Amlodipine: Hypertension Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Atorvastatin: Heterozygous Familial and Nonfamilial Hypercholesterolemia Elevated Serum TG Levels Primary Dysbetalipoproteinemia Homozygous Familial Hypercholesterolemia
Calcium channel blocker + antihypertensive
It is a combination product containing Amlodipine Besilate BP equivalent to 5 mg Amlodipine, a calcium channel blocker and Atorvastatin calcium INN equivalent to 10 mg Atorvastatin, a statin (HMG-CoA reductase inhibitor). Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Atorvastatin calcium is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoAto mevatonate, an early and rate limiting step in the synthesis of cholesterol.
Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day
Drug interaction with atorvastatin: The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals. When atorvastatin and antacid suspension containing magnesium and aluminum hydroxide were co administered, plasma concentrations of atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered. Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone. When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately. In healthy individuals, plasma concentrations of atorvastatin increased approximately 40% with co- administration of atorvastatin and erythromycin. Co- administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinylestradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking atorvastatin.
Drug interaction with amlodipine: Amlodipine may potentiate the effect of other antihypertensive (e.g.Beta-blockers, ACE inhibitors, Alpha-1-blockers and Diuretics). In clinical interaction studies, Amlodipine did not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin or Cyclosporine.
Active liver disease or unexplained persistent elevated hepatic transaminases. Pregnancy & lactation.Atorvastatin may cause myopathy, & rarely rhabdomyolysis w/ ARE secondary to myoglobinuria esp at high doses or in patients wl history ot renal impairment. Caution when used w/ CYP3A4 inhibitors which may increase plasma concentrations of Atorvastatin. Withhold/discontinue Atorvastatin if symptoms suggestive of myopathy or rhabdomyolysis are observed. Atorvastatin has been associated w/ biochemical abnormalities of liver; LET should be monitored prior to & at 12 wk following treatment initiation & dosage increment; caution in patients who consume large amounts of alcohol or w/ history of liver disease. Worsening of angina and/or Ml has been reported w/ use of dihydrophyridine Ca channel blockers, esp in patients w/ severe obstructive coronary artery disease. Amlodipine may cause dose-dependent peripheral oedema. Caution in patients w/ severe aortic stenosis, symptomatic hypotension may occur.
Amlodipine: Headache, dizziness, fatigue, somnolence, peripheral oedema, flushing, palpitations, nausea, abdominal pain; rarely pruritus, rash, dyspnoea, asthenia & muscle cramps. Atorvastatin: Nasopharyngitis, arthralgia, diarrhoea, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia, increased transaminases, abnormal liver function test, increased creatinine phosphokinase, thrombocytopenia, malaise, hepatitis
Advice and warnings for the use of Amlodipine / atorvastatin (Caduet) during pregnancy. FDA Pregnancy Category X - Not for use in pregnancy
Store in a cool and dry place. Protect from light and moisture. Keep all medicines out of the reach of children.
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