Nicardipine Hydrochloride (Page 4 of 6)

Pregnancy

Pregnancy Category C

Nicardipine was embryocidal when administered orally to pregnant Japanese White rabbits, during organogenesis, at 150 mg/kg/day (a dose associated with marked body weight gain suppression in the treated doe) but not at 50 mg/kg/day (25 times the maximum recommended antianginal or antihypertensive dose in man). No adverse effects on the fetus were observed when New Zealand albino rabbits were treated, during organogenesis, with up to 100 mg nicardipine/kg/day (a dose associated with significant mortality in the treated doe). In pregnant rats administered nicardipine orally at up to 100 mg/kg/day (50 times the maximum recommended human dose) there was no evidence of embryolethality or teratogenicity. However, dystocia, reduced birth weights, reduced neonatal survival, and reduced neonatal weight gain were noted. There are no adequate and well-controlled studies in pregnant women. Nicardipine hydrochloride capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Studies in rats have shown significant concentrations of nicardipine in maternal milk following oral administration. For this reason it is recommended that women who wish to breastfeed should not take this drug.

Pediatric Use

Safety and efficacy in patients under the age of 18 have not been established.

Geriatric Use

Pharmacokinetic parameters did not differ between elderly hypertensive patients (≥65 years) and healthy controls after 1 week of nicardipine hydrochloride capsules treatment at 20 mg tid. Plasma nicardipine hydrochloride capsules concentrations in elderly hypertensive subjects were similar to plasma concentrations in healthy young adult subjects when nicardipine hydrochloride capsules were administered at doses of 10, 20, and 30 mg tid, suggesting that the pharmacokinetics of nicardipine hydrochloride capsules are similar in young and elderly hypertensive patients.

Clinical studies of nicardipine 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

In multiple-dose U.S. and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride capsules alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them. Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect. Most adverse effects were expected consequences of the vasodilator effects of nicardipine hydrochloride capsules.

Angina

The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride capsules (n=520) and placebo (n=310), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator (except for certain cardiovascular events that were recorded in a different category). Where the frequency of adverse effects for nicardipine hydrochloride capsules and placebo is similar, causal relationship is uncertain. The only dose-related effects were pedal edema and increased angina.

Table 2

Percent of Patients With Adverse Effects in Controlled Studies

(Incidence of Discontinuations Shown in Parentheses)

Adverse Experience

NICARDIPINE HYDROCHLORIDE CAPSULES

(n= 520)

PLACEBO

(n= 310)

Pedal Edema

7.1

(0)

0.3

(0)

Dizziness

6.9

(1.2)

0.6

(0)

Headache

6.4

(0.6)

2.6

(0)

Asthenia

5.8

(0.4)

2.6

(0)

Flushing

5.6

(0.4)

1.0

(0)

Increased Angina

5.6

(3.5)

4.2

(1.9)

Palpitations

3.3

(0.4)

0.0

(0)

Nausea

1.9

(0)

0.3

(0)

Dyspepsia

1.5

(0.6)

0.6

(0.3)

Dry Mouth

1.4

(0)

0.3

(0)

Somnolence

1.4

(0)

1.0

(0)

Rash

1.2

(0.2)

0.3

(0)

Tachycardia

1.2

(0.2)

0.6

(0)

Myalgia

1.0

(0)

0.0

(0)

Other Edema

1.0

(0)

0.0

(0)

Paresthesia

1.0

(0.2)

0.3

(0)

Sustained Tachycardia

0.8

(0.6)

0.0

(0)

Syncope

0.8

(0.2)

0.0

(0)

Constipation

0.6

(0.2)

0.6

(0)

Dyspnea

0.6

(0)

0.0

(0)

Abnormal ECG

0.6

(0.6)

0.0

(0)

Malaise

0.6

(0)

0.0

(0)

Nervousness

0.6

(0)

0.3

(0)

Tremor

0.6

(0)

0.0

(0)

In addition, adverse events were observed that are not readily distinguishable from the natural history of the atherosclerotic vascular disease in these patients. Adverse events in this category each occurred in <0.4% of patients receiving nicardipine hydrochloride capsules and included myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia, and ventricular tachycardia. It is possible that some of these events were drug-related.

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