Amlodipine besylate and Atorvastatin calcium

Warning

Risk of myopathy and rhabdomyolysis, liver enzyme abnormalities, and increased risk of hemorrhagic stroke

Contraindications

• Pregnancy
• Active liver disease
• Unexplained persistent elevations in hepatic transaminase levels

Adverse Reactions

• Myopathy
• Rhabdomyolysis
• Liver enzyme abnormalities
• Increased risk of hemorrhagic stroke
• Edema
• Dizziness
• Fatigue
• Nausea
• Abdominal pain

General Guidance

Dose adjustments may be necessary in patients with renal impairment, hepatic impairment, or in patients taking certain medications

Pregnancy

• Amlodipine besylate and atorvastatin calcium tablets are contraindicated in women who are pregnant or may become pregnant
• Atorvastatin may cause fetal harm when administered to a pregnant woman

Nursing Mothers

• Amlodipine besylate and atorvastatin calcium tablets should not be used in nursing mothers unless the potential benefits justify the potential risks

Pediatric Use

• The safety and effectiveness of amlodipine besylate and atorvastatin calcium tablets have not been established in pediatric populations
• Amlodipine is effective in lowering blood pressure in patients 6 to 17 years old
• Atorvastatin is indicated for the treatment of heterozygous familial hypercholesterolemia in pediatric patients 10 to 17 years old

Geriatric Use

• Elderly patients have decreased clearance of amlodipine, and a lower initial dose may be required
• Atorvastatin is generally well-tolerated in elderly patients, but advanced age is a predisposing factor for myopathy