Pronunciation:

ir-be-SAR-tan

Brand Names:

• Avapro

Dosage Forms:

• Tablet

Warnings:

When pregnancy is detected, discontinue irbesartan as soon as possible; drugs that act directly on the renin-angiotensin system can cause serious fetal toxicity .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Irbesartan 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 stroke and heart attacks.

Irbesartan is also used to treat high blood pressure with diabetic nephropathy. Diabetic nephropathy is a complication of type 2 diabetes which causes the kidneys to not work properly.

Irbesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of irbesartan in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

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

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.

Other 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Sparsentan

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.

• Benazepril
• Capecitabine
• Captopril
• Carbamazepine
• Ceritinib
• Cilazapril
• Cyclosporine
• Enalapril
• Enalaprilat
• Entacapone
• Fluconazole
• Fosinopril
• Furosemide
• Lisinopril
• Lithium
• Mavacamten
• Moexipril
• Perindopril
• Phenobarbital
• Potassium Citrate
• Potassium Phosphate
• Primidone
• Quinapril
• Ramipril
• Spirapril
• Tacrolimus
• Trandolapril
• Trimethoprim
• Zofenopril

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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Other interactions—

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:

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetic patients who are also taking aliskiren (Tekturna®)—Should not be used in patients with this condition.

• Electrolyte imbalances (e.g., low sodium in the body) or
• Fluid imbalances (e.g., dehydration, vomiting, diarrhea) or
• Kidney disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes 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.

Take all other medicines your doctor has prescribed to treat your condition.

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—At first, 150 milligrams (mg) once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 300 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For diabetic nephropathy:
    • Adults—300 milligrams (mg) 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 This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure that 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. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. 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 dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also loose water by sweating, so drink plenty of water during exercise or in hot weather.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Side Effects of This Medicine:

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

Chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

Less common

Bladder pain

bloody or cloudy urine

chest pain

difficult, burning, or painful urination

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

lower back or side pain

Rare

Chest discomfort

decreased urine output

dilated neck veins

extreme fatigue

feeling of warmth

fever

irregular breathing

irregular heartbeat

nausea

pain or discomfort in the arms, jaw, back, or neck

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

shortness of breath

sweating

swelling of the face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

vomiting

weight gain

Incidence not known

Abdominal or stomach pain

black, tarry stools

bleeding gums

clay-colored stools

dark urine

decreased frequency of urine

headache

increased thirst

itching

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

loss of appetite

muscle cramps or spasms

muscle pain or stiffness

nervousness

numbness or tingling in the hands, feet, or lips

pinpoint red spots on the skin

rash

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

weakness or heaviness of the legs

weight gain

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

Acid or sour stomach

belching

body aches or pain

bone pain

congestion

cough

diarrhea

dryness or soreness of the throat

feeling of indigestion

general feeling of discomfort or illness

heartburn

hoarseness

joint pain

pain in the chest below the breastbone

runny nose

shivering

sneezing

stomach discomfort or upset

stuffy nose

sweating

tender, swollen glands in the neck

trouble sleeping

trouble with swallowing

voice changes

Rare

Blistering, crusting, irritation, itching, or reddening of the skin

bloated or full feeling

blurred or loss of vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in hearing

cracked, dry, scaly skin

decreased interest in sexual intercourse

depression

difficulty having a bowel movement (stool)

disturbed color perception

double vision

ear drainage

earache or pain in the ear

excess air or gas in the stomach or intestines

halos around lights

hives or welts

inability to have or keep an erection

large, flat, blue or purplish patches in the skin

loss in sexual ability, desire, drive, or performance

night blindness

overbright appearance of lights

pain, swelling, or redness in the joints

passing gas

sleepiness or unusual drowsiness

tunnel vision

Incidence not known

Feeling of constant movement of self or surroundings

sensation of spinning

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.