Avapro

DRUG DESCRIPTION

AVAPRO® (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.

Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1Htetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.

Its empirical formula is C25H28N6O, and the structural formula:

AVALIDE (irbesartan and hydrochlorothiazide) Structural Formula Illustration

Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.

AVAPRO is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, poloxamer 188, silicon dioxide, and magnesium stearate.

What are the possible side effects of irbesartan (Avapro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

    ...

Read All Potential Side Effects and See Pictures of Avapro »

What are the precautions when taking irbesartan (Avapro)?

Before taking irbesartan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not...

Read All Potential Precautions of Avapro »


Avapro Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, or upset stomach may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, slow/irregular heartbeat, unusual decrease in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking irbesartan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Avapro Patient Information Including Side Effects

Brand Names: Avapro

Generic Name: irbesartan (Pronunciation: ir be SAR tan)

  • What is irbesartan (Avapro)?
  • What are the possible side effects of irbesartan (Avapro)?
  • What is the most important information I should know about irbesartan (Avapro)?
  • What should I discuss with my healthcare provider before taking irbesartan (Avapro)?
  • How should I take irbesartan (Avapro)?
  • What happens if I miss a dose (Avapro)?
  • What happens if I overdose (Avapro)?
  • What should I avoid while taking irbesartan (Avapro)?
  • What other drugs will affect irbesartan (Avapro)?
  • Where can I get more information?

What is irbesartan (Avapro)?

Irbesartan is in a group of drugs called angiotensin II receptor antagonists. Irbesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Irbesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Irbesartan is also used to treat kidney problems caused by type 2 (not insulin-dependent) diabetes.

Irbesartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of irbesartan (Avapro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

  • feeling like you might pass out;
  • painful or difficult urination;
  • chest pain, fast heart rate;
  • swelling in your hands or feet.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • joint pain;
  • stomach pain, heartburn, diarrhea;
  • mild itching or skin rash;
  • feeling anxious or nervous;
  • headache, dizziness; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about irbesartan (Avapro)?

Do not use this medication without telling your doctor if you are pregnant. Irbesartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

You should not use this medication if you are allergic to irbesartan.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of irbesartan.

Do not use potassium supplements or salt substitutes while you are taking irbesartan, unless your doctor has told you to.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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