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Tarka

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Tarka

Tarka

Tarka Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tarka (trandolapril/verapamil hydrochloride) ER tablets is used to treat high blood pressure (hypertension). Trandolapril is an ACE (angiotensin converting enzyme) inhibitor, and verapamil is a calcium channel blocker. This medication is available in generic form. Common side effects include dizziness as your body adjusts to the medication. Dry cough, slow heartbeat, constipation, and nausea may also occur.

The recommended usual dosage range of trandolapril for hypertension is 1 to 4 mg per day administered in a single dose or two divided doses. The recommended usual dosage range of verapamil hydrochloride is 120 to 480 mg per day administered in a single dose or two divided doses. Tarka may interact with diuretics (water pills), cyclosporine, digoxin, gold injections (to treat arthritis), lithium, phenytoin or carbamazepine, rifampin, theophylline, antibiotics, heart rhythm medicines, or beta-blockers. Tell your doctor all medications you use. Tarka is not recommended for use during pregnancy due to the risk for harm to a fetus. Verapamil passes into breast milk. It is unknown if trandolapril passes into breast milk. Consult your doctor before breast-feeding.

Our Tarka (trandolapril/verapamil hydrochloride) 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.

Tarka 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 any of these serious side effects:

  • urinating less than usual or not at all;
  • swelling, weight gain, feeling short of breath;
  • feeling like you might pass out;
  • anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;
  • chest pain, fast, slow, or uneven heart rate; or
  • fever, upper stomach pain, and jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough;
  • headache;
  • runny or stuffy nose, sore throat;
  • constipation, diarrhea;
  • dizziness;
  • back pain;
  • joint pain; or
  • nausea.

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 Tarka (Trandolapril and Verapamil ER) »

What is Patient Information Overview?

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

Tarka Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness may occur as your body adjusts to the medication. Dry cough, slow heartbeat, constipation, and nausea may also occur. If any of these effects persist or worsen, tell 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling ankles/feet, unusual tiredness, shortness of breath, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), fast heartbeat, fainting.

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

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Tarka (Trandolapril and Verapamil ER)»

What is Prescribing information?

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

Tarka FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

TARKA has been evaluated in over 1,957 subjects and patients. Of these, 541 patients, including 23% elderly patients, participated in U.S. controlled clinical trials, and 251 were studied in foreign controlled clinical trials. In clinical trials with TARKA, no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with verapamil or trandolapril. TARKA has been evaluated for long-term safety in 272 patients treated for 1 year or more. Adverse experiences were usually mild and transient.

Discontinuation of therapy because of adverse events in U.S. placebo-controlled hypertension studies was required in 2.6% and 1.9% of patients treated with TARKA and placebo, respectively.

Adverse experiences occurring in 1% or more of the 541 patients in placebo-controlled hypertension trials who were treated with a range of trandolapril (0.5-8 mg) and verapamil (120-240 mg) combinations are shown below.

ADVERSE EVENTS OCCURRING in ≥ 1% of TARKA PATIENTS IN U.S. PLACEBO-CONTROLLED TRIALS

  TARKA
(N = 541)
% Incidence
(% Discontinuance)
PLACEBO
(N = 206)
% Incidence
(% Discontinuance)
AV Block First Degree 3.9 (0.2) 0.5 (0.0)
Bradycardia 1.8(0.0) 0.0 (0.0)
Bronchitis 1.5(0.0) 0.5 (0.0)
Chest Pain 2.2 (0.0) 1.0(0.0)
Constipation 3.3 (0.0) 1.0(0.0)
Cough 4.6 (0.0) 2.4 (0.0)
Diarrhea 1.5(0.2) 1.0(0.0)
Dizziness 3.1 (0.0) 1.9(0.5)
Dyspnea 1.3 (0.4) 0.0 (0.0)
Edema 1.3 (0.0) 2.4 (0.0)
Fatigue 2.8 (0.4) 2.4 (0.0)
Headache(s)+ 8.9 (0.0) 9.7 (0.5)
Increased Liver Enzymes* 2.8 (0.2) 1.0(0.0)
Nausea 1.5(0.2) 0.5 (0.0)
Pain Extremity(ies) 1.1 (0.2) 0.5 (0.0)
Pain Back+ 2.2 (0.0) 2.4 (0.0)
Pain Joint(s) 1.7 (0.0) 1.0(0.0)
Upper Respiratory Tract Infection(s)+ 5.4 (0.0) 7.8 (0.0)
Upper Respiratory Tract Congestion+ 2.4 (0.0) 3.4 (0.0)
* Also includes increase in SGPT, SGOT, Alkaline Phosphatase
+ Incidence of adverse events is higher in Placebo group than TARKA patients

Other clinical adverse experiences possibly, probably, or definitely related to drug treatment occurring in 0.3% or more of patients treated with trandolapril/verapamil combinations with or without concomitant diuretic in controlled or uncontrolled trials (N = 990) and less frequent, clinically significant events (in italics) include the following:

Cardiovascular

Angina, AV block second degree, bundle branch block, edema, flushing, hypotension, myocardial infarction, palpitations, premature ventricular contractions, nonspecific ST-T changes, near syncope, tachycardia.

Central Nervous System

Drowsiness, hypesthesia, insomnia, loss of balance, paresthesia, vertigo.

Dermatologic

Pruritus, rash.

Emotional, Mental, Sexual States

Anxiety, impotence, abnormal mentation.

Eye, Ear, Nose, Throat

Epistaxis, tinnitus, upper respiratory tract infection, blurred vision.

Gastrointestinal

Diarrhea, dyspepsia, dry mouth, nausea.

General Body Function

Chest pain, malaise, weakness.

Genitourinary

Endometriosis, hematuria, nocturia, polyuria, proteinuria.

Hemopoietic

Decreased leukocytes, decreased neutrophils.

Musculoskeletal System

Arthralgias/myalgias, gout (increased uric acid).

Pulmonary

Dyspnea.

Angioedema

Angioedema has been reported in 3 (0.15%) patients receiving TARKA in U.S. and foreign studies (N = 1,957). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with TARKA should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

Hypotension

(See WARNINGS). In hypertensive patients, hypotension occurred in 0.6% and near syncope occurred in 0.1%. Hypotension or syncope was a cause for discontinuation of therapy in 0.4% of hypertensive patients.

Treatment of Acute Cardiovascular Adverse Reactions

The frequency of cardiovascular adverse reactions which require therapy is rare, hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occur following oral administration of TARKA (verapamil component), the appropriate emergency measures should be applied immediately, e.g., intravenously administered isoproterenol HC1, levarterenol bitartrate, atropine (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine, metaraminol bitartrate or methoxamine) should be used to maintain blood pressure, and isoproterenol and levarterenol should be avoided. If further support is necessary, inotropic agents (dopamine or dobutamine) may be administered. Actual treatment and dosage should depend on the severity and the clinical situation and the judgment and experience of the treating physician.

Other adverse experiences (in addition to those in table and listed above) that have been reported with the individual components are listed below.

Verapamil Component

Cardiovascular

(See WARNINGS). CHF/pulmonary edema, AV block 3°, atrioventricular dissociation, claudication, purpura (vasculitis), syncope.

Digestive System

Gingival hyperplasia. Reversible, (upon discontinuation of verapamil) nonobstructive, paralytic ileus has been infrequently reported in association with the use of verapamil.

Hemic and Lymphatic

Ecchymosis or bruising.

Nervous System

Cerebrovascular accident, confusion, psychotic symptoms, shakiness, somnolence.

Skin

Exanthema, hair loss, hyperkeratosis, maculae, sweating, urticaria, Stevens-Johnson syndrome, erythema multiform.

Urogenital

Gynecomastia, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation.

Trandolapril Component

Emotional, Mental, Sexual States

Decreased libido.

Gastrointestinal

Pancreatitis.

Clinical Laboratory Test Findings

Hematology

(See WARNINGS). Low white blood cells, low neutrophils, low lymphocytes, low platelets.

Serum Electrolytes

Hyperkalemia (see PRECAUTIONS), hyponatremia.

Renal Function Tests

Increases in creatinine and blood urea nitrogen levels occurred in 1.1 percent and 0.3 percent, respectively, of patients receiving TARKA with or without hydrochlorothiazide therapy. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis (see PRECAUTIONS and WARNINGS).

Liver Function Tests

Elevations of liver enzymes (SGOT, SGPT, LDH, and alkaline phosphatase) and/or serum bilirubin occurred. Discontinuation for elevated liver enzymes occurred in 0.9 percent of patients (see WARNINGS).

Post Marketing Experience

There has been a single postmarketing report of paralysis (tetraparesis) associated with the combined use of verapamil and colchicine. This may have been caused by colchicine crossing the blood-brain barrier due to CYP3A4 and P-gp inhibition by verapamil. Combined use of verapamil and colchicine is not recommended (see PRECAUTIONS - DRUG INTERACTIONS).

Read the entire FDA prescribing information for Tarka (Trandolapril and Verapamil ER) »

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Tarka - User Reviews

Tarka 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 Tarka 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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