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Amlodipne + atorvastatin

Amlodipine is a dihydropyridine calcium channel blocker which relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It reduces peripheral vascular resistance and hence resulting in a reduction of blood pressure. In vasospastic angina, Amlodipine also inhibits coronary spasm in patients with vasopastic angina. Atorvastatin selectively and competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate which is a rate-limiting step in cholesterol biosynthesis. (1,2,3,4)

Hypertension or angina and hyperlipidaemia (1,2)

Active liver disease or unexplained persistent elevated hepatic transaminases. Pregnancy and lactation. (1,2,3,4)

Amlodipine: Headache, dizziness, fatigue, somnolence, peripheral oedema, flushing, palpitations, nausea, abdominal pain; rarely pruritus, rash, dyspnoea, asthenia and 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, cholestasis, bullous rashes. (1,2,3,4)

Rifamycins may increase the metabolism of both Amlodipine and Atorvastatin. Atorvastatin may increase AUC of norethindrone and ethinyl estradiol. Potentially Fatal: Atorvastatin: Increased risk of myopathy when used concurrently with fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4 inhibitors (e.g. clarithromycin, HIV protease inhibitors, itraconazole). Cyclosporine (OATP1B1 inhibitor) may significantly increase bioavailability of Atorvastatin. (1,2,3,4)

Atorvastatin may cause myopathy, and rarely rhabdomyolysis with acute renal failure secondary to myoglobinuria especially at high doses or in patients with history of renal impairment. Caution when used with CYP3A4 inhibitors which may increase plasma concentrations of Atorvastatin. Atorvastatin has been associated with biochemical abnormalities of liver; LFT should be monitored prior to and at 12 wk following treatment initiation and dosage increment Caution in patients who consume large amounts of alcohol or with history of liver disease. Worsening of angina and/or myocardial infarction has been reported with use of dihydrophyridine calcium channel blockers, especially in patients with severe obstructive coronary artery disease. Amlodipine may cause dose-dependent peripheral oedema. Caution in patients with severe aortic stenosis, symptomatic hypotension may occur. (1,2,3,4)

Adult: As combination tab containing Amlodipine (mg)/Atorvastatin (mg): 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80. Amlodipine: Initially 5 mg once daily, titrate over 1-2 wk to maximum of 10 mg once daily. Atorvastatin: Initially 10-20 mg once daily (anytime of the day), patients who require >45 % reduction in LDL cholesterol may be initiated at 40 mg once daily. Titrate dose at intervals of at least 4 week to maximum of 80 mg once daily.  Child: HTN: Amlodipine: 2.5-5 mg once daily in children ages 6-17 yr. Heterozygous familial hypercholesterolaemia: Atorvastatin: Initially 10 mg once daily in children ages 10-17 yr; maximum recommended dose is 20 mg once daily.  (1,2,3,4)

1. Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th ed. China: McGraw Hill; 2011. 2. National Formulary of India. 4 th ed. Government of India, Ministry of Health and Family Welfare. India: Indian Pharmacopoeia Commission; 2011. 3. Amlodipine. [cited on 2nd september]. Available online from website http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf 4. Amlodipine besylate and atorvastatin calcium. [cited on 2nd september]. Available online from website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s028lbl.pdf