Nicardipine Hydrochloride (Page 6 of 6)

OVERDOSAGE

Overdosage with a 600-mg single dose (15 to 30 times normal clinical dose) has been reported. Marked hypotension (blood pressure unobtainable) and bradycardia (heart rate 20 bpm in normal sinus rhythm) occurred, along with drowsiness, confusion and slurred speech. Supportive treatment with a vasopressor resulted in gradual improvement with normal vital signs approximately 9 hours posttreatment.

Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine.

For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.

DOSAGE AND ADMINISTRATION

Angina

The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride capsuels dose to ensure achievement of steady-state plasma drug concentrations.

Concomitant Use With Other Antianginal Agents

  • Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine hydrochloride capsules therapy.
  • Prophylactic Nitrate Therapy: nicardipine hydrochloride capsules may be safely coadministered with short- and long-acting nitrates.
  • Beta-blockers: Nicardipine hydrochloride capsules may be safely coadministered with beta-blockers (see Drug Interactions).

Hypertension

The dose of nicardipine hydrochloride capsules should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy (see PRECAUTIONS: Blood Pressure, INDICATIONS AND USAGE, CLINICAL PHARMACOLOGY, Effects in Hypertension). At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules dose to ensure achievement of steady-state plasma drug concentrations.

Concomitant Use With Other Antihypertensive Agents

1. Diuretics: nicardipine hydrochloride capsules may be safety coadministered with thiazide diuretics.

2. Beta-blockers: nicardipine hydrochloride capsules may be safely coadministered with beta-blocker (see PRECAUTIONS, Drug Interactions).

Special Patient Population

Renal Insufficiency

Although there is no evidence that nicardipine hydrochloride capsules impair renal function, careful dose titration beginning with 20 mg tid is advised (see PRECAUTIONS).

Hepatic Insufficiency

Nicardipine hydrochloride capsules should be administered cautiously in patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule (see PRECAUTIONS).

Congestive Heart Failure

Caution is advised when titrating nicardipine hydrochloride capsules dosage in patients with congestive heart failure (see WARNINGS).

HOW SUPPLIED

Nicardipine hydrochloride 20 mg capsules are available in light blue opaque/white opaque hard gelatin capsules imprinted “E501” in black ink on cap and body, filled with yellow powder. These are supplied: NDC: 24658-750-90 Bottles of 90 Capsules

Nicardipine hydrochloride 30 mg capsules are available in light blue opaque hard gelatin capsules imprinted “E502” with black ink on cap and body, filled with yellow powder. These are supplied:

NDC 24658-751-90 Bottles of 90 Capsules

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

The brands listed are trademarks of their respective owners.

Distributed by

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Franklin, KY 42134 USA

1-877-264-0258

Manufactured in USA

Rev. 08-2017-00

MF501BLUREV08/17

OE2603

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg, 90 Count

Nicardipine Hydrochloride Capsules, 20 mg

Rx Only

90 Capsules

nicardipine-20mg-90ct
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 30 mg, 90 Count

Nicardipine Hydrochloride Capsules, 30 mg

Rx Only

90 Capsules

nicardipine-30mg-90ct
(click image for full-size original)
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE (NICARDIPINE) NICARDIPINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
Product Characteristics
Color blue (Light Blue Opaque) , white (White Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code E501
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-750-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074928 12/15/2016
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-751
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE (NICARDIPINE) NICARDIPINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color blue (Light Blue Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E501
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-751-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074928 12/15/2016
Labeler — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
Registrant — Epic Pharma, LLC (827915443)
Establishment
Name Address ID/FEI Operations
Epic Pharma, LLC 827915443 manufacture (24658-750), manufacture (24658-751)

Revised: 01/2019 PuraCap Laboratories LLC dba Blu Pharmaceuticals

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 © 2022. All Rights Reserved.