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Cartia XT

[Diltiazem]


Overdosage & Contraindications
CONTRAINDICATIONS

Diltiazem is contraindicated in

(1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker,

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(2) patients with second-or third-degree AV block except in the presence of a functioning ventricular pace-maker,

(3) patients with hypotension (less than 90 mm Hg systolic),

(4) patients who have demonstrated hypersensitivity to the drug, and

(5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

WARNINGS

1. Cardiac Conduction

Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second-or third-degree AV block (13 of 3290 patients or 0.40%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem. (See ADVERSE REACTIONS.)

2. Congestive Heart Failure

Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/ dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ±6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/ dt).

Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem hydrochloride in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.

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