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[Diltiazem]


Indications & Dosage
INDICATIONS AND USAGE

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

Text Continues Below



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 war-ranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clin-ical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus brady-cardia 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.

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