Accupril

Name: Accupril

Do I need a prescription for quinapril?

Yes

What is the dosage for quinapril?

The recommended dose for treating high blood pressure is 10-80 mg a day as a single dose or in two doses every 12 hours. Start at 5 to 20 mg daily. The initial dose for heart failure is 5 mg every 12 hours and the maintenance dose is 20 to 40 mg a day as a single dose or in two divided doses every 12 hours. Quinapril should be taken on an empty stomach because food reduces its absorption.

Actions

  • Prodrug; not pharmacologically active until hydrolyzed in the liver to quinaprilat.1 2 3 47

  • Suppresses the renin-angiotensin-aldosterone system.1 47

Proper Use of Accupril

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these is most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Take all other medicines your doctor has prescribed to treat your condition.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—At first, 10 or 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 to 80 mg per day, taken as a single dose or divided into two doses.
      • Children—Use and dose must be determined by your doctor.
    • For heart failure:
      • Adults—At first, 5 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 to 40 mg per day, divided into two doses.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Accupril Side Effects

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Uses of Accupril

  • It is used to treat high blood pressure.
  • It is used to treat heart failure (weak heart).
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Accupril?

  • If you have an allergy to quinapril or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have ever had a very bad or life-threatening reaction called angioedema. Signs may be swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; unusual hoarseness.
  • If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
  • If you have taken a drug that has sacubitril in it in the last 36 hours.

This is not a list of all drugs or health problems that interact with Accupril.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Accupril) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take Accupril at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Indications and Usage for Accupril

Hypertension

Accupril is 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 Accupril.

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.

Accupril may be used alone or in combination with thiazide diuretics.

Heart Failure

Accupril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.

In using Accupril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that Accupril 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.

Overdosage

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.

PRINCIPAL DISPLAY PANEL - 5 mg Blister Pack

Accupril®
(Quinapril HCl
Tablets)

5 mg

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

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

Pfizer

NDC 0071-0530-23

Accupril®
(Quinapril HCl Tablets)

10 mg*

90 Tablets
Rx only

Uses of Accupril

Accupril is a prescription medication used to treat high blood pressure and congestive heart failure in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Parke-Davis Div of Pfizer Inc

Accupril Precautions

Serious side effects have been reported with Accupril including:

  • Hypotension: excessive perspiration and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
  • Decline in kidney function: Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction.
  • Hyperkalemia: Accupril may lead to increased levels of potassium, which could lead to side effects such as heart arrhythmias (irregular heartbeat) and nausea.
  • Cough: Persistent dry cough has been reported with all ACE inhibitors, and will resolve after discontinuation of therapy.
  • Valvular Stenosis: Those with aortic stenosis (stiffening of the main artery that carries blood away from the heart) might be at risk of decreased blood flow to the rest of the body.
  • Angioedema: Tell your healthcare profession right away if you have signs or symptoms of angioedema, which include:
    • swelling of face, eyes, lips, tongue, larynx and extremities
    • difficulty in swallowing or breathing
    • hoarseness (having difficulty making sounds when trying to speak)
  • Neutropenia: report any sign of infection such as sore throat or fever, which may be a sign of neutropenia (a decreased amount of white blood cells).
  • Edema: report any sign of edema (increase in swelling of the arms or legs), which may be a sign of declining kidney function.
  • Heart failure patients: caution is advised against rapid increases in exercise or physical activity for those who are being treated for heart failure.
  • Intestinal Angioedema: Intestinal angioedema (swelling within the gut) has been reported in patients treated with ACE inhibitors. Report signs and symptoms of intestinal angioedema, including abdominal (stomach-area) pain, with or without nausea or vomiting.
  • Liver failure: This is a rare occurrence. Nevertheless, report any signs or symptoms of hepatic failure, including:
    • yellowing of the skin or eyes
    • nausea
    • vomiting
    • fatigue
    • itching

Accupril can cause dizziness. Do not drive or operate heavy machinery until you know how Accupril affects you.

Do not take Accupril if you are hypersensitive to this product. Signs of a hypersensitivity reaction include:

  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • fainting
  • rash

Accupril Usage

  • Take Accupril exactly as prescribed.
  • Accupril comes in tablet form and is taken once or twice daily.
  • Take Accupril on an empty stomach - one hour before, or two hours after a meal.
  • If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Accupril at the same time.

Accupril Overdose

If you take too much Accupril call your healthcare provider or poison control center, or seek emergency medical attention right away.

Accupril FDA Warning

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Accupril as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Adverse Effects

1-10%

Dizziness (7.7%)

Coughing (4.3%)

Fatigue (2.6%)

Nausea and/or vomiting (2.4%)

Hypotension (2.9%)

Dyspnea (1.9%)

Diarrhea (1.7%)

Headache (1.7%)

Myalgia (1.5%)

Rash (1.4%)

Back pain (1.2%)

<1%

Angioedema

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Accupril dosing information

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day
Maintenance dose: 10 to 20 mg orally twice a day

Usual Adult Dose for Diabetic Nephropathy:

Initial dose: 10 mg orally once a day in patients not on diuretics
Maintenance dose: 20 to 80 mg/day orally, given in 1 to 2 divided doses

Usual Adult Dose for Hypertension:

Initial dose: 10 mg orally once a day in patients not on diuretics
Maintenance dose: 20 to 80 mg/day orally, given in 1 to 2 divided doses

Usual Adult Dose for Left Ventricular Dysfunction:

Initial dose: 10 mg orally once a day in patients not on diuretics
Maintenance dose: 20 to 80 mg/day orally, given in 1 to 2 divided doses

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