Irbesartan and hydrochlorothiazide Advanced Patient Information - Drugs.com

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# Irbesartan and hydrochlorothiazide (Oral)

Medically reviewed by Drugs.com. Last updated on Sep 11, 2022.

Oral route(Tablet)

May cause injury or death to a developing fetus. Discontinue use as soon as possible if pregnancy is detected .

## Commonly used brand name(s)

In the U.S.

- Avalide

Available Dosage Forms:

- Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Thiazide

## Uses for irbesartan and hydrochlorothiazide

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.

Irbesartan and hydrochlorothiazide is available only with your doctor's prescription.

## Before using irbesartan and hydrochlorothiazide

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 irbesartan and hydrochlorothiazide, the following should be considered:

### Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to irbesartan and hydrochlorothiazide 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.

### Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of irbesartan and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

### Geriatric

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

### Breastfeeding

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.

### Interactions with 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 irbesartan and hydrochlorothiazide, 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 irbesartan and hydrochlorothiazide 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
- Dofetilide

Using irbesartan and hydrochlorothiazide 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.

- Aceclofenac
- Acemetacin
- Acetyldigoxin
- Amphetamine
- Amtolmetin Guacil
- Arsenic Trioxide
- Aspirin
- Benazepril
- Benzphetamine
- Bromfenac
- Bufexamac
- Captopril
- Celecoxib
- Ceritinib
- Choline Salicylate
- Cilazapril
- Clonixin
- Deslanoside
- Desmopressin
- Dexibuprofen
- Dexketoprofen
- Dextroamphetamine
- Diclofenac
- Diflunisal
- Digitalis
- Digitoxin
- Digoxin
- Dipyrone
- Droperidol
- Droxicam
- Enalapril
- Enalaprilat
- Entacapone
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Flecainide
- Floctafenine
- Fluconazole
- Flufenamic Acid
- Flurbiprofen
- Fosinopril
- Furosemide
- Ibuprofen
- Indomethacin
- Ketanserin
- Ketoprofen
- Ketorolac
- Levomethadyl
- Lisdexamfetamine
- Lisinopril
- Lithium
- Lornoxicam
- Loxoprofen
- Lumiracoxib
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Methamphetamine
- Methotrexate
- Metildigoxin
- Moexipril
- Morniflumate
- Nabumetone
- Naproxen
- Nepafenac
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Ouabain
- Oxaprozin
- Oxyphenbutazone
- Parecoxib
- Perindopril
- Phenylbutazone
- Piketoprofen
- Piroxicam
- Porfimer
- Potassium Citrate
- Potassium Phosphate
- Proglumetacin
- Propyphenazone
- Proquazone
- Proscillaridin
- Quinapril
- Ramipril
- Rofecoxib
- Salicylic Acid
- Salsalate
- Sodium Salicylate
- Sotalol
- Spirapril
- Sulindac
- Tenoxicam
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolmetin
- Trandolapril
- Trimethoprim
- Valdecoxib
- Zofenopril

Using irbesartan and hydrochlorothiazide 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
- Aminolevulinic Acid
- Amtolmetin Guacil
- Bepridil
- Bromfenac
- Bufexamac
- Carbamazepine
- Celecoxib
- Cholestyramine
- Choline Salicylate
- Clonixin
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyrone
- Droxicam
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Ginkgo
- Gossypol
- Ibuprofen
- Indomethacin
- Ketoprofen
- Ketorolac
- Licorice
- 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
- Topiramate
- Valdecoxib

### Interactions with food/tobacco/alcohol

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 irbesartan and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:

- Anuria (not able to form urine) or
- Diabetes patients that are also taking aliskiren (Tekturna®) or
- Kidney disease, severe or
- Sulfa drug allergy (antibiotic or stomach medicines, eg, sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in patients with these conditions.

- Asthma, or history of—May increase likelihood of having an allergic reaction.

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

- Diabetes or
- Electrolyte imbalances (eg, low levels of potassium, sodium, or magnesium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Glaucoma, secondary angle closure or
- Gout or
- Hypercalcemia (high calcium in the blood) or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Hypertriglyceridemia (high triglycerides in the blood) or
- Liver disease or
- Myopia, acute (changes in the eyeball causing vision problems) or
- Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

- Sympathectomy—Blood pressure–lowering effects of irbesartan and hydrochlorothiazide may be increased.

## Related/similar drugs

amlodipine, lisinopril, metoprolol, losartan, furosemide, hydrochlorothiazide

## Proper use of irbesartan and hydrochlorothiazide

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 irbesartan and hydrochlorothiazide 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.

Swallow the tablet whole. Do not break, crush, or chew it. You may take irbesartan and hydrochlorothiazide with or without food.

If you are taking cholestyramine or colestipol, take Avalide® at least 1 hour before or 4 hours after these medicines.

### Dosing

The dose of irbesartan and hydrochlorothiazide 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 irbesartan and hydrochlorothiazide. 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) irbesartan and 12.5 mg hydrochlorothiazide once a day. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.

### Missed dose

If you miss a dose of irbesartan and hydrochlorothiazide, 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.

Detailed Hydrochlorothiazide / irbesartan dosage information

## Precautions while using irbesartan and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure that irbesartan and hydrochlorothiazide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using irbesartan and hydrochlorothiazide while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using irbesartan and hydrochlorothiazide, tell your doctor right away. You may need to stop using irbesartan and hydrochlorothiazide.

Irbesartan and hydrochlorothiazide may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to irbesartan and hydrochlorothiazide before you drive, use machines, or do anything else that could be dangerous if you are dizzy. 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. If you faint, call your doctor right away.

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

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor immediately if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. These could be signs of serious eye problems (eg, angle-closure glaucoma, myopia, and choroidal effusion). Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Irbesartan and hydrochlorothiazide may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Irbesartan and hydrochlorothiazide may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Hyperkalemia (high potassium in the blood) may occur while you are using irbesartan and hydrochlorothiazide. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness of the legs. Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with irbesartan and hydrochlorothiazide. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

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.

## Irbesartan and hydrochlorothiazide side effects

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:

Less common

- Bloody or cloudy urine
- chest pain
- confusion
- difficult with breathing
- difficult, burning, or painful urination
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- stomach pain
- swelling
- weakness or heaviness of the legs

Rare

- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of appetite
- muscle pain or cramps
- seizures
- sweating
- unusual tiredness or weakness

Incidence not known

- Dark-colored urine
- eye pain
- fever
- hives or welts, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle spasms or stiffness
- nearsightedness
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- upper right abdominal or stomach pain
- white, yellow or waxy scar-like area
- yellow eyes and 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:

More common

- Headache
- sunburn

Less common

- Acid or sour stomach
- blistering, peeling, loosening of the skin
- chills
- congestion
- cough
- diarrhea
- dryness or soreness of the throat
- joint pain
- red irritated eyes
- red skin lesions, often with a purple center
- sneezing
- sores, ulcers, or white spots in the mouth or on the lips
- stomach discomfort or upset
- tender, swollen glands in the neck
- trouble sleeping
- trouble swallowing

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.

Hydrochlorothiazide / irbesartan side effects (more detail)

## More about hydrochlorothiazide / irbesartan

- Check interactions
- Pricing & coupons
- Reviews (6)
- Drug images
- Latest FDA alerts (4)
- Side effects
- Dosage information
- During pregnancy
- Drug class: angiotensin II inhibitors with thiazides
- En español

### Patient resources

- Drug Information
- Irbesartan and Hydrochlorothiazide

#### Other brands

Avalide

### Professional resources

- Prescribing Information

### Related treatment guides

- High Blood Pressure

## Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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