Diltiazem Hydrochloride (Page 5 of 6)

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 dosage range studied in clinical trials was 120 to 540 mg once daily. The dosage may be titrated to a maximum of 540 mg daily.

Diltiazem hydrochloride extended-release tablets should be taken about the same time once each day either in the morning or at bedtime. The time of dosing should be considered when making dose adjustments based on trough effects.

Angina

Dosage for the treatment of angina should be individualized based on response. The initial dose of 180 mg once daily may be increased at intervals of 7 to 14 days if adequate response is not obtained. Diltiazem hydrochloride extended-release tablets doses above 360 mg appear to confer no additional benefit.

Diltiazem hydrochloride extended-release tablets can be given once daily, either in the evening or in the morning.

Concomitant Use with Other Cardiovascular Agents

  1. Sublingual NTG. May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release therapy.
  2. Prophylactic Nitrate Therapy. Diltiazem hydrochloride extended-release tablets may be safely coadministered with short-and long-acting nitrates.
  3. Beta-blockers. (See WARNINGS and PRECAUTIONS.)
  4. Antihypertensives. Diltiazem hydrochloride extended-release tablets have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release tablets or the concomitant antihypertensives may need to be adjusted when adding one to the other.

HOW SUPPLIED

Diltiazem Hydrochloride Extended-release Tablets, 120 mg are supplied as white, capsule-shaped tablets debossed with “120” on one side and “Logo 690”on the other.

Diltiazem Hydrochloride Extended-release Tablets, 180 mg are supplied as white, capsule-shaped tablets debossed with “180” on one side and “Logo 691”on the other.

Diltiazem Hydrochloride Extended-release Tablets, 240 mg are supplied as white, capsule-shaped tablets debossed with “240” on one side and “Logo 692”on the other.

Diltiazem Hydrochloride Extended-release Tablets, 300 mg are supplied as white, capsule-shaped tablets debossed with “300” on one side and “Logo 693”on the other.

Diltiazem Hydrochloride Extended-release Tablets, 360 mg are supplied as white, capsule-shaped tablets debossed with “360” on one side and “Logo 694”on the other.

Diltiazem Hydrochloride Extended-release Tablets, 420 mg are supplied as white, capsule-shaped tablets debossed with “420” on one side and “Logo 695”on the other.

NDC # 62037-xxx-yy
Strength QTY 30 QTY 90 QTY 1000
120 mg 690-30 690-90 690-10
180 mg 691-30 691-90 691-10
240 mg 692-30 692-90 692-10
300 mg 693-30 693-90 693-10
360 mg 694-30 694-90 694-10
420 mg 695-30 695-90 695-10

Storage conditions: Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

Avoid excessive humidity and temperatures above 30°C (86°F).

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

Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA

Rev. date: 02/11 191716-1

PRINCIPAL DISPLAY PANEL

NDC 62037-690-90
Diltiazem HCL
ER Tablets
120 mg
90 TabletsRx only

NDC 62037-690-90
Diltiazem HCL 
ER Tablets
120 mg
90 Tablets
Rx only
(click image for full-size original)

NDC 62037-691-90
Diltiazem HCL
ER Tablets
180 mg
90 TabletsRx only

NDC 62037-691-90
Diltiazem HCL 
ER Tablets
180 mg
90 Tablets
Rx only
(click image for full-size original)

NDC 62037-692-90
Diltiazem HCL
ER Tablets
240 mg
90 TabletsRx only

NDC 62037-692-90
Diltiazem HCL 
ER Tablets
240 mg
90 Tablets
Rx only
(click image for full-size original)

NDC 62037-693-90
Diltiazem HCL
ER Tablets
300 mg
90 TabletsRx only

NDC 62037-693-90
Diltiazem HCL 
ER Tablets
300 mg
90 Tablets
Rx only
(click image for full-size original)

NDC 62037-694-90
Diltiazem HCL
ER Tablets
360 mg
90 TabletsRx only

NDC 62037-694-90
Diltiazem HCL 
ER Tablets
360 mg
90 Tablets
Rx only
(click image for full-size original)

NDC 62037-695-90
Diltiazem HCL
ER Tablets
420 mg
90 TabletsRx only

NDC 62037-695-90
Diltiazem HCL 
ER Tablets
420 mg
90 Tablets
Rx only
(click image for full-size original)

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