Norvasc Protect Indications/Uses

Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) Tablet is indicated for the following patient populations: Patients at increased cardiovascular risk due to the presence of the two modifiable risk factors hypertension and dyslipidemia; and/or Patients at increased cardiovascular risk due to the presence of symptomatic Coronary Heart Disease (CHD) expressed as angina with the additional modifiable risk factor of dyslipidemia; and/or Prevention of cardiovascular complications in hypertensive patients (see Prevention of Cardiovascular Complications as follows).
In these patients with multiple cardiovascular risk factors, amlodipine/atorvastatin is indicated for: Hypertension: The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect), in the same manner as they would benefit from the addition of amlodipine alone.
Amlodipine is also indicated to reduce the risk of fatal CHD and non-fatal myocardial infarction (MI), and to reduce the risk of stroke.
Coronary Artery Disease: The amlodipine component is indicated to reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease (CAD).
Chronic Stable Angina: The amlodipine component is indicated for the first-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be used alone or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta-blockers.
Dyslipidemia: The atorvastatin component is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) and to increase high-density lipoprotein-cholesterol (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and in patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
The atorvastatin component is also indicated for the reduction of total C and LDL-C in patients with homozygous familial hypercholesterolemia (FH).
Prevention of Cardiovascular Complications: In patients without clinically evident cardiovascular disease (CVD), and with or without dyslipidemia, but with multiple risk factors for CHD such as smoking, hypertension, diabetes, low HDL-C, or a family history of early CHD, atorvastatin is indicated to: Reduce the risk of fatal CHD and non-fatal MI; Reduce the risk of stroke; Reduce the risk of revascularization procedures and angina pectoris.
In patients with clinically evident CHD, atorvastatin is indicated to: Reduce the risk of non-fatal MI; Reduce the risk of fatal and non-fatal stroke; Reduce the risk for revascularization procedures; Reduce the risk of hospitalization for congestive heart failure (CHF); Reduce the risk of angina.
Pediatric Patients (10-17 years of age): Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous FH if after an adequate trial of diet therapy the following findings are present: LDL-C remains ≥190 mg/dL; or LDL-C remains ≥160 mg/dL, and There is a positive family history of premature CVD or Two or more other CVD risk factors are present in the pediatric patient.