AMLODIPINE BESYLATE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Amlodipine Besylate (UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)

Verfügbar ab:

Dr Reddy's Laboratories

INN (Internationale Bezeichnung):

Amlodipine Besylate

Zusammensetzung:

Amlodipine Besylate 2.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Amlodipine besylate tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal drugs. Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

Produktbesonderheiten:

Amlodipine besylate tablets 2.5 mg (amlodipine besylate equivalent to 2.5 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed "RDY" on one side and "269" on other side and are supplied in bottles of 90, 100, 500 and unit dose packages of 100 (10 × 10).   Bottles of 90                            NDC 55111-269-90   Bottles of 100                          NDC 55111-269-01   Bottles of 500                          NDC 55111-269-05   Unit dose packages of 100       NDC 55111-269-78 Amlodipine besylate tablets 5 mg (amlodipine besylate equivalent to 5 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed "RDY" on one side and "270" on other side and are supplied in bottles of 90, 100, 300, 500 and unit dose packages of 100 (10 × 10).   Bottles of 90                            NDC 55111-270-90   Bottles of 100                          NDC 55111-270-01   Bottles of 300                          NDC 55111-270-03   Bottles of 500                          NDC 55111-270-05   Unit dose packages of 100       NDC 55111-270-78 Amlodipine besylate tablets 10 mg (amlodipine besylate equivalent to 10 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed "RDY" on one side and "271" on other side and are supplied in bottles of 90, 100, 500 and unit dose packages of 100 (10 × 10).   Bottles of 90                            NDC 55111-271-90   Bottles of 100                          NDC 55111-271-01   Bottles of 500                          NDC 55111-271-05   Unit dose packages of 100       NDC 55111-271-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
DR REDDY'S LABORATORIES
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AMLODIPINE BESYLATE TABLETS
DESCRIPTION
Amlodipine besylate is the besylate salt of amlodipine, a long-acting
calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl
(±)-2-[(2-aminoethoxy)methyl]-4-(2-
chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate,
monobenzenesulphonate. Its molecular
formula is C
H ClN O •C H O S, and its structural formula is:
Amlodipine besylate is a white crystalline powder with a molecular
weight of 567.1. It is slightly
soluble in water and sparingly soluble in ethanol. Amlodipine besylate
tablets are formulated as white
tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral
administration. In addition to the active
ingredient, amlodipine besylate, each tablet contains the following
inactive ingredients: colloidal
silicon dioxide, magnesium stearate, microcrystalline cellulose and
sodium starch glycolate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Amlodipine is a dihydropyridine calcium antagonist (calcium ion
antagonist or slow-channel blocker)
that inhibits the transmembrane influx of calcium ions into vascular
smooth muscle and cardiac muscle.
Experimental data suggest that amlodipine binds to both
dihydropyridine and nondihydropyridine binding
sites. 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. Amlodipine
inhibits calcium ion influx across cell membranes selectively, with a
greater effect on vascular smooth
muscle cells than on cardiac muscle cells. Negative inotropic effects
can be detected _in vitro _but such
effects have not been seen in intact animals at therapeutic doses.
Serum calcium concentration is not
affected by amlodipine. Within the physiologic pH range, amlodipine is
an ionized compound
(pKa=8.6), and its kinetic interaction with the calcium channel
receptor is characterized by a gradual rate
20
25
2
5