Quinapril Drug Information
Generic name: QUINAPRIL
Uses of Quinapril
Hypertension Quinapril tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
There are no controlled trials demonstrating risk reduction with quinapril tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.
Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril tablets may be used alone or in combination with thiazide diuretics.
Heart Failure Quinapril tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets do not have a similar risk (see WARNINGS ). Angioedema in black patients : Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks.
It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
Dosage & Administration of Quinapril
| Creatinine Clearance | Maximum RecommendedInitial Dose |
|---|---|
| >60 mL/min | 10 mg |
| 30–60 mL/min | 5 mg |
| 10–30 mL/min | 2.5 mg |
| <10 mL/min | Insufficient data for dosage recommendation |
Side Effects of Quinapril
Dizziness 3.9 2.6 Fatigue 2.6 1.0 Coughing 2.0 0.0 Nausea and/or Vomiting
1.4
Abdominal Pain 1.0 0.7 Heart Failure Quinapril has been evaluated for safety
in 1222 quinapril treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.
Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with quinapril are shown below. Quinapril Placebo (N=585) (N=295) Incidence Incidence (Discontinuance) (Discontinuance) Dizziness 7.7
Coughing 4.3 1.4 Fatigue 2.6 1.4 Nausea and/or Vomiting 2.4 0.7 Chest
Pain 2.4
Hypotension 2.9 1.0 Dyspnea 1.9 2.0 Diarrhea 1.7 1.0 Headache 1.7 1.0
Myalgia 1.5
Rash 1.4 1.0 Back Pain 1.2 0.3 See
PRECAUTIONS, Cough. Hypertension and/or Heart Failure Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to 1.0% (except as noted) of the patients with CHF or hypertension treated with quinapril (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system): General : back pain, malaise, viral infections, anaphylactoid reaction Cardiovascular : palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock Hematology : hemolytic anemia Gastrointestinal : flatulence, dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia Metabolism and Nutrition Disorders : hyponatremia Nervous/Psychiatric : somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia Integumentary : alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis Urogenital : urinary tract infection, impotence, acute renal failure, worsening renal failure Respiratory : eosinophilic pneumonitis Other : amblyopia, edema, arthralgia, pharyngitis, agranulocytosis, hepatitis, thrombocytopenia Angioedema Angioedema has been reported in patients receiving quinapril (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with quinapril should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.) Clinical Laboratory Test Findings Hematology : (See WARNINGS ) Hyperkalemia : (See PRECAUTIONS ) Creatinine and Blood Urea Nitrogen : Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with quinapril alone.
Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on quinapril alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with quinapril; most often these patients were receiving diuretics with or without digitalis.
Warnings & Cautions for Quinapril
- WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue quinapril as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
Contraindications for Quinapril
Quinapril tablets are 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. Quinapril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS)." Do not co-administer quinapril tablets with aliskiren in patients with diabetes.
Overdosage Information for Quinapril
Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. No specific information is available on the treatment of overdosage with quinapril. The most likely clinical manifestation would be symptoms attributable to severe hypotension.
Laboratory determinations of serum levels of quinapril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of quinapril overdose. No data are available to suggest physiological maneuvers (eg, maneuvers to change pH of the urine) that might accelerate elimination of quinapril and its metabolites. Hemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat.
Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of quinapril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of quinapril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat quinapril overdose by infusion of normal saline solution.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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