amlodipine besylate- Amlodipine Besylate tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Synthon Pharmaceuticals, Inc.

INN (Nama Internasional):

Amlodipine Besylate

Bentuk farmasi:

TABLET

Komposisi:

2.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Amlodipine besylate tablets, 2.5 mg , equivalent to 2.5 mg of amlodipine per tablet, are white to off-white, triangular, biconvex, unscored tablet, one side engraved "ADP bes" and the other side engraved with "2.5" and supplied as follows: Amlodipine besylate tablets, 5 mg , equivalent to 5 mg of amlodipine per tablet, are white to off-white, oblong, biconvex, unscored tablet, one side engraved with "ADP bes" and the other side engraved with "5" and supplied as follows: Amlodipine besylate tablets, 10 mg , equivalent to 10 mg of amlodipine per tablet, are white to off-white, round, biconvex, unscored tablet, one side engraved with "ADP bes" and the other side engraved with "10" and supplied as follows: Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature. Dispense in tight, light-resistant containers (USP).

Karakteristik produk

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
SYNTHON PHARMACEUTICALS, INC.
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AMLODIPINE BESYLATE TABLETS
PRESCRIBING INFORMATION
DESCRIPTION
Amlodipine besylate is a besylate salt of amlodipine, and is a
long-acting calcium channel blocker.
Amlodipine besylate monohydrate is chemically described as
3-Ethyl-5-methyl (±)-2-[(2-
aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate,
monobenzenesulphonate monohydrate. Its molecular formula is C
H ClN O •C H SO •H O and its
structural formula is:
Amlodipine besylate monohydrate is a white crystalline powder with a
molecular weight of 585.07. It is
slightly soluble in water, ethanol, acetone and 2-propanol and soluble
in N, N-dimethylformamide and
dimethylsulfoxide. Amlodipine besylate tablets are formulated as white
to off-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:
microcrystalline cellulose, sodium
starch glycolate, and magnesium stearate.
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 co