Diltiazem Hydrochloride (Page 4 of 6)

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Serious adverse reactions have been rare in studies with diltiazem hydrochloride extended-release capsules USP (once-a-day dosage), as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) ranging from 120 to 540 mg once daily. Two patients experienced first-degree AV block at the 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS*

Adverse Events

(COSTART Term)

Placebo

n=57

# pts (%)

Diltiazem Hydrochloride Extended-Release Capsules USP

(Once-a-Day Dosage)

up to 360 mg

n = 149

# pts (%)

480-540 mg

n = 48

# pts (%)

edema, peripheral

1 (2)

8 (5)

7 (15)

dizziness

4 (7)

6 (4)

2 (4)

vasoldilation

1 (2)

5 (3)

1 (2)

dyspepsia

0 (0)

7 (5)

0 (0)

pharyngitis

2 (4)

3 (2)

3 (6)

rash

0 (0)

3 (2)

0 (0)

infection

2 (4)

2 (1)

3 (6)

diarrhea

0 (0)

2 (1)

1 (2)

palpitations

0 (0)

2 (1)

1 (2)

nervousness

0 (0)

3 (2)

0 (0)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS*

Adverse Events

(COSTART Term)

Placebo

n=50

# pts (%)

Diltiazem Hydrochloride Extended-Release Capsules USP

(Once-a-Day Dosage)

up to 360 mg

n = 158

# pts (%)

540 mg

n = 49

# pts (%)

headache

1 (2)

13 (8)

4 (8)

edema, peripheral

1 (2)

3 (2)

5 (10)

pain

1 (2)

10 (6)

3 (6)

dizziness

0 (0)

5 (3)

5 (10)

asthenia

0 (0)

1 (1)

2 (4)

dyspepsia

0 (0)

2 (1)

3 (6)

dyspnea

0 (0)

1 (1)

3 (6)

bronchitis

0 (0)

1 (1)

2 (4)

AV block

0 (0)

0 (0)

2 (4)

infection

0 (0)

2 (1)

1 (2)

flu syndrome

0 (0)

0 (0)

1 (2)

cough increase

0 (0)

2 (1)

1 (2)

extrasystoles

0 (0)

0 (0)

1 (2)

gout

0 (0)

2 (1)

1 (2)

myalgia

0 (0)

0 (0)

1 (2)

impotence

0 (0)

0 (0)

1 (2)

conjunctivitis

0 (0)

0 (0)

1 (2)

rash

0 (0)

2 (1)

1 (2)

abdominal enlargement

0 (0)

0 (0)

1 (2)

*Adverse events occurring in treated patients at 2% or more than placebo-treated patients.

In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:

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