AMLODIPINE- amlodipine besylate tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

State of Florida DOH Central Pharmacy

ІПН (Міжнародна Ім'я):

AMLODIPINE BESYLATE

Склад:

AMLODIPINE 10 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 <40%, amlodipine besylate tablets are 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.

Огляд продуктів:

Amlodipine besylate tablets, 2.5 mg are white to off-white colored, diamond-shaped, flat-faced, beveled-edge tablets, debossed with 568 on one side and plain on the other side: Amlodipine besylate tablets, 5 mg are white to off-white colored, octagonal, flat-faced, beveled-edge tablets, debossed with 569 on one side and plain on the other side: Amlodipine besylate tablets, 10 mg are white to off-white colored, circular, flat-faced, beveled-edge tablets, debossed with 570 on one side and plain on the other side: They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light and moisture Viagra ® is a registered trademark of Pfizer. Maalox ® is a registered trademark of Novartis. Manufactured by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

AMLODIPINE - AMLODIPINE BESYLATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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,
monobenzene-sulphonate. 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
tablets equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine for oral
administration. In addition to the
active ingredient, amlodipine besylate, each tablet contains the
following Inactive Ingredients: dibasic
calcium phosphate (anhydrous), butylated hydroxytoluene,
microcrystalline cellulose, sodium starch
glycolate, 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 compound
(pK =8.6), and its kinetic interaction with the calcium channel
receptor is characterized by a gra