. However, increased chromosomal aberration frequency in Chinese hamster ovary cells was detected under metabolic activation conditions at a 20-hour harvest time.
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| Reproduction studies have been performed in rabbits at oral doses up to 0.7 times the MRHD on a mg/m2 basis, and in rats up to 90.9 times the MRHD on a mg/m2 basis. No indication of impaired fertility, reproductive toxicity, or teratogenicity was observed.
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