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Accuretic

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Accuretic

Side Effects
Interactions

SIDE EFFECTS

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
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 < 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):

BODY AS A WHOLE: Asthenia, Malaise

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

RESPIRATORY: Sinusitis, Dyspnea

INTEGUMENTARY: Pruritus, Sweating Increased, Erythema Multiforme, Exfoliative Dermatitis, Photosensitivity Reaction, Alopecia, Pemphigus

UROGENITAL SYSTEM: Acute Renal Failure, Impotence

OTHER: Agranulocytosis, Thrombocytopenia, Arthralgia

Angioedema: Angioedema has been reported in 0.1% of patients receiving quinapril (0.1%) (see WARNINGS).

Postmarketing Experience

The following serious nonfatal adverse events, regardless of their relationship to quinapril and HCTZ combination tablets, have been reported during extensive postmarketing experience:

BODY AS A WHOLE: Shock, accidental injury, neoplasm, cellulitis, ascites, generalized edema, hernia and anaphylactoid reaction.

CARDIOVASCULAR SYSTEM: Bradycardia, cor pulmonale, vasculitis, and deep thrombosis.

DIGESTIVE SYSTEM: Gastrointestinal carcinoma, cholestatic jaundice, hepatitis, esophagitis, vomiting, and diarrhea.

EYE DISORDERS: acute myopia and acute angle closure glaucoma (see WARNINGS).

HEMIC SYSTEM: Anemia.

METABOLIC AND NUTRITIONAL DISORDERS: Weight loss.

MUSCULOSKELETAL SYSTEM: Myopathy, myositis, and arthritis.

NERVOUS SYSTEM: Paralysis, hemiplegia, speech disorder, abnormal gait, meningism, and amnesia.

RESPIRATORY SYSTEM: Pneumonia, asthma, respiratory infiltration, and lung disorder.

SKIN AND APPENDAGES: Urticaria, macropapular rash, and petechiases.

SPECIAL SENSES: Abnormal vision.

UROGENITAL SYSTEM: Kidney function abnormal, albuminuria, pyuria, hematuria, and nephrosis.

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).

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 WARNINGS).

METABOLIC: Hyperglycemia, glycosuria, and hyperuricemia.

HYPERSENSITIVITY: Necrotizing angiitis, Stevens-Johnson syndrome, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity.

Clinical Laboratory Test Findings

Serum Electrolytes

See PRECAUTIONS.

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

See PRECAUTIONS.

Hematology

See WARNINGS.

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

DRUG INTERACTIONS

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.

Lithium

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.

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.

Other Agents

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.

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

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.

Side Effects
Interactions
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