Professional Information

Amlodipine Besylate / Atorvastatin Calcium

Pronouncation: (am-LOW-duh-PEEN BEH-sih-LATE/ah-TORE-vah-STAT-in KAL-see-uhm)
Class: Antihyperlipidemic combination

Trade Names:
Caduet
- Tablets 5 mg amlodipine per 10 mg atorvastatin
- Tablets 5 mg amlodipine per 20 mg atorvastatin
- Tablets 5 mg amlodipine per 40 mg atorvastatin
- Tablets 5 mg amlodipine per 80 mg atorvastatin
- Tablets 10 mg amlodipine per 10 mg atorvastatin
- Tablets 10 mg amlodipine per 20 mg atorvastatin
- Tablets 10 mg amlodipine per 40 mg atorvastatin
- Tablets 10 mg amlodipine per 80 mg atorvastatin

Pharmacology

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Amlodipine

Inhibits movement of calcium ions across cell membrane in systemic and coronary vascular smooth muscle.

Atorvastatin

Increases rate at which body removes cholesterol from blood and reduces production of cholesterol in body by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis; increases HDL; reduces LDL, VLDL, and triglycerides (TG).

Indications and Usage

Amlodipine

Treatment of hypertension; chronic stable angina; confirmed or suspected vasospastic angina (Prinzmetal or Variant angina).

Atorvastatin

As an adjunct to diet to reduce elevated total cholesterol (C), LDL-C, apo B, and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia; adjunct to diet for treatment of elevated serum TG levels (Fredrickson Type IV); treatment of primary dysbetalipoproteinemia (Fredrickson Type III); reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia, and apo B levels in boys and postmenarchal girls, 10 to 17 yr of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following are present: LDL-C remains at 190 mg/dL or higher; LDL-C remains at 160 mg/dL or higher and there is positive family history of premature cardiovascular disease (CVD) or 2 or more CVD risk factors are present in children.

Contraindications

Active liver disease; unexplained persistent elevations of serum transaminases; pregnancy; breast-feeding mothers hypersensitivity to any component of the product.

Dosage and Administration

Dosage must be individualized based on effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia. Amlodipine/Atorvastatin may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine/atorvastatin or a dose of amlodipine/atorvastatin with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, BP lowering, or lipid-lowering effect. As initial therapy for one indication and continuation of treatment of the other, select the recommended starting dose of amlodipine/atorvastatin based on the continuation of the component being used and the recommended starting dose of the added monotherapy. The max dose of amlodipine component is 10 mg once daily; the max dose of atorvastatin component is 80 mg daily.

Administer alone or in combination with other lipid-lowering therapy (eg, bile acid sequestrant) or with other cardiovascular medications for the treatment of hypertension and angina.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Antacids, colestipol

Atorvastatin plasma concentrations may be decreased.

Digoxin, oral contraceptives (eg, ethinyl estradiol, norethindrone)

Plasma concentrations of these agents may be elevated by atorvastatin, increasing the risk of side effects.

Erythromycin

Atorvastatin plasma concentrations may be increased, increasing the pharmacologic and adverse reactions.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Amlodipine

Palpitation (5%); vasodilation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension (less than 2%).

CNS

Amlodipine

Fatigue (5%); dizziness (3%); somnolence (2%).

Atorvastatin

Headache (17%); asthenia (4%); insomnia, dizziness (more than 2%); paresthesia, somnolence, amnesia, abnormal dreams, decreased libido, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia (less than 2%).

Dermatologic

Atorvastatin

Rash (4%); photosensitivity, pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer (less than 2%); bullous rash including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (postmarketing).

EENT

Amlodipine

Rhinitis (less than 2%).

Atorvastatin

Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion (less than 2%).

GI

Amlodipine

Nausea (3%); abdominal pain (2%).

Atorvastatin

Abdominal pain, diarrhea, dyspepsia (4%); constipation, flatulence (3%); nausea (more than 2%); gastroenteritis, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, pancreatitis, (less than 2%).

Genitourinary

Amlodipine

Gynecomastia (postmarketing).

Atorvastatin

UTI (more than 2%); urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage (less than 2%).

Hematologic-Lymphatic

Atorvastatin

Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechiae (less than 2%).

Hepatic

Amlodipine

Jaundice, hepatic enzyme elevations (postmarketing).

Atorvastatin

Abnormal LFTs, hepatitis, cholestatic jaundice (less than 2%).

Hypersensitivity

Atorvastatin

Anaphylaxis (postmarketing).

Metabolic-Nutritional

Atorvastatin

Peripheral edema (more than 2%); hyperglycemia, increased creatine phosphokinase, gout, weight gain, hypoglycemia (less than 2%).

Musculoskeletal

Atorvastatin

Arthralgia (5%); back pain (4%); myalgia (3%); arthritis (more than 2%); leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis (less than 2%); rhabdomyolysis (postmarketing).

Respiratory

Atorvastatin

Sinusitis (6%); pharyngitis (3%); bronchitis (more than 2%); pneumonia, dyspnea, asthma, epistaxis (less than 2%).

Miscellaneous

Amlodipine

Edema (15%); flushing (5%).

Atorvastatin

Infection (10%); accidental injury (4%); flu syndrome, allergic reaction (3%); chest pain (at least 2%); face edema, fever, malaise (less than 2%); angioneurotic edema (postmarketing).

Precautions

Monitor

CPK levels

If muscle pain, tenderness, and/or weakness develop during therapy, determine CPK levels. Notify health care provider if CPK levels are markedly increased or if muscle symptoms continue or worsen, or are accompanied by malaise or fever.

LFTs

Ensure LFTs (transaminases) are determined before and 12 wk following initiation of therapy, or after increase in dose of atorvastatin, and periodically thereafter (eg, every 6 mo).

Serum cholesterol/Triglycerides

Ensure serum cholesterol and triglycerides are measured before therapy is started and within 2 to 4 wk of starting therapy or changing the atorvastatin dose, and then periodically thereafter.

Serum transaminase levels

If elevated serum transaminase levels develop during treatment, repeat levels more frequently. If transaminase levels rise to 3 times upper limit of normal and persist, notify health care provider. Be prepared to reduce dose or discontinue therapy if ordered.

Pregnancy

Category X .

Lactation

Undetermined (see contraindications).

Children

Amlodipine

Safety and efficacy not established for treating hypertension in patients under 6 yr of age.

Atorvastatin

Safety and efficacy not established for pre-pubertal patients or patients younger than 10 yr of age.

Angina/MI

Rarely, patients have developed increased frequency, duration and severity of angina, or acute MI on starting or increasing the dose of calcium channel blocker therapy.

CHF

Use amlodipine with caution.

Hypercholesterolemia

Ensure secondary causes of hypercholesterolemia (eg, poorly controlled diabetes, hypothyroidism) are excluded before starting therapy.

Liver dysfunction

HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function.

Myopathy

Ensure therapy is temporarily withheld in patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension).

Skeletal muscle

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.

Overdosage

Symptoms

Might be expected to cause excessive peripheral vasodilation with marked hypotension and possible reflex tachycardia.

Patient Information

Advise patient to take once daily as prescribed, without regard to meals, but to take with food if stomach upset occurs.
Advise patient to try to take each dose at about the same time each day.
Inform patient that drug helps control, but not does cure, high BP, angina, or cholesterol abnormality, and to continue taking drug as prescribed to maintain beneficial effects.
Advise patient that dose of medication may be adjusted periodically to obtain max benefit.
Caution patient not to change the dose or stop taking unless advised by health care provider.
Advise patient that if a dose is missed, to take as soon as remembered. If several hours have passed, advise patient to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take more than 1 dose of medicine a day.
Instruct patient to continue taking other BP, angina, or cholesterol medications as prescribed by health care provider.
Instruct patient being treated for angina to notify health care provider if frequency or severity of chest pain, or need for sublingual nitroglycerin appears to be increasing.
Emphasize to patient importance of the following other modalities on cholesterol and BP control: dietary changes (reduced saturated fat intake, increased soluble fiber intake, moderate intake of salt and alcohol); weight control; regular exercise; smoking cessation.
Instruct patient in BP and pulse measurement skills.
Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Also advise patient to take record of BP and pulse to each follow-up visit.
Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
Advise patient to notify health care provider of any of the following: unexplained muscle pain, tenderness, and/or weakness; frequent episodes of dizziness when arising; slow heart beat; persistent fatigue; or any other unusual or unexplained symptom or sign.
Advise women of childbearing potential to use effective contraception during treatment.