Quinapril

Serious side effects have been reported with quinapril. 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 quinapril 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.

Serious side effects have been reported with quinapril 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: Quinapril 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

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

Do not take quinapril 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

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).

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 quinapril. You may need to stop using the medicine for a short time.

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

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

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.

quinapril is available only with your doctor's prescription.

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 quinapril, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to quinapril 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

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 quinapril, 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 quinapril 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 quinapril 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 quinapril 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 quinapril. 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.

• Tell all of your health care providers that you take quinapril. 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 quinapril 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 quinapril. 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

General

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 Quinapril hydrochloride tablets, 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 Quinapril hydrochloride 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 Quinapril hydrochloride tablets may be required.

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

In clinical trials, hyperkalemia (serum potassium ≥5.8 mmol/L) occurred in approximately 2% of patients receiving Quinapril hydrochloride tablets. 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).

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.

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Quinapril hydrochloride 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

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

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).

Caution patients that lightheadedness can occur, especially during the first few days of Quinapril hydrochloride tablet 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.

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

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 Quinapril hydrochloride tablets 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

As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Quinapril hydrochloride tablets. The possibility of hypotensive effects with Quinapril hydrochloride tablets may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with Quinapril hydrochloride tablets. If it is not possible to discontinue the diuretic, the starting dose of Quinapril should be reduced (see DOSAGE AND ADMINISTRATION).

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

Simultaneous administration of tetracycline with Quinapril hydrochloride tablets reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in Quinapril hydrochloride tablets. This interaction should be considered if coprescribing Quinapril hydrochloride and tetracycline or other drugs that interact with magnesium.

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.

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.

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.

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

Drug interaction studies of Quinapril hydrochloride with other agents showed:

• Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of Quinapril hydrochloride tablets.
• The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by Quinapril coadministration twice-daily.
• Quinapril hydrochloride tablet treatment did not affect the pharmacokinetics of digoxin.
• No pharmacokinetic interaction was observed when single doses of Quinapril hydrochloride and hydrochlorothiazide were administered concomitantly.
• Co-administration of multiple 10 mg doses of atorvastatin with 80 mg of Quinapril hydrochloride 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 Quinapril hydrochloride tablets and other agents that affect the RAS.

Do not co-administer aliskiren with Quinapril hydrochloride tablets in patients with diabetes. Avoid concomitant use of aliskiren with Quinapril hydrochloride tablets 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 Quinapril hydrochloride is secreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

Pediatric Use

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 Quinapril hydrochloride tablets, which cross the placenta, from the neonatal circulation is not significantly accelerated by these means.

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

Geriatric Use

Clinical studies of Quinapril hydrochloride tablets 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.

Hypertension

Quinapril hydrochloride tablets have been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril hydrochloride tablets have been evaluated for long-term safety in over 1400 patients treated for 1 year or more.

Adverse experiences were usually mild and transient.

In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.

Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with Quinapril hydrochloride tablets are shown below.

Heart Failure

Quinapril hydrochloride tablets have been evaluated for safety in 1222 Quinapril hydrochloride treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.

Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with Quinapril hydrochloride tablets are shown below.

See PRECAUTIONS, Cough.

Hypertension and/or Heart Failure

Clinical adverse experiences probably, possibly, or definitely related, or of uncertain relationship to therapy occurring in 0.5% to 1.0% (except as noted) of the patients with CHF or hypertension treated with Quinapril hydrochloride tablets (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):

General: back pain, malaise, viral infections, anaphylactoid reaction

Cardiovascular: palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock

Hematology: hemolytic anemia

Gastrointestinal: flatulence, dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia

Metabolism and Nutrition Disorders: hyponatremia

Nervous/Psychiatric: somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia

Integumentary: alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis

Urogenital: urinary tract infection, impotence, acute renal failure, worsening renal failure

Respiratory: eosinophilic pneumonitis

Other: amblyopia, edema, arthralgia, pharyngitis, agranulocytosis, hepatitis, thrombocytopenia

Angioedema

Angioedema has been reported in patients receiving Quinapril hydrochloride tablets (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with Quinapril hydrochloride tablets should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

Clinical Laboratory Test Findings

(see WARNINGS)

(see PRECAUTIONS)

Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with Quinapril hydrochloride tablets alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on Quinapril hydrochloride tablets alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with Quinapril hydrochloride tablets; most often these patients were receiving diuretics with or without digitalis.

1 hour; Peak effect: Antihypertensive: 2 to 4 hours postdose

Time to Peak

Infants and Children <7 years: 1.7 hours (range: 1 to 4 hours) (Blumer 2003)

Adults: Serum: Quinapril: 1 hour; Quinaprilat: ~2 hours

24 hours (chronic dosing)

Half-Life Elimination

Infants and Children <7 years: Quinaprilat: 2.3 hours (Blumer 2003)

Adults: Quinapril: 0.8 hours; Quinaprilat: 3 hours; increases as CrCl decreases

Protein Binding

Quinapril: 97%; Quinaprilat: 97%

A 1 mg/mL quinapril oral suspension may be made with tablets, K-Phos® Neutral (equivalent to 250 mg elemental phosphorus, 13 mEq sodium, and 1.1 mEq potassium per tablet), Bicitra®, and Ora-Sweet SF™. Place ten quinapril 20 mg tablets in an amber plastic prescription bottle (eg, 240 mL). In a separate container, prepare a buffer solution by crushing one K-Phos® Neutral tablet and dissolving it in 100 mL sterile water for irrigation. Add 30 mL of the prepared K-Phos® buffer solution to the quinapril tablets. Shake for at least 2 minutes, then remove cap and allow the concentrate to stand for 15 minutes, then shake the concentrate again for an additional minute. Add 30 mL of Bicitra® and shake for 2 minutes. Add quantity sufficient of Ora-Sweet SF® (~140 mL) to make 200 mL and shake the suspension. Store in amber plastic prescription bottles; label “shake well” and “refrigerate.” Stable for 28 days refrigerated (Freed, 2005).

May lead to false-negative aldosterone/renin ratio (ARR) (Funder 2016)

CrCl greater than 60 mL/min: Initial dose: 10 mg orally once a day
CrCl 30 to 60 mL/min: Initial dose: 5 mg orally once a day
CrCl 10 to 30 mL/min: Initial dose: 2.5 mg orally once a day
CrCl less than 10 mL/min: Data not available

Hemodialysis and peritoneal dialysis: Little effect on the elimination of quinapril