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Quinapril Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Quinapril safely and effectively. Before taking Quinapril please consult with your doctor. See full prescribing information for Quinapril.

Warning

USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, quinapril tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Indications And Usage

Hypertension: Quinapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. 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 does 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.

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Dosage And Administration

Creatinine Clearance Maximum Recommended Initial Dose
>60 mL/min 10 mg
30-60 mL/min 5 mg
10-30 mL/min 2.5 mg
<10 mL/min Insufficient data fordosage recommendation

Contraindications

Quinapril 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.

Adverse Reactions

Hypertension: Quinapril has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril has been evaluated for long-term safety in over 1400 patients treated for 1 year or more. Adverse experiences were usually mild and transient. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension. Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril hydrochloride are shown below. Adverse Events in Placebo-Controlled Trials Quinapril Hydrochloride (N=1563) Incidence (Discontinuance) Placebo (N=579) Incidence (Discontinuance) Headache 5.6 (0.7) 10.9 (0.7) Dizziness 3.9 (0.8) 2.6 (0.2) Fatigue 2.6 (0.3) 1.0 Coughing 2.0 (0.5) 0.0 Nausea and/or Vomiting 1.4 (0.3) 1.9 (0.2) Abdominal Pain 1.0 (0.2) 0.7 Hypertension: 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 hypertension treated with quinapril hydrochloride (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 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 Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality. 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.

Drug Interactions

Drug Interactions: Concomitant diuretic therapy: As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with quinapril. The possibility of hypotensive effects with quinapril may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with quinapril. If it is not possible to discontinue the diuretic, the starting dose of quinapril should be reduced (see DOSAGE AND ADMINISTRATION ). Agents increasing serum potassium: Quinapril can attenuate potassium loss caused by thiazide diuretics and increase serum potassium when used alone. If concomitant therapy of quinapril with potassium-sparing diuretics (eg, spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes is indicated, they should be used with caution along with appropriate monitoring of serum potassium (see PRECAUTIONS ). Tetracycline and other drugs that interact with magnesium: Simultaneous administration of tetracycline with quinapril reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in quinapril tablets. This interaction should be considered if coprescribing quinapril and tetracycline or other drugs that interact with magnesium. Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be coadministered with caution and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, it may increase the risk of lithium toxicity. Gold: 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. Other agents: Drug interaction studies of quinapril with other agents showed: Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of quinapril. The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by quinapril coadministration twice-daily. Quinapril treatment did not affect the pharmacokinetics of digoxin. No pharmacokinetic interaction was observed when single doses of quinapril and hydrochlorothiazide were administered concomitantly. Co-administration of multiple 10 mg doses of atorvastatin with 80 mg of quinapril resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

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