Caduet (Amlodipine Besylate, Atorvastatin Calcium) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Caduet

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High blood pressure (HBP) or hypertension means high pressure (tension) in the arteries. Arteries are vessels that carry blood from the pumping heart to all the tissues and organs of the body. High blood pressure does not mean excessive emotional tension, although emotional tension and stress can temporarily increase blood pressure. Normal blood pressure is below 120/80; blood pressure between 120/80 and 139/89 is called "pre-hypertension", and a blood pressure of 140/90 or above is considered high.

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CADUET®
(amlodipine besylate/atorvastatin calcium) Tablets

DRUG DESCRIPTION

CADUET® (amlodipine besylate, atorvastatin calcium) (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 (amlodipine besylate, atorvastatin calcium) 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•C₆H₆O₃S.

The atorvastatin calcium component of CADUET (amlodipine besylate, atorvastatin calcium) is chemically described as [R-(R*, R*)]2-(4-fluorophenyl)-β, δ-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•3H₂O.

The structural formulae for amlodipine besylate and atorvastatin calcium are shown below.

CADUET® (amlodipine besylate/atorvastatin calcium) Structural Formula Illustration

CADUET (amlodipine besylate, atorvastatin calcium) 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 (amlodipine besylate, atorvastatin calcium) tablets are formulated for oral administration in the following strength combinations:

Table 1: CADUET (amlodipine besylate, atorvastatin calcium) Tablet Strengths

	2.5 mg/ 10mg	2.5 mg/ 20mg	2.5 mg/ 40mg	5 mg/ 10mg	5 mg/ 20mg	5 mg/ 40mg	5 mg/ 80mg	10 mg/ 10 mg	10 mg/ 20 mg	10 mg/ 40 mg	10 mg/ 80 mg
amlodipine equivalent (mg)	2.5	2.5	2.5	5	5	5	5	10	10	10	10
atorvastatin equivalent (mg)	10	20	40	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 2.5 mg and 5 mg amlodipine are film coated white, and combinations of atorvastatin with 10 mg amlodipine are film coated blue.

What are the possible side effects of amlodipine and atorvastatin (Caduet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

Stop using this medication and call your doctor at once if you have any of...

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What are the precautions when taking amlodipine besylate, atorvastatin calcium (Caduet)?

Before taking this product, tell your doctor or pharmacist if you are allergic to amlodipine or atorvastatin; or to other calcium channel blockers (such as nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

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Last reviewed on RxList: 8/3/2009
This monograph has been modified to include the generic and brand name in many instances.