AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

amlodipine besylate (UNII: 864V2Q084H) (amlodipine - UNII:1J444QC288), atorvastatin calcium (UNII: 48A5M73Z4Q) (atorvastatin - UNII:A0JWA85V8F)

Dostępny od:

Physicians Total Care, Inc.

INN (International Nazwa):

amlodipine besylate

Skład:

amlodipine 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Amlodipine besylate/atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. AND Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, the atorvastatin component of amlodipine besylate/atorvastatin calcium tablets can be started simultaneously with diet restriction. - Reduce the risk of myocardial infarction - Reduce the risk of stroke - Reduce the risk for revascularization procedures and angina - Reduce the risk of myocardial infarction - Reduce the risk of stroke; - Reduce the risk of non-fatal myocardial infarction - Reduce the risk of fatal

Podsumowanie produktu:

Amlodipine besylate/atorvastatin calcium tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below. Amlodipine besylate/atorvastatin calcium tablets are differentiated by tablet color/size and have a unique number on one side and are blank on the other side. Amlodipine besylate/atorvastatin calcium tablets are supplied for oral administration in the following strengths and package configurations: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM - AMLODIPINE BESYLATE AND
ATORVASTATIN CALCIUM TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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AMLODIPINE BESYLATE/ATORVASTATIN CALCIUM TABLETS
DESCRIPTION
Amlodipine besylate/atorvastatin calcium tablets combine the calcium
channel blocker amlodipine
besylate with the lipid-lowering agent atorvastatin calcium.
The amlodipine besylate component of amlodipine besylate/atorvastatin
calcium tablets is chemically
described as 3-ethyl-5-methyl
(±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-
methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical
formula is
C
H ClN O •C H O S.
The atorvastatin calcium component of amlodipine besylate/atorvastatin
calcium tablets is chemically
described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß,
δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-
[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt
(2:1) trihydrate. Its empirical
formula is (C
H FN O ) Ca•3H O.
The structural formulae for amlodipine besylate and atorvastatin
calcium are shown below.
Amlodipine besylate
Atorvastatin calcium
Amlodipine besylate/atorvastatin calcium tablets contain amlodipine
besylate, a white to off-white
crystalline powder, and atorvastatin calcium, also a white to
off-white crystalline powder. Amlodipine
besylate has a molecular weight of 567.1 and atorvastatin calcium has
a molecular weight of 1209.42.
Amlodipine besylate is slightly soluble in water and sparingly soluble
in ethanol. Atorvastatin calcium
is insoluble in aqueous solutions of pH 4 and below. Atorvastatin
calcium is very slightly soluble in
distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly
soluble in ethanol, and freely soluble
in methanol.
Amlodipine besylate/atorvastatin calcium tablets are formulated for
oral administration in the following
strength combinations:
TABLE 1. AMLODIPINE BESYLATE/ATORVASTATIN CALCIUM TABLET STRENGTHS
20
25
2
5
6
6
3
33
34
2
5 2
2
2.5 MG/
10MG
2.5 MG/
20MG
2.5 MG/
40MG
5
MG/10
MG
5
MG/20
MG
5
MG/40