Is Amlodipine approved by the FDA?

Yes, amlodipine is FDA approved. The U.S. Food and Drug Administration (FDA) approved amlodipine, which is marketed under brand names such as Norvasc, Katerzia, and Norliqva, for medical use. This approval was granted on July 8, 2019.

What is Amlodipine?

Amlodipine besylate belongs to a class of medications called calcium channel blockers. It works by relaxing the blood vessels, which allows blood to flow more easily and the heart to pump more efficiently. This medication is commonly used to treat high blood pressure (hypertension), certain types of angina (chest pain), and other conditions caused by coronary artery disease.

Uses of Amlodipine

1. Hypertension:Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children aged six years and older. Lowering blood pressure helps reduce the risk of strokes and heart attacks.
2. Angina:It is used to treat angina (chest pain) by increasing the blood supply to the heart muscle. However, it does not stop chest pain once it starts but can help manage the condition when taken regularly.
3. Coronary Artery Disease (CAD):Amlodipine is also prescribed to treat coronary artery disease by improving blood flow and reducing the strain on the heart.

Dosage Forms

Amlodipine is available in various forms, including:

• Oral tablets: 2.5 mg, 5 mg, and 10 mg
• Oral liquid: 1 mg/mL (Norliqva)
• Oral suspension: 1 mg/mL (Katerzia)

Common Side Effects

Common side effects of amlodipine may include:

• Dizziness or drowsiness
• Swelling of legs or ankles
• Irregular heartbeat
• Pounding heartbeats or fluttering in the chest
• Muscle stiffness or uncontrolled muscle movements
• Tiredness
• Stomach pain or nausea
• Flushing (sudden warmth, redness, or tingly feeling)

Serious Side Effects

While rare, serious side effects may occur, especially when first starting the medication or adjusting the dose. These include:

• Worsening chest pain
• Symptoms of a heart attack (chest pain or pressure, pain spreading to the jaw or shoulder, nausea, sweating)

If any of these occur, seek emergency medical attention immediately.

Warnings and Precautions

• Alcohol: Drinking alcohol can lower blood pressure further and increase certain side effects of amlodipine.
• Congestive Heart Failure: Patients with this condition should use amlodipine with caution.
• Liver Disease: Tell your doctor if you have liver disease as it may affect how the medication works in your body.

Interactions

Amlodipine can interact with other medications, including over-the-counter drugs, vitamins, and herbal supplements. Always inform your healthcare provider of all the medications you are taking to avoid potential interactions.

Conclusion

Amlodipine is a widely used medication for treating high blood pressure, angina, and coronary artery disease. Its approval by the FDA underscores its effectiveness and safety when used as directed. As with any medication, it is important to follow your healthcare provider's instructions and be aware of potential side effects and interactions.

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