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Cartia XT - Side Effects & Drug Interactions

[Diltiazem]

ADVERSE REACTIONS

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsule (once-a-day dosing) product up to 360 mg with rates in placebo patients shown for comparison.

In clinical trials of Diltiazem hydrochloride Extended-release Capsules (Once A Day Dosage), diltiazem hydrochloride tablets and diltiazem hydrochloride extended-release capsules involving over 3200 patients, the most common events (i. e., greater than 1%) were

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edema (4.6%),

headache (4.6%),

dizziness (3.5%),

asthenia (2.6%),

first-degree AV block (2.4%),

bradycardia (1.7%),

flushing (1.4%),

nausea (1.4%)

rash (1.2%).

In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials:

Cardiovascular

Angina, arrhythmia, AV block (second-or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System

Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, pares-thesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal

Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see hepatic warnings), thirst, vomiting, weight increase.

Dermatological

Petechiae, photosensitivity, pruritus, urticaria.

Other

Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

The following postmarketing events have been reported infrequently in patients receiving diltiazem: