Accupril

Name: Accupril

What Is Quinapril (Accupril)?

Quinapril is the generic form of the brand-name medicine Accupril, which is used to treat high blood pressure and heart failure.

Lowering your blood pressure can reduce your risk of having a heart attack, a stroke, or another heart complication.

This prescription medicine belongs to a class of drugs called angiotensin-converting enzyme (ACE) inhibitors. It works by helping to relax your arteries.

The U.S. Food and Drug Administration (FDA) approved quinapril in 1991. It's marketed as Accupril by Pfizer.

Quinapril Warnings

Tell your healthcare provider you're using quinapril before having any type of medical test or surgery, including a dental procedure.

Before taking quinapril, tell your doctor if you have, or have ever had:

  • Heart disease, heart failure, a heart attack, or other heart problems
  • Kidney disease or a kidney transplant
  • Stroke
  • Liver disease
  • Diabetes
  • Lupus (an autoimmune disease characterized by inflammation and a variety of symptoms)
  • Scleroderma (a skin condition)
  • Rheumatoid arthritis
  • An electrolyte imbalance
  • Bone marrow problems
  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs)
  • Allergies to medication (especially ACE inhibitors)

Also, let your doctor know if you have diabetes and are taking the medicine Tekturna or Amturnide (aliskiren).

Quinapril could affect your blood sugar levels if you have diabetes. Be sure to monitor your condition carefully.

Excessive sweating, vomiting, diarrhea, or dehydration can increase your risk of low blood pressure. Tell your doctor if you experience any of these conditions.

Use caution when exercising or experiencing hot weather while taking quinapril.

This drug may cause you to sunburn more easily. Try to avoid unnecessary sun exposure, and wear sunscreen and protective clothing while outdoors.

Quinapril may be less effective and increase the risk of angioedema in people of African descent. Talk to your doctor if this is a concern.

Your doctor may recommend following a diet and exercise plan while using quinapril. You may also be told to drink more fluids. Follow these instructions carefully.

Don't take potassium or use salt substitutes while taking quinapril unless your doctor tells you to do so.

Keep all appointments with your doctor and laboratory while taking this medicine. You'll need to undergo frequent tests, including blood pressure checks.

Pregnancy and Quinapril

Quinapril contains a black box warning because it may cause harm or death in an unborn baby if taken during pregnancy.

Tell your doctor right away if you think you're pregnant while taking this medicine.

Use an effective form of birth control while using quinapril.

Quinapril passes into breast milk. Don't breastfeed a baby while using this drug.

What else should I know about quinapril?

What preparations of quinapril are available?

Tablets: 5, 10, 20 and 40 mg

How should I keep quinapril stored?

Tablets and solutions should be stored at room temperature 15 C to 30 C (59 F to 86 F).

What is the most important information I should know about quinapril?

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use quinapril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

What should I discuss with my healthcare provider before taking quinapril?

You should not use this medicine if you are allergic to quinapril or to any other ACE inhibitor, such as benazepril, captopril, fosinopril, enalapril, lisinopril, moexipril, perindopril, ramipril, or trandolapril.

If you have diabetes, do not use quinapril together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking quinapril with aliskiren if you have kidney disease.

To make sure quinapril is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);

  • liver disease;

  • a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis;

  • any history of circulation problems, heart disease, heart attack, or stroke;

  • if you also take a diuretic or "water pill"; or

  • if you are on a low-salt diet.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Quinapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

Quinapril can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Uses For Accupril

Quinapril is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of stroke and heart attacks.

Quinapril is an angiotensin converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, quinapril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Quinapril is also used to treat heart failure or may be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Precautions While Using Accupril

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

You should not use this medicine together with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, swelling of the face, fingers, or lower legs, weight gain, or increased blood pressure. These could be symptoms of a serious kidney problem.

Check with your doctor if you have a fever, chills, or sore throat. These may be symptoms of an infection resulting from low white blood cells.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium..

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

This medicine may be less effective in black patients. Black patients also have an increased risk of swelling of the hands, arms, face, mouth, or throat. Talk with your doctor if you have concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Accupril, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Accupril (quinapril). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Accupril.

Review Date: October 4, 2017

Accupril - Clinical Pharmacology

Mechanism of Action

Quinapril is deesterified to the principal metabolite, quinaprilat, which is an inhibitor of ACE activity in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor, angiotensin II. The effect of quinapril in hypertension and in congestive heart failure (CHF) appears to result primarily from the inhibition of circulating and tissue ACE activity, thereby reducing angiotensin II formation. Quinapril inhibits the elevation in blood pressure caused by intravenously administered angiotensin I, but has no effect on the pressor response to angiotensin II, norepinephrine or epinephrine. Angiotensin II also stimulates the secretion of aldosterone from the adrenal cortex, thereby facilitating renal sodium and fluid reabsorption. Reduced aldosterone secretion by quinapril may result in a small increase in serum potassium. In controlled hypertension trials, treatment with Accupril alone resulted in mean increases in potassium of 0.07 mmol/L (see PRECAUTIONS). Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity (PRA).

While the principal mechanism of antihypertensive effect is thought to be through the renin-angiotensin-aldosterone system, quinapril exerts antihypertensive actions even in patients with low renin hypertension. Accupril was an effective antihypertensive in all races studied, although it was somewhat less effective in blacks (usually a predominantly low renin group) than in nonblacks. ACE is identical to kininase II, an enzyme that degrades bradykinin, a potent peptide vasodilator; whether increased levels of bradykinin play a role in the therapeutic effect of quinapril remains to be elucidated.

Pharmacokinetics and Metabolism

Following oral administration, peak plasma quinapril concentrations are observed within one hour. Based on recovery of quinapril and its metabolites in urine, the extent of absorption is at least 60%. The rate and extent of quinapril absorption are diminished moderately (approximately 25–30%) when Accupril tablets are administered during a high-fat meal. Following absorption, quinapril is deesterified to its major active metabolite, quinaprilat (about 38% of oral dose), and to other minor inactive metabolites. Following multiple oral dosing of Accupril, there is an effective accumulation half-life of quinaprilat of approximately 3 hours, and peak plasma quinaprilat concentrations are observed approximately 2 hours post-dose. Quinaprilat is eliminated primarily by renal excretion, up to 96% of an IV dose, and has an elimination half-life in plasma of approximately 2 hours and a prolonged terminal phase with a half-life of 25 hours. The pharmacokinetics of quinapril and quinaprilat are linear over a single-dose range of 5–80 mg doses and 40–160 mg in multiple daily doses. Approximately 97% of either quinapril or quinaprilat circulating in plasma is bound to proteins.

In patients with renal insufficiency, the elimination half-life of quinaprilat increases as creatinine clearance decreases. There is a linear correlation between plasma quinaprilat clearance and creatinine clearance. In patients with end-stage renal disease, chronic hemodialysis or continuous ambulatory peritoneal dialysis has little effect on the elimination of quinapril and quinaprilat. Elimination of quinaprilat may be reduced in elderly patients (≥65 years) and in those with heart failure; this reduction is attributable to decrease in renal function (see DOSAGE AND ADMINISTRATION). Quinaprilat concentrations are reduced in patients with alcoholic cirrhosis due to impaired deesterification of quinapril. Studies in rats indicate that quinapril and its metabolites do not cross the blood-brain barrier.

Pharmacodynamics and Clinical Effects

Hypertension

Single doses of 20 mg of Accupril provide over 80% inhibition of plasma ACE for 24 hours. Inhibition of the pressor response to angiotensin I is shorter-lived, with a 20 mg dose giving 75% inhibition for about 4 hours, 50% inhibition for about 8 hours, and 20% inhibition at 24 hours. With chronic dosing, however, there is substantial inhibition of angiotensin II levels at 24 hours by doses of 20–80 mg.

Administration of 10 to 80 mg of Accupril to patients with mild to severe hypertension results in a reduction of sitting and standing blood pressure to about the same extent with minimal effect on heart rate. Symptomatic postural hypotension is infrequent although it can occur in patients who are salt-and/or volume-depleted (see WARNINGS). Antihypertensive activity commences within 1 hour with peak effects usually achieved by 2 to 4 hours after dosing. During chronic therapy, most of the blood pressure lowering effect of a given dose is obtained in 1–2 weeks. In multiple-dose studies, 10–80 mg per day in single or divided doses lowered systolic and diastolic blood pressure throughout the dosing interval, with a trough effect of about 5–11/3–7 mm Hg. The trough effect represents about 50% of the peak effect. While the dose-response relationship is relatively flat, doses of 40–80 mg were somewhat more effective at trough than 10–20 mg, and twice daily dosing tended to give a somewhat lower trough blood pressure than once daily dosing with the same total dose. The antihypertensive effect of Accupril continues during long-term therapy, with no evidence of loss of effectiveness.

Hemodynamic assessments in patients with hypertension indicate that blood pressure reduction produced by quinapril is accompanied by a reduction in total peripheral resistance and renal vascular resistance with little or no change in heart rate, cardiac index, renal blood flow, glomerular filtration rate, or filtration fraction.

Use of Accupril with a thiazide diuretic gives a blood-pressure lowering effect greater than that seen with either agent alone.

In patients with hypertension, Accupril 10–40 mg was similar in effectiveness to captopril, enalapril, propranolol, and thiazide diuretics.

Therapeutic effects appear to be the same for elderly (≥65 years of age) and younger adult patients given the same daily dosages, with no increase in adverse events in elderly patients.

Heart Failure

In a placebo-controlled trial involving patients with congestive heart failure treated with digitalis and diuretics, parenteral quinaprilat, the active metabolite of quinapril, reduced pulmonary capillary wedge pressure and systemic vascular resistance and increased cardiac output/index. Similar favorable hemodynamic effects were seen with oral quinapril in baseline-controlled trials, and such effects appeared to be maintained during chronic oral quinapril therapy. Quinapril reduced renal hepatic vascular resistance and increased renal and hepatic blood flow with glomerular filtration rate remaining unchanged.

A significant dose response relationship for improvement in maximal exercise tolerance has been observed with Accupril therapy. Beneficial effects on the severity of heart failure as measured by New York Heart Association (NYHA) classification and Quality of Life and on symptoms of dyspnea, fatigue, and edema were evident after 6 months in a double-blind, placebo-controlled study. Favorable effects were maintained for up to two years of open label therapy. The effects of quinapril on long-term mortality in heart failure have not been evaluated.

Warnings

Anaphylactoid and Possibly Related Reactions

Presumably because ACE inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Accupril) may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema

Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors and has been seen in 0.1% of patients receiving Accupril.

In two similarly sized U.S. postmarketing trials that, combined, enrolled over 3,000 black patients and over 19,000 non-blacks, angioedema was reported in 0.30% and 0.55% of blacks (in study 1 and 2 respectively) and 0.39% and 0.17% of non-blacks.

Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with Accupril should be discontinued immediately, the patient treated in accordance with accepted medical care, and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, emergency therapy including, but not limited to, subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be promptly administered (see ADVERSE REACTIONS).

Patients taking concomitant mammalian target of rapamycin (mTOR) inhibitor (e.g., temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

Intestinal Angioedema

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Patients with a history of angioedema

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see also CONTRAINDICATIONS).

Anaphylactoid reactions during desensitization

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.

Anaphylactoid reactions during membrane exposure

Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

Hepatic Failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Hypotension

Excessive hypotension is rare in patients with uncomplicated hypertension treated with Accupril alone. Patients with heart failure given Accupril commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. Caution should be observed when initiating therapy in patients with heart failure (see DOSAGE AND ADMINISTRATION). In controlled studies, syncope was observed in 0.4% of patients (N=3203); this incidence was similar to that observed for captopril (1%) and enalapril (0.8%).

Patients at risk of excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include patients with the following conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients with heart failure), reduce the diuretic dose or cautiously increase salt intake (except in patients with heart failure) before initiating therapy with Accupril in patients at risk for excessive hypotension who are able to tolerate such adjustments.

In patients at risk of excessive hypotension, therapy with Accupril should be started under close medical supervision. Such patients should be followed closely for the first two weeks of treatment and whenever the dose of Accupril and/or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident.

If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of Accupril, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of Accupril or concomitant diuretic may be necessary.

Neutropenia/Agranulocytosis

Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease, such as systemic lupus erythematosus or scleroderma. Agranulocytosis did occur during Accupril treatment in one patient with a history of neutropenia during previous captopril therapy. Available data from clinical trials of Accupril are insufficient to show that, in patients without prior reactions to other ACE inhibitors, Accupril does not cause agranulocytosis at similar rates. As with other ACE inhibitors, periodic monitoring of white blood cell counts in patients with collagen vascular disease and/or renal disease should be considered.

Fetal Toxicity

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Accupril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Accupril, unless it is considered life-saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Accupril for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS, Pediatric Use). No teratogenic effects of Accupril were seen in studies of pregnant rats and rabbits. On a mg/kg basis, the doses used were up to 180 times (in rats) and one time (in rabbits) the maximum recommended human dose.

Accupril Dosage and Administration

Hypertension

Monotherapy

The recommended initial dosage of Accupril in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2–6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40–80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.

Concomitant Diuretics

If blood pressure is not adequately controlled with Accupril monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of Accupril. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with Accupril (see WARNINGS). Then, if blood pressure is not controlled with Accupril alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg Accupril should be used with careful medical supervision for several hours and until blood pressure has stabilized.

The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS, and Drug Interactions).

Renal Impairment

Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows:

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 for dosage recommendation

Patients should subsequently have their dosage titrated (as described above) to the optimal response.

Elderly (≥65 years)

The recommended initial dosage of Accupril in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response.

Heart Failure

Accupril is indicated as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. The recommended starting dose is 5 mg twice daily. This dose may improve symptoms of heart failure, but increases in exercise duration have generally required higher doses. Therefore, if the initial dosage of Accupril is well tolerated, patients should then be titrated at weekly intervals until an effective dose, usually 20 to 40 mg daily given in two equally divided doses, is reached or undesirable hypotension, orthostatis, or azotemia (see WARNINGS) prohibit reaching this dose.

Following the initial dose of Accupril, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostatis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostatis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.

DOSE ADJUSTMENTS IN PATIENTS WITH HEART FAILURE AND RENAL IMPAIRMENT OR HYPONATREMIA

Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with heart failure and renal impairment, the recommended initial dose of Accupril is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients with a creatinine clearance less than 10 mL/min (see DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS, and PRECAUTIONS, Drug Interactions).

If the initial dose is well tolerated, Accupril may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack

Accupril®
(Quinapril HCl
Tablets)

10 mg

DISTRIBUTED BY:
PARKE-DAVIS
DIV OF PFIZER INC, NY, NY 10017
MADE IN IRELAND

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack

Accupril®
(Quinapril HCl
Tablets)

20 mg

DISTRIBUTED BY:
PARKE-DAVIS
DIV OF PFIZER INC, NY, NY 10017
MADE IN IRELAND

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

Pfizer

NDC 0071-0535-23

Accupril®
(Quinapril HCl Tablets)

40 mg*

90 Tablets
Rx only

Accupril 
quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0071-0527
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX  
CROSPOVIDONE (15 MPA.S AT 5%)  
GELATIN, UNSPECIFIED  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM CARBONATE  
MAGNESIUM STEARATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code PD;527;5
Contains     
Packaging
# Item Code Package Description
1 NDC:0071-0527-23 90 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0071-0527-40 100 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019885 11/19/1991
Accupril 
quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0071-0530
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 10 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX  
CROSPOVIDONE (15 MPA.S AT 5%)  
GELATIN, UNSPECIFIED  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM CARBONATE  
MAGNESIUM STEARATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN Score no score
Shape TRIANGLE Size 10mm
Flavor Imprint Code PD;530;10
Contains     
Packaging
# Item Code Package Description
1 NDC:0071-0530-23 90 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0071-0530-40 100 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019885 11/19/1991
Accupril 
quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0071-0532
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 20 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX  
CROSPOVIDONE (15 MPA.S AT 5%)  
GELATIN, UNSPECIFIED  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM CARBONATE  
MAGNESIUM STEARATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 9mm
Flavor Imprint Code PD;532;20
Contains     
Packaging
# Item Code Package Description
1 NDC:0071-0532-23 90 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0071-0532-40 100 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019885 11/19/1991
Accupril 
quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0071-0535
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 40 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX  
CROSPOVIDONE (15 MPA.S AT 5%)  
GELATIN, UNSPECIFIED  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM CARBONATE  
MAGNESIUM STEARATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 15mm
Flavor Imprint Code PD;535;40
Contains     
Packaging
# Item Code Package Description
1 NDC:0071-0535-23 90 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019885 11/19/1991
Labeler - Parke-Davis Div of Pfizer Inc (829076962)
Registrant - Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 ANALYSIS(0071-0527, 0071-0530, 0071-0532, 0071-0535), MANUFACTURE(0071-0527, 0071-0530, 0071-0532, 0071-0535), PACK(0071-0527, 0071-0530, 0071-0532, 0071-0535)
Revised: 07/2017   Parke-Davis Div of Pfizer Inc

Accupril Overview

Accupril is a prescription medication used to treat high blood pressure and congestive heart failure. Accupril belongs to a group of drugs called angiotensin converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient.

This medication comes in tablet form and is taken once or twice daily. It should be taken on an empty stomach - one hour before, or two hours after a meal.

Common side effects of Accupril include headache, fatigue, and cough. Accupril may cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Side Effects of Accupril

Serious side effects have been reported with Accupril. See “Drug Precautions” section.

Common side effects include:

  • headache
  • fatigue
  • dizziness
  • cough
  • extremely low blood pressure
  • nausea
  • vomiting
  • stomach pain

This is not a complete list of Accupril side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Inform MD

Before taking Accupril, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have a history of angioedema (swelling under the skin)
  • have diabetes (high blood sugar) and you are taking aliskiren (Tekturna; also in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take Accupril if you have diabetes and you are also taking aliskiren.
  • have or have ever had heart or kidney disease or diabetes
  • have liver disease
  • are having surgery, including dental surgery. Inform the doctor or dentist that you are taking Accupril.
  • are using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these instructions carefully.
  • pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 20mg
  • 40mg

Hypertension

Initial: 10-20 mg PO qDay; may administer 5 mg in patients receiving diuretic therapy if the diuretic is continued

Maintenance: 20-80 mg PO qDay or divided q12hr

Congestive Heart Failure

Initial: 5 mg PO q12hr

Maintenance: 20-40 mg PO qDay or divided q12hr

Diabetic Nephropathy (Off-Label)

Slows rate of progression of renal disease in patients with HTN, DM, and microalbuminuria

Initial: 10-20 mg PO qDay

Maintenance: 20-80 mg PO qDay or divided q12hr

Dosage Modification

Renal impairment with hypertension

  • CrCl >60 mL/min: 10 mg/day
  • CrCl 30-60 mL/min: 5 mg/day
  • CrCl 10-30 mL/min: 2.5 mg/day
  • CrCl <10 mL/min: Insufficient data

Renal impairment with CHF

  • CrCl >30 mL/min: 5 mg/day
  • CrCl 10-30 mL/min: 2.5 mg/day
  • CrCl <10 mL/min: Insufficient data

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
  • 20mg
  • 40mg

Hypertension (Off-label)

5-10 mg PO qDay initially

2.5-5 mg/day initially; increase dose by increments of 2.5-5 mg at 1-2 week intervals; adjust for renal impairment

Patient Handout

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Before taking this medicine

You should not use Accupril if you are allergic to quinapril or to any other ACE inhibitor, such as benazepril, captopril, fosinopril, enalapril, lisinopril, moexipril, perindopril, ramipril, or trandolapril.

You may also need to avoid taking quinapril with aliskiren if you have kidney disease.

To make sure Accupril is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);

  • liver disease;

  • a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis;

  • any history of circulation problems, heart disease, heart attack, or stroke;

  • if you also take a diuretic or "water pill"; or

  • if you are on a low-salt diet.

Do not use Accupril if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Accupril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

Quinapril can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid?

Do not use salt substitutes or potassium supplements while taking Accupril, unless your doctor has told you to.

Drinking alcohol with this medicine can cause side effects.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

In Summary

More frequent side effects include: cough. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to quinapril: oral tablet

Along with its needed effects, quinapril (the active ingredient contained in Accupril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking quinapril:

Less common
  • Blurred vision
  • chest pain
  • confusion
  • diarrhea
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • nausea
  • stomach pain
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
Rare
  • Bleeding gums
  • cold, clammy skin
  • enlarged pupils
  • fast or slow heartbeat
  • increased sensitivity of the skin or eyes to sunlight
  • stiff or sore neck

Some side effects of quinapril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
Less common
  • Back pain
  • coughing
  • difficulty with moving
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • rash
  • swollen joints

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