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olmesartan medoxomil

Benicar, Olmetec (UK)

Pharmacologic class: Angiotensin II type 1-receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

Pregnancy risk category C (first trimester), D (second and third trimesters)

FDA Box Warning

• When used during second or third trimester of pregnancy, drug may cause fetal harm or death. Discontinue as soon as possible when pregnancy is detected.


Selectively blocks binding of angiotensin II to specific tissue receptors in vascular smooth muscle and adrenal gland. This action blocks vasoconstrictive effects of renin-angiotensin system as well as aldosterone release, thereby reducing blood pressure and possibly preventing vascular remodeling related to arteriosclerosis.


Tablets: 5 mg, 20 mg, 40 mg

Indications and dosages


Adults and children ages 6 to 16 weighing more than 35 kg (77 lb): 20 mg P.O. once daily; may titrate to 40 mg daily after 2 weeks, if needed

Children ages 6 to 16 weighing 20 kg (44 lb) to less than 35 kg (77 lb): 10 mg P.O. daily; may titrate to 20 mg daily after 2 weeks, if needed.

Dosage adjustment

• Volume depletion


• Hypersensitivity to drug or its components


Use cautiously in:
• hepatic disease, renal dysfunction, hypovolemia, sodium depletion
• elderly patients
• pregnant patients (first trimester; not recommended in second and third trimesters)
• breastfeeding patients
• children (safety and efficacy not established).


• Give with or without food.
• Know that drug may be used alone or with other antihypertensives.

Adverse reactions

CNS: fatigue, dizziness, headache, insomnia

CV: orthostatic hypotension, chest pain, peripheral edema, syncope, tachycardia

EENT: sinusitis, rhinitis, pharyngitis

GI: nausea, diarrhea, constipation, abdominal pain, dry mouth

GU: hematuria

Hematologic: hyperglycemia

Musculoskeletal: back pain, arthritis, muscle weakness

Respiratory: upper respiratory infection symptoms, bronchitis, cough

Skin: dry skin, rash, inflammation, pruritus, alopecia, angioedema

Other: dental pain, flulike symptoms


Drug-diagnostic tests.Triglycerides: increased level

Drug-herbs.Ephedra (ma huang): antagonism of antihypertensive effect

Patient monitoring

• Monitor vital signs and cardiovascular status. Stay alert for orthostatic hypotension, syncope, and peripheral edema.
• Check temperature and watch for signs and symptoms of flu and other infections (especially respiratory and EENT infections).
• Watch for angioedema.
• In volume-depleted patient, monitor blood pressure carefully after initial dose. Transient blood pressure drop may occur.

Patient teaching

• Tell patient to take at same time each day, with or without food.
• Advise patient to promptly report signs and symptoms of infection, particularly respiratory symptoms.
• Inform patient that when he begins therapy, inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may cause blood pressure to drop. Tell him to change position slowly to avoid dizziness or fainting.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

Tell female patient to notify pre-scriber immediately if she suspects pregnancy.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the tests and herbs mentioned above.


(ole-me-sar-tan me-dox-o-mil) ,


(trade name),


(trade name)


Therapeutic: antihypertensives
Pharmacologic: angiotensin ii receptor antagonists
Pregnancy Category: D


Hypertension (alone or with other agents).


Blocks vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites including vascular smooth muscle and the adrenal glands.

Therapeutic effects

Lowering of BP.


Absorption: Olmesartan medoxomil is a prodrug that is converted to olmesartan (the active component); 26% bioavailability of olmesartan.
Distribution: Crosses the placenta.
Protein Binding: 99%.
Metabolism and Excretion: No further metabolism following conversion of pro-drug to active drug; 35–50% excreted unchanged in urine; remainder eliminated in feces via bile.
Half-life: 13 hr.

Time/action profile (antihypertensive effect with chronic dosing)

POwithin 1 wk2 wk24 hr


Contraindicated in: Hypersensitivity; Bilateral renal artery stenosis; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula. Pediatric: Children <1 yr (may have effects on development of immature kidneys)
Use Cautiously in: Volume- or salt-depleted patients or patients receiving high doses of diuretics (correct deficits before initiating therapy or initiate at lower doses); Black patients (may not be as effective); Impaired renal function due to primary renal disease or HF (may worsen renal function); Patients with childbearing potential; Pediatric: Children 1–6 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness


  • hypotension

Fluid and Electrolyte

  • hyperkalemia


  • sprue-like enteropathy


  • impaired renal function


  • angioedemA (life-threatening)


Drug-Drug interaction

Additive hypotension with other antihypertensives .NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.Excessive hypotension may occur with concurrent use of diuretics.↑ risk of hyperkalemia with concurrent use of potassium supplements,potassium-containing salt substitutes, or potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/min↑ levels and may ↑ risk of lithium toxicity.Colesevelam may ↓ levels; administer olmesartan ≥4 hr before colesevelam


Oral (Adults) 20 mg once daily; may be ↑ up to 40 mg daily (initiate therapy at a lower dose in patients receiving diuretics or who are volume depleted).
Oral (Children 6–16 yr) ≥35 kg-20 mg once daily; may be ↑ after 2 wk up to 40 mg once daily; 20–34.9 kg-10 mg once daily; may be ↑ after 2 wk up to 20 mg once daily.


Tablets: 5 mg, 20 mg, 40 mg
In combination with: hydrochlorothiazide (Benicar HCT), amlodipine (Azor); amlodipine and hydrochlorothiazide (Tribenzor); seecombination drugs.

Nursing implications

Nursing assessment

  • Assess BP (sitting, lying, standing) and pulse periodically during therapy.
  • Monitor frequency of prescription refills to determine adherence to therapy.
  • Assess patient for signs of angioedema (dyspnea, facial swelling). May rarely cause angioedema.
  • Monitor patient for signs and symptoms of sprue-like enteropathy (severe, chronic diarrhea with substantial weight loss). May develop months or years after start of olmesartan. May require hospitalization and discontinuation of therapy.
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.May rarely cause slight ↓ in hemoglobin and hematocrit.
    • May occasionally cause ↑ AST, ALT, and total serum bilirubin.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Noncompliance (Patient/Family Teaching)


  • Do not confuse Benicar with Mevacor.
  • Correct volume depletion, if possible, before initiation of therapy.
    • Doses greater than 40 mg do not appear to have a greater effect. Twice daily dosing offers no advantage over the same total dose given once daily.
  • Oral: Administer once daily without regard to food.

Patient/Family Teaching

  • Emphasize the importance of continuing to take as directed, even if feeling well. Take missed doses as soon as remembered if not almost before next dose; do not double doses. Medication controls but does not cure hypertension. Instruct patient to take medication at the same time each day. Warn patient not to discontinue therapy unless directed by health care professional.
  • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
  • Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, smoking cessation, moderation of alcohol consumption, regular exercise, and stress management). Medication controls but does not cure hypertension.
  • Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.
  • Caution patient to avoid sudden position changes to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
  • May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs and cough, cold, or allergy medications, without consulting health care professional.
  • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
  • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Olmesartan should be discontinued as soon as possible when pregnancy is detected.
  • Emphasize the importance of follow-up exams to evaluate effectiveness of medication.

Evaluation/Desired Outcomes

  • Decrease in BP without excessive side effects.


A trademark for the drug olmesartan medoxomil.


An angiotensin-II receptor blocker used as a monotherapy or with other agents to manage hypertension.
Adverse effects
References in periodicals archive ?
Patients treated with Benicar in BeniVICTOR study experienced significantly greater blood pressure reductions and higher goal attainment rates than patients treated with Cozaar after 8 weeks
com's Austin Kirk reported Tuesday that there are currently 1,034 cases pending against Benicar makers Daiichi Sankyo and Forest Laboratories, which is 1,000 more cases than in April 2015 when the MDL was established.
Benicar, Daiichi Sankyo's currently marketed ARB, is the fastest growing medication in the fastest growing class of blood pressure-lowering drugs.
The company said the falls in its pretax and operating profits were attributable to an increase in sales and administrative expenses, mainly those spent to boost sales of antihypertensive drug Olmetec, known as Benicar in the United States.
The subpoena requests documents relating to Benicar[R], Benicar HCT[R] (collectively "Benicar") and Azor[R], prescription medications approved for the treatment of hypertension.
24, 2015 /PRNewswire/ -- Seeger Weiss LLP is reporting that the number of Benicar lawsuits in the multidistrict litigation, as of July 15, 2015, has reached 915 lawsuits-an increase of 70 since the previous month.
The medication is currently sold under brand names as Diovan, Micardis, Cozaar, Benicar and Avapro.
Disclosures: The study was funded by Daiichi-Sankyo, which manufactures olmesartan under the name Benicar.
Two of Tribenzor s ingredients, olmesartan medoxomil and amlodipine, are an angiotensin receptor blocker and a calcium channel blocker, respectively, sold by Daiichi Sankyo as Benicar and by Pfizer as Norvasc.
Marshall's important discoveries occurred when he found that 40 mg Benicar (olmesartan), taken three or four times daily, greatly potentiated the bacterial killing from pulsed antibiotics.
The drug was developed by Sankyo and launched in the US under the brand name Benicar in May 2002 and is now sold in more than 35 countries worldwide as Benicar or Olmetic.