ResoundingHealth
Search
  
Basic Drug Info
Drug Name:nifedipine
Manufacturer:Actavis Elizabeth LLC
Other Info:



Clinical Trials:


Indications and Usage

l.

Vasospastic Angina:Nifedipine is indicated for the 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.

Nifedipine 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 blockers.ll.

Chronic Stable Angina (Classical Effort-Associated Angina):Nifedipine is indicated for the 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) nifedipine 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.

(See WARNINGS.)
Prinzmetal angina -- A clinical syndrome characterized by the development of CHEST PAIN at rest with concomitant transient ST segment elevation in the ELECTROCARDIOGRAM, but with preserved exercise capacity.

Angina Pectoris -- The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.

Coronary Artery Vasospasm -- Spasm of the large- or medium-sized coronary arteries.

Diseases, Obstructive --

Vasospasm -- spasm of the blood vessels resulting in decrease in their caliber.

Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Contraindications
Known hypersensitivity reaction to nifedipine.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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

These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment.

Although patients have rarely experienced excessive hypotension on nifedipine alone, this may be more common in patients on concomitant beta blocker therapy.

Although not approved for this purpose, nifedipine capsules have been used (orally and sublingually) for acute reduction of blood pressure.

Several well-documented reports describe cases of profound hypotension, myocardial infarction, and death when immediate-release nifedipine was used in this way.

Nifedipine capsules should not be used for the acute reduction of blood pressure.

Nifedipine capsules have also been used for the long-term control of essential hypertension, although no properly-controlled studies have been conducted to define an appropriate dose or dose interval for such treatment.

Nifedipine capsules should not be used for the control of essential hypertension.

Several well-controlled randomized trials studied the use of immediate-release nifedipine in patients who had just sustained myocardial infarctions.

In none of these trials did immediate-release nifedipine appear to provide any benefit.

In some of the trials, patients who received immediate-release nifedipine had significantly worse outcomes than patients who received placebo.

Nifedipine 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).

Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving nifedipine together with a beta-blocking agent who underwent coronary artery bypass surgery using high dose fentanyl anesthesia.

The interaction with high dose fentanyl appears to be due to the combination of nifedipine and a beta blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out.

In nifedipine treated patients where surgery using high dose-fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient's condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery.Increased Angina And/Or Myocardial Infarction: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 nifedipine or at the time of dosage increase.

The mechanism of this effect is not established.Beta Blocker Withdrawal:Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.

Initiation of nifedipine treatment will not prevent this occurrence and might be expected to exacerbate it by provoking reflex catecholamine release.

There have been occasional reports of increased angina in a setting of beta blocker withdrawal and nifedipine initiation.

It is important to taper beta blockers if possible, rather than stopping them abruptly before beginning nifedipine.Congestive Heart Failure: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.
Branded Drugs
The following US Branded drugs contain nifedipine


ADALAT -- BAYER PHARMACEUTICALS CORP

PROCARDIA -- PFIZER INC

ADALAT CC -- BAYER PHARMACEUTICALS CORP

AFEDITAB CR -- WATSON LABORATORIES INC

PROCARDIA XL -- PFIZER LABORATORIES DIV PFIZER INC


This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.