Amlodipine + Valsartan
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Generic Name of Amlodipine + Valsartan - Learn More
Amlodipine + Valsartan
Amlodipine + Valsartan Precaution - What You Need to Know
The combination of amlodipine and valsartan is used primarily for managing hypertension and heart failure. However, certain precautions should be considered before use:
- Renal Impairment: Both amlodipine and valsartan can impact renal function, and caution is required in patients with pre-existing renal impairment. Valsartan, an angiotensin II receptor blocker (ARB), can cause hyperkalemia and worsening renal function, particularly in those with renal artery stenosis or underlying kidney disease. Kidney function should be monitored closely during therapy.
- Hypotension: Amlodipine, as a calcium channel blocker, can cause vasodilation and potentially lead to a significant drop in blood pressure, especially in volume-depleted or elderly patients. It is important to monitor blood pressure closely when initiating therapy, particularly after the first dose.
- Pregnancy and Breastfeeding: Both amlodipine and valsartan are contraindicated in pregnancy, particularly during the second and third trimesters, as ARBs like valsartan can cause fetal harm (e.g., renal dysfunction, hypotension, and death). Amlodipine is classified as Category C (risk cannot be ruled out) in pregnancy, and it should only be used if the potential benefits outweigh the risks. Both drugs are excreted into breast milk, and their use should be avoided during breastfeeding unless necessary.
- Hyperkalemia: Valsartan can increase potassium levels, which may result in hyperkalemia, especially when used in combination with potassium-sparing diuretics or potassium supplements. Monitoring of potassium levels is essential, particularly in patients with kidney disease.
Amlodipine + Valsartan Indication - Uses and Benefits
Amlodipine and valsartan are commonly prescribed together for the treatment of hypertension (high blood pressure) and heart failure. The combination targets blood pressure through two complementary mechanisms:
- Amlodipine: A calcium channel blocker, amlodipine works by inhibiting calcium ion influx into smooth muscle cells, causing arterial vasodilation. This reduces systemic vascular resistance and helps lower blood pressure.
- Valsartan: As an angiotensin II receptor blocker (ARB), valsartan blocks the effects of angiotensin II, a potent vasoconstrictor, leading to vasodilation, reduced secretion of aldosterone, and fluid balance regulation. This also aids in lowering blood pressure.
Together, these medications offer a powerful approach for managing hypertension in patients who do not achieve adequate control with a single agent. The combination is also effective in patients with heart failure, as valsartan helps reduce the load on the heart and amlodipine enhances blood flow.
Off-label uses of this combination may include treatment for chronic kidney disease (CKD) and stroke prevention, particularly for patients who are at high risk.
Amlodipine + Valsartan Contraindications - Important Warnings
There are several contraindications for the combination of amlodipine and valsartan:
- Hypersensitivity: Patients with a known allergy or hypersensitivity to either amlodipine, valsartan, or any of the components of the formulation should avoid this combination.
- Pregnancy: This combination is contraindicated in pregnancy, particularly after the first trimester, as both amlodipine and valsartan can harm the fetus. ARBs like valsartan are known to cause fetal injury or death, including renal failure and hypotension.
- Severe Renal Impairment: The combination should be avoided in patients with severe renal impairment (creatinine clearance < 30 mL/min) due to the risk of further kidney damage. Regular monitoring of renal function is required during treatment.
- Bilateral Renal Artery Stenosis: For patients with bilateral renal artery stenosis or unilateral renal artery stenosis with a single kidney, this combination is contraindicated as it may cause acute renal failure due to decreased renal perfusion.
- Hepatic Impairment: Caution is required in patients with hepatic impairment. The combination should be used with caution in patients with liver disease, and dose adjustments may be necessary for valsartan.
Amlodipine + Valsartan Side Effects - What to Expect
Side effects of amlodipine and valsartan are generally mild but can include:
- Common Side Effects:
- Amlodipine: Swelling of the feet or ankles (peripheral edema), dizziness, headache, and fatigue. These side effects are typically related to vasodilation and can be mitigated by dose adjustments or adding diuretics if necessary.
- Valsartan: Headache, dizziness, fatigue, and low blood pressure. In some cases, valsartan can lead to elevated potassium levels (hyperkalemia) or worsening renal function, which requires monitoring.
- Combination: Hypotension, particularly in the early stages of treatment or after dose increases. The risk is higher in patients who are volume-depleted or elderly.
- Serious Side Effects:
- Amlodipine: Rarely, amlodipine can cause severe allergic reactions, including angioedema (swelling of the throat or face), which requires immediate medical attention.
- Valsartan: Though rare, valsartan can cause angioedema, severe hypotension, and acute renal failure. Signs of hyperkalemia (e.g., muscle weakness, irregular heart rhythms) should be promptly addressed.
- Combination: Electrolyte imbalances (e.g., hyperkalemia or hyponatremia), worsening kidney function, and severe dizziness or fainting in vulnerable patients. Immediate medical attention should be sought if these occur.
Amlodipine + Valsartan Pregnancy Category ID - Safety Information
17
Amlodipine + Valsartan Mode of Action - How It Works
The combination of amlodipine and valsartan works through two complementary mechanisms to reduce blood pressure and manage heart failure:
- Amlodipine: A calcium channel blocker, amlodipine prevents calcium from entering smooth muscle cells in blood vessel walls, leading to vasodilation (relaxation of blood vessels). This reduces vascular resistance and helps lower blood pressure. Additionally, it improves myocardial oxygen supply, which is beneficial in treating angina.
- Valsartan: Valsartan, an angiotensin II receptor blocker (ARB), blocks the action of angiotensin II, a hormone that causes vasoconstriction. By preventing angiotensin II from binding to its receptors, valsartan promotes vasodilation, reduces aldosterone secretion (decreasing fluid retention), and helps lower blood pressure. Valsartan also has beneficial effects on the heart in heart failure by decreasing preload and afterload, thus reducing the heart’s workload.
This dual approach effectively controls hypertension while providing additional benefits for patients with heart failure.
Amlodipine + Valsartan Drug Interactions - What to Avoid
Several interactions may occur when amlodipine and valsartan are used with other drugs:
- Other Antihypertensive Agents: The combination with other antihypertensive medications (such as beta-blockers, diuretics, or ACE inhibitors) can result in an additive blood pressure-lowering effect. Monitoring blood pressure is crucial to avoid hypotension, especially when starting or adjusting doses.
- Potassium-Sparing Diuretics and Supplements: Valsartan can increase serum potassium levels, which increases the risk of hyperkalemia, particularly when used with potassium-sparing diuretics (e.g., spironolactone) or potassium supplements. Regular monitoring of serum potassium is required.
- NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Combining valsartan with NSAIDs (e.g., ibuprofen) can decrease the antihypertensive effect of valsartan and lead to kidney damage, especially in patients with existing renal issues. Fluid retention and worsening of hypertension are possible.
- Lithium: The combination of valsartan with lithium can increase the risk of lithium toxicity. Lithium levels should be closely monitored, especially when starting or adjusting valsartan doses.
- Cytochrome P450 Inhibitors: Amlodipine is metabolized by the CYP3A4 enzyme, and drugs that inhibit this enzyme (e.g., ketoconazole) may increase amlodipine levels. This could increase the risk of side effects such as swelling or dizziness. Conversely, CYP3A4 inducers (e.g., rifampin) may reduce amlodipine effectiveness.
Amlodipine + Valsartan Pregnancy Category Note - Key Information
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters).
Amlodipine + Valsartan Adult Dose - Recommended Dosage
For the treatment of hypertension:
- Amlodipine: The usual starting dose is 5 mg once daily, which can be increased to 10 mg once daily if needed based on the patient's response and tolerability.
- Valsartan: The typical starting dose is 80 mg once daily, which can be increased to 160 mg or 320 mg daily, depending on the patient’s response.
Fixed-dose combination tablets of amlodipine (5 mg) + valsartan (80 mg) or amlodipine (5 mg) + valsartan (160 mg) are available for convenience and dose adjustment. The maximum dose for amlodipine is 10 mg daily, and for valsartan, it is 320 mg daily.
Amlodipine + Valsartan Child Dose - Dosage for Children
The use of the combination of amlodipine and valsartan in pediatric patients is not well studied. Amlodipine can be used in children 6 years and older for the treatment of hypertension, starting at 2.5 mg daily. Valsartan is typically not used in children unless prescribed off-label for specific conditions such as pediatric hypertension or nephropathy, and dosing must be carefully adjusted based on weight and renal function.
The combination of amlodipine and valsartan is generally not recommended for children due to insufficient data on its safety and efficacy. Pediatric use should only be considered under strict medical supervision with close monitoring of renal function and electrolytes.
Amlodipine + Valsartan Renal Dose - Dosage for Kidney Conditions
In patients with renal impairment, particularly those with a creatinine clearance of less than 30 mL/min, caution is advised. Both amlodipine and valsartan can affect kidney function, and their combination may lead to worsening renal function.
- Mild to Moderate Renal Impairment: No specific dosage adjustment is required for amlodipine, but valsartan should be used with caution. Dose adjustments may be necessary depending on the degree of renal impairment.
- Severe Renal Impairment: The combination of amlodipine and valsartan is not recommended in patients with severe renal impairment. Regular monitoring of renal function and electrolytes (especially potassium) is essential.
