Pronunciation:

am-LOE-di-peen BES-i-late, ol-me-SAR-tan me-DOX-oh-mil

Brand Names:

• Azor

Dosage Forms:

• Tablet

Warnings:

Drugs with direct action on the renin-angiotensin system can cause injury or death to the developing fetus when used during pregnancy. Stop therapy as soon as possible if pregnancy occurs .

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Amlodipine

Chemical—

Amlodipine

Uses of This Medicine:

Amlodipine and olmesartan is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, olmesartan relaxes blood vessels. This lowers the blood pressure and increases the supply of blood and oxygen to the heart.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and olmesartan combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and olmesartan combination in the elderly. However, elderly patients may need a lower dose of this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Atazanavir
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Domperidone
• Droperidol
• Epirubicin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Itraconazole
• Lacosamide
• Lithium
• Mavacamten
• Melphalan
• Netupitant
• Omaveloxolone
• Phenobarbital
• Piperaquine
• Primidone
• Rifampin
• Ritonavir
• Simvastatin
• Tacrolimus
• Tegafur
• Telaprevir
• Trimethoprim

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Boceprevir
• Ciprofloxacin
• Cobicistat
• Colesevelam
• Crizotinib
• Diltiazem
• Dronedarone
• Fluconazole
• Fluvoxamine
• Idelalisib
• Indinavir
• Ketoconazole
• Letermovir
• Lopinavir
• Nefazodone
• Nelfinavir
• Nilotinib
• Posaconazole
• Rifapentine
• Saquinavir
• Telithromycin
• Verapamil
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Electrolyte imbalances (eg, low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart attack, acute or
• Heart failure or other heart problems (eg, aortic stenosis, obstructive coronary artery disease) or
• Kidney disease—Use with caution. May make these conditions worse.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetes patients who are also taking aliskiren (Tekturna®) or
• Patients with kidney problems who are taking aliskiren (Tekturna®)—Should not be used in these patients.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Azor®.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—One tablet containing 5 milligrams (mg) of amlodipine and 20 mg of olmesartan once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of olmesartan per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. You may need to stop using this medicine and change to another blood pressure medicine.

Dizziness, lightheadedness, or fainting may also occur especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and may lead to blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor right away if you have chest pain that is worse than usual, trouble breathing, nausea, unusual sweating, faintness, or pain in your arms, jaw, back, or neck. This medicine may worsen the symptoms of an existing heart problem.

Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor right away if you have these symptoms.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

unusual tiredness or weakness

Incidence not known

Dark urine

decreased urine output

diarrhea

fever

itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

muscle pain or stiffness

stomach pain

upper right abdominal or stomach pain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Dizziness

feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

sleepiness or unusual drowsiness

Incidence not known

Hives or welts

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.