Caduet

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-5?­methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5?­pyridinedicarboxylate, 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)-?, ?-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...

Read All Potential Side Effects and See Pictures of Caduet »

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...

Read All Potential Precautions of Caduet »


Caduet Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet, tiredness, or flushing may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 perform such activities safely.

To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with atorvastatin. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of the drug, especially muscle problems and dizziness.

This product must not be used during pregnancy. Atorvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if amlodipine or atorvastatin passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.


Caduet Patient Information Including Side Effects

Brand Names: Caduet

Generic Name: amlodipine and atorvastatin (Pronunciation: am LOE di peen and a TORE va sta tin)

  • What is amlodipine and atorvastatin (Caduet)?
  • What are the possible side effects of amlodipine and atorvastatin (Caduet)?
  • What is the most important information I should know about amlodipine and atorvastatin (Caduet)?
  • What should I discuss with my healthcare provider before taking amlodipine and atorvastatin (Caduet)?
  • How should I take amlodipine and atorvastatin (Caduet)?
  • What happens if I miss a dose (Caduet)?
  • What happens if I overdose (Caduet)?
  • What should I avoid while taking amlodipine and atorvastatin (Caduet)?
  • What other drugs will affect amlodipine and atorvastatin (Caduet)?
  • Where can I get more information?

What is amlodipine and atorvastatin (Caduet)?

Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin blocks the production of cholesterol (a type of fat) in the body.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes the blood vessels, improving blood flow and making it easier for the heart to pump.

The combination of amlodipine and atorvastatin is used to treat high blood pressure (hypertension) or chest pain (angina) that occurs with high cholesterol or triglyceride levels.

Amlodipine and atorvastatin may also be used for other purposes not listed in this medication guide.

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 these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • slow, fast, uneven, or pounding heartbeats;
  • chest pain;
  • feeling light-headed, fainting; or
  • swelling of your hands or feet.

Less serious side effects may include:

  • headache, dizziness;
  • warmth or tingly feeling;
  • mild stomach pain, diarrhea, gas, upset stomach;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • mild itching or skin rash; or
  • drowsiness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amlodipine and atorvastatin (Caduet)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take this medication if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), or if you have liver disease.

Before taking amlodipine and atorvastatin, tell your doctor if you have liver problems, heart disease, congestive heart failure, a serious illness or infection, or if you are taking other heart or blood pressure medications.

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.

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol. Both alcohol and atorvastatin can be damaging to the liver. Alcohol can also further lower blood pressure and can increase some of the side effects of amlodipine and atorvastatin.

Amlodipine and atorvastatin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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