Nicardipine Hydrochloride (Page 5 of 5)

Rare Events

The following rare adverse events have been reported in clinical trials or the literature:

Body as a Whole: infection, allergic reaction

Cardiovascular: hypotension, postural hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia

Digestive: sore throat, abnormal liver chemistries

Musculoskeletal: arthralgia

Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety

Respiratory: rhinitis, sinusitis

Special Senses: tinnitus, abnormal vision, blurred vision

Urogenital: increased urinary frequency

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 post treatment.

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 three days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady state plasma drug concentrations.

Concomitant Use With Other Antianginal Agents

  1. Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine therapy.
  2. Prophylactic Nitrate Therapy- nicardipine may be safely coadministered with short- and long-acting nitrates
  3. Beta-blockers- nicardipine may be safely coadministered with beta-blockers. (See PRECAUTIONS, Drug Interactions.)

Hypertension

The dose of nicardipine hydrochloride 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 pressures, INDICATIONS AND USAGE, CLINICAL PHARMACOLOGY, Effects in Hypertension.) At least three days should be allowed before increasing the nicardipine dose to ensure achievement of steady state plasma drug concentrations.

Concomitant use with other Antihypertensive Agents

  1. Diuretics- nicardipine may be safely coadministered with thiazide diuretics.
  2. Beta-blockers- nicardipine may be safely coadministered with beta-blockers. (See PRECAUTIONS, Drug Interactions.)

Special Patient Populations

Renal Insufficiency — although there is no evidence that nicardipine impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS.)

Hepatic Insufficiency — nicardipine 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 dosage in patients with congestive heart failure. (See WARNINGS.)

HOW SUPPLIED

Nicardipine hydrochloride 20 mg capsules are available in opaque white/light blue hard gelatin capsules printed “G” on the cap and “0041” on the capsule body. These are supplied in bottles of 100 (NDC 55567-041-18), bottles of 500 (NDC 55567-041-25) and in cartons of 100 unit dose blister packages (NDC 55567-041-06).

Nicardipine hydrochloride 30 mg capsules are available in opaque light blue hard gelatin capsules printed “G” on the cap and “0042” on the capsule body. These are supplied in bottles of 100 (NDC 55567-042-18), bottles of 500 (NDC 55567-042-25) and in cartons of 100 unit dose blister packages (NDC 55567-042-06).

Store bottles at room temperature between 15° and 30°C (59° and 86°F) [see USP] and dispense in tight, light resistant containers.

To protect from light, product should remain in manufacture’s package until consumed.

Rx only.

Manufactured by:

GENPHARM INC.

Toronto, Canada

M8Z 2S6

Rev August, 2001

003-168 REV.#04

NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicardipine Hydrochloride (Nicardipine) Nicardipine 20 mg
Inactive Ingredients
Ingredient Name Strength
D&C Yellow #10
FD&C Blue #1
FD&C Blue #1
FD&C Blue #2
FD&C Red #40
gelatin
magnesium stearate
pregelatinized starch
titanium dioxide
Product Characteristics
Color WHITE, BLUE Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G;0041
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-041-18 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:55567-041-25 500 CAPSULE (500 CAPSULE) in 1 BOTTLE None
3 NDC:55567-041-06 100 CAPSULE (100 CAPSULE) in 1 BLISTER PACK None
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-042
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicardipine Hydrochloride (Nicardipine) Nicardipine 30 mg
Inactive Ingredients
Ingredient Name Strength
D&C Yellow #10
FD&C Blue #1
FD&C Blue #1
FD&C Blue #2
FD&C Red #40
gelatin
magnesium stearate
pregelatinized starch
titanium dioxide
Product Characteristics
Color BLUE Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code G;0042
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-042-06 100 CAPSULE (100 CAPSULE) in 1 BLISTER PACK None
2 NDC:55567-042-25 500 CAPSULE (500 CAPSULE) in 1 BOTTLE None
3 NDC:55567-042-18 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
Labeler — GENPHARM INC.

Revised: 11/2006 GENPHARM INC.

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