Cardizem LA

CARDIZEM LA- diltiazem hydrochloride tablet, extended release
Valeant Pharmaceuticals North America LLC

1 INDICATIONS AND USAGE

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 guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

CARDIZEM LA may be used alone or in combination with other antihypertensive medications.

1.2 Angina

CARDIZEM LA is indicated to improve exercise tolerance in patients with chronic stable angina.

2 DOSAGE AND ADMINISTRATION

Take CARDIZEM LA once a day at approximately the same time. Do not chew or crush the tablet.

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 doses of CARDIZEM LA may be needed in some patients based on clinical response.

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets with 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, or 420 mg diltiazem hydrochloride per tablet. CARDIZEM LA Tablets are white, capsule-shaped, and debossed with “B” on one side and the diltiazem content (mg) on the other.

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.

5 WARNINGS AND PRECAUTIONS

5.1 Bradycardia or AV Block

CARDIZEM LA may cause abnormally slow heart rates or second- or third-degree AV block. Patients with sick sinus syndrome are at increased risk of bradycardia. 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 (6)]. Monitor for effects on heart rate and cardiac conduction.

5.2 Heart Failure

Worsening of heart failure has been reported in patients with impairment of ventricular function. Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited.

5.3 Acute Hepatic Injury

Significant elevations in liver enzymes such as alkaline phosphatase, LDH, AST (SGOT), ALT (SGPT) and signs of acute hepatic injury have been reported with diltiazem therapy. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have also been observed. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment.

5.4 Severe Skin Reactions

Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and/or exfoliative dermatitis have been reported.

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)]

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 plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg.

Placebo Diltiazem hydrochloride extended-release
Adverse Reactions (MedDRA Term) n=120 # pts. (%) 120-360 mg n=501 # pts. (%) 540 mg n=123 # pts. (%)

Edema lower limb

4 (3)

24 (5)

10 (8)

Sinus congestion

0 (0)

2 (1)

2 (2)

Rash

0 (0)

3 (1)

2 (2)

In the angina study, the adverse event profile of CARDIZEM LA was consistent with what has been previously described for CARDIZEM LA and other formulations of diltiazem HCl. The most frequent adverse effects experienced by CARDIZEM LA-treated patients were edema lower-limb (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), first-degree atrioventricular block (3.2%), and cough (2%).

In addition, the following events have been reported infrequently (less than 1%) in angina or hypertension trials:

Cardiovascular: Angina, bundle branch block, palpitations, syncope, tachycardia, ventricular extrasystoles [see Warnings and Precautions (5.1, 5.2)].

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus, urticaria [see Warnings and Precautions (5.4)].

Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

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