Nicardipine Hydrochloride (Page 3 of 5)

Nursing Mothers

Studies in rats have shown significant concentrations of nicardipine hydrochloride capsules 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 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 US 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.

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.