INDICATIONS
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, in the extended release tablets,
in unstable angina where electrocardiographic findings
are compatible with intermittent vasospasm), or when angina
is refractory to nitrates and/or adequate doses of beta
blockers.
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 8 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.)
Additional Information for Extended Release Tablets
Hypertension: Nifedipine is also indicated
for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive agents.
DOSAGE AND ADMINISTRATION
Immediate Release Capsules
The dosage of nifedipine 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
3 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 3 or 4 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, nifedipine 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
nifedipine may be increased from 10 mg tid to 20 mg tid
and then to 30 mg tid over a 3-day period.
In hospitalized patients under close observation, the
dose may be increased in 10 mg increments over 4- to 6-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 nifedipine. However, if discontinuation
of nifedipine 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 nifedipine titration. See DRUG INTERACTIONS for
information on co-administration of nifedipine with beta
blockers or long-acting nitrates.
Extended Release Tablets
Dosage must be adjusted according to each patient's needs.
Therapy for either hypertension or angina should be initiated
with 30 or 60 mg once daily. Nifedipine extended release
tablets should be swallowed whole and should not be bitten
or divided. In general, titration should proceed over
a 7-14 day period so that the physician can fully assess
the response to each dose level and monitor blood pressure
before proceeding to higher doses. Since steady-state
plasma levels are achieved on the second day of dosing,
if symptoms so warrant, titration may proceed more rapidly
provided the patient is assessed frequently. Titration
to doses above 120 mg are not recommended.
Angina patients controlled on nifedipine capsules alone
or in combination with other antianginal medications may
be safety switched to nifedipine extended release tablets
at the nearest equivalent total daily dose (e.g., 30 mg
tid of nifedipine capsules may be changed to 90 mg once
daily of nifedipine extended release tablets). Subsequent
titration to higher or lower doses may be necessary and
should be initiated as clinically warranted. Experience
with dose greater than 90 mg in patients with angina is
limited. Therefore, doses greater than 90 mg should be
used with caution and only when clinically warranted.
No "rebound effect" has been observed upon
discontinuation of nifedipine extended release tablets.
However, if discontinuation of nifedipine is necessary,
sound clinical practice suggests that the dosage should
be decreased gradually with close physician supervision.
Care should be taken when dispensing nifedipine to assure
that the extended release dosage form has been prescribed.
Co-administration With Other Antianginal Drugs:
Sublingual nitroglycerin may be taken as required
for the control of acute manifestations of angina, particularly
during nifedipine titration. See DRUG INTERACTIONS for
information on co-administration of nifedipine with beta
blockers or long-acting nitrates.
HOW SUPPLIED
Procardia Immediate Release Capsules
Procardia soft gelatin capsules are supplied as:
10 mg orange #260; 20 mg orange and light brown #261.
Storage: The capsules should be protected
from light and moisture and stored at controlled room
temperature 15- 25°C (59-77°F) in the manufacturer's
original container.
Procardia XL Extended Release Tablets
Procardia XL extended release tablets are supplied as
30 mg, 60 mg, and 90 mg round biconvex, rose-pink, film-coated
tablets.
Storage: Stored below 30°C (86°F)
Protect from moisture and humidity.
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