amlodipine + atorvastatin




Zuellig Pharma
Concise Prescribing Info
Amlodipine besylate, atorvastatin Ca
Patients at increased CV risk due to the presence of 2 modifiable risk factors HTN & dyslipidemia; &/or chronic stable angina. Prevention of CV complications in hypertensive patients. 1st-line treatment of HTN & can be used as the sole agent to control BP in the majority of patients. Reduce the risk of fatal CHD & non-fatal MI, & to reduce the risk of stroke. Myocardial ischemia, whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. May be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. May be used alone or in combination w/ other anti-anginal drugs in patients w/ angina that is refractory to nitrates &/or adequate doses of β-blockers. Adjunct to diet for the treatment of patients w/ elevated total cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Types IIa & IIb), elevated serum triglyceride levels (Fredrickson Type IV), & for patients w/ dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. Reduction of total cholesterol & LDL-cholesterol in patients w/ homozygous familial hypercholesterolemia when response to diet & other nonpharmacological measures are inadequate. 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 a family history of early CHD. Reduce the risk of nonfatal MI, fatal & nonfatal 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 years, w/ heterozygous familial hypercholesterolemia 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 & there is a positive family history of premature CV disease or ≥2 other CVD risk factors.
Dosage/Direction for Use
Dosage range of amlodipine/atorvastatin: 5 mg/10 mg to a max dose of 10 mg/80 mg once daily.
May be taken with or without food.
Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Pregnancy, lactation or women of childbearing potential who are not using adequate contraceptive measures.
Special Precautions
Heart failure, impaired hepatic function. Perform liver function tests before initiating treatment & periodically thereafter. Patient who consume substantial quantities of alcohol &/or have a history of liver disease. Discontinue drug if markedly elevated creatinine phosphokinase levels occur or myopathy is diagnosed or suspected. Acute, serious condition suggestive of myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis.
Adverse Reactions
Amlodipine: Flushing, fatigue, edema, dizziness, headache, abdominal pain, nausea, palpitations, somnolence. Atorvastatin: Insomnia, headache, GI disturbances, myalgia, asthenia.
Drug Interactions
Digoxin, erythromycin/clarithromycin, PIs, diltiazem HCl, itraconazole, grapefruit juice, colestipol, OC containing norethindrone & ethinyl estradiol. CYP3A4 inhibitors & inducers. Grapefruit juice.
ATC Classification
C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.
Caduet tab 10/40 mg
4 × 7's
Caduet tab 5/10 mg
4 × 7's
Caduet tab 10/20 mg
4 × 7's
Caduet tab 10/10 mg
4 × 7's
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