DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Dilt-CD (Diltiazem Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications.

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) are 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 DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of DILT-CD (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 NTG

May be taken as required to abort acute anginal attacks during DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) therapy.

2. Prophylactic Nitrate Therapy

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) may be safely coadministered with short- and long-acting nitrates.

Beta-blockers

(See WARNINGS and PRECAUTIONS.)

4. Antihypertensives

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of DILT-CD (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

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 120 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO 007” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0007-2), bottles of 90 (NDC 60505-0007-4) and bottles of 500 (NDC 60505-0007-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 180 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light blue opaque cap. “APO 008” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0008-2), bottles of 90 (NDC 60505-0008-4) and bottles of 500 (NDC 60505-0008-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 240 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light blue opaque cap. “APO 009” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0009-2), bottles of 90 (NDC 60505-0009-4) and bottles of 500 (NDC 60505-0009-8).

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 300 mg are available for oral administration as hard gelatin capsules with a white opaque body and a light gray opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as bottles of 30 (NDC 60505-0010-2), bottles of 90 (NDC 60505-0010-4) and bottles of 500 (NDC 60505-0010-8).

Storage Conditions:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in a tight, light-resistant container [see USP].

APOTEX INC.

DILT-CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) (Once-a-day dosage) 

120 mg, 180 mg, 240 mg and 300 mg

Manufactured by:                  Manufactured for:

Apotex Inc.                           Apotex Corp.

Toronto, Ontario                   Weston, Florida

Canada M9L 1T9                  33326

Revised: November 2011

Rev. 2

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017