Prescription Drug Information: Procardia (Page 3 of 3)

OVERDOSAGE

Experience with nifedipine overdosage is limited. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, and judicious use of calcium infusion, pressor agents, and fluids. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.

DOSAGE AND ADMINISTRATION

The dosage of PROCARDIA needed to suppress angina and that can be tolerated by the patient must be established by titration. Excessive doses can result in hypotension.

Therapy should be initiated with the 10 mg capsule. The starting dose is one 10 mg capsule, swallowed whole, 3 times/day. The usual effective dose range is 10–20 mg three times daily. Some patients, especially those with evidence of coronary artery spasm, respond only to higher doses, more frequent administration, or both. In such patients, doses of 20–30 mg three or four times daily may be effective. Doses above 120 mg daily are rarely necessary. More than 180 mg per day is not recommended.

In most cases, PROCARDIA titration should proceed over a 7–14 day period so that the physician can assess the response to each dose level and monitor the blood pressure before proceeding to higher doses.

If symptoms so warrant, titration may proceed more rapidly provided that the patient is assessed frequently. Based on the patient’s physical activity level, attack frequency, and sublingual nitroglycerin consumption, the dose of PROCARDIA may be increased from 10 mg t.i.d. to 20 mg t.i.d. and then to 30 mg t.i.d. over a three-day period.

In hospitalized patients under close observation, the dose may be increased in 10 mg increments over four- to six-hour periods as required to control pain and arrhythmias due to ischemia. A single dose should rarely exceed 30 mg.

Avoid co-administration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).

No “rebound effect” has been observed upon discontinuation of PROCARDIA. However, if discontinuation of PROCARDIA is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Co-Administration with Other Antianginal Drugs

Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during PROCARDIA titration. See PRECAUTIONS, Drug Interactions, for information on co-administration of PROCARDIA with beta blockers or long-acting nitrates.

HOW SUPPLIED

PROCARDIA soft gelatin capsules are supplied in:

Bottles of 100: 10 mg (NDC 0069-2600-66)

The capsules should be protected from light and moisture and stored at controlled room temperature, 59° to 77°F (15° to 25°C) in the manufacturer’s original container.

Logo

LAB-0178-7.0

July 2016

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

Pfizer
NDC 0069-2600-66

Procardia ®
nifedipine

10 mg

Capsules

100 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)
PROCARDIA nifedipine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2600
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
PEPPERMINT OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C YELLOW NO. 6
FERRIC OXIDE RED
WATER
SACCHARIN SODIUM
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code PROCARDIA;PFIZER;260
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-2600-66 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018482 12/31/1981 10/31/2021
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 943955690 ANALYSIS (0069-2600)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 ANALYSIS (0069-2600), MANUFACTURE (0069-2600), API MANUFACTURE (0069-2600)
Establishment
Name Address ID/FEI Operations
Pfizer Laboratories Div Pfizer Inc 001147495 ANALYSIS (0069-2600)

Revised: 06/2021 Pfizer Laboratories Div Pfizer Inc

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