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Quinapril Hydrochloride/Hydrochlorothiazide
Overview
What is Quinapril Hydrochloride/Hydrochlorothiazide?
Quinapril and hydrochlorothiazide tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide.
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 molecular formula is CHNO. HCl and its structural formula is:
Quinapril hydrochloride USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents.
Hydrochlorothiazide is chemically described as: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is CHClNOSand its structural formula is:
Hydrochlorothiazide USP is a white to off-white, crystalline powder which is slightly soluble in water but freely soluble in sodium hydroxide solution.
Quinapril and hydrochlorothiazide tablets, USP are available for oral use as fixed combination tablets in three strengths of quinapril with hydrochlorothiazide: 10 mg with 12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20 mg with 25 mg (quinapril and hydrochlorothiazide20/25). The strength of the quinapril hydrochloride component is in terms of quinapril. Inactive ingredients: lactose monohydrate, magnesium carbonate, crospovidone, povidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol 400, titanium dioxide, iron oxide red and iron oxide yellow.
What does Quinapril Hydrochloride/Hydrochlorothiazide look like?
What are the available doses of Quinapril Hydrochloride/Hydrochlorothiazide?
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What should I talk to my health care provider before I take Quinapril Hydrochloride/Hydrochlorothiazide?
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How should I use Quinapril Hydrochloride/Hydrochlorothiazide?
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/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 ) 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 subject who received 10 mg to 40 mg/12.5 mg to 25 mg experienced a milder reduction in serum potassium than that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Patients whose blood pressures are not adequately controlled with quinapril monotherapy may instead be given quinapril and hydrochlorothiazide tablets 10 mg/12.5 mg or 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve blood pressure control with less electrolyte disturbance if they are switched to quinapril and hydrochlorothiazide tablets 10 mg/12.5 mg or 20 mg/12.5 mg.
For convenience, patients who are adequately treated with 20 mg of quinapril and 25 mg of hydrochlorothiazide and experience no significant electrolyte disturbances may instead wish to receive quinapril and hydrochlorothiazide tablets 20 mg/25 mg.
Regimens of therapy with quinapril and hydrochlorothiazide tablets need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/ 1.73 m (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides. Therefore, quinapril and hydrochlorothiazide tablets are not recommended for use in these patients.
What interacts with Quinapril Hydrochloride/Hydrochlorothiazide?
- Quinapril and hydrochlorothiazidetablets 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 are 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 and ). 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 tablets with aliskiren:
What are the warnings of Quinapril Hydrochloride/Hydrochlorothiazide?
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Neutropenia/Agranulocytosis
Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease, such as systemic lupus erythematosus or scleroderma. Agranulocytosis did occur during quinapril treatment in one patient with a history of neutropenia during previous captopril therapy. Available data from clinical trials of quinapril are insufficient to show that, in patients without prior reactions to other ACE inhibitors, quinapril does not cause agranulocytosis at similar rates. As with other ACE inhibitors, periodic monitoring of white blood cell counts in patients with collagen vascular disease and/or renal disease should be considered.
Fetal Toxicity
Pregnancy Category D
in utero
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Systemic Lupus Erythematosus
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What are the precautions of Quinapril Hydrochloride/Hydrochlorothiazide?
General
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Information for Patients
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Laboratory Tests
The hydrochlorothiazide component of quinapril and hydrochlorothiazide may decrease serum PBI levels without signs of thyroid disturbance.
Therapy with quinapril and hydrochlorothiazide should be interrupted for a few days before carrying out tests of parathyroid function.
Drug Interactions
- Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of quinapril.
- The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by quinapril coadministration twice daily.
- Digoxin: Thiazide-induced electrolyte disturbances, i.e. hypokalemia, hypomagnesemia, increase the risk of digoxin toxicity, which may lead to fatal arrhythmic events (See
- No pharmacokinetic interaction was observed when single doses of quinapril and hydrochlorothiazide were administered concomitantly.
- Alcohol, Barbiturates, or Narcotics—potentiation of orthostatic hypotension may occur.
- Antidiabetic Drugs (oral hypoglycemic agents and insulin)—dosage adjustments of the antidiabetic drug may be required (See ).
- Cholestyramine and Colestipol Resin—absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.
- Corticosteroids, ACTH—intensified electrolyte depletion, particularly hypokalemia.
- Pressor Amines (e.g., norepinephrine)—possible decreased response to pressor amines, but not sufficient to preclude their therapeutic use.
- Skeletal Muscle Relaxants, Nondepolarizing (e.g., tubocurarine)—possible increased responsiveness to the muscle relaxant.
- Non-steroidal Anti-inflammatory Drugs-the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics may be reduced by concurrent administration of nonsteroidal anti-inflammatory agents.
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When administered concurrently, the following drugs may interact with thiazide diuretics.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been conducted in animals with quinapril and hydrochlorothiazide. Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 or 60 times the maximum human daily dose, respectively, on a mg/kg basis and 3.8 or 10 times the maximum human daily dose on a 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). Under the auspices of the National Toxicology Program, rats and mice received hydrochlorothiazide in their feed for 2 years, at doses up to 600 mg/kg/day in mice and up to 100 mg/kg/day in rats. These studies uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was “equivocal” evidence of hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of (the Ames test); in the Chinese hamster ovary (CHO) test for chromosomal aberrations; or assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the sex-linked recessive lethal trait gene. Positive test results were obtained in the CHO sister chromatid exchange (clastogenicity) test and in the mouse lymphoma cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 mcg/mL. Positive test results were also obtained in the nondisjunction assay, using an unspecified concentration of hydrochlorothiazide. Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diets, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.
Nursing Mothers
Because quinapril and hydrochlorothiazide are secreted in human milk, caution should be exercised when quinapril and hydrochlorothiazide is administered to a nursing woman. Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of quinapril in infants, a decision should be made whether to discontinue nursing or to discontinue quinapril and hydrochlorothiazide, taking into account the importance of the drug to the mother.
Geriatric Use
Clinical studies of quinapril hydrochloride/hydrochlorothiazide 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.
Pediatric Use
Neonates with a history of in utero exposure to quinapril and hydrochlorothiazide
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What are the side effects of Quinapril Hydrochloride/Hydrochlorothiazide?
Quinapril and hydrochlorothiazidehas 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, 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 hydrochlorothiazidewere cough (1%; see ) 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.
Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥0.5% to <1% (except as noted) of the patients treated with quinapril/HCTZ in controlled and uncontrolled trials (N=1571) and less frequent, clinically significant events seen in clinical trials or postmarketing experience (the rarer events are in italics) include (listed by body system):
Postmarketing Experience
Clinical Laboratory Test Findings
Serum Electrolytes:
PBI and Tests of Parathyroid Function:
| Percent of Patients in Controlled Trials | ||
| Quinapril/HCTZ N = 943 | Placebo N = 100 | |
| Headache | 6.7 | 30 |
| Dizziness | 4.8 | 4 |
| Coughing | 3.2 | 2 |
| Fatigue | 2.9 | 3 |
| Myalgia | 2.4 | 5 |
| Viral Infection | 1.9 | 4 |
| Rhinitis | 2 | 3 |
| Nausea and/or Vomiting | 1.8 | 6 |
| Abdominal Pain | 1.7 | 4 |
| Back Pain | 1.5 | 2 |
| Diarrhea | 1.4 | 1 |
| Upper Respiratory Infection | 1.3 | 4 |
| Insomnia | 1.2 | 2 |
| Somnolence | 1.2 | 0 |
| Bronchitis | 1.2 | 1 |
| Dyspepsia | 1.2 | 2 |
| Asthenia | 1.1 | 1 |
| Pharyngitis | 1.1 | 2 |
| Vasodilatation | 1 | 1 |
| Vertigo | 1 | 2 |
| Chest Pain | 1 | 2 |
| BODY AS A WHOLE: | Asthenia, Malaise | |
| CARDIOVASCULAR: | Palpitation, Tachycardia, | |
| GASTROINTESTINAL: | Mouth or Throat Dry, | |
| NERVOUS/PSYCHIATRIC: | Nervousness, Vertigo, | |
| RESPIRATORY: | Sinusitis, Dyspnea | |
| INTEGUMENTARY: | Pruritus, Sweating Increased, | |
| UROGENITAL SYSTEM: OTHER: | ||
| Angioedema: | Angioedema has been reported in 0.1% of patients receiving quinapril (0.1%) (see ). | |
| BODY AS A WHOLE: | Weakness. | |
| CARDIOVASCULAR: | Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics). | |
| DIGESTIVE: | Pancreatitis, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and anorexia. | |
| NEUROLOGIC: | Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness. | |
| MUSCULOSKELETAL: | Muscle spasm. | |
| HEMATOLOGIC: | Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, and hemolytic anemia. | |
| RENAL: | Renal failure, renal dysfunction, interstitial nephritis (see ). | |
| METABOLIC: | Hyperglycemia, glycosuria, and hyperuricemia. | |
| HYPERSENSITIVITY: | Necrotizing angiitis, Stevens-Johnson syndrome, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity. |
What should I look out for while using Quinapril Hydrochloride/Hydrochlorothiazide?
What might happen if I take too much Quinapril Hydrochloride/Hydrochlorothiazide?
No specific information is available on the treatment of overdosage with quinapril and hydrochlorothiazide or quinapril monotherapy; treatment should be symptomatic and supportive. Therapy with quinapril and hydrochlorothiazide should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.
The oral median lethal dose of quinapril/hydrochlorothiazide in combination ranges from 1063/664 to 4640/2896 mg/kg in mice and rats. Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.
Data from human overdoses of ACE inhibitors are scanty; the most likely manifestation of human quinapril overdosage is hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
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 (e.g., maneuvers to change the 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 Quinapril Hydrochloride/Hydrochlorothiazide?
Store at Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg Bottles of 90 NDC 65862-161-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg Bottles of 30 NDC 65862-162-30 Bottles of 90 NDC 65862-162-90Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg Bottles of 90 NDC 65862-163-90Store atDistributed by: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad–500 038, India Revised: 09/2017
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Reference
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