Tarka
- Generic Name: trandolapril and verapamil er
- Brand Name: Tarka
Tarka (Trandolapril and Verapamil ER) side effects drug center
Tarka Side Effects Center
What Is Tarka?
Tarka (trandolapril/verapamil hydrochloride) ER tablets is a combination of an ACE (angiotensin converting enzyme) inhibitor and a calcium channel blocker used to treat high blood pressure (hypertension). Tarka ER is available in generic form.
What Are Side Effects of Tarka?
Common side effects of Tarka ER include dizziness as your body adjusts to the medication. Other side effects of Tarka ER include:
- dry cough,
- slow heartbeat,
- constipation,
- nausea,
- headache,
- runny or stuffy nose,
- sore throat,
- constipation,
- diarrhea,
- back pain, or
- joint pain.
Tell your doctor if you have unlikely but serious side effects of Tarka ER including:
- swelling ankles or feet,
- unusual tiredness,
- shortness of breath,
- symptoms of a high potassium blood level (such as muscle weakness, irregular heartbeat),
- fast heartbeat, or
- fainting.
Dosage for Tarka
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.
What Drugs, Substances, or Supplements Interact with Tarka?
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 During Pregnancy or Breastfeeding
p>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 breastfeeding.Additional Information
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.
Tarka Consumer Information
Get emergency medical help if you have 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 light-headed feeling, like you might pass out;
- upper stomach pain, and jaundice (yellowing of the skin or eyes);
- chest pain, fast, slow, or uneven heart rate;
- high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- low white blood cell counts--fever, chills, feeling light-headed, mouth sores, skin sores, sore throat, cough, trouble breathing; or
- fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats.
Common side effects may include:
- cough;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- headache, dizziness;
- chest pain, back pain;
- constipation;
- feeling tired; or
- abnormal liver function tests.
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)
Tarka Professional Information
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. PLACEBOCONTROLLED 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 HCl, 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
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).
DRUG INTERACTIONS
No Information provided
Read the entire FDA prescribing information for Tarka (Trandolapril and Verapamil ER)
&Copy; Tarka Patient Information is supplied by Cerner Multum, Inc. and Tarka Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.