Norvasc Protect

Patients at increased CV risk due to the presence of HTN & dyslipidemia, &/or symptomatic CHD expressed as angina w/ dyslipidemia, &/or prevention of CV complications in hypertensive patients for the following: Amlodipine: 1st-line treatment of HTN; myocardial ischemia whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Reduces the risk of fatal CHD & non-fatal MI, & stroke; coronary revascularization procedures & the need for hospitalization due to angina in patients w/ CAD. Atorvastatin: Adjunct to diet for the treatment of patients w/ elevated total cholesterol (total-C), LDL-C, Apo B & triglycerides (TG) & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV), & in patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ HoFH. Reduces the risk of fatal CHD & non-fatal MI, stroke, or revascularization procedures & angina pectoris in patients w/o clinically evident CV disease, & w/ or w/o dyslipidemia, but w/ multiple risk factors for CHD (eg, smoking, HTN, diabetes, low HDL-C, or family history of early CHD). Reduces the risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF, or angina in patients w/ clinically evident CHD. Adjunct to diet to reduce total-C, LDL-C, & Apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if, after an adequate trial of diet therapy, LDL-C remains ≥190 mg/dL, or LDL-C remains ≥160 mg/dL & there is a +ve family history of premature CVD or ≥2 other CVD risk factors are present.

Individualized starting & maintenance dose. Dose range: 5 mg/10 mg to max 10 mg/20 mg once daily.

May be taken with or without food.

Hypersensitivity to amlodipine, atorvastatin, or other dihydropyridines. Active liver disease or unexplained persistent elevations of serum transaminases >3 times ULN. Women of childbearing potential not using adequate contraception. Pregnancy & lactation.

Perform LFT before the initiation of treatment & periodically thereafter, & in patients who develop any signs or symptoms suggesting liver injury. Dose reduction or w/drawal is recommended should an increase in ALT or AST of >3 times ULN persist. Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Temporarily w/hold or discontinue in patients w/ acute, serious condition suggestive of myopathy or w/ risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg, severe acute infection; hypotension; major surgery; trauma; severe metabolic, endocrine & electrolyte disorders; uncontrolled seizures). Caution in patients who consume substantial quantities of alcohol &/or have history of liver disease. Amlodipine: Increased reports of pulmonary edema in patients w/ NYHA class III-IV heart failure of nonischemic etiology. Atorvastatin: Increased incidence of hemorrhagic stroke in patients w/o CHD who had a stroke or transient ischemic attack w/in the preceding 6 mth & were initiated on atorvastatin 80 mg. Increased HbA1c & fasting serum glucose levels. Caution when considering combined therapy w/ fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, HIV/HCV PIs, HCV NS5A/NS5B inhibitors, letermovir, or lipid-modifying doses of niacin. Not recommended in concurrent use w/ fusidic acid.

Nausea. Amlodipine: Headache, dizziness, somnolence; palpitations; flushing; abdominal pain; edema, fatigue. Atorvastatin: Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhea, dyspepsia, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood creatinine phosphokinase.

Amlodipine: Increased systemic exposure w/ diltiazem in the elderly. Plasma conc may be increased w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of hypotension w/ clarithromycin. Plasma conc may be lowered w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Bioavailability may be increased w/ grapefruit or grapefruit juice. May affect trough conc of cyclosporine in renal transplant patients. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, & everolimus). Atorvastatin: Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP3A4/transporter inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP3A4 inhibitors; erythromycin/clarithromycin; PIs; diltiazem; grapefruit juice. Increased AUC w/ itraconazole. Increased exposure w/ cyclosporine; glecaprevir, pibrentasvir; letermovir, elbasvir, grazoprevir. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin); oral antacid susp containing Mg & Al hydroxides; colestipol. Increased digoxin conc. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Increased risk of rhabdomyolysis w/ fusidic acid. Reports of myopathy w/ colchicine.

Calcium Antagonists / Dyslipidaemic Agents

C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

Rx