Azor

Name: Azor

Azor and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azor falls into category D. Azor is not usually recommended for use during pregnancy. See the “FDA Warning” section.

Azor FDA Warning

Fetal Toxicity:

  • When pregnancy is detected, discontinue Azor as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

How should I take amlodipine and olmesartan?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take this medication with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using amlodipine and olmesartan.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Blood pressure medication is only part of a complete treatment program that may also include diet, exercise, regular blood pressure testing, lifestyle changes, and other medications. Follow your doctor's instructions very closely.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or stop taking any of your medications without your doctor's advice.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Uses of Azor

  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Azor?

  • Tell all of your health care providers that you take Azor. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • It is rare, but worse chest pain and heart attack can happen after Azor is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • If you also take colesevelam, take it at least 4 hours after you take this medicine.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Azor with your other drugs.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • If you are 65 or older, use this medicine with care. You could have more side effects.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Very bad dizziness or passing out.
  • Chest pain that is new or worse.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Very loose stools (diarrhea).
  • Loose stools (diarrhea) that will not go away.
  • A big weight loss.
  • Stiff muscles, shakiness, or muscle movements that are not normal.

How supplied/storage and handling

Azor tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.

Azor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Azor tablets are supplied for oral administration in the following strength and package configurations:

Tablet Strength

(amlodipine equivalent/

olmesartan
medoxomil) mg

Package Configuration

NDC#

Product Code

Tablet Color

5/20 mg

Bottle of 30

65597-110-30 C73 White

Bottle of 90

65597-110-90

10 blisters of 10

65597-110-10

Bottle of 1000

65597-110-11
10/20 mg

Bottle of 30

65597-111-30 C74 Grayish Orange

Bottle of 90

65597-111-90

10 blisters of 10

65597-111-10

Bottle of 1000

65597-111-11
5/40 mg

Bottle of 30

65597-112-30 C75 Cream

Bottle of 90

65597-112-90

10 blisters of 10

65597-112-10

Bottle of 1000

65597-112-11
10/40 mg

Bottle of 30

65597-113-30 C77 Brownish Red

Bottle of 90

65597-113-90

10 blisters of 10

65597-113-10

Bottle of 1000

65597-113-11

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Important information

Do not use Azor if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use Azor together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Call your doctor at once if you have swelling in your hands or feet, rapid weight gain, pounding heartbeats or fluttering in your chest, urinating less than usual, jaundice (yellowing of the skin or eyes), chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, or if you feel like you might pass out.

Before taking this medicine

You should not use Azor if you are allergic to amlodipine (Norvasc) or olmesartan (Benicar).

If you have diabetes, do not use Azor together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

You may also need to avoid taking Azor with aliskiren if you have kidney disease.

To make sure Azor is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • coronary artery disease;

  • angina (chest pain), congestive heart failure;

  • high levels of potassium in your blood;

  • if you are on a low-salt diet;

  • if you are 75 years or older; or

  • if you have recently have had a heart attack.

Do not use Azor if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Amlodipine and olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

It is not known whether amlodipine and olmesartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Azor is not approved for use by anyone younger than 18 years old.

Azor dosing information

Usual Adult Dose for Hypertension:

Initial dose: Amlodipine 5 mg-Olmesartan 20 mg orally once a day; may increase dose after 1 to 2 weeks of therapy.

Maximum dose: Amlodipine 10 mg-Olmesartan 40 mg orally once a day

Uses:
-Substitution therapy for patients maintained on the individual components separately or for patients not adequately controlled with one of the components or a component within the same antihypertensive class.
-Initial therapy in patients who are likely to need more than 1 antihypertensive agent to control blood pressure.

For the Consumer

Applies to amlodipine / olmesartan: oral tablet

Along with its needed effects, amlodipine / olmesartan 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 while taking amlodipine / olmesartan:

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
  • Abdominal or stomach pain
  • dark urine
  • decreased urine output
  • diarrhea
  • fever
  • itching skin or 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
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some side effects of amlodipine / olmesartan 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

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