Accupril

Name: Accupril

What brand names are available for quinapril?

Accupril

Is quinapril available as a generic drug?

GENERIC AVAILABLE: Yes

Which drugs or supplements interact with quinapril?

: The use of ACE inhibitors with potassium supplements, salt substitutes or diuretics (for example, spironolactone [Aldactone]) that increase potassium in the blood may lead to excessive potassium levels in the body. Potassium levels should be closely monitored whenever ace inhibitors are use in combination with these drugs.

Patients receiving diuretics or are dehydrated or have low blood sodium may experience excessive reduction in blood pressure when quinapril is started. Stopping the diuretic or increasing salt intake prior to taking quinapril may prevent this excessive reduction in blood pressure. 

There have been reports that aspirin and other nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen (Advil, Children's Advil/Motrin, Medipren, Motrin, Nuprin, PediaCare Fever, etc.), indomethacin (Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ACE inhibitors.

Combining quinapril or other ACE inhibitors with non-steroidal anti-inflammatory drugs (NSAIDs) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.

There have been reports of increased lithium (Eskalith, Lithobid) levels when lithium is used in combination with ACE inhibitors. The reason for this interaction is not known.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) may occur when injectable gold (sodium aurothiomalate), used in the treatment of rheumatoid arthritis, is combined with ACE inhibitors, including quinapril.

Quinapril should not be combined with aliskiren (Tekturna) because the combination of both drugs increases blockade of angiotensin leading to low blood pressure, increased blood potassium, and possible kidney damage.

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Reviewed on 7/30/2014 References Reference: FDA Prescribing Information

What should I avoid while taking quinapril?

Do not use salt substitutes or potassium supplements while taking quinapril, 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.

Quinapril side effects

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • little or no urination;

  • jaundice (yellowing of the skin or eyes);

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or

  • signs of infection--sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms.

Common side effects may include:

  • headache;

  • cough; or

  • dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cautions for Accupril

Contraindications

  • Known hypersensitivity (e.g., history of angioedema) to quinapril or another ACE inhibitor.1 47

Warnings/Precautions

Warnings

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.1 47

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1 47

Hypotension

Possible symptomatic hypotension.1 47 Risk of marked hypotension, sometimes associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death, in patients with heart failure, hyponatremia, or severe volume and/or salt depletion; patients undergoing dialysis; and those receiving diuretic therapy with high doses, recent increase in dosage, or recent intensive diuresis.600 Potential for MI or stroke in patients with ischemic cardiovascular or cerebrovascular disease.1 47

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1 47

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1 47 May minimize potential for hypotension in patients at risk of excessive hypotension by withholding diuretic therapy (except in patients with heart failure), reducing diuretic dosage, and/or cautiously increasing sodium intake (except in patients with heart failure) prior to initiation of quinapril.1 47 600 (See Dosage under Dosage and Administration.)

In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of quinapril or any increase in quinapril or diuretic dosage.1 47

If excessive hypotension occurs, immediately place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride solution.1 47 Quinapril therapy usually can be continued following restoration of volume and BP.1 47 If symptomatic hypotension develops, dosage reduction or discontinuance of quinapril or diuretic may be necessary.1 47

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease.1 47 Data insufficient to rule out similar incidence of agranulocytosis with quinapril.1 47

Consider monitoring leukocytes in patients with collagen vascular disease and/or renal disease.1 47

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 47 65 66 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.66

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.65 66

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.66 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.1 47

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal.1 47 b Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1 47

Intestinal angioedema reported; sometimes occurs in patients with no prior history of facial angioedema.1 b Manifestations include abdominal pain (with or without nausea or vomiting).1 b Consider intestinal angioedema in the differential diagnosis of patients receiving ACE inhibitors presenting with abdominal pain.1 b

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.1 47

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1 47

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.1 47

General Precautions

Renal Effects

Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.1 47 Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.1 47

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe heart failure.1 47

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.1 47 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.1 47

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).1 47 (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.1 47

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.1 47

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.47

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 47 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk.1 47 Caution if used in nursing women.47 3 4

Pediatric Use

Safety and efficacy remain to be fully established in children;1 47 however, some experts have recommended dosages for hypertension based on current limited clinical experience.62

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 47 However, cautious dosing recommended due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.1 47

Renal Impairment

Deterioration of renal function may occur. (See Renal Effects under Cautions.)1 47

Initial dosage adjustment recommended in patients with renal impairment.1 (See Renal Impairment under Dosage and Administration.) Safety and efficacy not established in patients with Clcr <10 mL/minute.1 47

Quinapril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment (Clcr ≤30 mL/minute or Scr >3 mg/dL).47

Hepatic Impairment

Use with caution in patients with hepatic impairment or progressive liver disease.47

Black Patients

BP reduction may be smaller in black patients compared with patients of other races.1 24 25 47 48 49 (See Hypertension under Uses.)

Higher incidence of angioedema reported with ACE inhibitors in black patients compared with other races.1 47 49 500

Common Adverse Effects

Patients with hypertension: Headache, dizziness, fatigue, cough, nausea, vomiting, abdominal pain.1 47 With fixed combination preparation, myalgia, virus infection, rhinitis, back pain, diarrhea, upper respiratory tract infection, insomnia, somnolence, bronchitis, dyspepsia, asthenia, pharyngitis, vasodilation, vertigo, chest pain.47

Patients with heart failure: Dizziness, cough, fatigue, nausea, vomiting, chest pain, hypotension, dyspnea, diarrhea, headache, myalgia, rash, back pain, increased serum creatinine concentration, increased BUN.1

Before Using Accupril

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of quinapril in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quinapril in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose for patients receiving quinapril.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Sacubitril

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alteplase, Recombinant
  • Amiloride
  • Azathioprine
  • Azilsartan
  • Azilsartan Medoxomil
  • Candesartan Cilexetil
  • Canrenoate
  • Eplerenone
  • Eprosartan
  • Everolimus
  • Irbesartan
  • Lithium
  • Losartan
  • Mercaptopurine
  • Olmesartan Medoxomil
  • Potassium
  • Sirolimus
  • Spironolactone
  • Telmisartan
  • Triamterene
  • Trimethoprim
  • Valsartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Azosemide
  • Bromfenac
  • Bufexamac
  • Bumetanide
  • Bupivacaine
  • Bupivacaine Liposome
  • Capsaicin
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Furosemide
  • Gold Sodium Thiomalate
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Nesiritide
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piretanide
  • Piroxicam
  • Proglumetacin
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angioedema (swelling of the face, arms, hands, legs, or throat), history of—May increase the risk of this condition occurring again.
  • Collagen vascular disease (an autoimmune disease) or
  • Kidney disease—Increased risk of blood problems.
  • Congestive heart failure with low blood pressure or
  • Diabetic patients with end organ damage or
  • Hyperkalemia (high potassium in the blood) or
  • Kidney problems, moderate to severe—Patients with these conditions should not use quinapril together with other ACE inhibitors and angiotensin receptor blockers (ARB).
  • Congestive heart failure with low blood pressure or
  • Diabetes or
  • Hyperkalemia (high potassium in the blood)—Patients with these conditions should not use quinapril together with aliskiren (Tekturna®).
  • Electrolyte imbalances (eg, low sodium in the body) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Kidney disease or
  • Liver disease—Use with caution. May make these conditions worse.

What are some things I need to know or do while I take Accupril?

  • Tell all of your health care providers that you take Accupril. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are on dialysis, talk with your doctor.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • If you are taking Accupril and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • This medicine may not work as well in black patients. Talk with the doctor.
  • A very bad reaction called angioedema has happened with Accupril. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Accupril Description

Accupril® (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.

Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is:

M.W.=474.98

Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents.

Accupril tablets contain 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.

Precautions

General

Impaired renal function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Accupril, may be associated with oliguria and/or progressive azotemia and rarely acute renal failure and/or death.

In clinical studies in hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy.

Some patients with hypertension or heart failure with no apparent preexisting renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when Accupril has been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of any diuretic and/or Accupril may be required.

Evaluation of patients with hypertension or heart failure should always include assessment of renal function (see DOSAGE AND ADMINISTRATION).

Hyperkalemia

In clinical trials, hyperkalemia (serum potassium ≥5.8 mmol/L) occurred in approximately 2% of patients receiving Accupril. In most cases, elevated serum potassium levels were isolated values which resolved despite continued therapy. Less than 0.1% of patients discontinued therapy due to hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of other drugs that raise serum potassium levels. Monitor serum potassium in such patients (see PRECAUTIONS, Drug Interactions).

Cough

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent non-productive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.

Surgery/anesthesia

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Accupril will block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Information for Patients

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to Accupril during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.

Angioedema

Angioedema, including laryngeal edema can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients and tell them to immediately report any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician (see WARNINGS).

Symptomatic hypotension

Caution patients that lightheadedness can occur, especially during the first few days of Accupril therapy, and that it should be reported to a physician. If actual syncope occurs, tell patients to temporarily discontinue the drug until they have consulted with their physician (see WARNINGS).

Caution all patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure because of reduction in fluid volume, with the same consequences of lightheadedness and possible syncope.

Tell patients planning to undergo any surgery and/or anesthesia to inform their physician that they are taking an ACE inhibitor.

Hyperkalemia

Tell patients not to use potassium supplements or salt substitutes containing potassium without consulting their physician (see PRECAUTIONS).

Neutropenia

Tell patients to promptly report any indication of infection (eg, sore throat, fever) which could be a sign of neutropenia.

NOTE: As with many other drugs, certain advice to patients being treated with Accupril is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

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 Accupril. The possibility of hypotensive effects with Accupril may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with Accupril. 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

Coadministration of Accupril with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

Tetracycline and other drugs that interact with magnesium

Simultaneous administration of tetracycline with Accupril reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in Accupril tablets. This interaction should be considered if coprescribing Accupril 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.

Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)

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 quinapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving quinapril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including quinapril may be attenuated by NSAIDs.

Agents that inhibit mTOR or other drugs known to cause angioedema

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

Other agents

Drug interaction studies of Accupril with other agents showed:

  • Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of Accupril.
  • The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by quinapril coadministration twice-daily.
  • Accupril treatment did not affect the pharmacokinetics of digoxin.
  • No pharmacokinetic interaction was observed when single doses of Accupril and hydrochlorothiazide were administered concomitantly.
  • Co-administration of multiple 10 mg doses of atorvastatin with 80 mg of Accupril resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Dual Blockade of the Renin-Angiotensin System (RAS)

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. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Accupril and other agents that affect the RAS.

Do not co-administer aliskiren with Accupril in patients with diabetes. Avoid concomitant use of aliskiren with Accupril in patients with renal impairment (GFR<60 mL/min/1.73 m2).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 to 60 times the maximum human daily dose, respectively, on an mg/kg basis and 3.8 to 10 times the maximum human daily dose when based on an mg/m2 basis) for 104 weeks. Female rats given the highest dose level had an increased incidence of mesenteric lymph node hemangiomas and skin/subcutaneous lipomas. Neither quinapril nor quinaprilat were mutagenic in the Ames bacterial assay with or without metabolic activation. Quinapril was also negative in the following genetic toxicology studies: in vitro mammalian cell point mutation, sister chromatid exchange in cultured mammalian cells, micronucleus test with mice, in vitro chromosome aberration with V79 cultured lung cells, and in an in vivo cytogenetic study with rat bone marrow. There were no adverse effects on fertility or reproduction in rats at doses up to 100 mg/kg/day (60 and 10 times the maximum daily human dose when based on mg/kg and mg/m2, respectively).

Nursing Mothers

Because Accupril is secreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

Pediatric Use

Neonates with a history of in utero exposure to Accupril

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Removal of Accupril, which crosses the placenta, from the neonatal circulation is not significantly accelerated by these means.

The safety and effectiveness of Accupril in pediatric patients have not been established.

Geriatric Use

Clinical studies of Accupril did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Elderly patients exhibited increased area under the plasma concentration time curve and peak levels for quinaprilat compared to values observed in younger patients; this appeared to relate to decreased renal function rather than to age itself.

Adverse Reactions

Hypertension

Accupril has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Accupril 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 Accupril are shown below.

Adverse Events in Placebo-Controlled Trials
Accupril
(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

Heart Failure

Accupril has been evaluated for safety in 1222 Accupril 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 Accupril are shown below.

Accupril
(N=585)
Incidence
(Discontinuance)
Placebo
(N=295)
Incidence
(Discontinuance)
Dizziness 7.7 (0.7) 5.1 (1.0)
Coughing 4.3 (0.3) 1.4
Fatigue 2.6 (0.2) 1.4
Nausea and/or Vomiting 2.4 (0.2) 0.7
Chest Pain 2.4 1.0
Hypotension 2.9 (0.5) 1.0
Dyspnea 1.9 (0.2) 2.0
Diarrhea 1.7 1.0
Headache 1.7 1.0 (0.3)
Myalgia 1.5 2.0
Rash 1.4 (0.2) 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 Accupril (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 Accupril (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 Accupril 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 Accupril alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on Accupril 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 Accupril; most often these patients were receiving diuretics with or without digitalis.

How is Accupril Supplied

Accupril tablets are supplied as follows:

5-mg tablets: brown, film-coated, elliptical scored tablets, coded "PD 527"on one side and "5"on the other.
NDC 0071-0527-23 bottles of 90 tablets
NDC 0071-0527-40 10 × 10 unit dose blisters

10-mg tablets: brown, film-coated, triangular tablets, coded "PD 530"on one side and "10"on the other.
NDC 0071-0530-23 bottles of 90 tablets
NDC 0071-0530-40 10 × 10 unit dose blisters

20-mg tablets: brown, film-coated, round tablets, coded "PD 532"on one side and "20"on the other.
NDC 0071-0532-23 bottles of 90 tablets
NDC 0071-0532-40 10 × 10 unit dose blisters

40-mg tablets: brown, film-coated, elliptical tablets, coded "PD 535"on one side and "40"on the other.
NDC 0071-0535-23 bottles of 90 tablets

Dispense in well-closed containers as defined in the USP.

Storage

Store at controlled room temperature 15º–30ºC (59º–86ºF).

Protect from light.

LAB-0215-16.0

July 2017

PRINCIPAL DISPLAY PANEL - 10 mg Carton

UNIT DOSE

Pfizer

NDC 0071-0530-40

Accupril®
(Quinapril HCl Tablets)

10 mg*

For in-institution use only

100 Tablets
Rx only

Accupril Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Accupril, salt substitutes containing potassium should be avoided.

 

Accupril and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Accupril has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Accupril , a choice should be made whether to stop nursing or to stop use of this medication. Determining the importance of the drug to the mother should be considered.

How should I take Accupril?

Take Accupril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of water each day while you are taking this medication.

Your blood pressure will need to be checked often, and you may need frequent blood tests.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking quinapril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

If you need surgery, tell the surgeon ahead of time that you are using Accupril. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using Accupril even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Administrative Information

LactMed Record Number

234

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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