Cardizem (Diltiazem Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

CARDIZEM is indicated for the management of chronic stable angina and angina due to coronary artery spasm.

DOSAGE AND ADMINISTRATION

Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm

Dosage must be adjusted to each patient's needs. Starting with 30 mg four times daily, before meals, and at bedtime, dosage should be increased gradually (given in divided doses three or four times daily) at 1- to 2-day intervals until optimum response is obtained. Although individual patients may respond to any dosage level, the average optimum dosage range appears to be 180 to 360 mg/day. There are no available data concerning dosage requirements in patients with impaired renal or hepatic function. If the drug must be used in such patients, titration should be carried out with particular caution.

Concomitant Use With Other Cardiovascular Agents

• 1. Sublingual NTG may be taken as required to abort acute anginal attacks during CARDIZEM (diltiazem hydrochloride) therapy.
• 2. Prophylactic Nitrate Therapy. CARDIZEM may be safely coadministered with short- and long-acting nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination.
• 3. Beta-blockers. (See WARNINGS and PRECAUTIONS.)

HOW SUPPLIED

CARDIZEM 30-mg tablets are supplied in bottles of 100 (NDC 64455-771-47) and 500 (NDC 64455-771-55). Each green tablet is engraved with MARION on one side and 1771 on the other.

CARDIZEM 60-mg scored tablets are supplied in bottles of 100 (NDC 64455-772-47) and 500 (NDC 64455-772-55). Each yellow tablet is engraved with MARION on one side and 1772 on the other.

CARDIZEM 90-mg scored tablets are supplied in bottles of 100 (NDC 64455-791-47). Each green oblong tablet is engraved with CARDIZEM on one side and 90 mg on the other.

CARDIZEM 120-mg scored tablets are supplied in bottles of 100 (NDC 64455-792-47). Each yellow oblong tablet is engraved with CARDIZEM on one side and 120 mg on the other.

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

Avoid excessive humidity.

Prescribing Information as of August 2001

®Cardizem is a registered trademark of Biovail Laboratories Incorporated

Manufactured by:
Aventis Pharmaceuticals Inc.
Kansas City, MO, 64137, USA

Distributed by:
Biovail Pharmaceuticals, Inc.
Bridgewater, NJ, 08807, USA

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