Tarka Side Effects

Please note - some side effects for Tarka may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tarka - for the Consumer

Tarka

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tarka:

Diarrhea; dizziness; lightheadedness when sitting up or standing; nausea; persistent, dry cough; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; decreased urination; difficulty swallowing; muscle pain or cramping; numbness of an arm or leg; one-sided weakness; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); swelling of the hands or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of low blood pressure (eg, fainting, severe dizziness or lightheadedness); unusually fast, slow, or irregular heartbeat; yellowing of the skin or eyes.

Tarka Side Effects - for the Professional

Tarka

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.

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.

Hypotension

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.

Fetal/Neonatal Morbidity and Mortality

See WARNINGS - Fetal Neonatal Morbidity and Mortality.

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

Cardiovascular

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.

Emotional, Mental, Sexual States

decreased libido.

Gastrointestinal

pancreatitis.

Clinical Laboratory Test Findings

Low white blood cells, low neutrophils, low lymphocytes, low platelets.

Hyperkalemia, hyponatremia.

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.

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.

Side Effects by Body System

General

In general, side effects associated with this combination drug have been mild and transient. Side effects associated with each component of this drug may be observed. Discontinuation of therapy because of adverse events in US placebo-controlled hypertension studies was required in 2.6% and 1.9% of patients receiving drug and placebo, respectively.

Cardiovascular

The use of trandolapril-verapamil in some patients with depressed left ventricular systolic function and atrial fibrillation is somewhat controversial because verapamil can (1) accelerate AV conduction, particularly in patients with an accessory AV nodal pathway (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes) and (2) further depress LV systolic function. In general, verapamil is not recommended for patients with atrial fibrillation and premature ventricular depolarizations.

Angina pectoris has been reported in as many as 36% of patients in the Trandolapril Cardiac Evaluation (TRACE) study, but the incidence of underlying coronary artery disease in the patient population studied was essentially 100% (patients with a history of myocardial infarction). Moreover, the incidence of angina pectoris among placebo patients in the TRACE study was 38% (not significantly different).

Cardiovascular side effects including 1st-degree AV heart block in 3.9%, sinus bradycardia in 1.8%, chest pain in 2.2% (any origin), dizziness in 3.1%, and edema in 1.3% of patients have been reported. Verapamil may have negative inotropic activity, and may induce or exacerbate congestive heart failure in 2% of patients. This may be particularly important in elderly patients and in patients with tenuous left ventricular (LV) systolic function and/or who are also taking a beta-blocker.

Gastrointestinal

Less common side effects associated with verapamil, as well as some other calcium channel blockers, include gingival hyperplasia, diarrhea, dry mouth, and dyspepsia. Trandolapril has rarely been associated with vomiting, appetite or weight changes, and dry mouth in approximately 0.5% of patients.

Gastrointestinal side effects may be related to the verapamil component. Constipation has been reported in 3.3% (up to 7% of patients on verapamil alone), nausea in 3%, and diarrhea in 1.5% of patients. Constipation can often be controlled by increasing dietary fiber.

Respiratory

Respiratory side effects including cough, a common respiratory system side effect associated with angiotensin converting enzyme (ACE) inhibitors, have been reported in up to 5% of patients who receive trandolapril-verapamil. The incidence of dyspnea among patients in controlled trials averages 1.3% among patients who received the drug, compared with 0% of patients on placebo.

Nervous system

Nervous system side effects include dizziness (possibly related to drug-induced hypotension) in 3.1%, fatigue in 2.8%, and headaches in 8.9% of patients. The incidence of the latter two side effects were comparable to placebo in controlled studies.

Trandolapril has also been associated with sleep or taste disturbances, nervousness, mood changes, tinnitus, asthenia, or anxiety in approximately 2% of patients.

Hepatic

The mechanism of hepatic injury associated with verapamil is not known; in some cases, the mechanism is considered either idiosyncratic or due to hypersensitivity.

Hepatic side effects including elevated hepatic transaminase and alkaline phosphatase enzymes have been reported in 2.8% of patients. Hepatic side effects associated with the use of ACE inhibitors have included a rare syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Experts recommend discontinuation of therapy with this drug if jaundice or markedly elevated hepatic serum enzymes develop. The use of verapamil monotherapy has rarely been associated with significant hepatotoxicity.

Renal

Renal side effects including new or worsened renal insufficiency have been associated with the use of ACE inhibitors, particularly in patients with underlying cardiovascular or renal disease.

Hypersensitivity

Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, trandolapril should be discontinued immediately, the patient treated in accordance with accepted medical care and carefully observed until the swelling disappears. In cases where the swelling is confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including, but not limited to subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL) should be administered promptly.

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general. Urticaria, rash, pemphigus, pruritus, and photosensitivity have been reported in less than 1% of patients who received trandolapril.

Metabolic

Metabolic side effects associated with ACE inhibitors include mild hyperkalemia, the result of inhibition of aldosterone secretion.

Hematologic

Hematologic problems rarely reported with some ACE inhibitors include agranulocytosis and bone marrow depression.

Musculoskeletal

Musculoskeletal pains have been rarely associated with trandolapril-verapamil.

Genitourinary

Genitourinary complaints associated with verapamil monotherapy appear to be limited to rare cases of sexual impotence and loss of libido among males.

Endocrine

Endocrine side effects as a result of verapamil have included hyperprolactinemia and galactorrhea.

Although the mechanism is not known, verapamil may interfere with the release or synthesis of prolactin inhibitor factor in the hypothalamus. Due to verapamil-induced hyperprolactinemia, rare cases of galactorrhea have been reported in both men and women.

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