Generic Name

Amlodipine besylate and Valsartan

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Classification

FDA Approved Indications

• Hypertension
• Heart failure (specifically Valsartan)

Mechanism of Action

Amlodipine inhibits calcium influx into vascular smooth muscle and cardiac muscle, resulting in vasodilation. Valsartan blocks angiotensin II receptors, leading to vasodilation and decreased aldosterone secretion, reducing blood pressure.

Dosage and Administration

Adult: Typically, 5-10 mg once daily, with adjustments based on response.

Pediatric: Not approved for pediatric use.

Geriatric: Start at lower dose due to increased sensitivity.

Renal Impairment: Adjust dosing as necessary, monitor renal function.

Hepatic Impairment: Use with caution; start at lower doses and titrate slowly.

Pharmacokinetics

Absorption: Rapidly absorbed after oral administration.

Distribution: Amlodipine: 97.5% protein-bound; Valsartan: 94% protein-bound.

Metabolism: Amlodipine undergoes minimal first-pass metabolism; Valsartan is minimally metabolized.

Excretion: Amlodipine: primarily hepatic; Valsartan: primarily via feces; some renal excretion.

Half Life: Amlodipine: ~30-50 hours; Valsartan: ~6 hours.

Contraindications

• History of hypersensitivity to amlodipine or valsartan.
• Pregnancy (especially at term), known bilateral renal artery stenosis.

Precautions

• Monitor blood pressure, renal function, and electrolytes regularly.
• Use cautiously in hepatic impairment.

Adverse Reactions - Common

• Swelling (edema) (Common)
• Dizziness (Common)
• Headache (Common)

Adverse Reactions - Serious

• Hypotension (Serious)
• Angioedema (Rare)
• Elevated liver enzymes, hepatic failure (Rare)

Drug-Drug Interactions

• Other antihypertensives, diuretics, potassium supplements, NSAIDs

Drug-Food Interactions

• Limit alcohol intake; excessive salt may reduce efficacy.

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed.
• Rise slowly from sitting/lying to prevent dizziness.
• Report swelling, difficulty breathing, or chest pain.
• Maintain regular blood pressure and renal function tests.

Special Considerations

Black Box Warnings:

• Fetal toxicity: can cause fetal death when used during pregnancy.

Genetic Factors: Genetic variations may affect drug metabolism and response.

Lab Test Interference: May affect serum potassium and renal function tests.

Overdose Management

Signs/Symptoms: Severe hypotension, tachycardia or bradycardia, dizziness.

Treatment: Supportive care; monitor vital signs; administer fluids or vasopressors as needed; activated charcoal if ingestion is recent.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F).

Stability: Stable under recommended storage conditions.