Diltiazem hydrochloride tablet warnings: Difference between revisions
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==WARNINGS== | |||
1. '''Cardiac Conduction'''. CARDIZEM 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-degree AV block|second-]]or [[third-degree AV block]] (six of 1243 patients for 0.48%). 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 [[Diltiazem hydrochloride tablet adverse reactions|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). Experience with the use of CARDIZEM alone or in combination with beta-blockers in patients with impaired ventricular function is very limited. Caution should be exercised when using the drug in such patients. | |||
3. '''Hypotension'''. Decreases in blood pressure associated with CARDIZEM therapy may occasionally result in symptomatic [[hypotension]]. | |||
4. '''Acute Hepatic Injury'''. In rare instances, significant elevations in enzymes such as [[alkaline phosphatase]], [[LDH]], [[SGOT]], [[SGPT]], and other phenomena consistent with acute hepatic injury have been noted. These reactions have been reversible upon discontinuation of drug therapy. The relationship to CARDIZEM is uncertain in most cases, but probable in some (see [[Diltiazem hydrochloride tablet precautions|PRECAUTIONS]]).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [BTA PHARMACEUTICALS] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=461fe23f-4453-4e3f-9621-0e3fda057d14 | publisher = | date = | accessdate = 5 March 2014 }}</ref> | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [BTA PHARMACEUTICALS] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=461fe23f-4453-4e3f-9621-0e3fda057d14 | publisher = | date = | accessdate = 5 March 2014 }}</ref> | |||
==References== | ==References== | ||
Revision as of 15:18, 5 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
WARNINGS
1. Cardiac Conduction. CARDIZEM 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 (six of 1243 patients for 0.48%). Concomitant use of diltiazem withbeta-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). Experience with the use of CARDIZEM alone or in combination with beta-blockers in patients with impaired ventricular function is very limited. Caution should be exercised when using the drug in such patients.
3. Hypotension. Decreases in blood pressure associated with CARDIZEM therapy may occasionally result in symptomatic hypotension.
4. Acute Hepatic Injury. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions have been reversible upon discontinuation of drug therapy. The relationship to CARDIZEM is uncertain in most cases, but probable in some (see PRECAUTIONS).[1]
References
- ↑ "CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [BTA PHARMACEUTICALS]". Retrieved 5 March 2014.