Avalide

DRUG DESCRIPTION

AVALIDE (irbesartan-hydrochlorothiazide) Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5- ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is:

Irbesartan 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.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.

AVALIDE is available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, silicon dioxide, ferric oxide red, ferric oxide yellow, polyethylene glycol, titanium dioxide, and carnauba wax.

What are the possible side effects of hydrochlorothiazide and irbesartan (Avalide)?

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, hydrochlorothiazide and 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...

Read All Potential Side Effects and See Pictures of Avalide

What are the precautions when taking irbesartan-hydrochlorothiazide (Avalide)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to irbesartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged...

Read All Potential Precautions of Avalide


Avalide 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, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

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 this medication, tell your doctor or pharmacist if you are allergic to irbesartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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

Older adults may be more sensitive to the effects of this drug, especially dizziness.

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 irbesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Avalide Patient Information Including Side Effects

Brand Names: Avalide

Generic Name: hydrochlorothiazide and irbesartan (Pronunciation: HYE droe KLOR oh THYE a zide and ir be SAR tan)

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

What is hydrochlorothiazide and irbesartan (Avalide)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

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.

The combination of hydrochlorothiazide and irbesartan is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and irbesartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and irbesartan (Avalide)?

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, hydrochlorothiazide and 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;
  • chest pain, feeling short of breath, even with mild exertion;
  • fever;
  • swelling, rapid weight gain;
  • urinating more or less than usual, or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects may include:

  • stomach pain, heartburn;
  • muscle pain;
  • dizziness, drowsiness;
  • headache;
  • runny or stuffy nose, sore throat; or
  • dry cough.

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 hydrochlorothiazide and irbesartan (Avalide)?

You should not use this medication if you are allergic to irbesartan or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

Do not use this medication without telling your doctor if you are pregnant. Hydrochlorothiazide and 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.

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

In rare cases, hydrochlorothiazide and 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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