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Olmesartan (Monograph)

Brand names: Azor (combination), Benicar
Drug class: Angiotensin II Receptor Antagonists
VA class: CV805
Chemical name: Cyclic 2,3 carbonate 2,3-dihydroxy-2-butenyl-4-(1-hydroxy-1-methylethyl)-1-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate
Molecular formula: C29H30N6O6
CAS number: 144689-63-4

Medically reviewed by Drugs.com on Oct 26, 2023. Written by ASHP.

Warning

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 31 42 43 44 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue as soon as possible.1 31 43 44

Introduction

Olmesartan is an angiotensin II type 1 (AT1) receptor antagonist (i.e., angiotensin II receptor blocker, ARB).1 2 3 16 28 31 44 139

Uses for Olmesartan

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents);1 2 3 8 9 28 31 44 139 1200 may be used in fixed combination with amlodipine and/or hydrochlorothiazide when such combined therapy is indicated.31 44 139

Angiotensin II receptor antagonists are recommended as one of several preferred agents for the initial management of hypertension according to current evidence-based hypertension guidelines; other preferred options include ACE inhibitors, calcium-channel blockers, and thiazide diuretics.501 502 503 504 1200 While there may be individual differences with respect to recommendations for initial drug selection and use in specific patient populations, current evidence indicates that these antihypertensive drug classes all generally produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.501 502 503 504 1200 1213

Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).501 502 503 504 515 1200 1201

A 2017 ACC/AHA multidisciplinary hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.1200 (See Table 1.)

Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.

Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).

Table 1. ACC/AHA BP Classification in Adults1200

Category

SBP (mm Hg)

DBP (mm Hg)

Normal

<120

and

<80

Elevated

120–129

and

<80

Hypertension, Stage 1

130–139

or

80–89

Hypertension, Stage 2

≥140

or

≥90

The goal of hypertension management and prevention is to achieve and maintain optimal control of BP.1200 However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.501 503 504 505 506 507 508 515 523 526 530 1200 1201 1207 1209 1222 1223 1229

The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) of <130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200 In addition, an SBP goal of <130 mm Hg is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg.1200 These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.1200 1202 1210

Previous hypertension guidelines generally have based target BP goals on age and comorbidities.501 504 536 Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk and have used higher BP thresholds and target BPs in elderly patients501 504 536 compared with those recommended by the 2017 ACC/AHA hypertension guideline.1200

Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the current ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.1222 1223 1224 1229

Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient’s BP treatment goal.1200 1220 1229

For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors.1200 1207 ASCVD risk assessment recommended by ACC/AHA for all adults with hypertension.1200

ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).1200

For secondary prevention in patients with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.1200

Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg.1200

In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP.1200 Initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes recommended in adults with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.1200

Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to angiotensin II receptor antagonists.501 504 1200 However, the combination of an ACE inhibitor or an angiotensin II receptor antagonist with a calcium-channel blocker or thiazide diuretic produces similar BP lowering in black patients as in other racial groups.1200

Angiotensin II receptor antagonists or ACE inhibitors may be particularly useful in hypertensive patients with diabetes mellitus or CKD; angiotensin II receptor antagonists also may be preferred, as an alternative to ACE inhibitors, in hypertensive patients with heart failure or ischemic heart disease and/or post-MI.501 502 504 523 524 527 534 535 536 543 1200 1214 1215

Diabetic Nephropathy

A recommended agent in the management of patients with diabetes mellitus and persistent albuminuria† [off-label] who have modestly elevated (30–300 mg/24 hours) or higher (>300 mg/24 hours) levels of urinary albumin excretion; slows rate of progression of renal disease in such patients.535 536 1232

Heart Failure

Angiotensin II receptor antagonists have been used in the management of heart failure† [off-label].524 528 800

Because of their established benefits, ACE inhibitors have been the preferred drugs for inhibition of the renin-angiotensin-aldosterone (RAA) system in patients with heart failure and reduced left ventricular ejection fraction (LVEF); 524 however, some evidence indicates that therapy with an ACE inhibitor (enalapril) may be less effective than angiotensin receptor-neprilysin inhibitor (ARNI) therapy (e.g., sacubitril/valsartan) in reducing cardiovascular death and heart failure-related hospitalization.701 702 703 800

Angiotensin II receptor antagonists may be used as an alternative for those patients in whom an ACE inhibitor or ARNI is inappropriate.524 800

No additional therapeutic benefit when angiotensin II receptor antagonist used in combination with an ACE inhibitor.1

ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend that patients with chronic symptomatic heart failure and reduced LVEF (NYHA class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality.800

Olmesartan Dosage and Administration

General

BP Monitoring and Treatment Goals

Administration

Oral Administration

Administer olmesartan orally once daily without regard to meals.1 2

May administer as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets.1

Reconstitution

Preparation of extemporaneous suspension containing olmesartan medoxomil 2 mg/mL: Add 50 mL of purified water to an amber polyethylene terephthalate (PET) bottle containing twenty 20-mg tablets of olmesartan medoxomil; allow contents to stand for ≥5 minutes.1 Shake container for ≥1 minute and allow to stand for ≥1 minute; repeat this alternating shaking and standing step 4 additional times.1 Dilute concentrated suspension with 100 mL of syrup (Ora-Sweet) and 50 mL of suspending vehicle (Ora-Plus) and shake well for ≥1 minute to disperse ingredients.1 Shake suspension well before dispensing each dose.1

Dosage

Olmesartan is available as olmesartan medoxomil; dosage expressed in terms of the salt.1 31 44

Pediatric Patients

Hypertension
Oral

Pediatric patients 6–16 years of age who weigh 20 to <35 kg: Initially, 10 mg once daily; may increase to maximum of 20 mg once daily after 2 weeks.1 137 1150

Pediatric patients 6–16 years of age who weigh ≥35 kg: Initially, 20 mg once daily; may increase to maximum of 40 mg once daily after 2 weeks.1 137 1150

Adults

Hypertension
Olmesartan Therapy
Oral

Initially, 20 mg once daily as monotherapy in adults without intravascular volume depletion.1

Usual dosage: 20–40 mg once daily; no additional therapeutic benefit with higher dosages or with twice-daily dosing.1 28 1200

Olmesartan/Amlodipine Fixed-combination Therapy
Oral

Fixed-combination olmesartan/amlodipine tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.144

If the patient’s baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 48, 46, or 68% and of achieving DBP control (DBP <90 mm Hg) is 51, 60, or 85% with olmesartan medoxomil (40 mg daily) alone, amlodipine (10 mg daily) alone, or amlodipine combined with olmesartan medoxomil (same dosages), respectively.144

If BP is not adequately controlled by monotherapy with olmesartan (or another angiotensin II receptor antagonist) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to olmesartan/amlodipine fixed combination.144

Can use the fixed combination as a substitute for the individually titrated drugs.144 Can switch to the fixed-combination preparation containing the corresponding individual doses of olmesartan and amlodipine; alternatively, can increase the dosage of one or both components for additional antihypertensive effects.144

Adjust dosage of olmesartan/amlodipine fixed combination, up to a maximum of olmesartan medoxomil 40 mg and amlodipine 10 mg once daily, according to patient’s response after ≥2 weeks at the current dosage.144

When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is olmesartan medoxomil 20 mg and amlodipine 5 mg once daily.144 May increase dosage after 1–2 weeks for additional BP control, up to maximum of olmesartan medoxomil 40 mg and amlodipine 10 mg once daily.144

Olmesartan/Hydrochlorothiazide Fixed-combination Therapy
Oral

Manufacturer states fixed-combination preparation should not be used for initial antihypertensive therapy.31

If BP is not adequately controlled by monotherapy with olmesartan or hydrochlorothiazide, can switch to fixed-combination olmesartan/hydrochlorothiazide tablets.31 In patients already receiving olmesartan, initiate hydrochlorothiazide at dosage of 12.5 mg once daily; in those receiving hydrochlorothiazide, consider reducing hydrochlorothiazide dosage to 12.5 mg and initiate olmesartan medoxomil at dosage of 20 mg once daily.31 Increase dosages to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg once daily, if needed, to control BP.31

If BP is controlled with olmesartan and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.31

Adjust dosage of olmesartan/hydrochlorothiazide fixed combination according to patient’s response after 2–4 weeks at the current dosage.31

Olmesartan/Amlodipine/Hydrochlorothiazide Fixed-combination Therapy
Oral

Manufacturer states fixed-combination preparation should not be used for initial antihypertensive therapy.139

Can switch to fixed-combination olmesartan/amlodipine/hydrochlorothiazide tablets if BP is not adequately controlled by combined therapy with any 2 of the following drug classes at maximally tolerated, labeled, or usual dosages: angiotensin II receptor antagonists, calcium-channel blockers, or diuretics.139

In patients who experience dose-limiting adverse effects to olmesartan, amlodipine, or hydrochlorothiazide while receiving any dual combination of these drugs, may switch to the triple fixed-combination preparation containing a lower dose of that component.139

Can use the fixed combination as a substitute for the individually titrated drugs.139

May increase dosage of the fixed combination after 2 weeks if additional BP control is needed (up to maximum of olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 25 mg once daily).139

Special Populations

The following information addresses dosage of olmesartan in special populations. Dosages of drugs administered in fixed combination with olmesartan also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.31 44

Hepatic Impairment

No adjustment of initial olmesartan dosage necessary in patients with moderate to severe hepatic impairment.1 31

Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.44 139

Renal Impairment

Manufacturer states that no adjustment of initial olmesartan dosage is necessary in patients with moderate to severe renal impairment (Clcr <40 mL/minute).1 31 44 However, some clinicians recommend lower initial dosage in patients with Clcr <20 mL/minute, with maximum dosage of 20 mg once daily in such patients.10

Dosage of olmesartan in patients with end-stage renal disease not determined.29

Fixed combinations containing hydrochlorothiazide are not recommended in patients with severe renal impairment (Clcr ≤30 mL/minute).31 139 Loop diuretics are preferred to thiazides in these patients.31 139

Geriatric Patients

No adjustment of initial olmesartan dosage is necessary.1 31

Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients ≥75 years of age.44 139

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiation of olmesartan therapy or initiate therapy under close medical supervision using lower initial dosage.1 31 44

Detailed Olmesartan dosage information

Cautions for Olmesartan

Contraindications

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Possible reduction in fetal renal function and increase in fetal and neonatal morbidity and mortality when drugs that act on the renin-angiotensin system (e.g., angiotensin II receptor antagonists, ACE inhibitors, aliskiren) are used during the second and third trimesters of pregnancy.1 31 43 44 (See Boxed Warning.) ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.56 57 Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.1 Potential neonatal effects include skull hypoplasia, anuria, hypotension, renal failure, and death.1

Discontinue olmesartan as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 31 42 43 44 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible with angiotensin II receptor antagonists;1 2 7 14 extreme caution recommended in patients with a history of angioedema associated with2 7 45 or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.15

Other Warnings and Precautions

Infant Morbidity

Olmesartan must not be used for treatment of hypertension in infants <1 year of age; drugs that act directly on the RAA system can affect the development of immature kidneys.1 (See Pediatric Use under Cautions.)

Hypotension

Possible symptomatic hypotension with olmesartan, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics).1 31 44 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate olmesartan therapy cautiously after BP is stabilized (e.g., with volume expansion).1 31 44

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126

Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe heart failure.1 31 44

Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 31 44

Sprue-like Enteropathy

Risk of sprue-like enteropathy, an intestinal condition characterized by severe chronic diarrhea with substantial weight loss; intestinal biopsy may reveal villous atrophy.1 133 134 135 139 Can occur months to years after initiating olmesartan.1 133 134 139 Clinical improvement is expected after the drug is discontinued.133 134 135

Not associated with other angiotensin II receptor antagonists to date; not considered to be a class effect of the drugs.133

If symptoms of sprue-like enteropathy develop, exclude other etiologies (e.g., celiac disease); if no other causative factor can be identified, consider drug discontinuance.1 133 139

Increased Cardiovascular Risk in Patients with Diabetes

Findings from several studies have prompted concerns of an increased risk of cardiovascular death (e.g., fatal MI, sudden cardiac death) in patients with diabetes mellitus receiving high-dose olmesartan.1 124 132 140 Following review of all the available data, FDA has concluded that the collective evidence to date does not clearly demonstrate such an association and that the benefits of olmesartan in hypertensive patients continue to outweigh potential risks.1 124 138 140 141 142 143

Use of Fixed Combinations

When olmesartan is used in fixed combination with amlodipine and/or hydrochlorothiazide, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent(s).31 44 139 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.31 44 139

Specific Populations

Pregnancy

Category D.1 (See Boxed Warning.)

May cause fetal and neonatal morbidity and mortality when administered to a pregnant woman.1 Discontinue as soon as possible when pregnancy is detected.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.1 31 44 Discontinue nursing or the drug.1 31 44

Pediatric Use

If oliguria or hypotension occurs in neonates with a history of in utero exposure to olmesartan, support BP and renal function; exchange transfusions or dialysis may be required.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Safety and efficacy of olmesartan in fixed combination with amlodipine and/or hydrochlorothiazide not established.31 44 139

Safety and efficacy of olmesartan established in pediatric patients 6–16 years of age with hypertension.1 136 Although evaluated in pediatric patients 1–5 years of age, statistically significant reductions in BP were not observed.1

Not evaluated in infants <1 year of age; because of the possibility of abnormal kidney development, do not use in this age group.1

Adverse effects in pediatric patients appear to be similar to those observed in adults.1

Geriatric Use

No overall differences in safety or efficacy of olmesartan alone or in fixed combination with amlodipine and/or hydrochlorothiazide relative to younger adults, but increased sensitivity cannot be ruled out.1 44 139 In general, select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.31

Hepatic Impairment

Systemic exposure to olmesartan may be increased.1 31 44 (See Absorption: Special Populations, under Pharmacokinetics.)

Renal Impairment

Systemic exposure to olmesartan may be increased.1 31 44 (See Absorption: Special Populations, under Pharmacokinetics and also see Renal Impairment under Dosage and Administration.)

Use of olmesartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr ≤30 mL/minute.31 139

Deterioration of renal function may occur.1 31 44 (See Renal Effects under Cautions.)

Black Patients

BP reduction with olmesartan may be smaller in black patients than in patients of other races.1 5 31 1200 (See Hypertension under Uses.)

Common Adverse Effects

Dizziness,1 2 3 back pain,1 bronchitis,1 2 12 diarrhea,1 headache,1 2 3 12 hematuria,1 hyperglycemia,1 hypertriglyceridemia,1 influenza-like symptoms,1 2 12 pharyngitis,1 rhinitis,1 sinusitis,1 upper respiratory tract infection.2 3 12

Drug Interactions

Olmesartan is not metabolized by and does not inhibit or induce CYP isoenzymes.1 2

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Increased risk of renal impairment, hyperkalemia, and hypotension1

Generally avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly1

Aliskiren

Increased risk of renal impairment, hyperkalemia, and hypotension1 550

Generally avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly1 550

Concomitant use contraindicated in patients with diabetes mellitus1 550

Avoid concomitant use in patients with GFR <60 mL/minute1 550

Angiotensin II receptor antagonists

Increased risk of renal impairment, hyperkalemia, and hypotension1

Generally avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly1

Antacids

Pharmacokinetic interactions unlikely1 2 28

Colesevelam

Decreased AUC and peak plasma concentrations of olmesartan1

Consider administering olmesartan at least 4 hours before colesevelam1

Digoxin

Pharmacokinetic interactions unlikely1 2 28

Hydrochlorothiazide

Pharmacokinetic interactions unlikely2 28

Lithium

Increased serum lithium concentrations and lithium toxicity1

Carefully monitor serum lithium concentrations 1

NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors

Possible deterioration of renal function, including possible acute renal failure, in geriatric, volume-depleted, or renally impaired patients1

Possible decreased hypotensive effect1

Monitor renal function periodically1

Warfarin

Pharmacokinetic interaction unlikely1 2 28
Olmesartan drug interactions (more detail)

Olmesartan Pharmacokinetics

Absorption

Bioavailability

Olmesartan medoxomil (prodrug) is rapidly and completely hydrolyzed to olmesartan during absorption in the GI tract.1 31 44

Absolute bioavailability of olmesartan is about 26%.1 31 44 Bioavailability of the extemporaneously prepared suspension (see Reconstitution under Dosage and Administration) is similar to that of olmesartan tablets.1

Peak plasma olmesartan concentration generally reached 1–2 hours following oral administration.1 31 44

Onset

Antihypertensive effect of olmesartan is evident within 2 weeks, with maximum BP reduction after 4–6 weeks.1 3

Food

Food does not affect bioavailability of olmesartan.1 31 44

Special Populations

In patients with moderate hepatic impairment, peak plasma concentration of olmesartan is increased; AUC increased by about 60%.1 31 44

In patients with severe renal impairment (Clcr <20 mL/minute), plasma concentrations and AUC of olmesartan are increased.1 31 44 After repeated dosing, AUC values are approximately triple those in patients with normal renal function.1 31 44

In women, peak plasma concentration and AUC of olmesartan are about 10–15% higher than values in men.1 31 44

Distribution

Extent

Olmesartan crosses the placenta and is distributed in the fetus in animals.1 31 44

Olmesartan crosses the blood-brain barrier poorly, if at all, in animals.1 31 44

Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.1 31 44

Plasma Protein Binding

Olmesartan: 99%.1 31 44

Elimination

Metabolism

Olmesartan medoxomil undergoes rapid and complete ester hydrolysis to olmesartan.1 2 28 31 44 Virtually no further metabolism of olmesartan occurs; not metabolized by CYP isoenzymes.1 2 28 31 44

Elimination Route

Olmesartan is eliminated mainly in urine (35–50%) and feces (via bile).1 2 31 44

Half-life

Biphasic; terminal half-life of olmesartan is approximately 13 hours.1 31 44

Special Populations

Clearance (adjusted for body weight) in pediatric patients 1–16 years of age is similar to that in adults.1

In geriatric patients, renal clearance of olmesartan is decreased by approximately 30%.1 31 44

Stability

Storage

Oral

Extemporaneous Suspension

2-mg/mL preparation of olmesartan medoxomil in a mixture of syrup (Ora-Sweet) and suspending vehicle (Ora-Plus) (see Reconstitution under Dosage and Administration): Up to 4 weeks at 2–8°C.1

Tablets

Olmesartan or olmesartan/hydrochlorothiazide fixed combination: 20–25°C.1 31

Olmesartan/amlodipine or olmesartan/amlodipine/hydrochlorothiazide fixed combination: 25ºC (may be exposed to 15–30ºC).44 139

Actions

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Olmesartan Medoxomil

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

5 mg

Benicar

Sankyo

20 mg

Benicar

Sankyo

40 mg

Benicar

Sankyo
Olmesartan Medoxomil Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg with Amlodipine Besylate 5 mg (of amlodipine)

Azor

Daiichi Sankyo

20 mg with Amlodipine Besylate 10 mg (of amlodipine)

Azor

Daiichi Sankyo

40 mg with Amlodipine Besylate 5 mg (of amlodipine)

Azor

Daiichi Sankyo

40 mg with Amlodipine Besylate 10 mg (of amlodipine)

Azor

Daiichi Sankyo

Tablets, film-coated

20 mg with Amlodipine Besylate 5 mg (of amlodipine) and Hydrochlorothiazide 12.5 mg

Tribenzor

Daiichi Sankyo

20 mg with Hydrochlorothiazide 12.5 mg

Benicar HCT

Daiichi Sankyo

40 mg with Amlodipine Besylate 5 mg (of amlodipine) and Hydrochlorothiazide 12.5 mg

Tribenzor

Daiichi Sankyo

40 mg with Amlodipine Besylate 5 mg (of amlodipine) and Hydrochlorothiazide 25 mg

Tribenzor

Daiichi Sankyo

40 mg with Amlodipine Besylate 10 mg (of amlodipine) and Hydrochlorothiazide 12.5 mg

Tribenzor

Daiichi Sankyo

40 mg with Amlodipine Besylate 10 mg (of amlodipine) and Hydrochlorothiazide 25 mg

Tribenzor

Daiichi Sankyo

40 mg with Hydrochlorothiazide 12.5 mg

Benicar HCT

Daiichi Sankyo

40 mg with Hydrochlorothiazide 25 mg

Benicar HCT

Daiichi Sankyo

AHFS DI Essentials™. © Copyright 2024, Selected Revisions November 5, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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16. Sankyo Pharma, New York, NY: Personal communication.

17. AstraZeneca, Wayne, PA: personal communication on Candesartan 24:32.08.

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