AMLODIPINE + ATORVASTATIN

Indications & Dose:

Concomitant Medication:

The amlodipine component of amlodipine/ atorvastatin hos been safely co-administered with thiazide diuretics, alpha blockers, beta blockers, angiotensin-converting enzyme inhibitors, longacting nitrates, and with sublingual nitroglycerine. Amlodipine/atorvastatin has also been safely administered with the aforementioned medicines. Special Populations and Special Considerations for Dosing:

Coronary Artery Disease (CAD): For patients with coronary artery disease the recommended dosage range is 5-10 mg amlodipine once daily. In clinical studies the majority of patients required 10 mg once daily.

Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia: The majority of patients are controlled with 10 mg atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.

Homozygous Familial Hypercholesterolemia: In a compassionate-use study 0 patients with homozygous familial hypercholesterolemia, most patients responded to 80 mg of atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).

Use in Patients with Impaired Hepatic Function: Amlodipine/atorvastatin should not be used in patients with hepatic impairment.

Use in Patients with Impaired Renal Function: No adjustment of the dose is required in patients with impaired renal function.

Elderly: No adjustment of the dose is required in elderly patients.

Children: There have been no studies conducted to determine the safety or effectiveness of amlodipine/ atorvastatin (combination product) in pediatric populations. However, there have been studies with pediatrics with amlodipine alone and atorvastatin alone.

POSOLOGY AND METHOD OF ADMINISTRATION: Amlodipine/atorvastatin is a combination product targeting concomitant cardiovascular conditions; hypertension/angina and dyslipidemia. The dosage range for amlodipine/ atorvastatin is 5mg/10mg to a maximum dose of 10mg/80mg once daily. The starting dose and maintenance dose should be individualized on the basis of both effectiveness and tolerance for each individual camponent in the treatment of hypertension/angina and dyslipidemia. Following initiation and/or titration of amlodipine/atorvastatin, lipid levels should be analyzed and blood pressure measured within 2 to 4 weeks, and dosage of amlodipine and atorvastatin components should be adjusted accordingly.

Contraindications:

Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal, women who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures

Side Effects:

flushing, fatigue, edema, dizziness, headache, abdominal pain, nausea, palpitations, and somnolence. Atorvastatin is generally well-tolerated. The common (1 %) adverse effects associated with atorvastatin therapy: insomnia, headache, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence, myalgia, and asthenia.

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