| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 10MG BASE | No | No |
| 002 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 12.5MG;EQ 20MG BASE | No | No |
| 003 | QUINARETIC | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | 25MG;EQ 20MG BASE | No | No |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076374-001 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET / ORAL | AB | 2004-03-31 | |
| A076374-002 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 | |
| A076374-003 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE | TABLET / ORAL | AB | 2004-03-31 |
| Application-product | TE code |
|---|---|
| A076374-001 | AB |
| A076374-002 | AB |
| A076374-003 | AB |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Quinapril HCL and Hydrochlorothiazide | QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals,Inc. | 383ecaa6-29c8-4280-a442-c47f101d7c88 | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | |
| Quinapril and Hydrochlorothiazide | QUINAPRIL AND HYDROCHLOROTHIAZIDE | Chartwell RX, LLC | 2eae533f-d0af-47e8-a1f2-94bc8cc89b5a | 2023-12-11 | Boxed warning, Warnings, Adverse reactions |
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WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Quinapril and Hydrochlorothiazide Tablets 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
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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, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx likely to cause airway obstruction, emergency therapy including, but not limited to, subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ). Patients taking concomitant mammalian target of rapamycin (mTOR inhibitor) (e.g., temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema. 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 angio...
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ADVERSE REACTIONS Quinapril and Hydrochlorothiazide Tablets has 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 are shown below. Percent of Patients in Controlled Trials Quinapril/HCTZ N = 943 Placebo N = 100 Headache 6.7 30.0 Dizziness 4.8 4.0 Coughing 3.2 2.0 Fatigue 2.9 3.0 Myalgia 2.4 5.0 Viral Infection 1.9 4.0 Rhinitis 2.0 3.0 Nausea and/or Vomiting 1.8 6.0 Abdominal Pain 1.7 4.0 Back Pain 1.5 2.0 Diarrhea 1.4 1.0 Upper Respiratory Infection 1.3 4.0 Insomnia 1.2 2.0 Somnolence 1.2 0.0 Bronchitis 1.2 1.0 Dyspepsia 1.2 2.0 Asthenia 1.1 1.0 Pharyngitis 1.1 2.0 Vasodilatation 1.0 1.0 Vertigo 1.0 2.0 Chest Pain 1.0 2.0 Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥0.5% to 0.5%: depression, back pain, constipation, syncope, and amblyopia. Hydrochlorothiazide has been extensively prescribed for many years, but there has not been enough systematic collection of data to support an estimate of the frequency of the observed adverse reactions. Within organ-system groups, the reported reactions are listed here in decreasing order of severity, without regard to frequency BODY AS A WHOLE: Weakness. CARDIOVASCULAR: Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics). DIGESTIVE: Pancreatitis,...
Percent of Patients in Controlled Trials Quinapril/HCTZ N = 943 Placebo N = 100 Headache 6.7 30.0 Dizziness 4.8 4.0 Coughing 3.2 2.0 Fatigue 2.9 3.0 Myalgia 2.4 5.0 Viral Infection 1.9 4.0 Rhinitis 2.0 3.0 Nausea and/or Vomiting 1.8 6.0 Abdominal Pain 1.7 4.0 Back Pain 1.5 2.0 Diarrhea 1.4 1.0 Upper Respiratory Infection 1.3 4.0 Insomnia 1.2 2.0 Somnolence 1.2 0.0 Bronchitis 1.2 1.0 Dyspepsia 1.2 2.0 Asthenia 1.1 1.0 Pharyngitis 1.1 2.0 Vasodilatation 1.0 1.0 Vertigo 1.0 2.0 Chest Pain 1.0 2.0
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43386-710 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCl and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-710 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCl and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-711 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-711 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-712 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-712 | Quinapril HCL and Hydrochlorothiazide | Quinapril HCL and Hydrochlorothiazide | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| Document | Submission type | Date |
|---|---|---|
| 31112 | ORIG | 2004-04-07 |