Nicardipine Hydrochloride (Page 5 of 5)

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 and 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 safely coadministered with thiazide diuretics.
2.
Beta-blockers: Nicardipine hydrochloride capsules may be safely coadministered with beta-blockers (see Drug Interactions).

Special Patient Populations

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 Capsules 20 mg are available as hard gelatin capsules with an opaque light green cap and opaque light green body imprinted ‘ANI 205’ in black ink. They are supplied in bottles of 90 (NDC 62559-205-90).

Nicardipine Hydrochloride Capsules 30 mg are available as hard gelatin capsules with an opaque green cap and opaque light green body imprinted ‘ANI 206’ in black ink. They are supplied in bottles of 90 (NDC 62559-206-90).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and dispense in light-resistant containers.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc.

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
Logo

10623 Rev 12/22

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

niCARdipine Hydrochloride Capsules, 20 mg
NDC 62559-205 -90
Rx only
90 Capsules

Label-20mg
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

niCARdipine Hydrochloride Capsules, 30 mg
NDC 62559-206 -90
Rx only
90 Capsules

Label-30mg
(click image for full-size original)

NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-205
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
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C GREEN NO. 3
D&C YELLOW NO. 10
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color GREEN (Light green cap) , GREEN (light green body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code ANI;205
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-205-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074670 06/25/2021
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-206
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
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C GREEN NO. 3
D&C YELLOW NO. 10
FD&C BLUE NO. 1
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color GREEN (Green cap) , GREEN (Light green body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ANI;206
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-206-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074670 06/25/2021
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 04/2023 ANI Pharmaceuticals, Inc.

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