Azor

Generic Name: amlodipine and olmesartan (Oral route)

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

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

• Azor

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Azor

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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

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

Olmesartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, olmesartan relaxes blood vessels. This lowers 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 Azor

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and olmesartan combination in the elderly.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Interactions with 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 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.

• Amiodarone


• Atazanavir


• Benazepril


• Conivaptan


• Dantrolene


• Droperidol


• Enalapril


• Enalaprilat


• Lisinopril


• Moexipril


• Perindopril


• Quinapril


• Ramipril


• Simvastatin


• Telaprevir


• Trandolapril

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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Carteolol


• Carvedilol


• Celecoxib


• Celiprolol


• Clopidogrel


• Dalfopristin


• Diclofenac


• Diflunisal


• Dilevalol


• Diltiazem


• Esmolol


• Etodolac


• Fenoprofen


• Fluconazole


• Flurbiprofen


• Ibuprofen


• Imatinib


• Indinavir


• Indomethacin


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nepafenac


• Oxaprozin


• Oxprenolol


• Penbutolol


• Pindolol


• Piroxicam


• Propranolol


• Quinupristin


• Rifapentine


• Ritonavir


• Salsalate


• Sotalol


• St John's Wort


• Sulindac


• Talinolol


• Tertatolol


• Timolol


• Tolmetin

Interactions with Food/Tobacco/Alcohol

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


• Heart attack, acute—Use with caution. This medicine may make these conditions worse.

• Dehydration or


• Heart failure or other heart problems (e.g., aortic stenosis, coronary artery disease) or


• Hyponatremia (low sodium in the blood)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

• Kidney disease or


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

Proper Use of Azor

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.

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 once a 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 Azor

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

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness or lightheadedness may occur after the first dose of this medicine, especially 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 not alert.

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 or salt which may cause low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or when the weather is hot. Heavy sweating may cause you to lose too much water or salt which may cause low blood pressure. Use extra care during exercise or hot weather.

Azor Side Effects

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


• tingling of the hands or feet


• unusual weight gain or loss

Less common

• Fast, irregular, pounding, or racing heartbeat or pulse

Incidence not known

• Abdominal or stomach pain


• agitation


• chills


• clay-colored stools


• coma


• confusion


• dark urine


• decreased urine output


• depression


• diarrhea


• dizziness


• fever


• headache


• hostility


• irritability


• itching


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


• lethargy


• light-colored stools


• loss of appetite


• muscle cramps or spasms


• muscle pain or stiffness


• muscle twitching


• nausea


• rash


• seizures


• stupor


• unpleasant breath odor


• unusual tiredness or weakness


• upper right abdominal pain


• vomiting of blood


• 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

• Feeling of warmth


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


• sleepiness or unusual drowsiness

Incidence not known

• Hair loss or thinning of the hair


• hives or welts


• lack or loss of strength


• redness of the skin


• swelling of the breasts or breast soreness in both females and males

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.

See also: Azor side effects (in more detail)

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More Azor resources

• Azor Side Effects (in more detail)
• Azor Dosage
• Azor Use in Pregnancy & Breastfeeding
• Drug Images
• Azor Drug Interactions
• Azor Support Group
• 34 Reviews for Azor - Add your own review/rating

• Azor Prescribing Information (FDA)


• Azor MedFacts Consumer Leaflet (Wolters Kluwer)


• Azor Consumer Overview

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