Quinapril Hydrochloride (Page 4 of 6)

Agents increasing serum potassium

Quinapril can attenuate potassium loss caused by thiazide diuretics and increase serum potassium when used alone. If concomitant therapy of quinapril hydrochloride tablets with potassium-sparing diuretics (eg, spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes is indicated, they should be used with caution along with appropriate monitoring of serum potassium (see ). PRECAUTIONS

Tetracycline and other drugs that interact with magnesium

Simultaneous administration of tetracycline with quinapril hydrochloride tablets reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in quinapril hydrochloride tablets. This interaction should be considered if coprescribing quinapril hydrochloride and tetracycline or other drugs that interact with magnesium.

Lithium

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be coadministered with caution and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, it may increase the risk of lithium toxicity.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy.

Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including quinapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving quinapril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including quinapril may be attenuated by NSAIDs.

Agents that inhibit mTOR

Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema.

Other agents

Drug interaction studies of quinapril hydrochloride with other agents showed:

  • Multiple dose therapy with propranolol or cimetidine has no effect on the pharmacokinetics of single doses of quinapril hydrochloride tablets.
  • The anticoagulant effect of a single dose of warfarin (measured by prothrombin time) was not significantly changed by quinapril coadministration twice-daily.
  • Quinapril hydrochloride tablet treatment did not affect the pharmacokinetics of digoxin.
  • No pharmacokinetic interaction was observed when single doses of quinapril hydrochloride and hydrochlorothiazide were administered concomitantly.
  • Co-administration of multiple 10 mg doses of atorvastatin with 80 mg of quinapril hydrochloride resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on quinapril hydrochloride tablets and other agents that affect the RAS.

Do not co-administer aliskiren with Quinapril hydrochloride tablets in patients with diabetes. Avoid concomitant use of aliskiren with quinapril hydrochloride tablets in patients with renal impairment (GFR <60 mL/min/1.73 m ). 2

Carcinogenesis, Mutagenesis, Impairment of Fertility

Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 to 60 times the maximum human daily dose, respectively, on an mg/kg basis and 3.8 to 10 times the maximum human daily dose when based on an 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). 2 in vitro in vitro in vivo 2

Nursing Mothers

Because quinapril hydrochloride is secreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

Pediatric Use

Neonates with a history of exposure to quinapril hydrochloride tablets in utero

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Removal of quinapril hydrochloride tablets, which cross the placenta, from the neonatal circulation is not significantly accelerated by these means.

The safety and effectiveness of quinapril hydrochloride in pediatric patients have not been established.

Geriatric Use

Clinical studies of quinapril hydrochloride tablets 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Elderly patients exhibited increased area under the plasma concentration time curve and peak levels for quinaprilat compared to values observed in younger patients; this appeared to relate to decreased renal function rather than to age itself.

ADVERSE REACTIONS

Hypertension

Quinapril hydrochloride tablets have been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril hydrochloride tablets have 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 hydrochloride tablets are shown below.

Adverse Events in Placebo-Controlled Trials
Quinapril HCl (N=1563) Incidence (Discontinuance)
Placebo (N=579) Incidence (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

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