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Accuretic

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Accuretic

Accuretic Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Accuretic (quinapril HCl/hydrochlorothiazide) is a combination of two drugs, quinapril and HCl/hydrochlorothiazide. Both are used to treat hypertension (high blood pressure). Accuretic is not indicated for the initial treatment of hypertension. It is available as a generic termed Quinaretic. Side effects of Accuretic can include anaphylaxis (a serious allergic reaction), angioedema (similar to hives, but deeper in the skin), low blood pressure, and liver failure. African American patients may be particularly sensitive to Accuretic.

Accuretic is supplied in three strengths 10-12.5mg, 20-12.5mg and 20-25mg strength tablets containing quinapril HCL/hydrochlorothiazide, respectively. Patients taking Accuretic should have their potassium levels closely monitored. Accuretic and lithium should be co-administered with caution, and frequent monitoring of serum lithium levels is recommended. Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) when given Accuretic. Severe side effects such as shock, cardiac arrhythmias, jaundice, and other problems may occur and require immediate medical care. When pregnancy is detected, Accuretic should be discontinued as soon as possible. ACE inhibitors like Accuretic can cause fetal and neonatal injury and death when given to pregnant women. Breastfeeding females are cautioned because of unknown effects of this drug in breast milk on infants. Use in pediatric patients has not been studied.

Accuretic (quinapril HCl/hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Accuretic in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain, vision problems;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • dry mouth, thirst, nausea, vomiting;
  • feeling weak, drowsy, restless, or light-headed;
  • a red, blistering, peeling skin rash;
  • jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • cough;
  • dizziness, headache, tired feeling;
  • muscle or back pain;
  • runny nose;
  • sleep problems (insomnia);
  • diarrhea, constipation, upset stomach; or
  • mild skin rash, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Accuretic (Quinapril HCl/Hydrochlorothiazide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Accuretic Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, headache, tiredness, blurred vision, or dry cough may occur as your body adjusts to the medication. You may also experience decreased sexual ability or increased sensitivity to the sun. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), numbness/tingling/swelling of the hands/feet, muscle/joint aches, decrease in vision, eye pain.

This drug may rarely cause serious (possibly fatal) liver problems. Seek immediate medical attention if you notice any of the following rare but very serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent tiredness, persistent nausea/vomiting.

Seek immediate medical attention if this rare but very serious side effect occurs: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Accuretic (Quinapril HCl/Hydrochlorothiazide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Accuretic FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Accuretic (Quinapril HCl/Hydrochlorothiazide) »

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Accuretic - User Reviews

Accuretic User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Accuretic sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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