Tarka Side Effects

Generic name: trandolapril / verapamil

Note: This document contains side effect information about trandolapril / verapamil. Some of the dosage forms listed on this page may not apply to the brand name Tarka.

Some side effects of Tarka may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to trandolapril / verapamil: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking trandolapril / verapamil: 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 of trandolapril / verapamil 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.

For Healthcare Professionals

Applies to trandolapril / verapamil: oral tablet extended release

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. Postmarketing reports have included malaise and fever.

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. Postmarketing side effects include myocardial infarction, myocardial ischemia, angina pectoris, cardiac failure, ventricular tachycardia, tachycardia, transient ischemic attack, and arrhythmia.

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. Postmarketing reports have included dry mouth and pancreatitis.

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. Postmarketing reports have included bronchitis.

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. Postmarketing reports have included cerebral hemorrhage.

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. Postmarketing reports include elevated liver transaminases, elevated bilirubin, jaundice and hepatitis.

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.
Postmarketing reports have included renal failure, elevated creatinine, and elevated blood urea nitrogen.

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. Postmarketing reports include hyponatremia.

Hematologic

Hematologic problems rarely reported with some ACE inhibitors include agranulocytosis and bone marrow depression. Postmarketing reports have included thrombocytopenia, agranulocytosis and pancytopenia.

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.

Dermatologic

Dermatologic side effects have included postmarketing reports of alopecia, sweating, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Psychiatric

Psychiatric side effects have included postmarketing reports of hallucination and depression.

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