Irbesartan and Hydrochlorothiazide

Irbesartan and hydrochlorothiazide is a prescription medication used to treat high blood pressure.

It is a single product containing 2 medications: irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of drugs called angiotensin II receptor blockers (ARBs) which helps lower blood pressure by blocking a natural substance that causes blood vessels to narrow. This allows blood to flow more smoothly and makes the heart more efficient at pumping blood. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form and is typically given once daily with or without food.

Common side effects of irbesartan and hydrochlorothiazide include dizziness, muscle pain, and tiredness (fatigue). Do not drive or operate heavy machinery until you know how this medication affects you. 

Irbesartan and hydrochlorothiazide is a prescription medication used to treat high blood pressure. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Irbesartan and Hydrochlorothiazide may be found in some form under the following brand names:

• Avalide

Serious side effects have been reported with irbesartan and hydrochlorothiazide. See the "Irbesartan and hydrochlorothiazide Precautions" section. 

Common side effects of irbesartan and hydrochlorothiazide include the following:

• chest pain
• tiredness (fatigue)
• flu symptoms
• retaining fluid/swelling (edema)
• fast heart rate (tachycardia)
• stomach (abdominal) pain
• indigestion/heartburn
• nausea/vomiting
• allergy
• muscle pain
• dizziness/dizziness upon standing
• abnormal changes in urination

This is not a complete list of irbesartan and hydrochlorothiazide side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

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)
• alcohol
• 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 irbesartan and hydrochlorothiazide drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with irbesartan and hydrochlorothiazide or its ingredients including the following:

• Harm to an unborn baby (fetal toxicity). Do not take irbesartan and hydrochlorothiazide if you are pregnant or will become pregnant.
• Allergic reactions. More likely with a history of allergic reactions. 
• Increase in liver function tests. Your doctor will monitor your labs. 
• An autoimmune disease in which the body's immune system mistakenly attacks healthy tissue (systemic lupus erythematosus)
• Imbalances in the levels of salts and fluids in your body (electrolyte and fluid imbalance). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • dry mouth
  • thirst
  • weakness
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • low blood pressure
  • low output of urine
  • fast heart rate
  • nausea
  • vomiting
• Increased levels of potassium. Your doctor will monitor your labs. 
• Increase levels of cholesterol and triglyceride. Your doctor will monitor your labs. 
• A condition of excess of uric acid in the blood (hyperuricemia)
• Painful joint(s) (gout)
• Decrease in kidney function. Your doctor may hold or stop irbesartan and hydrochlorothiazide if your kidney does not work as well.
• Increase in blood sugar in patients with diabetes. Your doctor may need to adjust your diabetic medication

Do not take irbesartan and hydrochlorothiazide if you:

• are allergic to irbesartan and hydrochlorothiazide or any of its ingredients or sulfonamide-derived drugs
• your kidneys do not produce urine (anuria)
• are a diabetic patient who is taking aliskiren

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of irbesartan and hydrochlorothiazide, salt substitutes containing potassium should be avoided.

Before taking irbesartan and hydrochlorothiazide, tell your doctor about all of your medical conditions. Especially tell your doctor if:

• are allergic to irbesartan and hydrochlorothiazide or any of its ingredients or sulfonamide-derived drugs
• have liver disease
• you have or have ever had heart failure
• your kidneys do not produce urine (anuria)
• you have kidney disease
• are a diabetic patient, especially if you are taking aliskiren
• you are pregnant or plan to become pregnant
• you are breastfeeding or plan to breastfeed

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Irbesartan and hydrochlorothiazide falls into category C during the first trimester. Irbesartan and hydrochlorothiazide falls into category D during the second and third trimesters. Drugs that act directly on the renin-angiotensin system can cause injury and death to the unborn baby. When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if irbesartan is excreted in human breast milk. Hydrochlorothiazide has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from irbesartan and hydrochlorothiazide, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

Take irbesartan and hydrochlorothiazide exactly as prescribed. 

• Irbesartan and hydrochlorothiazide comes in a tablet form and is taken by mouth once daily with or without food. 
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of irbesartan and hydrochlorothiazide at the same time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

If you take too much irbesartan and hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store at room temperature, 59°F-86°F (15°C-30°C).
• Keep this and all medicines out of the reach of children. 

Warning: Fetal Toxicity

• When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.