Indicated for:

Vasospastic Angina:

• Management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. PROCARDIA may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blocker.

Chronic Stable Angina (Classical Effort-Associated Angina):

• Management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina), PROCARDIA has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete.

Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs–Rarely, patients, particularly those who have severe obstructive coronary artery disease, have developed well documented increased frequency, duration, and/or severity of angina or acute myocardial infarction on starting PROCARDIA or at the time of dosage increase.

PROCARDIA capsules should not be administered within the first week or two after myocardial infarction, and they should also be avoided in the setting of acute coronary syndrome (when infarction may be imminent).

Because PROCARDIA decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of PROCARDIA is suggested.

Although, in most patients, the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension.

Very rarely, introduction of PROCARDIA therapy was associated with an increase in anginal pain, possibly due to associated hypotension. Transient unilateral loss of vision has also occurred.

Rarely, patients, usually receiving a beta blocker, have developed heart failure after beginning nifedipine. Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit to these patients, owing to their fixed impedance to flow across the aortic valve.

In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by nifedipine. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.

Mild to moderate peripheral edema, typically associated with arterial vasodilation and not due to left ventricular dysfunction, occurs in about one in ten patients treated with nifedipine. This edema occurs primarily in the lower extremities and usually responds to diuretic therapy.

Positive direct Coombs Test with/without hemolytic anemia has been reported but a causal relationship between nifedipine administration and positivity of this laboratory test, including hemolysis, could not be determined.

Since there have been isolated reports of patients with elevated digoxin levels, and since there is a possible interaction between digoxin and nifedipine, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing nifedipine to avoid possible over- or under-digitalization.

Avoid co-administration of nifedipine with phenytoin or any known CYP3A4 inducer or consider an alternative antihypertensive therapy.

CYP3A inhibitors such as fluconazole, itraconazole, clarithromycin, erythromycin, nefazodone, fluoxetine, saquinavir, indinavir, and nelfinavir may result in increased exposure to nifedipine when co-administered.

Avoid ingestion of grapefruit and grapefruit juice while taking nifedipine.

Concomitant administration of nifedipine and beta-blocking agents is usually well tolerated, but there have been occasional literature reports suggesting that the combination may increase the likelihood of congestive heart failure, severe hypotension or exacerbation of angina.

There have been rare reports of an interaction between quinidine and nifedipine (with a decreased plasma level of quinidine).

There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered. However, the relationship to nifedipine therapy is uncertain.

Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT and SGPT have been noted.

There are no adequate and well-controlled studies in pregnant women. Animal studies: embryotoxic, placentotoxic, and fetotoxic effects, including stunted fetuses, rib deformities, cleft palate, small placentas and underdeveloped chorionic villi, embryonic and fetal deaths, and prolonged pregnancy/decreased neonatal survival.

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• Dosage greater than 120 mg daily. GoToSource

• Use in patients under the age of 18. GoToSource

• Iron overload. GoToSource

• Hypertensive emergencies associated with pregnancy. GoToSource

• Neuroleptic-induced tardive dyskinesia. GoToSource 

• Reduce risk of multiple thrombo-emboli in patients with systemic sclerosis. GoToSource

• Prevention and treatment of cognitive decline and dementia. GoToSource

• Use with prednisolone for expulsion of radiopaque ureteral stones. GoToSource

• Treatment of alcohol detoxification. GoToSource

• Raynaud’s phenomenon. GoToSource

• High altitude pulmonary edema. GoToSource

• Management of preterm labor. GoToSource

• Intractable hiccups. GoToSource

• Prevention of migraines. GoToSource

• Diabetic nephropathy. GoToSource

Male infertility. GoToSource

Gingival overgrowth. GoToSource

Increased risk of stroke in elderly hypertensive patients. GoToSource

Severe muscle cramps. GoToSource

Peripheral edema (swelling from fluid accumulation in body tissues), hypotension (low blood pressure), constipation, polyuria (excessive passage of urine), gastrointestinal hemorrhage and acute myocardial infarction. GoToSource

Invasive breast cancers in postmenopausal women. GoToSource

Stevens-johnson syndrome and erythema multiforme (severe skin reactions). GoToSource

Lip cancer. GoToSource 

Gynecomastia (swelling of male breast tissue). GoToSource

Lawsuits filed for stevens-johnson syndrome.