Cardizem Cd
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Questions & Answers
Side Effects & Adverse Reactions
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 (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 CARDIZEM (diltiazem hydrochloride) in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
3. Hypotension. Decreases in blood pressure associated with CARDIZEM therapy may occasionally result in symptomatic hypotension.
4. Acute Hepatic Injury. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. 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 tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to CARDIZEM is uncertain in some cases, but probable in some. (see PRECAUTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
History
There is currently no drug history available for this drug.
Other Information
CARDIZEM® (diltiazem hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. CARDIZEM CD is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride. The 120 mg, 180 mg, 240 mg, and 300 mg capsules also contain: acetyl tributyl citrate, ammonio methylcrylate copolymer dispersion, black iron oxide, castor oil, ethylcellulose, FD&C Blue #1, fumaric acid, gelatin, silicone dioxide, simethicone, starch, steraic acid, sucrose, talc, titanium dioxide and white wax. The 360 mg capsule also contains: acetyl tributyl citrate, ammonio methylcrylate copolymer dispersion, black iron oxide, diethyl phthalate, FD&C Blue #1, gelatin, povidone, simethicone, sodium lauryl sulfate, starch, sucrose, talc and titanium dioxide.
For oral administration.
Sources
Cardizem Cd Manufacturers
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Cardinal Health
![Cardizem Cd (Diltiazem Hydrochloride) Capsule [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cardizem Cd | Cardinal Health
Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.
Angina. Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Concomitant Use With Other Cardiovascular Agents1. Sublingual NTG. May be taken as required to abort acute anginal attacks during CARDIZEM CD (diltiazem hydrochloride) therapy.
2. Prophylactic Nitrate Therapy. CARDIZEM CD may be safely coadministered with short- and long-acting nitrates.
3. Beta-blockers. (See WARNINGS and PRECAUTIONS).
4. Antihypertensives. CARDIZEM CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of CARDIZEM CD or the concomitant antihypertensives may need to be adjusted when adding one to the other.
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Physicians Total Care, Inc.
Cardizem Cd | Physicians Total Care, Inc.
Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.
Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Concomitant Use With Other Cardiovascular Agents Sublingual NTG. May be taken as required to abort acute anginal attacks during CARDIZEM CD (diltiazem hydrochloride) therapy. Prophylactic Nitrate Therapy. CARDIZEM CD may be safely coadministered with short- and long-acting nitrates. Beta-blockers (see WARNINGS and PRECAUTIONS). Antihypertensives. CARDIZEM CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of CARDIZEM CD or the concomitant antihypertensives may need to be adjusted when adding one to the other. -
Valeant Pharmaceuticals North America Llc
Cardizem Cd | Valeant Pharmaceuticals North America Llc
Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.
Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Concomitant Use With Other Cardiovascular Agents Sublingual NTG. May be taken as required to abort acute anginal attacks during CARDIZEM CD (diltiazem hydrochloride) therapy. Prophylactic Nitrate Therapy. CARDIZEM CD may be safely coadministered with short- and long-acting nitrates. Beta-blockers (see WARNINGS and PRECAUTIONS). Antihypertensives. CARDIZEM CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of CARDIZEM CD or the concomitant antihypertensives may need to be adjusted when adding one to the other. -
Bta Pharmaceuticals Inc.
Cardizem Cd | Bta Pharmaceuticals Inc.
Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.
Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Concomitant Use With Other Cardiovascular Agents Sublingual NTG. May be taken as required to abort acute anginal attacks during CARDIZEM CD (diltiazem hydrochloride) therapy. Prophylactic Nitrate Therapy. CARDIZEM CD may be safely coadministered with short- and long-acting nitrates. Beta-blockers (see WARNINGS and PRECAUTIONS). Antihypertensives. CARDIZEM CD has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of CARDIZEM CD or the concomitant antihypertensives may need to be adjusted when adding one to the other.
![Cardizem Cd (Diltiazem Hydrochloride) Capsule [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1b67a7ed-32e9-432a-962e-4a424b9f4610&name=2149.jpg)
![Cardizem Cd (Diltiazem Hydrochloride) Capsule, Coated, Extended Release [Valeant Pharmaceuticals North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1042fa13-e6af-46b9-8008-6c941f0978b1&name=cardizem-cd-02.jpg)
![Cardizem Cd (Diltiazem Hydrochloride) Capsule [Bta Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=867fd84c-902e-4ddc-a3ec-2204c1de2c5e&name=cardizem-cd-02.jpg)
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