Usage
- Amlodipine + Lisinopril is primarily prescribed for the treatment of hypertension (high blood pressure). It may also be used when blood pressure is not adequately controlled by either medication alone. It may be prescribed for other cardiovascular conditions as deemed appropriate by a physician.
- Pharmacological Classification: This combination drug belongs to two classes: Amlodipine is a calcium channel blocker, and Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor.
- Mechanism of Action: Amlodipine works by relaxing and widening blood vessels, making it easier for blood to flow. Lisinopril works by blocking the production of a substance that narrows blood vessels. Together, they lower blood pressure synergistically.
Alternate Names
- No widely recognized alternate generic names exist. The combination is often referred to as “amlodipine/lisinopril”.
- Brand Names: Several brand names exist depending on the region, including Lisonorm (EU), and various others in India, such as Aamin L, Acedip, Alis, Alis Plus, among many others. It is not currently available in the United States, Canada, or Australia under a brand name.
How It Works
- Pharmacodynamics: Amlodipine inhibits calcium influx into vascular smooth muscle cells, leading to vasodilation. Lisinopril inhibits the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This reduces vasoconstriction, aldosterone secretion, and ultimately lowers blood pressure.
- Pharmacokinetics: Amlodipine is well absorbed orally and undergoes extensive hepatic metabolism. Lisinopril is orally active and is primarily excreted unchanged by the kidneys.
- Mode of Action: Amlodipine blocks L-type calcium channels. Lisinopril inhibits the ACE enzyme.
- Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Amlodipine primarily interacts with L-type calcium channels. Lisinopril inhibits the ACE enzyme.
- Elimination Pathways: Amlodipine is primarily eliminated through hepatic metabolism, with metabolites excreted in the urine and feces. Lisinopril is mainly excreted unchanged in the urine.
Dosage
Standard Dosage
Adults:
- Initial dose: Typically, Amlodipine 5 mg + Lisinopril 10 mg once daily. This may be adjusted up to a maximum of Amlodipine 10 mg + Lisinopril 40 mg per day as needed based on blood pressure response. Some patients may initiate therapy at lower doses, especially those already on other antihypertensive medications.
Children:
- Not generally recommended for use in children under 18 years of age for this combination. Individual components may be used in pediatrics with careful dose adjustment under the supervision of a specialist.
Special Cases:
- Elderly Patients: Initial doses should generally be lower, such as Amlodipine 2.5 mg + Lisinopril 5 mg, due to potential age-related changes in drug clearance. Close monitoring is essential.
- Patients with Renal Impairment: Lisinopril dosage should be reduced in patients with renal impairment as it is primarily excreted by the kidneys. Amlodipine dosage usually doesn’t require adjustment. Careful monitoring of renal function is required.
- Patients with Hepatic Dysfunction: Amlodipine dosage may require reduction in patients with hepatic impairment. Lisinopril dosage is usually unaffected.
- Patients with Comorbid Conditions: Dosage adjustments may be needed for patients with diabetes, heart failure, or other cardiovascular conditions. For example, patients with diabetes should be monitored for hyperkalemia when taking Lisinopril.
Clinical Use Cases
- The combination is primarily used for chronic hypertension management. It’s generally not indicated for acute situations like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations like cardiac arrest. In such situations, individual components may be used with appropriate dosing adjustments.
Dosage Adjustments
- Dosage adjustments are based on blood pressure response, renal function, hepatic function, and the presence of other medical conditions. Individual components of the combination may need adjustment. Regular monitoring of blood pressure, electrolytes, and renal function is advisable.
Side Effects
Common Side Effects
- Dizziness, headache, fatigue, swelling in the ankles or feet (peripheral edema), cough, flushing, nausea, abdominal pain, hypotension (low blood pressure).
Rare but Serious Side Effects
- Angioedema (swelling of the face, lips, tongue, throat, or extremities), hyperkalemia (elevated potassium levels), severe hypotension, acute renal failure, liver dysfunction, and neutropenia (low white blood cell count).
Long-Term Effects
- Potential long-term effects can include persistent cough with Lisinopril and electrolyte imbalances. Regular monitoring of blood pressure and relevant laboratory values is important during chronic therapy.
Adverse Drug Reactions (ADR)
- Angioedema, acute kidney injury, severe hypotension, and hyperkalemia represent potentially life-threatening ADRs requiring immediate medical intervention.
Contraindications
- History of angioedema related to ACE inhibitor use, bilateral renal artery stenosis, pregnancy (especially second and third trimesters), hypersensitivity to Amlodipine or Lisinopril.
Drug Interactions
- Other Antihypertensives: Additive hypotensive effects may occur.
- Potassium-sparing diuretics (e.g., spironolactone): Increased risk of hyperkalemia.
- NSAIDs (e.g., ibuprofen, naproxen): Reduced antihypertensive effect of lisinopril and increased risk of renal impairment.
- Lithium: Lisinopril can increase lithium levels.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase Amlodipine levels.
- Simvastatin: Dosage adjustment of Simvastatin may be necessary.
- Alcohol: Can enhance the hypotensive effects.
- High-potassium foods: May increase risk of hyperkalemia with Lisinopril.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: D (Lisinopril is contraindicated, Amlodipine should be used with caution only if the benefits outweigh the risks). ACE inhibitors are known to cause fetal harm, especially in the second and third trimesters.
- Breastfeeding: Not recommended. Amlodipine passes into breast milk. While there are limited data on the combined effects, it’s generally advised to discontinue breastfeeding or the medication.
Drug Profile Summary
- Mechanism of Action: Amlodipine: Calcium channel blocker, vasodilator. Lisinopril: ACE inhibitor, reduces vasoconstriction.
- Side Effects: Dizziness, headache, edema, cough, hypotension, hyperkalemia.
- Contraindications: Angioedema history with ACE inhibitors, pregnancy, bilateral renal artery stenosis.
- Drug Interactions: Other antihypertensives, potassium-sparing diuretics, NSAIDs, lithium, CYP3A4 inhibitors, simvastatin, alcohol.
- Pregnancy & Breastfeeding: Contraindicated in pregnancy (especially 2nd/3rd trimesters); not recommended during breastfeeding.
- Dosage: Adults: Amlodipine 5-10 mg + Lisinopril 10-40 mg once daily; adjust based on response and patient-specific factors.
- Monitoring Parameters: Blood pressure, renal function, electrolytes (especially potassium), signs of angioedema.
Popular Combinations
- Amlodipine and Lisinopril are frequently used together as a combination therapy for hypertension due to their synergistic effects and ability to control blood pressure more effectively than either drug alone. Sometimes a thiazide diuretic, like hydrochlorothiazide, is added for enhanced blood pressure control.
Precautions
- General Precautions: Assess renal and hepatic function before starting therapy. Monitor blood pressure and potassium levels regularly.
- Pregnant Women: Contraindicated, especially in the second and third trimesters.
- Breastfeeding Mothers: Not recommended.
- Children & Elderly: Use with caution and initiate at lower doses in elderly patients. Combined product is typically not recommended for children.
- Lifestyle Considerations: Advise patients to limit alcohol intake and avoid high-potassium foods if taking Lisinopril. Caution with driving and operating machinery due to potential dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Amlodipine + Lisinopril?
A: The initial dose is typically Amlodipine 5 mg + Lisinopril 10 mg once daily, adjustable up to a maximum of Amlodipine 10 mg + Lisinopril 40 mg/day based on patient response. Lower starting doses are often used in elderly patients and those with renal or hepatic impairment.
Q2: What are the most common side effects?
A: Common side effects include dizziness, headache, peripheral edema, cough, and fatigue.
A: Angioedema, severe hypotension, acute kidney injury, and hyperkalemia require immediate medical attention.
Q4: Can this combination be used in pregnant or breastfeeding women?
A: No, it is contraindicated in pregnancy, especially during the second and third trimesters. It’s generally advised to discontinue breastfeeding or the medication while breastfeeding.
Q5: What are the main drug interactions to be aware of?
A: Significant interactions can occur with other antihypertensives, potassium-sparing diuretics, NSAIDs, lithium, CYP3A4 inhibitors (like ketoconazole), and simvastatin.
Q6: How does this combination work to lower blood pressure?
A: Amlodipine widens blood vessels by blocking calcium channels. Lisinopril inhibits an enzyme that produces a vasoconstrictor, therefore promoting vasodilation. These combined actions synergistically lower blood pressure.
Q7: What should I monitor in patients taking this medication?
A: Monitor blood pressure, renal function, electrolytes (particularly potassium), and signs of angioedema.
Q8: Are there any lifestyle modifications recommended for patients on this combination?
A: Advise patients to limit alcohol intake, avoid high-potassium foods if on Lisinopril, and take precautions when driving or operating machinery due to potential dizziness.
Q9: When should this medication be avoided?
A: Avoid in patients with a history of angioedema related to ACE inhibitors, bilateral renal artery stenosis, pregnancy (especially second/third trimester), or hypersensitivity to either component.
