Amlodipine/atorvastatin

What is Amlodipine/atorvastatin?

• Amlodipine/atorvastatin (Caduet) tablets are combination of the calcium channel blocker amlodipine besylate with the lipid-lowering agent atorvastatin calcium.

Amlodipine

Amlodipine 3D ball

Atorvastatin

Atorvastatin-from-xtal-3D-bs-17

What are the uses of this medicine?

• Amlodipine/atorvastatin (Caduet) is a prescription drug that combines Norvasc (amlodipine besylate) and Lipitor (atorvastatin calcium) in one pill.

Norvasc is used to treat:

• High blood pressure (hypertension) and
• Chest pain (angina) and
• Blocked arteries of the heart (coronary artery disease)
• Lipitor is used to lower the levels of "bad" cholesterol and triglycerides in your blood. It can also raise the levels of "good" cholesterol.

Lipitor is also used to lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as:

• age, smoking, high blood pressure, low HDL-C, heart disease in the family
• Lipitor can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:
• diabetic eye or kidney problems, smoking, or high blood pressure.

• Caduet (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

How does this medicine work?

• Caduet is a combination of two drugs, a dihydropyridine calcium channel blocker amlodipine and an HMG-CoA reductase inhibitor atorvastatin.
• The amlodipine component of Caduet inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
• The atorvastatin component of Caduet is a selective, competitive inhibitor of HMG-CoA reductase (statin), the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Like other members of its class (the “statins”), atorvastatin lowers total serum cholesterol and low density lipoprotein (LDL) concentrations, thereby reducing the risk of atherosclerosis and its complications – myocardial infarction and stroke.
• Like other calcium channel blockers, amlodipine acts by blocking the influx of calcium ions into vascular smooth muscle and cardiac muscle cells during membrane depolarization. This action causes relaxation of vascular and arterial smooth muscle cells, resulting in arterial vasodilation and a decrease in cardiac work and oxygen consumption.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• active liver disease
• hypersensitivity to any component of this medication
• who are pregnant or may become pregnant
• Are breastfeeding

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take medicines for:

• your immune system
• infections
• cholesterol
• birth control
• heart failure
• HIV (AIDS)
• You can use nitroglycerin and Caduet together. If you take nitroglycerin for chest pain (angina), do not stop taking it while taking Caduet.

Is this medicine FDA approved?

• Yes, it is FDA approved.
• Amlodipine/atorvastatin is marketed under the brand name Caduet in the United States, Australia, and Russia, and Envacar in the Philippines.

How should this medicine be used?

Recommended dosage: Amlodipine (Hypertension or angina)Adults:

• The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily.
• The recommended dose of amlodipine for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
• The recommended dose range of amlodipine for patients with coronary artery disease is 5–10 mg once daily.

Children:

• The effective antihypertensive oral dose of amlodipine in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily.

Atorvastatin:

• The recommended starting dose of atorvastatin is 10 or 20 mg once daily.
• Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily.
• The dosage range of atorvastatin is 10 to 80 mg once daily.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age):

• The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population).

Blood Cholesterol Levels in Children Adolescents:

• The dosage of atorvastatin in patients with homozygous FH is 10 to 80 mg daily.

Administration:

• Take Caduet once a day, exactly as your doctor tells you.
• Do not change your dose or stop Caduet without talking to your doctor.
• Take Caduet each day at any time of day, at about the same time each day.
• Caduet can be taken with or without food.
• Do not break the tablets before taking them. Talk to your doctor if you have a problem swallowing pills.
• Your doctor should start you on a low-fat diet before giving you Caduet.
• Stay on this low-fat diet when you take Caduet.
• Caduet comes in many different strengths.
• Your doctor will test your cholesterol and blood pressure to find the right dose for you.
• If you miss a dose, take it as soon as you remember.
• Do not take Caduet if it has been more than 12 hours since your missed dose.
• Just take the next dose at your regular time. Do not take 2 doses of Caduet at the same time.
• If too much Caduet is taken by accident, call your doctor or poison control center, or go to the nearest emergency room.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Caduet tablets contain amlodipine besylate and atorvastatin calcium

This medicine is available in fallowing brand namesː

• Caduet

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• tiredness
• stomach pain
• upset stomach
• swelling of your legs or ankles (edema)
• hot or warm feeling in your face (flushing)
• irregular heartbeat (arrhythmia)
• very fast heartbeat (heart palpitations)
• muscle and joint pain
• alterations in some laboratory blood tests
• dizziness
• extreme sleepiness
• nausea
• diarrhea

Additional side effects have been reported: tendon problems.

Caduet can cause serious side effects which may include:

• Muscle problems
• Liver problems

What special precautions should I follow?

• Because of the risk of myopathy with statins, the drug class to which the atorvastatin component of Caduet belongs, advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
• The amlodipine component of Caduet is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.
• Statins, such as the atorvastatin component of Caduet interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Use caution when administering a statin with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.
• Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with the atorvastatin component of Caduet and with other statins. Such patients merit closer monitoring for skeletal muscle effects.
• The atorvastatin component of Caduet, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Caduet therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
• Statins, like the atorvastatin component of Caduet and like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function.
• Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
• Avoid getting pregnant. If you get pregnant, stop taking Caduet right away and call your doctor.
• Do not breastfeed. Caduet can pass into your breast milk and may harm your baby.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Amlodipine overdose:

• peripheral vasodilation
• hypotension
• reflex tachycardia

Management of overdosage:

• If overdose should occur, begin active cardiac and respiratory monitoring.
• Perform frequent blood pressure measurements.
• Should hypotension occur, initiate cardiovascular support including elevation of the extremities and administration of fluids.
• If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with specific attention to circulating volume and urine output.
• As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
• There is no specific treatment for atorvastatin overdosage.
• In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
• Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Caduet contains atorvastatin and is therefore contraindicated in women who are pregnant or may become pregnant.

Can this medicine be used in children?

• Caduet has not been studied in children.

What are the active and inactive ingredients in this medicine?

• Active ingredients: amlodipine besylate, atorvastatin calcium
• Inactive ingredients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium stearate
• Film coating: 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)

Who manufactures and distributes this medicine?

Manufactured by:

• Pfizer Ireland Pharmaceuticals
• Dublin, Ireland

What should I know about storage and disposal of this medication?

• Store Caduet at room temperature, 68 to 77°F (20 to 25°C).
• Do not keep medicine that is out-of-date or that you no longer need.
• Keep Caduet and all medicines out of the reach of children. Keep medicines in places where children cannot get it.

• Dailymed label info on Amlodipine/atorvastatin
• FDA Amlodipine/atorvastatin

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