Irbesartan and hydrochlorothiazide (Oral)

Irbesartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload of the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can lower 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 makes blood vessels tighten. As a result, irbesartan relaxes the blood vessels. This lowers blood pressure and increases the flow of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It lowers the amount of water in the body by increasing urine flow, which helps lower blood pressure.

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

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away. You may need to stop using this medicine.

This medicine may cause dizziness, lightheadedness, or fainting, especially when you stand up suddenly from a lying or sitting position. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything else that could be dangerous if you feel dizzy. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from coming back. If you faint, call your doctor right away.

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

Check with your doctor right away if you notice bloody urine, a decrease in how often or how much you urinate, 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 signs of a serious kidney problem.

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

This medicine may affect blood sugar levels. If you notice a change in your blood or urine sugar test results, or if you have any questions, check with your doctor.

This medicine may increase your risk of skin cancer (for example, non-melanoma skin cancer). Avoid sun exposure. Use 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 this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in your hands, feet, or lips, trouble breathing, or weakness or heaviness in your legs. Ask your doctor before using medicines, supplements, or salt substitutes that contain potassium.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when used with this medicine. 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 is especially important for over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as they may increase your blood pressure.

In deciding to use a drug, the chances of using the drug 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 clinician if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also inform 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 issues that would limit the usefulness of irbesartan and hydrochlorothiazide combination in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using this drug while breastfeeding.

Interactions with Medicines

Although certain drugs 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 physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medications is not recommended. Your physician may decide not to treat you with this medication or change some of the other drugs you take.

• Aliskiren
• Dofetilide
• Sparsentan

Using this medicine with any of the following drugs is usually not advised, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Capecitabine
• Captopril
• Celecoxib
• Ceritinib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalapril
• Enalaprilat
• Entacapone
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Furosemide
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Spirapril
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Zofenopril

Using this medicine with any of the following medicines may cause an increased chance of certain side effects, but using both drugs may be the best treatment for you. If both drugs are prescribed together, your physician 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
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medications 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 additionally cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you tell your doctor if you have any other medical issues, especially:

• Anuria (not capable to form urine) or
• Diabetes patients that are also taking aliskiren (Tekturna®) or
• Kidney disease, serious 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 raise likelihood of having an allergic reaction.

• Congestive heart failure, serious—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 drug from the body.

• Sympathectomy—Blood pressure–lowering effects of this medication may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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
• Difficulty with breathing
• Difficulty, 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.

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

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.

Swallow the tablet whole. Do not break, crush, or chew it. 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.

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) 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 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.