AMLODIPINE BESYLATE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

AMLODIPINE BESYLATE

Kompozīcija:

AMLODIPINE 2.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Amlodipine is contraindicated in patients with known sensitivity to amlodipine.

Produktu pārskats:

Amlodipine besylate tablets 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white to off-white circular, beveled-edged, uncoated tablets with ‘G’ debossed on one side and ‘58’ on the other side. Amlodipine besylate tablets 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as white to off-white circular, beveled-edged, uncoated tablets with ‘G58’ debossed on one side and ‘5’ on the other side. Amlodipine besylate tablets 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as white to off-white circular, beveled-edged, uncoated tablets with ‘G58’ debossed on one side and ‘10’ on the other side. Store at 20° - 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). Viagra® is a registered trademark of Pfizer. Maalox® is a registered trademark of Novartis. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkgenerics.com April 2009 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, OK     74146

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMLODIPINE BESYLATE - AMLODIPINE BESYLATE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
Amlodipine 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 CIN 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 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, corn starch, 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
20
25
2
5
6
6
3
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
(pK =8.6), and its kinetic interaction with the calcium channel
receptor is characterized by a gradual rate
of association a