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Tiazac

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Tiazac

INDICATIONS

Hypertension

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

Chronic Stable Angina

Tiazac (diltiazem hcl) is indicated for the treatment of chronic stable angina.

DOSAGE AND ADMINISTRATION

Hypertension

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.

Angina

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.

Concomitant use with Other Cardiovascular Agents

  1. Sublingual Nitroglycerin (NTG): May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.
  2. Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered 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 (diltiazem hcl) 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.

Sprinkling the Capsule Contents on Food

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.

HOW SUPPLIED

Tiazac® (diltiazem hydrochloride) Extended-Release Capsules

Strength Description Quantity NDC#
120 mg #3 lavender/lavender capsule
imprinted: Tiazac 120
7's 0456-2612-07
30's 0456-2612-30
90's 0456-2612-90
1000's 0456-2612-00
HUD's 0456-2612-63
180 mg #2 white/blue-green capsule
imprinted: Tiazac 180
7's 0456-2613-07
30's 0456-2613-30
90's 0456-2613-90
1000's 0456-2613-00
HUD's 0456-2613-63
240 mg #1 blue-green/lavender capsule
imprinted: Tiazac 240
7's 0456-2614-07
30's 0456-2614-30
90's 0456-2614-90
1000's 0456-2614-00
HUD's 0456-2614-63
300 mg #0 white/lavender capsule
imprinted: Tiazac 300
7's 0456-2615-07
30's 0456-2615-30
90's 0456-2615-90
1000's 0456-2615-00
HUD's 0456-2615-63
360 mg #0 blue-green/blue-green capsule
imprinted: Tiazac 360
7's 0456-2616-07
30's 0456-2616-30
90's 0456-2616-90
1000's 0456-2616-00
HUD's 0456-2616-63
420 mg #00 white/white capsule
imprinted: Tiazac 420
7's 0456-2617-07
30's 0456-2617-30
90's 0456-2617-90
1000's 0456-2617-00

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.

Manufactured by: Biovail Laboratories International SRL, Street B #34, Sabano Abajo Industrial Park, Carolina, PR 00983 OR Biovail Corporation, Mississauga, Ontario, Canada L5N 8M5. Manufactured for: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. Rev. 04/10

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.

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