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Buy Caduet (Amlodipine Besylate, Atorvastatin Calcium) cardiovascular medication
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CADUET (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Caduet (Amlodipine Besylate and Atorvastatin Calcium) tablets combine the calcium channel blocker amlodipine besylate with the lipid-lowering agent atorvastatin calcium.

The amlodipine besylate component of Caduet is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5 x C6H6O3S.

The atorvastatin calcium component of Caduet is chemically described as [R-(R*, R*)]2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca x 3H2O.

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: 2.5 mg / 10 mg, 2.5 mg / 20 mg, 2.5 mg / 40 mg, 5 mg / 10 mg, 5 mg / 20 mg, 5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg.

Each tablet also contains croscarmellose sodium, calcium carbonate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, hydroxypropyl cellulose, colloidal silicon dioxide (anhydrous), purified water, magnesium stearate, Opadry II White 85F28751 (titanium dioxide, polyvinyl alcohol, PEG 3000, talc) or Opadry II Blue 85F10919 (titanium dioxide, polyvinyl alcohol, PEG 3000, talc, FD&C blue #2). Combinations of atorvastatin with 2.5 mg and 5 mg amlodipine are film coated white, and combinations of atorvastatin with 10 mg amlodipine are film coated blue.


CLINICAL PHARMACOLOGY

Caduet clinical pharmacology


PHARMACOKINETICS

Caduet pharmacokinetics


PHARMACOKINETICS in SPECIFIC POPULATIONS

Caduet pharmacokinetics in specific populations


PHARMACODYNAMICS

Caduet pharmacodynamics


CLINICAL STUDIES

Clinical Study of Combined Amlodipine and Atorvastatin (Caduet) in Patients with Hypertension and Dyslipidemia

In a double-blind, placebo-controlled study, a total of 1660 patients with co-morbid hypertension and dyslipidemia received once daily treatment with eight dose combinations of amlodipine and atorvastatin (Caduet 5/10, 10/10, 5/20, 10/20, 5/40, 10/40, 5/80, or 10/80 mg), amlodipine alone (5 mg or 10 mg), atorvastatin alone (10 mg, 20 mg, 40 mg, or 80 mg) or placebo. In addition to concomitant hypertension and dyslipidemia, 15% of the patients had diabetes mellitus, 22% were smokers and 14% had a positive family history of cardiovascular disease. At eight weeks, all eight combination-treatment groups of amlodipine and atorvastatin demonstrated statistically significant dose-related reductions in systolic blood pressure (SBP), diastolic blood pressure (DBP) and LDL-C compared to placebo, with no overall modification of effect of either component on SBP, DBP and LDL-C.


CLINICAL STUDIES WITH AMLODIPINE

Caduet clinical studies with amlodipine


CLINICAL STUDIES WITH ATORVASTATIN

Caduet clinical studies with atorvastatin


INDICATIONS AND USAGE

Caduet indications and usage


CONTRAINDICATIONS

Caduet contraindications


WARNINGS

Caduet warnings


PRECAUTIONS

Caduet precautions


DRUG INTERACTIONS

Caduet drug interactions


NONCLINICAL TOXICOLOGY

Caduet nonclinical toxicology


USE IN PREGNANCY

Caduet use in pregnancy


USE IN SPECIFIC POPULATIONS

Caduet use in specific populations


ADVERSE REACTIONS

Caduet adverse reactions


OVERDOSAGE

Caduet overdosage


DOSAGE AND ADMINISTRATION

Caduet dosage and administration


HOW SUPPLIED

Caduetr tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below.

Caduet tablets are differentiated by tablet color/size and are engraved with "Pfizer" on one side and a unique number on the other side. Caduet tablets are supplied for oral administration in the following strengths and package configurations:

Caduet (Amlodipine Besylate / Atorvastatin Calcium) tablet strength Engraving Tablet Color
2.5 / 10 mg CDT 251 White
2.5 / 20 mg CDT 252 White
2.5 / 40 mg CDT 254 White
5 / 10 mg CDT 051 White
5 / 20 mg CDT 052 White
5 / 40 mg CDT 054 White
5 / 80 mg CDT 058 White
10 / 10 mg CDT 101 Blue
10 / 20 mg CDT 102 Blue
10 / 40 mg CDT 104 Blue
10 / 80 mg CDT 108 Blue


Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured and distributed by Pfizer pharmaceutical company and its divisions.

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