Quinapril 10 mg/1
Quinapril · TABLET · Proficient Rx LP
Quinapril is a tablet containing quinapril at 10 mg/1, taken oral. Manufactured by Proficient Rx LP.
Key Facts
- Brand Name
- Quinapril
- Generic Name
- Quinapril
- NDC Code (Product)
63187-425- Manufacturer
- Proficient Rx LP
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078457
- Marketing Start
- 01/20/2012
Recall History
Pfizer Inc.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Aidapak Services, LLC
Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Lupin Pharmaceuticals Inc.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Pfizer Inc.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Pfizer Inc.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Pfizer Inc.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Pfizer Inc.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Pfizer Inc.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Aidapak Services, LLC
Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hypertension Quinapril tablets are 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. 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 acti…
Dosage & Administration
DOSAGE AND ADMINISTRATION Hypertension Monotherapy: 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 (2–6 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 40–80 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. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy wit…
Warnings
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue quinapril as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
Contraindications
CONTRAINDICATIONS Quinapril 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 tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS)." Do not co-administer quinapril tablets with aliskiren in patients with diabetes.
Adverse Reactions
ADVERSE REACTIONS Hypertension Quinapril has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril 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 quinapril are shown below. Adverse Events in Placebo-Controlled Trials Quinapril Placebo (N=1563) (N=579) Incidence Incidence (Discontinuance) (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 has been evaluated for safety in 1222 quinapril treated patients. Of these, 632 patients participated in controlled clinical trials. In place…
Frequently Asked Questions
What is Quinapril used for?
Quinapril contains Quinapril. It is a tablet taken oral. Consult your doctor for specific uses.
Is Quinapril a controlled substance?
Quinapril is not classified as a controlled substance by the DEA.
What is the generic name for Quinapril?
The generic name for Quinapril is Quinapril. There are 4 other brand versions of Quinapril.
What is the NDC code for Quinapril 10 mg/1?
The NDC (National Drug Code) for Quinapril 10 mg/1 is 63187-425, listed by Proficient Rx LP.