Drug Guide
Amlodipine Besylate and Atorvastatin Calcium
Classification
Therapeutic: Antihypertensive, Lipid-Lowering Agent
Pharmacological: Calcium Channel Blocker, HMG-CoA Reductase Inhibitor
FDA Approved Indications
- Hypertension
- Dyslipidemia (high cholesterol)
Mechanism of Action
Amlodipine inhibits calcium influx into vascular smooth muscle and cardiac muscle, leading to vasodilation. Atorvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis in the liver.
Dosage and Administration
Adult: As prescribed, typically once daily, dosage depends on patient response and tolerability.
Pediatric: Not approved for pediatric use.
Geriatric: Start at lower dose, monitor closely due to increased risk of adverse effects.
Renal Impairment: Use with caution; dose adjustments may be necessary.
Hepatic Impairment: Use with caution; contraindicated in active liver disease.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Widely distributed; highly protein-bound.
Metabolism: Amlodipine is extensively metabolized in the liver; atorvastatin is metabolized primarily by CYP3A4.
Excretion: Amlodipine excreted mainly via urine; atorvastatin predominantly excreted in bile.
Half Life: Amlodipine: ~30-50 hours; Atorvastatin: ~14 hours.
Contraindications
- Hypersensitivity to amlodipine or atorvastatin.
- Active liver disease, unexplained persistent elevations of serum transaminases.
Precautions
- Use cautiously in patients with congestive heart failure, hypotension, or renal impairment. Monitor liver function and lipid levels periodically.
Adverse Reactions - Common
- Dizziness (Common)
- Peripheral edema (Common)
- Muscle pain (Less common)
Adverse Reactions - Serious
- Myopathy/rhabdomyolysis (Rare)
- Hepatotoxicity (Rare)
- Allergic reactions (Rare)
Drug-Drug Interactions
- Simvastatin, lovastatin (avoid co-administration due to increased risk of myopathy)
- Grapefruit juice (inhibits CYP3A4, increasing statin levels)
Drug-Food Interactions
- Grapefruit juice
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood pressure, lipid profile, liver enzymes, and muscle symptoms.
Diagnoses:
- Risk for hypotension
- Risk for muscle injury
- Risk for hepatotoxicity
Implementation: Administer once daily; monitor patient response; educate patient on signs of adverse effects.
Evaluation: Evaluate blood pressure, lipid levels, and adherence regularly.
Patient/Family Teaching
- Take medication as prescribed.
- Report muscle pain, weakness, or symptoms of liver problems.
- Avoid grapefruit juice and discuss other potential food interactions.
- Follow up for lab tests as scheduled.
Special Considerations
Black Box Warnings:
- Myopathy and rhabdomyolysis; risk increased with concomitant use of certain drugs.
- Hepatotoxicity; hepatic function should be monitored.
- Not indicated for use in children.
Genetic Factors: Patients with certain genetic variants may have increased risk of statin-related side effects.
Lab Test Interference: Statins may slightly elevate liver enzymes; monitor periodically.
Overdose Management
Signs/Symptoms: Severe hypotension, tachycardia or bradycardia, muscle pain, hepatic dysfunction.
Treatment: Supportive care; activated charcoal if ingestion is recent; monitor cardiac and hepatic function; manage hypotension with IV fluids or vasopressors as needed.
Storage and Handling
Storage: Store at room temperature away from moisture and light.
Stability: Stable under recommended storage conditions.