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diltiazem HCl

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diltiazem HCl
(diltī´zem),
n brand names: Cardizem, Cardizem SR, Cardizem CD;
drug class: calcium channel blocker;
action: inhibits calcium ion influx across cell membrane during cardiac depolarization; produces relaxation of coronary vascular smooth muscle, dilates coronary arteries, slows SA/AV node conduction;
uses: chronic stable angina pectoris, coronary artery spasm, hypertension.
Enlarge picture
Dilaceration.


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The deviations included an incorrect calculation applied to data on diltiazem HCl tablets, noncompliance with lab investigation procedures for test result invalidation and investigation reports on out-of-specification (OOS) results, inadequate validation and monitoring of the system used to produce USP Purified/HPLC-grade water and modification of test methods without study or documentation to justify the changes.
The post-approval inspection examined the manufacture of alprazolam tablets, diltiazem HCl tablets, ketoprofen capsules and naproxen tablets.
Cardizem(R)LA's clinical benefits are resonating well with physicians and Biovail's recent sales force initiatives have resulted in the attainment of new once-daily diltiazem HCl market share highs for Cardizem(R)LA for both Total Prescriptions (10.
 
 
 
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