Tiazac Indications, Dosage, Storage, Stability - Diltiazem Hcl

Tiazac Indications, Dosage, Storage, Stability - Diltiazem Hcl

INDICATIONS AND USAGE

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

Tiazac® is indicated for the treatment of chronic stable angina.

Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, usual starting doses are 120 to 240 mg once daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 120 to 540 mg once daily. Current clinical experience with 540 mg dose is limited; however, the dose may be increased to 540 mg once daily.

Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 mg to 180 mg once daily. Individual patients may respond to higher doses of up to 540 mg once daily. When necessary, titration should be carried out over 7 to 14 days.

1. Sublingual Nitroglycerin may be taken as required to abort acute angi-nal attacks during diltiazem hydrochloride therapy.

2. Prophylactic Nitrate Therapy - Diltiazem hydrochloride may be safely co-administered with short- and long-acting nitrates.

3. Beta-blockers. (See WARNINGS and PRECAUTIONS.)

4. Antihypertensives — Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other. Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Tiazac® capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.

Tiazac® (diltiazem hydrochloride) Extended-release Capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. Any capsule contents/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a Tiazac® (diltiazem hydrochloride) Extended-release Capsule is not recommended.

Tiazac® (diltiazem hydrochloride) Extended Release Capsules

Storage conditions: Store at controlled room temperature 20°-25°C (68°-77°F).

Avoid excessive humidity.

Manufactured by: Biovail Corporation, Mississauga, Ontario CANADA L5N 8M5

Manufactured for:Forest Pharmaceuticals,Inc., Subsidiary of Forest Laboratories, Inc. St.Louis, Missouri 63045, Rev.07/03 LB0001-08