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Quinapril (Quinapril Hydrochloride) - Indications and Dosage




Quinapril tablets USP 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 tablets USP.

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 or diabetic kidney disease). These considerations may guide selection of therapy.

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

In using quinapril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets does not have a similar risk (see WARNINGS).

Angioedema in Black Patients

Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.




The recommended initial dosage of quinapril in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2 to 6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40 to 80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.

Concomitant Diuretics

If blood pressure is not adequately controlled with quinapril monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril tablets (see WARNINGS). Then, if blood pressure is not controlled with quinapril tablets alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril should be used with careful medical supervision for several hours and until blood pressure has stabilized.

The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS, and Drug Interactions).

Renal Impairment

Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows:

Maximum Recommended
Initial Dose

>60 mL/min

10 mg

30-60 mL/min

5 mg

10-30 mL/min

2.5 mg

<10 mL/min

Insufficient data for
dosage recommendation

Patients should subsequently have their dosage titrated (as described above) to the optimal response.

Elderly (≥65 years)

The recommended initial dosage of quinapril tablets in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response.

Following the initial dose of quinapril tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostasis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostasis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.


Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with heart failure and renal impairment, the recommended initial dose of quinapril is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients, with a creatinine clearance less than 10 mL/min. (See WARNINGS, and PRECAUTIONS, Drug Interactions).

If the initial dose is well tolerated, quinapril may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.


Quinapril tablets USP are supplied as follows:

5-mg tablets: Yellow colored, oval shaped, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘F01’ on the other side.

NDC 68001-189-05               bottles of 90 tablets

10-mg tablets: Yellow colored, circular shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F02’ on the other side.

NDC 68001-188-05               bottles of 90 tablets

20-mg tablets: Yellow colored, round shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F03’ on the other side.

NDC 68001-187-05               bottles of 90 tablets

40-mg tablets: Yellow colored, elliptical shaped, film-coated biconvex tablets, debossed with ‘LU’ on one side and ‘F04’ on the other side.

NDC 68001-186-05               bottles of 90 tablets

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

40-mg tablets: Yellow colored, round shaped, beveled edge film-coated biconvex tablets, debossed with ‘LU’ on one side and ‘F04’ on the other side.

NDC 68001-260-05 bottles of 90 tablets

Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Manufactured By:

Lupin Limited

Goa 403 722


For BluePoint Laboratories

Rev.: 08/14

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