Irbesartan

Irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Irbesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.

Irbesartan may also be used to treat heart failure.

Irbesartan is available under the following different brand names: Avapro.

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 75mg
• 150mg
• 300mg

Dosage Considerations – Should be Given as Follows:

Hypertension

Adult: 150 mg/day orally initially; may be increased to 300 mg/day orally

Hypovolemia

75 mg/day orally initially

Children under 6 years

Safety and efficacy not established

Children 6-12 years

75 mg/day orally initially; not to exceed 150 mg/day

Children over 12 years

150 mg/day orally initially; may be increased to 300 mg/day orally

Nephropathy in Type 2 Diabetes

75-300 mg/day orally

Dosage Modifications

Mild-to-severe renal impairment: Dosage adjustment not necessary unless patient is hypovolemic

Dosing Considerations

Also given in combination with hydrochlorothiazide (Avalide)

Generally, adjust dosage monthly; adjust more aggressively in high-risk patients

Common side effects of irbesartan include:

• High blood potassium (hyperkalemia)
• Dizziness
• Dizziness upon standing
• Upper respiratory tract infection (URTI)
• Fatigue
• Diarrhea
• Indigestion
• Heartburn
• Lightheadedness
• Upset stomach as your body adjusts to the medication
• Tiredness

Postmarketing side effects of irbesartan reported include Hives; angioedema (involving swelling of the face, lips, pharynx, or tongue); elevated liver function test results; yellowing skin and eyes (jaundice); hepatitis; hyperkalemia, and low blood platelets (thrombocytopenia) Impaired kidney function, including cases of kidney failure, has been reported Increased creatine phosphokinase (CPK) levels and muscle wasting (rhabdomyolysis) have been reported in patients receiving angiotensin-receptor blockers (ARBs)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of irbesartan include:
  • aliskiren
• Serious interactions of irbesartan include:
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • lisinopril
  • lithium
  • moexipril
  • perindopril
  • quinapril
  • ramipril
  • trandolapril
• Irbesartan has moderate interactions with at least 122 different drugs.
• Mild interactions of irbesartan include:
  • agrimony
  • cornsilk
  • lofexidine
  • noni juice
  • octacosanol
  • reishi
  • ruxolitinib
  • shepherd's purse

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death.

This medication contains irbesartan. Do not take Avapro if you are allergic to irbesartan or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Hypersensitivity

Do not coadminister with aliskiren in patients with diabetes

Effects of Drug Abuse

No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Irbesartan?"

Long-Term Effects

Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis.

• See "What Are Side Effects Associated with Using Irbesartan?"

Cautions

Angioedema, volume-depletion, severe congestive heart failure (CHF), hepatic or renal impairment, hypertrophic cardiomyopathy, aortic or mitral valve stenosis, surgery or anesthesia.

Discontinue immediately if patient is pregnant; risk of congenital malformations (see Contraindications and Warnings).

Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis.

Risk of low blood pressure (hypotension) or hyperkalemia.

Dual blockade of the renin-angiotensin system with ARBs, angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy.

Risk of heart failure-related morbidity; concomitant treatment with ACE inhibitors and beta-adrenergic agents is not recommended.

Pregnancy and Lactation

Use irbesartan with caution during the first trimester of pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

Use irbesartan only in LIFE-THREATENING emergencies during the second and third trimesters of pregnancy when no safer drug is available. There is positive evidence of human fetal risk. Discontinue as soon as possible when pregnancy is detected; the drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death.

Irbesartan has potential to cause harm to nursing infants; discontinue the drug, or do not nurse while using irbesartan.