Quinapril and Hydrochlorothiazide 12.5 mg/1
Quinapril and Hydrochlorothiazide · TABLET · Chartwell RX, LLC
Quinapril and Hydrochlorothiazide is a tablet containing quinapril and hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Quinapril and Hydrochlorothiazide
- Generic Name
- Quinapril and Hydrochlorothiazide
- NDC Code (Product)
62135-667- Manufacturer
- Chartwell RX, LLC
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076374
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 03/31/2004
Recall History
Pfizer Inc.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Aurobindo Pharma USA Inc.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
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 and hydrochlorothiazide tablets, USP 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 and hydrochlorothiazide 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 pharm…
Dosage & Administration
DOSAGE AND ADMINISTRATION As individual monotherapy, quinapril is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg and hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg. In clinical trials of quinapril and hydrochlorothiazide combination therapy using quinapril doses of 2.5 mg to 40 mg and hydrochlorothiazide doses of 6.25 mg to 25 mg, the antihypertensive effects increased with increasing dose of either component. The side effects (see WARNINGS ) of quinapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of quinapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens that combine low doses of hydrochlorothiazide with quinapril produce minimal effects on serum potassium. In clinical trials of quinapril and hydrochlorothiazide tablets, the average change in serum potassium was near zero in subjects who received HCTZ 6.25 mg in the combination, and the average subj…
Warnings
WARNINGS Anaphylactoid and Possibly Related Reactions: Presumably because angiotensin converting inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including quinapril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors and has been seen in 0.1% of patients receiving quinapril. In two similarly sized US postmarketing quinapril trials that, combined, enrolled over 3,000 black patients and over 19,000 non-blacks, angioedema was reported in 0.30% and 0.55% of blacks (in Study 1 and 2, respectively) and 0.39% and 0.17% of non-blacks. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with quinapril and hydrochlorothiazide tablets should be discontinued immediately, the patient treated in accordance with accepted medical care, and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, th…
Contraindications
CONTRAINDICATIONS Quinapril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril and hydrochlorothiazide tablets is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril and hydrochlorothiazide tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS). Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer quinapril and hydrochlorothiazide with aliskiren: in patients with diabetes.
Adverse Reactions
ADVERSE REACTIONS Quinapril and hydrochlorothiazide tablets have been evaluated for safety in 1571 patients in controlled and uncontrolled studies. Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years. In clinical trials with quinapril and hydrochlorothiazide tablets, no adverse experience specific to the combination has been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide. Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies. The most common reasons for discontinuation of therapy with quinapril and hydrochlorothiazide tablets were cough (1.0%; see PRECAUTIONS ) and headache (0.7%). Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials a…
Frequently Asked Questions
What is Quinapril and Hydrochlorothiazide used for?
Quinapril and Hydrochlorothiazide contains Quinapril and Hydrochlorothiazide. It is a tablet taken oral. Consult your doctor for specific uses.
Is Quinapril and Hydrochlorothiazide a controlled substance?
Quinapril and Hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for Quinapril and Hydrochlorothiazide?
The generic name for Quinapril and Hydrochlorothiazide is Quinapril and Hydrochlorothiazide. There are 3 other brand versions of Quinapril and Hydrochlorothiazide.
What is the NDC code for Quinapril and Hydrochlorothiazide 12.5 mg/1?
The NDC (National Drug Code) for Quinapril and Hydrochlorothiazide 12.5 mg/1 is 62135-667, listed by Chartwell RX, LLC.