Amlodipine + Atorvastatin

Amlodipine + Atorvastatin is a combination of two medicines: Amlodipine (a calcium channel blocker) and Atorvastatin (a statin). Amlodipine relaxes blood vessels and lowers blood pressure. Atorvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis and lowering LDL cholesterol and triglycerides while increasing HDL cholesterol.

Common side effects include headache, nausea, stomach pain, flushing, ankle swelling, and muscle pain.

• Hypertension
• Chronic stable angina
• Coronary Artery Disease (CAD)
• Primary hypercholesterolemia (heterozygous familial and non-familial)
• Mixed dyslipidemia (Fredrickson Types IIa and IIb)
• Hypertriglyceridemia (Fredrickson Type IV)
• Primary dysbetalipoproteinemia (Fredrickson Type III)
• Homozygous Familial Hypercholesterolemia (HoFH)

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to reduce peripheral vascular resistance and lower blood pressure. The vasodilation induced by amlodipine is gradual in onset, so acute hypotension is rarely reported after oral administration.

Atorvastatin is a synthetic lipid-lowering agent that inhibits HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol synthesis.

Amlodipine inhibits calcium ion influx into vascular smooth muscle, relaxing blood vessels and lowering blood pressure. Atorvastatin inhibits hepatic HMG-CoA reductase, reducing cholesterol synthesis and increasing LDL receptors, which lowers LDL cholesterol and triglycerides while raising HDL cholesterol.

Amlodipine:

• Hypertension: 5 mg once daily (maximum 10 mg)
• Elderly/Hepatic impairment: Start with 2.5 mg once daily
• Chronic stable/vasospastic angina: 5-10 mg daily

Atorvastatin:

• Hypercholesterolemia & mixed dyslipidemia: Start with 10 mg daily (range 10-80 mg)
• Homozygous FH: 10-80 mg daily
• Renal impairment: No dose adjustment needed
• Hepatic dysfunction: Exposure is increased in moderate-severe disease

Take this medicine in the dose and duration as advised by your doctor. Swallow the tablet whole - do not chew, crush, or break. May be taken at any time of the day, with or without food, but take at a fixed time.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

• Headache
• Nausea
• Stomach pain
• Flushing
• Ankle swelling
• Palpitations
• Constipation
• Muscle pain
• Tiredness
• Sleepiness
• Increased blood glucose
• Increased liver enzymes

Serious Precautions:

• Patients with severe obstructive coronary artery disease may develop increased frequency of angina or MI when starting calcium channel blocker therapy or increasing dose
• Report any muscle pain, tenderness, or weakness to your doctor
• Report signs of liver damage (abdominal pain, dark urine, yellow skin/eyes)
• Do not use during pregnancy and breastfeeding
• Contraindicated in active liver disease or unexplained liver enzyme elevations (>3x ULN)
• Use with caution in patients with heart failure
• Caution in severe aortic stenosis

• Hypersensitivity to amlodipine or atorvastatin
• Active liver disease or unexplained persistent liver enzyme elevations (>3x ULN)
• Pregnancy and lactation

• Atorvastatin:
• Cyclosporine, fibrates, niacin, erythromycin, azole antifungals - increase risk of myopathy
• Antacids (Mg/Al hydroxide) - decrease atorvastatin plasma levels by ~35%
• Colestipol - decreases atorvastatin plasma levels by ~25%
• Digoxin - increases digoxin plasma levels by ~20%
• Erythromycin - increases atorvastatin plasma levels by ~40%
• Oral contraceptives - increase norethindrone and ethinyl estradiol AUC by ~30% and ~20%
• Amlodipine: Potentiates effect of other antihypertensives (beta-blockers, ACE inhibitors, diuretics)

[UNSAFE] Alcohol with Amlodipine + Atorvastatin may increase the risk of liver problems.

[UNSAFE] Do not use during pregnancy (Category D). Amlodipine has fetal risk and atorvastatin is contraindicated during pregnancy.

[SAFE IF PRESCRIBED] Amlodipine is excreted in breast milk; atorvastatin data is limited. Use during breastfeeding is not recommended.

Safety and efficacy of atorvastatin in children have not been established.

Elderly patients should start amlodipine at 2.5 mg daily. Atorvastatin efficacy and safety in elderly patients are similar to the general population.

Renal Impairment: No dose adjustment needed. Hemodialysis is not expected to enhance atorvastatin clearance.

Hepatic Impairment: Contraindicated in active liver disease or unexplained enzyme elevations. Exposure is increased in moderate-severe hepatic dysfunction.

No specific antidote for overdose. Symptomatic and supportive treatment is required. Amlodipine overdose may cause excessive peripheral vasodilation and reflex tachycardia.

Store in a cool and dry place, protected from light and moisture. Keep out of reach of children.

Amlodipine besilate (C₂₀H₂₅ClN₂O₅) + Atorvastatin calcium (C₃₃H₃₅FN₂O₅·Ca)