What is Benicar, and what is it used for?

Benicar (olmesartan medoxomil) is an angiotensin II receptor antagonist used to treat hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

What are the side effects of Benicar?

WARNING

FETAL TOXICITY

When pregnancy is detected, discontinue Benicar as soon as possible. Drugs that act directly on the renin-angiotens in system can cause injury and death to the developing fetus.

Common side effects of Benicar include:

Potentially serious side effects of Benicar include:

Is Benicar addictive?

No information provided

What is the dosage for Benicar?

Adult Hypertension

  • 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.
  • For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate Benicar under close medical supervision and give consideration to use of a lower starting dose.

Pediatric Hypertension (6 Years Of Age And Older)

  • 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 lbs), 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.
  • Use of Benicar in children <1 year of age is not recommended.
  • For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below. Follow the suspension preparation instructions below to administer Benicar as a suspension.

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow

What drugs interact with Benicar?

Agents Increasing Serum Potassium

  • Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

  • 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. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.
  • The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual Blockade Of The Renin-Angiotensin System (RAS)

  • Dual blockade of the RAS with angiotensin receptor blockers, 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. Closely monitor blood pressure, renal function and electrolytes in patients on Benicar and other agents that affect the RAS.
  • 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).

Lithium

  • Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Benicar. Monitor serum lithium levels during concomitant use.

Colesevelam Hydrochloride

  • 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.

Benicar contraindications, and pregnancy and breastfeeding safety

  • Benicar can cause fetal harm when administered to a pregnant woman.
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
  • There is no information regarding the presence of olmesartan in human milk, the effects on the breastfed infant, or the effects on milk production.
  • 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.

Treatment & Diagnosis

Medications & Supplements

QUESTION

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Medically Reviewed on 11/8/2021
References
All sections courtesy of the U.S. Food and Drug Administration