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ACCURETIC 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 ACCURETIC, 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 ACCURETIC 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 inControlled Trials|
N = 943
N = 100
|Nausea and/or Vomiting||1.8||6.0|
|Upper Respiratory Infection||1.3||4.0|
Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥ 0.5% to < 1.0% (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):
CARDIOVASCULAR: Palpitation, Tachycardia, Heart Failure, Hyperkalemia, Myocardial Infarction, Cerebrovascular Accident, Hypertensive Crisis, Angina Pectoris, Orthostatic Hypotension, Cardiac Rhythm Disturbance
GASTROINTESTINAL: Mouth or Throat Dry, Gastrointestinal Hemorrhage, Pancreatitis, Abnormal Liver Function Tests
NERVOUS/PSYCHIATRIC: Nervousness, Vertigo, Paresthesia
INTEGUMENTARY: Pruritus, Sweating Increased, Erythema Multiforme, Exfoliative Dermatitis, Photosensitivity Reaction, Alopecia, Pemphigus
UROGENITAL SYSTEM: Acute Renal Failure, Impotence
OTHER: Agranulocytosis, Thrombocytopenia, Arthralgia
The following serious nonfatal adverse events, regardless of their relationship to quinapril and HCTZ combination tablets, have been reported during extensive postmarketing experience:
HEMIC SYSTEM: Anemia.
METABOLIC AND NUTRITIONAL DISORDERS: Weight loss.
SKIN AND APPENDAGES: Urticaria, macropapular rash, and petechiases.
SPECIAL SENSES: Abnormal vision.
Quinapril monotherapy has been evaluated for safety in 4960 patients. In clinical trials adverse events which occurred with quinapril were also seen with ACCURETIC. In addition, the following were reported for quinapril at an incidence > 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).
MUSCULOSKELETAL: Muscle spasm.
RENAL: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS).
Clinical Laboratory Test Findings
Creatinine, Blood Urea Nitrogen
Increases ( > 1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 3% and 4%, respectively, of patients treated with ACCURETIC. Most increases were minor and reversible, which can occur in patients with essential hypertension but most frequently in patients with renal artery stenosis (see PRECAUTIONS).
PBI and Tests of Parathyroid Function
Other (causal relationships unknown)
Other clinically important changes in standard laboratory tests were rarely associated with ACCURETIC administration. Elevations in uric acid, glucose, magnesium, cholesterol, triglyceride, and calcium (see PRECAUTIONS) have been reported.
Read the Accuretic (quinapril hcl/hydrochlorothiazide) Side Effects Center for a complete guide to possible side effects
Potassium Supplements and Potassium-Sparing Diuretics
Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated monitored serum potassium frequently.
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. Because renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity is presumably raised further when, as in therapy with ACCURETIC, a thiazide diuretic is coadministered with the ACE inhibitor. ACCURETIC and lithium should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended.
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. Closely monitor blood pressure, renal function and electrolytes in patients on ACCURETIC and other agents that affect the RAS. Do not co-administer aliskiren with ACCURETIC in patients with diabetes. Avoid use of aliskiren with ACCURETIC in patients with renal impairment (GFR < 60 ml/min).
Tetracycline and Other Drugs That Interact with Magnesium
Simultaneous administration of tetracycline with quinapril reduced the absorption of tetracycline by approximately 28% to 37%, possibly due to the high magnesium content in quinapril tablets. This interaction should be considered if coprescribing quinapril and tetracycline or other drugs that interact with magnesium.
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.
Drug interaction studies of quinapril and other agents showed:
- 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 PRECAUTIONS).
- No pharmacokinetic interaction was observed when single doses of quinapril and hydrochlorothiazide were administered concomitantly.
When administered concurrently, the following drugs may interact with thiazide diuretics.
- 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 PRECAUTIONS).
- 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 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.
Read the Accuretic Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/31/2014
This monograph has been modified to include the generic and brand name in many instances.
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