×
Min. Age:
Max. Age:
Gender:
Reason:
Duration:

Benicar

Generic Name: Olmesartan Medoxomil
Drug Category: ARB
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 3 years.

Approved Uses

• Indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. It may be used alone or in combination with other antihypertensive agents. 

There are no controlled trials demonstrating risk reduction with Benicar.

Benicar has not been shown to be effective for hypertension in children under 6 years of age. 

Do not co-administer aliskiren with Benicar in patients with diabetes.

Avoid use of aliskiren with Benicar in patients with renal impairment (GFR <60 ml/min).

Adult dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

Pediatric dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of Benicar is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported.

Facial edema was reported in five patients receiving Benicar. Angioedema has been reported with angiotensin II antagonists.

In patients with an activated renin-angiotensin-aldosterone system, such as volume and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may be anticipated after initiation of treatment with Benicar.

Serum potassium should be monitored in patients receiving Benicar. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.

Use with Lithium increases serum lithium concentrations and lithium toxicity.

Use with NSAID may lead to increased risk of renal impairment and loss of antihypertensive effect.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure.

ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Benicar can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Benicar as soon as possible.

It is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

Off-label Uses

• Use in patients under the age of 6. GoToSource

• Prevent renal damage. GoToSource

• Delay or prevention of microalbuminuria in type 2 diabetes. GoToSource

• Glaucoma. GoToSource

• Systemic lupus erythematosus, rheumatoid arthritis, scleroderma, sarcoidosis, sjogren’s syndrome, autoimmune thyroid disease, psoriasis, ankylosing spondylitis, reiter’s syndrome, type I and II diabetes mellitus and uveitis. GoToSource 

• Migraine prevention. GoToSource

Adverse Events

Angioedema. GoToSource

Increased risk of cancer. GoToSource

Maculopapular rash. GoToSource

Sprue-like enteropathy (intestinal disease). GoToSource

Villous atrophy (inflammation of the small bowel mucosa and atrophy of the villi). GoToSource

Heart attacks, strokes and sudden death. GoToSource

Hypotension (low blood pressure) hyperkalemia, (high levels of potassium), upper-respiratory tract infection and bronchitis. GoToSource

Kidney failure. GoToSource

Litigation

Lawsuits filed for heart attacks, strokes, sudden death and birth defects.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

 iOSAndroidAppOrchard - EPIC EHR

Site Last Updated March 29, 2024