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Irbesartan and hydrochlorothiazide combination is used alone or together 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.
Irbesartan 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, irbesartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
What Is Avalide?
Avalide is a combination prescription medicine that contains the drugs hydrochlorothiazide and irbesartan. It's used to treat high blood pressure.
Lowering your blood pressure can reduce your risk of experiencing a heart attack, a stroke, or another cardiovascular complication.
Avalide is sometimes also used to treat heart failure.
Hydrochlorothiazide is a thiazide diuretic that prevents your body from absorbing too much salt.
Irbesartan is an angiotensin II receptor antagonist that keeps blood vessels from narrowing.
The U.S. Food and Drug Administration (FDA) approved Avalide in 1997. It's marketed by Sanofi-Aventis.
Before taking Avalide, tell your doctor if you have, or have ever had:
- Heart problems (including congestive heart failure)
- Glaucoma, secondary angle closure, or myopia (eye conditions)
- Kidney disease
- Liver disease
- High cholesterol or triglyceride levels
- Trouble urinating
- Lupus (an autoimmune disease characterized by inflammation and a variety of symptoms)
- Gout (a form of arthritis)
- High or low levels of potassium in your blood
- Allergies to medications (especially to penicillin, sulfa drugs, or any of the ingredients in Avalide)
Before using this drug, tell your doctor if you're also taking a medication that contains aliskiren (including Amturnide, Tekturna, Tekamlo, or Valturna).
Tell your healthcare provider you're taking this medicine before having any type of test or surgery, including a dental procedure.
This medicine may cause you to become sunburned more easily. Avoid exposure to the sun and sunlamps until you know how Avalide affects you. Wear sunscreen and protective clothing while outdoors.
In rare cases, Avalide may cause certain eye problems that could lead to permanent vision loss if untreated. Tell your doctor immediately if you experience any of the following symptoms:
- Eye pain
- Blurry vision
- Vision changes
Your doctor may recommend that you follow a specific diet and exercise program while taking Avalide. You may also be told to drink extra fluids. Follow your doctor's instructions carefully.
Don't use a salt substitute, or any product that has potassium in it, while taking Avalide unless your doctor has told you to do so.
You can become easily dehydrated or dizzy while taking Avalide. Tell your doctor immediately if you notice severe diarrhea, vomiting, or sweating.
To prevent dizziness, try to sit or stand up slowly, especially in the morning when getting out of bed.
If you have diabetes, Avalide may affect your blood sugar levels. Monitor your condition carefully.
Let your doctor know if you've recently had a type of nerve surgery called sympathectomy.
Older adults may be more sensitive to the effects of Avalide.
In rare cases, Avalide can cause a condition that leads to kidney failure. Tell your doctor right away if you experience the following symptoms while taking Avalide:
- Muscle pain, tenderness, or weakness (especially if you also have fever, nausea, and dark-colored urine)
Keep all appointments with your doctor and laboratory while taking Avalide. Your doctor will probably want to frequently check your blood pressure and perform other tests to monitor your body's response to this drug.
Pregnancy and Avalide
Avalide contains a black box warning because it may cause birth defects or death of a fetus if you take it during your second or third trimester of pregnancy.
Use an effective method of birth control to prevent pregnancy while taking Avalide.
Call your doctor right away if you think you might be pregnant while taking this drug.
It's not known whether Avalide passes into breastmilk or could hurt a breastfeeding baby. Don't breastfeed while taking this drug.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:
- angiotensin receptor blockers (ARBs) like valsartan (Diovan), ACE inhibitors (ACE) like enalapril (Vasotec, Vaseretic), or aliskiren (Tekturna)
- a class of drugs called barbiturates
- pain medications called narcotics
- diabetic medications including insulin
- cholestyramine (Questran) and colestipol (Colestid)
- medicines that provide relief for inflamed areas of the body (corticosteroids) such as methylprednisolone (Medrol) and dexamethasone (Decadron)
- substances that raise blood pressure (pressor amines) such as norepinephrine (Levophed)
- medicines that relax skeletal muscles
- lithium (Lithobid)
- nonsteroidal anti-inflammatory drugs (NSAIDS) such as naproxen (Aleve) and ibuprofen (Advil)
This is not a complete list of Avalide drug interactions. Ask your doctor or pharmacist for more information.
Avalide FDA Warning
Warning: Fetal Toxicity
- When pregnancy is detected, discontinue Avalide as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include fast or slow heartbeat, feeling light-headed, or fainting.
Proper Use of Avalide
In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these is 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. Therefore, 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 taking cholestyramine or colestipol, take Avalide® at least 1 hour before or 4 hours after these medicines.
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 once a day. Your doctor may increase your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For high blood pressure:
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.
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.
What are some things I need to know or do while I take Avalide?
- Tell all of your health care providers that you take Avalide. 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.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
- It may take a few weeks to see the full effect.
- 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.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Avalide.
- 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.
- 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.
- Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
- 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 taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
- If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with Avalide.
- Watch for gout attacks.
- If you have lupus, this medicine can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
Avalide Dosage and Administration
The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See Adverse Reactions (6).]
Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
Avalide may be administered with or without food.
Avalide may be administered with other antihypertensive agents.
Renal impairment. The usual regimens of therapy with Avalide may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Avalide is not recommended.
Hepatic impairment. No dosage adjustment is necessary in patients with hepatic impairment.
In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of Avalide, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. [See Clinical Studies (14.2).]
Avalide may be substituted for the titrated components.
The usual starting dose is Avalide 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Avalide is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
How Supplied/Storage and Handling
Avalide® (irbesartan-hydrochlorothiazide) film-coated tablets have markings on both sides and are available in the strengths and packages listed in the following table:
|Tablet Strength |
(irbesartan and hydrochlorothiazide)
|Film-Coated Tablet |
|Package Size||NDC Code|
|150 mg/12.5 mg||peach, biconvex, oval-shaped||heart debossed on one side and "2875" on the reverse||Bottles of 30 |
Bottles of 90
|300 mg/12.5 mg||peach, biconvex, oval-shaped||heart debossed on one side and "2876" on the reverse||Bottles of 30 |
Bottles of 90
Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].
|All Trimesters||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.|
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 an angiotensin II receptor antagonist. 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 purposes not listed in this medication guide.
What happens if i miss a dose (avalide)?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What should i avoid while taking hydrochlorothiazide and irbesartan (avalide)?
Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and irbesartan.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and irbesartan, unless your doctor has told you to.
What is Avalide?
Avalide tablets contain a combination of hydrochlorothiazide and irbesartan. Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.
Irbesartan is an angiotensin II receptor antagonist. Irbesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.
Avalide is used to treat high blood pressure (hypertension).
Avalide may also be used for purposes not listed in this medication guide.
How should I take Avalide?
Take Avalide exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Avalide with or without food.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.
Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated.
If you need surgery or medical tests, tell the surgeon ahead of time that you are using Avalide.
It may take up to 4 weeks for this medication to control your blood pressure. 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.
Store at room temperature away from moisture and heat.
What should I avoid while taking Avalide?
If you also take cholestyramine or colestipol, avoid taking these medications within 4 hours before or 4 hours after you take Avalide.
Drinking alcohol can further lower your blood pressure and may cause side effects.
Do not use potassium supplements or salt substitutes while you are taking Avalide, unless your doctor has told you to.
Pregnancy & Lactation
Therapy can cause fetal harm when administered to a pregnant woman; use of drugs that act on the renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in first trimester have not distinguished drugs affecting reninangiotensin system from other antihypertensive agents; when pregnancy is detected, discontinue therapy as soon as possible
Hypertension in pregnancy increases maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and postpartum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death; perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate,
Based on week of pregnancy; patients and physicians should be aware, however, that oligohydramnios may not appear until after fetus has sustained irreversible injury; closely observe infants with histories of in utero exposure to drug for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment; in neonates with a history of in utero exposure to drug, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion; exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function
Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults
There are no available data on the presence of irbesartan in human milk, effects on milk production, or breastfed infant; irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats
Thiazides appear in human milk; because of potential for adverse effects on nursing infant, the drug is not recommended in breastfeeding women
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.