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Indications
Dosage
How Supplied

INDICATIONS

Diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) is indicated for the management of chronic stable angina and angina due to coronary artery spasm.

DOSAGE AND ADMINISTRATION

Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules USP (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 doses to 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.

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 usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.

Concomitant Use With Other Cardiovascular Agents

  1. Sublingual Nitroglycerin. May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules, (Once A Day Dosage) therapy.
  2. Prophylactic Nitrate Therapy. Diltiazem hydrochloride extended-release capsules, (Once A Day Dosage) may be safely coadministered with short- and long-acting nitrates.
  3. Beta-blockers. (See WARNINGS and PRECAUTIONS.)
  4. Antihypertensives. Diltiazem hydrochloride extended-release capsules (Once A Day Dosage) have an additive antihypertensive effect when used with other antihypertensive agents.

Therefore, the dosage of diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) or the concomitant antihypertensives may need to be adjusted when adding one to the other.

HOW SUPPLIED

Diltiazem Hydrochloride Extended-release Capsules USP (Once-a-day dosage)

Strength Qty. NDC# Description
120 mg 7's 62037-597-07 White/orange opaque capsule imprinted with “Andrx 597” on one end and “120 mg” on the other.
30's 62037-597-30
90's 62037-597-90
500's 62037-597-05
1000's 62037-597-10
180 mg 7's 62037-598-07 Yellow/orange opaque capsules imprinted with “Andrx 598” on one end and &lduqo;180 mg” on the other.
30's 62037-598-30
90's 62037-598-90
500's 62037-598-05
1000's 62037-598-10
240 mg 7's 62037-599-07 Light Brown/orange opaque capsules imprinted with “Andrx 599” on one end and &lduqo;240 mg” on the other.
30's 62037-599-30
90's 62037-599-90
500's 62037-599-05
1000's 62037-599-10
300 mg 7's 62037-600-07 Orange/orange opaque capsules imprinted with “Andrx 600” on one end and “300 mg” on the other.
30's 62037-600-30
90's 62037-600-90
500's 62037-600-05
1000's 62037-600-10

NOTE: THE PRODUCT MAY HAVE AN ODOR.

Storage Conditions

Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP]

Avoid excessive humidity.

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

Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA. Distributed by: Watson Pharma, Inc., Rev. date: 12/06.

Last reviewed on RxList: 1/19/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Hypertension

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