NIFEDICAL XL- nifedipine tablet, film coated, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)

Inapatikana kutoka:

Cardinal Health

INN (Jina la Kimataifa):

NIFEDIPINE

Tungo:

NIFEDIPINE 60 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Nifedical XL® tablets are 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. Nifedical XL® tablets 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 unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. Nifedical XL® tablets are indicated for the management of chronic stable angina (effort-associated angin

Bidhaa muhtasari:

Nifedical XL® Extended-release Tablets, USP, are supplied as 30 and 60 mg reddish brown, unscored, film-coated, round tablets, debossed with "B" on one side and "30" or "60" on the other. Nifedical XL® Extended-release Tablets, USP, are supplied in: Strength Bottles of 100 30 mg NDC 0093-0819-01 Bottles of 300 30 mg NDC 0093-0819-55 Bottles of 100 60 mg NDC 0093-5173-01 Bottles of 300 60 mg NDC 0093-5173-55 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Protect from moisture and humidity. Dispense in a tight, light-resistant container. Packed with desiccant.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

NIFEDICAL XL- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
CARDINAL HEALTH
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NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED EXTENDED RELEASE USP
Rx only
For Oral use
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as the calcium channel
blockers. Nifedipine is 3,5-pyridinedicarboxylic acid,
1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-,
dimethyl ester, C
H N O , and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in
water but soluble in ethanol. It has
a molecular weight of 346.3. Each extended-release tablet, formulated
as a once-a-day controlled
release tablet for oral administration, delivers 30 or 60 mg of
nifedipine.
In addition, each extended-release tablet contains the following
inactive ingredients: anhydrous lactose,
colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose,
hypromellose, magnesium stearate,
methacrylic acid copolymer type A, methacrylic acid copolymer type B,
microcrystalline cellulose,
polyethylene glycol, red ferric oxide, sodium lauryl sulfate, talc and
titanium dioxide.
Nifedipine Extended-release Tablets meet USP Dissolution Test 3.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist) and inhibits
the transmembrane influx of calcium ions into cardiac muscle and
smooth muscle. The contractile
processes of cardiac muscle and vascular smooth muscle are dependent
upon the movement of
extracellular calcium ions into these cells through specific ion
channels. Nifedipine selectively inhibits
calcium ion influx across the cell membrane of cardiac muscle and
vascular smooth muscle without
altering serum calcium concentrations.
MECHANISM OF ACTION
A) ANGINA
The precise mechanisms by which inhibition of calcium influx relieves
angina has not been fully
determined, but includes at least the following two mechanisms:
1) RELAXATION AND PREVENTION OF CORONARY ARTERY SPASM
Nifedipine dilates the main coronary arteries and coronary ar