Benicar for treating high blood pressure in adults and children

Benicar is an oral medication used to treat hypertension (high blood pressure) in adults and children aged six years and older. It belongs to a class of drugs called angiotensin II receptor blockers (ARBs), which help lower blood pressure by relaxing blood vessels. Lower blood pressure helps reduce the risk of stroke, heart attack, and other cardiovascular problems.

Benicar is prescribed to manage hypertension in:

• Adults
• Children six years of age and older

It can be used alone or with other blood pressure-lowering medications. Lowering blood pressure with Benicar reduces the risk of fatal and nonfatal cardiovascular events, including strokes and myocardial infarctions.

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Benicar works by blocking the effects of angiotensin II, a substance in the body that causes blood vessels to narrow. By blocking angiotensin II at its receptor sites, Benicar relaxes the blood vessels, leading to lower blood pressure and improved blood flow.

Adults

• The usual starting dose is 20 mg once daily for patients who are not volume- or salt-depleted.
• After at least 2 weeks, if further blood pressure reduction is needed, the dose may be increased to 40 mg once daily.
• Doses above 40 mg have not shown additional benefit.
• For patients with volume or salt depletion (e.g., on diuretics with impaired kidney function), start under medical supervision and consider a lower starting dose.

Children (6 years and older)

• For children weighing 20 to less than 35 kg, start with 10 mg once daily; the dose can be increased up to 20 mg once daily if needed.
• For children weighing 35 kg or more, start with 20 mg once daily; the dose can be increased up to 40 mg once daily if needed.
• Use in children under 1 year old is not recommended.
• Children who cannot swallow tablets can receive the drug as a suspension prepared by crushing tablets and mixing with specified agents, stored refrigerated up to 4 weeks.

Benicar is contraindicated in patients with diabetes who are receiving aliskiren.

Fetal Toxicity

Benicar can cause injury or death to a developing fetus when used during the second and third trimesters of pregnancy. If pregnancy is detected, treatment should be stopped as soon as possible.

Infants

Use in children under 1 year is not recommended due to potential effects on immature kidneys.

Hypotension

In patients who are volume- or salt-depleted, symptomatic low blood pressure may occur after starting Benicar. Close medical supervision and possibly a lower starting dose are advised. If hypotension occurs, placing the patient in a supine position and administering intravenous saline may be necessary.

Renal Function

Patients with compromised kidney function, such as severe heart failure or renal artery stenosis, may experience worsening kidney function. Monitoring is important in these cases.

Sprue-like enteropathy

Severe, chronic diarrhea with weight loss has been reported months to years after starting olmesartan. Intestinal biopsy often shows villous atrophy. Consider alternative therapies if no other cause is found.

Hyperkalemia

Monitor potassium levels as Benicar can increase potassium, especially in patients with kidney problems, diabetes, or those taking potassium supplements or potassium-sparing diuretics.

Common in adults

• Dizziness (3% incidence, higher than placebo)

Less common or post-marketing reports

• Facial edema and angioedema
• Asthenia (weakness), anaphylaxis
• Vomiting, sprue-like enteropathy
• Hyperkalemia
• Rhabdomyolysis
• Acute renal failure, increased blood creatinine
• Alopecia, pruritus, urticaria

Benicar should not be used with aliskiren in patients with diabetes due to increased risk of adverse effects. Concurrent use with potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes increases risk of hyperkalemia. Close monitoring of renal function and potassium levels is recommended when used with other drugs affecting the renin-angiotensin system.

Pregnancy

Benicar can cause fetal harm when administered during the second and third trimesters. Treatment should be discontinued as soon as pregnancy is detected.

Breastfeeding

Information not provided in the label.

Manifestations of overdose are not detailed in the label. Management should include supportive measures and monitoring for hypotension and kidney function changes.

Tablets and suspension should be stored refrigerated at 2-8°C (36-46°F). The oral suspension, once prepared, should be shaken well before each use and can be stored for up to 4 weeks.