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Cartia XT

[Diltiazem]

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

allergic reactions,
alopecia,
angioedema (including facial or periorbital edema),
asystole,
erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis),
exfoliative dermatitis,
extrapyramidal symptoms,
gingival hyperplasia,
hemolytic anemia,
increased bleeding time,
leukopenia,
purpura,
retinopathy,
thrombocytopenia.

In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem therapy is yet to be established.

Text Continues Below



Drug Interactions

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/ or conduction. (See WARNINGS.) Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomi-tantly with diltiazem. (See WARNINGS.)

As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem undergoes biotransformation by cytochrome P-450 mixed function oxidase. Coadministration of diltiazem with other agents which follow the same route of biotransformation may result in the competitive inhibition of metabolism. Especially in patients with renal and/ or hepatic impairment, dosages of similarly metabolized drugs, particularly those of low therapeutic ratio, may require adjustment when starting or stopping concomitantly administered diltiazem to maintain optimum therapeutic blood levels.

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