Isordil (Isosorbide Dinitrate) - Indications and Dosage

INDICATIONS AND USAGE

Isordil (isosorbide dinitrate) Titradose tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

DOSAGE AND ADMINISTRATION

As noted under " CLINICAL PHARMACOLOGY," multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isordil Titradose tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.

As also noted under " CLINICAL PHARMACOLOGY," the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Large controlled studies with other nitrates suggest that no dosing regimen with Isordil Titradose tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of Isordil Titradose is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.

HOW SUPPLIED

Isordil^® (isosorbide dinitrate) Oral Titradose™ Tablets are available as follows:

5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side:

NDC 64455-152-01, bottles of 100.

40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side:

NDC 64455-192-01, bottles of 100.

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15 -30° (59-86°F)

Protect from light.

Keep bottles tightly closed.

Dispense in a light-resistant, tight container.

Isordil^® is a registered trade mark of Biovail Laboratories International SRL.

Manufactured by:
MEDA Manufacturing GmbH
Cologne, Germany D-51063

For:
BTA Pharmaceuticals, Inc.
Bridgewater, NJ, 08807, USA

Tablets made in Germany.

LB0058-02    Rev. 09/08