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Accupril
Overview
What is Accupril?
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 CHNO ∙HCl and its structural formula is:
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.
What does Accupril look like?
What are the available doses of Accupril?
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What should I talk to my health care provider before I take Accupril?
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How should I use Accupril?
ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
ACCUPRIL may be used alone or in combination with thiazide diuretics
What interacts with Accupril?
ACCUPRIL is 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.
ACCUPRIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ACCUPRIL within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).
Do not co-administer ACCUPRIL with aliskiren in patients with diabetes.
What are the warnings of Accupril?
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.
What are the precautions of Accupril?
General
Impaired renal function
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 ).
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 ).
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 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 ).
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)
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:
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 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 ACCUPRIL 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 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.
What are the side effects of Accupril?
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.
| 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.
See .
| 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 |
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:
anaphylactoid reaction
Cardiovascular:
heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock
Hematology:
hemolytic anemia
Gastrointestinal:
gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests
, dyspepsia
Metabolism and Nutrition Disorders:
Nervous/Psychiatric:
Integumentary:
exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis
Urogenital:
acute renal failure, worsening renal failure
Respiratory:
eosinophilic pneumonitis
Other:
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 )
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 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.
What should I look out for while using Accupril?
ACCUPRIL is 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.
ACCUPRIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ACCUPRIL within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).
Do not co-administer ACCUPRIL with aliskiren in patients with diabetes.
What might happen if I take too much Accupril?
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 Accupril?
PROTECT FROM LIGHTKeep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].CAUTION: DEA Order Form Required.PROTECT FROM LIGHTKeep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].CAUTION: DEA Order Form Required.PROTECT FROM LIGHTKeep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].CAUTION: DEA Order Form Required.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.ACCUPRIL tablets are supplied as follows:5-mg tablets:10-mg tablets:20-mg tablets:40-mg tablets:Dispense in well-closed containers as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical 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 ACCUPRIL 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. ACCUPRIL was an effective antihypertensive in all races studied, although it was somewhat less effective in blacks (usually a predominantly low renin group) than in nonblacks. ACE is identical to kininase II, an enzyme that degrades bradykinin, a potent peptide vasodilator; whether increased levels of bradykinin play a role in the therapeutic effect of quinapril remains to be elucidated.
Non-Clinical Toxicology
ACCUPRIL is 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.ACCUPRIL is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ACCUPRIL within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see and ).
Do not co-administer ACCUPRIL with aliskiren in patients with diabetes.
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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