Quinapril Hydrochloride

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Overview

What is Quinapril Hydrochloride?

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 CHNO ∙HCl and its structural formula is:

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

Quinapril hydrochloride 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.

What does Quinapril Hydrochloride look like?

What are the available doses of Quinapril Hydrochloride?

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What should I talk to my health care provider before I take Quinapril Hydrochloride?

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How should I use Quinapril Hydrochloride?

Quinapril hydrochloride 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 quinapril hydrochloride.

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.

Quinapril hydrochloride may be used alone or in combination with thiazide diuretics.

What interacts with Quinapril Hydrochloride?

Quinapril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Quinapril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer quinapril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).

Do not co-administer quinapril hydrochloride tablets with aliskiren in patients with diabetes.

What are the warnings of Quinapril Hydrochloride?

Anaphylactoid and Possibly Related Reactions

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

Head and Neck Angioedema

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

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 ).

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

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

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 quinapril hydrochloride tablet treatment in one patient with a history of neutropenia during previous captopril therapy. Available data from clinical trials of quinapril hydrochloride tablets are insufficient to show that, in patients without prior reactions to other ACE inhibitors, quinapril hydrochloride 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 quinapril hydrochloride tablets 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 quinapril hydrochloride tablets, unless they are 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 exposure to quinapril hydrochloride tablets for hypotension, oliguria, and hyperkalemia (see ).

No teratogenic effects of quinapril hydrochloride tablets 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.

What are the precautions of Quinapril Hydrochloride?

General

Impaired renal function

Hyperkalemia

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 ).

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, 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

Pregnancy

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

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 ).

Symptomatic hypotension

Hyperkalemia

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

Neutropenia

Drug Interactions

Concomitant diuretic therapy

As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with quinapril 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 ).

Agents increasing serum potassium

Coadministration of quinapril hydrochloride tablets 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 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.

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)

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 quinapril hydrochloride with other agents showed:

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 m).

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/m 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: mammalian cell point mutation, sister chromatid exchange in cultured mammalian cells, micronucleus test with mice, chromosome aberration with V79 cultured lung cells, and in an 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/m, 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.

What are the side effects of Quinapril Hydrochloride?

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.


		Quinapril HCl(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

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 .

	Quinapril HCl(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

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):

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Metabolism and Nutrition Disorders:

Nervous/Psychiatric:

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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 ).

Clinical Laboratory Test Findings

Hematology

(see )

Hyperkalemia

(see )

Creatinine and Blood Urea Nitrogen

Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with quinapril 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.

What should I look out for while using Quinapril Hydrochloride?

Quinapril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Quinapril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer quinapril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).

Do not co-administer quinapril hydrochloride tablets with aliskiren in patients with diabetes.

What might happen if I take too much Quinapril Hydrochloride?

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.

How should I store and handle Quinapril Hydrochloride?

Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.Quinapril hydrochloride tablets are supplied as follows:5-mg tablets:NDC 59762-5019-1 bottles of 90 tablets10-mg tablets:NDC 59762-5020-1 bottles of 90 tablets20-mg tablets:NDC 59762-5021-1 bottles of 90 tablets40-mg tablets:NDC 59762-5022-1 bottles of 90 tabletsDispense in well-closed containers as defined in the USP.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 quinapril hydrochloride alone resulted in mean increases in potassium of 0.07 mmol/L (see ). 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. Quinapril hydrochloride 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.

Non-Clinical Toxicology

Quinapril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Quinapril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer quinapril hydrochloride tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).

Do not co-administer quinapril hydrochloride tablets with aliskiren in patients with diabetes.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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