Olmesartan

Hypertension Management

Olmesartan is primarily used to lower high blood pressure. Controlling hypertension is essential for reducing the risk of life-threatening cardiovascular events, including:

• Strokes
• Heart attacks
• Kidney damage

Usage in Different Groups

This medication is approved for use in adults and in children and adolescents between the ages of 6 and 16. It is not typically used in children younger than 6 years old.

Combination Treatment

Olmesartan may be prescribed as a single-ingredient medication or as part of a combination therapy. It is often used alongside other blood pressure medications, such as diuretics (water pills) or calcium channel blockers, when one drug alone is not sufficient to control blood pressure levels.

How Olmesartan Works

Olmesartan belongs to a class of medications known as angiotensin II receptor blockers. It works by blocking the action of a natural substance in the body called angiotensin II, which is a hormone that causes blood vessels to tighten and narrow.

By preventing this substance from binding to its receptors on the blood vessels, olmesartan helps the vessels to:

• Relax and dilate (widen).
• Allow blood to flow more smoothly.
• Reduce the overall pressure within the arteries.

When blood pressure is lowered, the heart does not have to work as hard to pump blood throughout the body. This medication is primarily used to treat hypertension (high blood pressure).

Common Side Effects

• Dizziness or lightheadedness
• Headache
• Back pain
• Cold or flu-like symptoms, such as a runny nose, sore throat, or sneezing
• Mild diarrhea
• Joint or muscle pain

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Signs of an allergic reaction, including swelling of the face, lips, tongue, throat, eyes, hands, or feet
• Difficulty breathing or swallowing
• Severe, chronic diarrhea accompanied by significant weight loss
• Fainting or feeling very lightheaded
• Hoarseness
• Changes in urination or other signs of kidney problems

Fetal Toxicity

Olmesartan can cause serious injury or death to an unborn baby if taken during pregnancy. If pregnancy is detected, the medication must be discontinued as soon as possible. Use of drugs that act on the renin-angiotensin system during the second and third trimesters reduces fetal renal function and increases the risk of fetal and neonatal morbidity and death.

Sprue-like Enteropathy

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan. This condition, known as sprue-like enteropathy, may develop months to years after starting the drug. If a patient develops these symptoms and no other cause is identified, the medication is typically discontinued.

Hypotension and Electrolyte Imbalance

Low blood pressure (hypotension) may occur, particularly in patients who are volume- or salt-depleted due to high-dose diuretics, dietary salt restriction, diarrhea, or vomiting. There is also a risk of hyperkalemia (high potassium levels), especially in patients with kidney impairment or diabetes. Monitoring of serum potassium levels may be necessary.

Kidney Function

Changes in kidney function may occur in susceptible individuals, such as those with severe heart failure or pre-existing renal artery stenosis. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system, treatment with olmesartan may be associated with acute renal failure.

Drug Interactions

Olmesartan should not be used in combination with aliskiren in patients with diabetes. Combining olmesartan with other drugs that block the renin-angiotensin system, such as ACE inhibitors, generally increases the risk of hypotension, hyperkalemia, and changes in kidney function without providing additional benefit.

Pregnancy

Olmesartan carries a boxed warning because it can cause severe injury or death to a developing fetus. This risk is most significant during the second and third trimesters of pregnancy. Exposure to the drug during this time may lead to serious complications for the baby, including:

• Reduced kidney function or kidney failure
• Low blood pressure (hypotension)
• Abnormal development of the skull
• Death

If you are pregnant or planning to become pregnant, talk to your healthcare provider about alternative treatments for high blood pressure. If you discover you are pregnant while taking olmesartan, stop the medication and contact your doctor right away.

Breastfeeding

It is not known whether olmesartan passes into human breast milk. However, studies in animals have shown that the drug is present in milk. Due to the potential for serious side effects in a nursing baby, healthcare providers typically advise against breastfeeding while taking this medication. A decision should be made to either stop nursing or stop the drug, depending on the importance of the medication to the mother's health.

Available Forms

Olmesartan medoxomil is supplied as a film-coated tablet for oral administration. It is available as a single-ingredient medication and in several fixed-dose combination tablets.

Combination oral tablets include:

• Olmesartan and hydrochlorothiazide (a diuretic)
• Olmesartan and amlodipine (a calcium channel blocker)
• Olmesartan, amlodipine, and hydrochlorothiazide

FDA Approval and Indications

Olmesartan was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension (high blood pressure) in adults and children 6 years of age and older. It is intended to lower blood pressure, which helps reduce the risk of fatal and nonfatal cardiovascular events, such as strokes and heart attacks.

Boxed Warning

The FDA has issued a boxed warning for olmesartan regarding fetal toxicity. Drugs that act directly on the renin-angiotensin system can cause injury and even death to a developing fetus. Because of this risk, olmesartan should be discontinued as soon as pregnancy is detected.

Major Safety Communications

The FDA has issued specific safety communications and label updates for olmesartan based on clinical evidence:

• Sprue-like Enteropathy: In 2013, the FDA required label changes to include warnings about sprue-like enteropathy. This condition causes severe, chronic diarrhea with substantial weight loss. It may develop months to years after starting the medication and often requires hospitalization.
• Combination with Aliskiren: The FDA warned that olmesartan should not be used in combination with aliskiren in patients with diabetes. Additionally, the combination should be avoided in patients with moderate to severe renal impairment due to increased risks of low blood pressure, high potassium levels, and kidney dysfunction.

Generic Availability

Olmesartan medoxomil is available as a generic medication. Generic versions are typically more affordable than the brand-name version, Benicar. Choosing the generic form is a common way to reduce out-of-pocket expenses for this blood pressure treatment.

Insurance and Pharmacy Factors

The amount you pay for olmesartan can be influenced by several factors:

• Insurance Plans: Most health insurance and Medicare plans cover the generic version of olmesartan. Your specific copay or coinsurance will depend on your plan's formulary and tier structure.
• Pharmacy Selection: Prices can vary between different retail pharmacies. Some pharmacies may offer discount programs or lower prices for a 90-day supply compared to a 30-day supply.
• Combination Medications: Olmesartan is sometimes prescribed in combination with other drugs, such as amlodipine or hydrochlorothiazide. The cost of these combination products may differ from the cost of olmesartan alone.

It is recommended to consult with your pharmacist or insurance provider to determine the exact cost for your prescription based on your specific coverage.