Norvasc Protect

Per 5 mg/10 mg tab Amlodipine besilate 5 mg, atorvastatin Ca 10 mg. Per 10 mg/10 mg tab Amlodipine besilate 10 mg, atorvastatin Ca 10 mg. Per 5 mg/20 mg tab Amlodipine besilate 5 mg, atorvastatin Ca 20 mg. Per 10 mg/20 mg tab Amlodipine besilate 10 mg, atorvastatin Ca 20 mg

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. Amlodipine besilate: 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. Reduce the risk of fatal CHD, non-fatal MI & stroke; coronary revascularization procedures & the need for hospitalization due to angina in patients w/ CAD. Atorvastatin Ca: Adjunct to diet for the treatment of patients w/ elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apo B & triglycerides (TG). Increase HDL cholesterol (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. Reduce the risk of fatal CHD & non-fatal MI, stroke, & 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). Reduce the risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & 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.

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

May be taken with or without food.

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

Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Temporarily w/held 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). Patients who consume substantial quantities of alcohol &/or have history of liver disease. Amlodipine besilate: Increased risk of pulmonary edema. Atorvastatin Ca: Increased risk for recurrent hemorrhagic stroke. Increased HbA1c & fasting serum glucose levels. Perform LFT before the initiation of treatment & periodically thereafter. Concomitant use 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 w/ concurrent use of fusidic acid.

Nausea. Amlodipine besilate: Headache, dizziness, somnolence; palpitations; flushing; abdominal pain; edema, fatigue. Atorvastatin Ca: 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 besilate: Increased systemic exposure w/ diltiazem. May increase plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of hypotension w/ clarithromycin. May lower plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased bioavailability w/ grapefruit or grapefruit juice. May affect trough conc of cyclosporine in renal transplant patients. Increased risk of tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, & everolimus). Atorvastatin Ca: Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP450 3A4/transporter inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP450 3A4 inhibitors; erythromycin/clarithromycin; PIs; diltiazem; grapefruit juice. Increased AUC w/ itraconazole. Increased exposure w/ cyclosporine; glecaprevir, pibrentasvir; letermovir, elbasvir, grazoprevir. Reduced plasma conc w/ CYP450 3A4 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. Myopathy w/ colchicine.

Calcium Antagonists / Dyslipidaemic Agents

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

Rx