amlodipine besylate and atorvastatin calcium (redirected from Caduet)

amlodipine besylate and atorvastatin calcium

Caduet

Pharmacologic class: Calcium channel blocker, HMG-CoA reductase inhibitor

Therapeutic class: Antihypertensive, antianginal, lipid-lowering agent

Pregnancy risk category X

Action

Amlodipine inhibits influx of extracellular calcium ions, thereby decreasing myocardial contractility, relaxing coronary and vascular muscles, and reducing peripheral resistance. Atorvastatin inhibits HMG-CoA reductase, which catalyzes first step in cholesterol synthesis; this action reduces serum cholesterol and low-density lipoprotein (LDL) levels; atorvastatin also moderately increases concentration of high-density lipoproteins (HDLs).

Availability

Tablets: (amlodipine besylate/atorvastatin calcium) 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg

⊘Indications and dosages

➣ Patients for whom treatment with both amlodipine and atorvastatin is appropriate, such as those with hypertension (used alone or combined with other antihypertensives), coronary artery disease, cardiovascular disease prevention, heterozygous familial or nonfamilial hypercholesterolemia, homozygous familial hypercholesterolemia, elevated serum triglycerides, or dysbetalipoproteinemia

Adults: Dosage individualized based on efficacy of and tolerance for each component. Maximum amlodipine dosage: 10 mg P.O. daily; maximum atorvastatin dosage: 80 mg P.O. daily.

Dosage adjustment

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than three times upper limit of normal
• Small, frail, or elderly patients

Contraindications

• Hypersensitivity to drug or its components
• Active hepatic disease or unexplained persistent serum transaminase elevations
• Pregnant or breastfeeding patients

Precautions

Use cautiously in:
• hepatic or renal impairment; aortic stenosis; heart failure; hypotension; uncontrolled seizures; myopathy; severe metabolic, endocrine, or electrolyte disorders
• alcohol abuse
• concurrent use of fibric acid derivatives (such as gemfibrozil) or drugs that may decrease endogenous steroids (such as cimetidine, ketoconazole, spironolactone)
• elderly patients
• females of childbearing potential
• children (safety and efficacy not established).

Administration

• Before starting therapy, patient should attempt to control hypercholesterolemia with appropriate diet, exercise, and weight reduction (if obese) and should receive treatment for other underlying medical problems.
• Administer with or without food.
• Don't give with grapefruit juice or antacids.
• Titrate dosage over 7 to 14 days. (Titration may be more rapid if warranted and if patient is assessed frequently.)
• Dosage of amlodipine, atorvastatin, or both may be increased, if appropriate, for additional antianginal, hypotensive, or lipid-lowering effect.

Route	Onset	Peak	Duration
P.O.	Unknown	Unknown	Unknown

Adverse reactions

Amlodipine component

CNS: dizziness, headache, fatigue, somnolence

CV: palpitations, chest pain, arrhythmias

EENT: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus

GI: nausea, abdominal pain, dry mouth

GU: frequent urination, urination disorder, nocturia

Hematologic: purpura, leukopenia, thrombocytopenia

Metabolic: hyperglycemia

Skin: flushing, erythema multiforme

Other: edema, increased sweating, thirst

Atorvastatin component

CNS: headache, migraine, asthenia, insomnia, dizziness, malaise, depression, peripheral neuropathy, somnolence, amnesia, abnormal dreams, emotional lability, facial paralysis, incoordination, hyperkinesia, paresthesia, hypoesthesia, hypertonia

CV: chest pain, palpitations, vasodilation, syncope, hypertension, orthostatic hypotension, phlebitis, angina pectoris, arrhythmias

EENT: amblyopia, refraction disorder, eye hemorrhage, glaucoma, dry eyes, hearing loss, tinnitus, parosmia, epistaxis, rhinitis, sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, enteritis, gastroenteritis, colitis, gastritis, esophagitis, eructation, biliary pain, duodenal ulcer, gastric ulcer, pancreatitis, cholestatic jaundice, tenesmus, melena, dysphagia, cheilitis, glossitis, stomatitis, dry mouth, ulcerative stomatitis, rectal and gum hemorrhage

GU: decreased libido, sexual dysfunction, fibrocystic breasts, breast enlargement, metrorrhagia, epididymitis, abnormal ejaculation, urinary tract infection, hematuria, albuminuria, urinary frequency, urinary incontinence, urinary retention, urinary urgency, nocturia, cystitis, dysuria, renal calculus, nephritis, vaginal and uterine hemorrhage

Hematologic: anemia, thrombocytopenia

Hepatic: abnormal liver function tests, hepatitis

Metabolic: gout

Musculoskeletal: back pain, arthralgia, myalgia, myositis, myasthenia, arthritis, neck rigidity, leg cramps, bursitis, tenosynovitis, tendon contracture

Respiratory: bronchitis, pneumonia, dyspnea, asthma

Skin: rash, pruritus, contact dermatitis, alopecia, dry skin, acne, urticaria, eczema, seborrhea, skin ulcer, ecchymosis, petechiae, photosensitivity

Other: taste loss or alteration; appetite changes; weight gain; infection; lymphadenopathy; accidental injury; flulike syndrome; peripheral, facial, or generalized edema; allergic reaction

Interactions

Interactions

Drug-drug. Antacids, colestipol: decreased atorvastatin level

Azole antifungals, cyclosporine, erythromycin, fibric acid derivatives, niacin, other HMG-CoA inhibitors: increased myopathy risk

Beta-adrenergic blockers: increased risk of adverse effects (amlodipine component)

Cimetidine, ketoconazole, spironolactone: decreased levels or activity of endogenous steroids (atorvastatin component)

Digoxin: increased digoxin level, increased risk of digoxin toxicity

Fentanyl, nitrates, other antihypertensives, quinidine: additive hypotension (amlodipine component)

Hormonal contraceptives: increased estrogen level

Drug-diagnostic tests. ALT, AST, creatinine kinase: increased (atorvastatin component)

Blood glucose: increased or decreased

CBCs, platelets: decreased

Drug-food. Grapefruit juice: increased drug level, greater risk of adverse effects

Drug-herb. Red yeast rice: increased risk of adverse herbal effects

Drug-behaviors. Acute alcohol ingestion: additive hypotension (amlodipine component)

Patient monitoring

• Monitor heart rate and rhythm and blood pressure, especially at start of therapy.
• Monitor liver function tests before therapy starts, at 12 weeks, and after dosage increase; thereafter, monitor periodically.
• Watch for signs and symptoms of allergic response.
☞ Monitor patient for worsening angina.
☞ Assess for heart failure; promptly report signs and symptoms (peripheral edema, dyspnea).
• Monitor patients who develop transaminase elevations until these resolve.
☞ Evaluate for muscle weakness (a symptom of myositis and possibly rhabdomyolysis).
• Measure blood glucose level regularly.

Patient teaching

• Tell patient drug may be taken with or without food.
• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Instruct patient to avoid grapefruit juice during therapy.
☞ Urge patient to immediately report unexplained muscle pain, tenderness, or weakness - especially if accompanied by malaise or fever.
☞ Instruct patient to immediately report signs and symptoms of liver damage, such as nausea, fatigue, anorexia, jaundice, dark urine, light-colored stools, intense itching, or tender abdomen.
☞ Tell patient to promptly report chest pain, swelling, or difficulty breathing.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• Instruct patient to avoid alcohol use during therapy.
• Advise female with childbearing potential to avoid pregnancy and breastfeeding during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.