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.
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.
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.
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.
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.
PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label
100 CapsulesRx only
|PROCARDIA nifedipine capsule|
|Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)|
|Pfizer Inc||943955690||ANALYSIS (0069-2600)|
|Pfizer Pharmaceuticals LLC||829084545||ANALYSIS (0069-2600), MANUFACTURE (0069-2600), API MANUFACTURE (0069-2600)|
|Pfizer Laboratories Div Pfizer Inc||001147495||ANALYSIS (0069-2600)|
Revised: 06/2021 Pfizer Laboratories Div Pfizer Inc
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