Drugplain

Cardizem LA 420 mg/1

Diltiazem Hydrochloride · TABLET, EXTENDED RELEASE · Bausch Health US LLC

No Recall HistoryCurrently in Shortage
Plain English

Cardizem LA is a tablet, extended release containing diltiazem hydrochloride at 420 mg/1, taken oral. Manufactured by Bausch Health US LLC.

Key Facts

Brand Name
Cardizem LA
Generic Name
Diltiazem Hydrochloride
NDC Code (Product)
0187-2050
Manufacturer
Bausch Health US LLC
Strength
420 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA021392
Marketing Start
12/25/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,297 reports
pain1,179 reports
fatigue1,120 reports
fall1,051 reports
diarrhoea878 reports
headache877 reports
arthralgia876 reports
dizziness860 reports
hypotension836 reports
nausea833 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for: • treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1 ) • improving exercise tolerance in patients with chronic stable angina. ( 1.2 ) 1.1 Hypertension CARDIZEM ® LA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guid…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take CARDIZEM LA once a day at approximately the same time. Do not chew or crush the tablet. • Tablet should be swallowed whole and not chewed or crushed. ( 2 ) • Hypertension: Initial adult dose is 180 to 240 mg once daily. Adjust dose according to blood pressure response to a maximum of 540 mg daily. ( 2.1 ) • Angina: Initial adult dose is 180 mg once daily. Adjust dose according to response to a maximum of 360 mg. ( 2.2 ) • Switching to CARDIZEM LA: Patients may be switched to the nearest equivalent total daily diltiazem dose. ( 2.3 ) 2.1 Hypertension Initiate dosing at 180 to 240 mg once daily, although some patients may respond to lower doses. Titrate according to blood pressure to a maximum of 540 mg daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy. 2.2 Angina Initiate dosing at 180 mg once daily and increase dose at intervals of 7 to 14 days if adequate response is not obtained, to a maximum of 360 mg. 2.3 Switching to CARDIZEM LA Tablets Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM LA once a day at the nearest equivalent total daily dose. Higher…

Contraindications

4 CONTRAINDICATIONS CARDIZEM LA is contraindicated in: • Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Patients with hypotension (less than 90 mm Hg systolic). • Patients who have demonstrated hypersensitivity to the drug. • Patients with acute myocardial infarction and pulmonary. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. ( 4 ) • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. ( 4 ) • Hypotension (less than 90 mm Hg systolic). ( 4 ) • Hypersensitivity to the drug. ( 4 ) • Acute myocardial infarction and pulmonary. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Beta-blockers, digitalis, and other agents known to impair cardiac contractility and conduction may increase risk for hypotension, bradycardia, and heart failure. ( 7.1 ) • CYP450 3A4: Diltiazem is both a substrate and inhibitor of CYP450 3A4. CYP450 3A4 substrates may require dosage adjustment. ( 7.2 ) 7.1 Agents Known to Impair Cardiac Contractility and Conduction Using other agents known to affect cardiac conduction or contractility with diltiazem may increase the risk of bradycardia, AV block, and heart failure [see Warnings and Precautions ( 5.1 , 5.2 )] . Ivabradine: Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid concomitant use of ivabradine and diltiazem. 7.2 P-glycoprotein (P-gp) and Cytochrome P450 3A4 Mediated Drug Interactions Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways. Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes [see Clinical Pharmacology ( 12.3 )] .

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail, in other sections: • Bradycardia and AV block [see Warnings and Precautions ( 5.1 )] • Heart failure [see Warnings and Precautions ( 5.2 )] • Acute hepatic injury [see Warnings and Precautions ( 5.3 )] • Severe skin reactions [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (>2%) are lower limb edema, sinus congestion and rash in patients treated for hypertension, and lower limb edema, headache, dizziness, fatigue, bradycardia, first-degree AV block and cough in patients treated for angina. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. For the hypertension studies, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausib…

Frequently Asked Questions

What is Cardizem LA used for?

Cardizem LA contains Diltiazem Hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Cardizem LA a controlled substance?

Cardizem LA is not classified as a controlled substance by the DEA.

What is the generic name for Cardizem LA?

The generic name for Cardizem LA is Diltiazem Hydrochloride. There are 11 other brand versions of Diltiazem Hydrochloride.

What is the NDC code for Cardizem LA 420 mg/1?

The NDC (National Drug Code) for Cardizem LA 420 mg/1 is 0187-2050, listed by Bausch Health US LLC.

Product NDC

0187-2050

Package NDC

0187-2050-30

Other Cardizem LA Dosages

Other Diltiazem Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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