CARDIZEM LA is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

CARDIZEM LA is indicated for the management of chronic stable angina.

CARDIZEM LA Tablets are an extended release formulation intended for once-a-day administration. Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM LA Tablets once-a-day at the nearest equivalent total daily dose. Higher doses of CARDIZEM LA Tablets once-a-day dosage 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 the safety and efficacy of doses as high as 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. The tablet should be swallowed whole and not chewed or crushed.

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 dosage range studied in clinical trials was 120 to 540 mg once daily. The dosage may be titrated to a maximum of 540 mg daily.

CARDIZEM LA Tablets should be taken about the same time once each day either in the morning or at bedtime. The time of dosing should be considered when making dose adjustments based on trough effects.

Angina

Dosage for the treatment of angina should be individualized based on response. The initial dose of 180 mg once daily may be increased at intervals of 7 - 14 days if adequate response is not obtained. CARDIZEM LA doses above 360 mg appear to confer no additional benefit. CARDIZEM LA can be given once daily, either in the evening or in the morning.

Concomitant Use with Other Cardiovascular Agents

1. Sublingual NTG. May be taken as required to abort acute anginal attacks during Diltiazem Hydrochloride Extended-release therapy.
2. Prophylactic Nitrate Therapy. Diltiazem Hydrochloride Extended Release Tablets may be safely coadministered with short-and long-acting nitrates.
3. Beta-blockers. (see WARNINGS and PRECAUTIONS.)
4. Antihypertensives. CARDIZEM LA has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem Hydrochloride Extended Release Tablets or the concomitant antihypertensives may need to be adjusted when adding one to the other.

CARDIZEM LA is supplied as white, capsule-shaped tablets debossed with "B" on one side and the diltiazem content (mg) on the other.

Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Avoid excessive humidity and temperatures above 30°C (86°F).

Dispense in tight, light resistant container as defined in USP.

® Cardizem is a registered trademark of Biovail Laboratories International SRL. Manufactured By: Biovail Corporation Mississauga, ON L5N 8M5 Canada. Distributed By: Kos Pharmaceuticals, Inc. Cranbury, NJ 08512. Rev. 0406. FDA Rev date: 4/27/2007

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