Azor

(Amlodipine Besylate/Olmesartan Medoxomil)

The active ingredients in Azor are amlodipine and olmesartan medoxomil.

Amlodipine is a calcium channel blocker that relaxes and widens blood vessels. Olmesartan is an angiotensin II receptor blocker (ARB), which blocks a hormone that normally tightens them. Together, they reduce pressure in the arteries, make it easier for the heart to pump, and help lower the risk of heart and kidney complications.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Azor. However, the following is a synopsis of the general guidelines for the use of Azor:

• Azor is taken by mouth once daily.
• It may be taken with or without food.
• Tablets should be swallowed whole with water.
• Try to take Azor at the same time each day to maintain consistent blood levels.
• Do not stop taking Azor without medical advice, even if you feel well.
• If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose and resume your regular schedule.
• Blood pressure may not improve immediately, and it can take several weeks to see the full benefit. Regular follow-up with your healthcare provider is important.

Some mild or common side effects of Azor include:

• Swelling of the ankles or feet (edema).
• Dizziness or lightheadedness.
• Headache.
• Fatigue.
• Flushing.
• Weight gain or weight loss.

Some individuals may experience serious side effects while using Azor. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Very low blood pressure with fainting.
• Chest pain or worsening angina.
• Signs of kidney problems, such as reduced urine output or swelling.
• High potassium levels, which can cause weakness or irregular heartbeat.
• Severe allergic reactions, including swelling of the face, lips, tongue, or throat.

These are not all of the possible side effects of Azor. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Azor, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney disease or kidney problems.
• Heart disease, including heart failure or aortic stenosis.
• Liver disease.
• Low blood pressure (hypotension) or dehydration.
• High potassium levels (hyperkalemia) or use of potassium supplements.
• A history of allergic reactions to blood pressure medications.

Boxed Warning

Azor has a boxed warning regarding pregnancy. Drugs that act on the renin-angiotensin system can cause injury or death to an unborn baby when used during pregnancy. Azor should be stopped as soon as pregnancy is detected.

Azor should not be used in patients with known hypersensitivity to amlodipine, olmesartan medoxomil, or any component of the formulation. It should not be used in pregnant women. Concomitant use with aliskiren or in patients with diabetes is contraindicated.

Azor begins lowering blood pressure within the first week of treatment. Full blood pressure control may take several weeks. Your healthcare provider may adjust the dose based on response and tolerance.

When Azor is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, which may reduce blood pressure control and affect kidney function.
• Lithium, which may increase lithium levels and risk of toxicity.
• Potassium supplements or salt substitutes, which may raise potassium levels.
• Diuretics, which may increase the risk of low blood pressure.
• Aliskiren, which may increase the risk of kidney problems and low blood pressure.
• Simvastatin, which may have increased blood levels when used with amlodipine.
• Colesevelam.
• Cyclosporine.

Azor is available in several tablet strengths combining different doses of amlodipine and olmesartan medoxomil. Your healthcare provider will choose the appropriate dose based on your blood pressure response and medical history.

It should be stored at room temperature, away from the reach of children or pets.

Azor is manufactured by Daiichi Sankyo.

Yes. Generic name versions containing amlodipine and olmesartan medoxomil are available.

Do not stop taking Azor without speaking to your healthcare provider. Stopping treatment suddenly may cause blood pressure to rise. Your provider may gradually adjust your therapy if needed.

Azor should not be used during pregnancy due to the risk of serious harm to the unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

It is not known if olmesartan passes into breast milk, and amlodipine may pass into breast milk in small amounts. Your healthcare provider will help determine the safest option.