A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Caduet Online, Description, Chemistry, Ingredients - Amlodipine besylate/atorvastatin
Caduet Online, Description, Chemistry, Ingredients - Amlodipine besylate/atorvastatin
CADUETâ
(amlodipine besylate/atorvastatin calcium) Tablets
DESCRIPTION
CADUET® (amlodipine besylate and atorvastatin calcium)
tablets combine the long-acting calcium channel blocker amlodipine besylate
with the synthetic lipid-lowering agent atorvastatin calcium.
The amlodipine besylate component of CADUET 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 C20H25 ClN2O5•C6H 6O3S.
The atorvastatin calcium component of CADUET is chemically
described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, d-dihydroxy-5- (1-methylethyl)-3-phenyl-4-[ (phenylamino)carbonyl]-
1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula
is (C33H34 FN2O5)2Ca•3H20.
The structural formula for amlodipine besylate and atorvastatin calcium is:
CADUET contains 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.
CADUET tablets are formulated for oral administration in the
following strength combinations:
|
Table 1: CADUET Tablet Strengths
|
|
|
5mg/10mg
|
5mg/20mg
|
5mg/40mg
|
5mg/80mg
|
10mg/10mg
|
10mg/20mg
|
10mg/40mg
|
10mg/80mg
|
|
amlodipine equivalent (mg)
|
5
|
5
|
5
|
5
|
10
|
10
|
10
|
10
|
|
atorvastatin Equivalent (mg)
|
10
|
20
|
40
|
80
|
10
|
20
|
40
|
80
|
Each tablet also contains calcium carbonate, croscarmellose
sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl
cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium
stearate, Opadry® II White 85F28751 (polyvinyl alcohol, titanium dioxide,
PEG 3000 and talc) or Opadry® II Blue 85F10919 (polyvinyl alcohol, titanium
dioxide, PEG 3000, talc and FD&C blue #2). Combinations of atorvastatin
with 5 mg amlodipine are film coated white, and combinations of atorvastatin
with 10 mg amlodipine are film coated blue.
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