OLMESARTAN MEDOXOMIL 40 mg Tablet, Film Coated, 90-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin 2 Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. Olmesartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart dise...
Read the full MedlinePlus article ↗- Olmesartan is used to treat high blood pressure — also called hypertension — in adults and in kids as young as 6. Keeping your blood pressure in a healthy range matters because unc...
- Nope — food doesn't change how well olmesartan is absorbed, so you can take it with or without a meal. What matters most is taking it at the same time every day so your blood press...
- Does it matter if I take olmesartan with food or on an empty stomach?
- The most common one is dizziness, especially when you first start or if you stand up quickly. That usually settles down as your body adjusts. The things that warrant a call to your...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Olmesartan Medoxomil — tap one for details:
Olmesartan Medoxomil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII UKE75GEA7F
Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
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UNII 2165RE0K14
A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2000 | $18.00 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Olmesartan Medoxomil 40 mg 00527-2427-32 | Lannett | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 31722-0854-30 | Camber | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan medoxomil 40 mg 33342-0180-07 | Macleods | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 43547-0301-03 | Solco | 30 tablets | $0.108 | AB | Availability likely | — |
| olmesartan medoxomil 40 mg 50228-0341-10 | ScieGen | 1000 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 64980-0603-03 | Rising | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan medoxomil 40 mg 72205-0167-30 | Novadoz | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 72241-0080-04 | Modavar | 90 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 72303-0850-01 | HEC | 30 tablets | $0.108 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 82009-0075-90 | QUALLENT | 90 tablets | $0.108 | AB | Availability likely | — |
| olmesartan medoxomil 40 mg 16729-0322-10 | Accord | 30 tablets | $0.110 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 70756-0810-30 | Lifestar | 30 tablets | $0.133 | AB | FDA listed | — |
| Benicar 40 mg 00713-0862-30 | Cosette | 30 tablets | $17.242 | AB | Availability likely | — |
| Benicar 40 mg 00713-0942-30 | Cosette | 30 tablets | $17.242 | AB | Availability likely | — |
| Olmesartan Medoxomil 40 mg 42571-0203-05 | Micro | 500 tablets | — | AB | Discontinued | — |
| Olmesartan Medoxomil 40 mg 46708-0133-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 49252-0067-10 | Inventia | 30 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 50090-3487-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-3655-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-4451-01 | A-S | 90 tablets | — | AB | FDA listed | — |
| Olmesartan medoxomil 40 mg 50090-6632-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Olmesartan medoxomil 40 mg 50090-6633-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7087-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7680-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7681-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7810-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7979-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 50090-7980-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 51407-0199-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 59746-0466-01 | Jubilant | 100 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 60290-0011-01 | Umedica | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 62135-0882-30 | Chartwell | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 62332-0133-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 63629-8524-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 63629-8525-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 65862-0743-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 67877-0447-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 68462-0438-10 | Glenmark | 1000 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 70518-1345-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 70518-4053-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 71205-0174-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 71205-0459-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 71209-0081-01 | Cadila | 30 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 71335-0817-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Olmesartan Medoxomil 40 mg 71335-2362-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| olmesartan medoxomil 40 mg 71335-2380-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 71335-2605-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 71335-2749-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mgthis 72189-0138-90 | direct | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 72189-0549-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 72189-0660-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Olmesartan medoxomil 40 mg 72603-0952-01 | NorthStar | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0138-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-138-30) | 2020-12-02 | Active |
| 72189-0138-90 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (72189-138-90) | 2020-12-02 | Active |
You're viewing the largest of 2 pack sizes for this product.
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What quantity is in NDC 72189-0138-90?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible (5.1). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1).
🎯 Indications and Usage ▾
Olmesartan medoxomil tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.
⏱️ Dosage and Administration ▾
2.1Adult Hypertension Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil tablets 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 olmesartan medoxomil 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. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction [see WARNINGS AND PRECAUTIONS (5.4), USE IN SPECIFIC POPULATIONS (8.5, 8.6, 8.7) and CLINICAL PHARMACOLOGY (12.3)] .
For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate olmesartan medoxomil under close medical supervision and give consideration to use of a lower starting dose [see WARNINGS AND PRECAUTIONS (5.3)] . Olmesartan medoxomil tablets may be administered with or without food. If blood pressure is not controlled by olmesartan medoxomil alone, a diuretic may be added.
Olmesartan medoxomil tablets may be administered with other antihypertensive agents.
2.2Pediatric Hypertension (6 to 16 years of age) Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of olmesartan medoxomil tablets 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 olmesartan medoxomil 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.
Children <1 year of age must not receive olmesartan medoxomil for hypertension. For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below [see CLINICAL PHARMACOLOGY (12.3)] . Follow the suspension preparation instructions below to administer olmesartan medoxomil as a suspension.
Preparation of Suspension (for 200 mL of a 2 mg/mL suspension) Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty olmesartan medoxomil 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times.
Add 100 mL of Ora-Sweet ®1 and 50 mL of Ora-Plus ®1 to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2°C to 8°C (36°F to 46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator.
1 Ora-Sweet ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc.
💊 Dosage Forms and Strengths ▾
5 mg light yellow, round, biconvex, film coated non-scored tablets, debossed with “FS1” on one side and plain on other side 20 mg white to off white, round, biconvex, film coated non-scored tablets, debossed with “FS2” on one side and plain on other side 40 mg white to off white, oval, biconvex, film coated non-scored tablets, debossed with “FS3” on one side and plain on other side
⛔ Contraindications ▾
Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see DRUG INTERACTIONS (7 )].
⚠️ Warnings and Cautions ▾
5.1Fetal Toxicity Pregnancy Category D 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. 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 olmesartan medoxomil tablets as soon as possible [see USE IN SPECIFIC POPULATIONS (8.1)] .
5.2Morbidity in Infants Children <1 year of age must not receive olmesartan medoxomil for hypertension. Drugs that act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the development of immature kidneys [see USE IN SPECIFIC POPULATIONS (8.4)] .
5.3Hypotension in Volume- or Salt-Depleted Patients 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 olmesartan medoxomil. Initiate treatment under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline [see DOSAGE AND ADMINISTRATION (2.1)] .
A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
5.4Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.
Similar results may be anticipated in patients treated with olmesartan medoxomil [see DOSAGE AND ADMINISTRATION (2.1), DRUG INTERACTIONS (7), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)] . 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. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.
5.5Sprue-like Enteropathy 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. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of olmesartan medoxomil in cases where no other etiology is identified.
5.6Electrolyte Imbalances Olmesartan medoxomil tablets contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.
🤒 Adverse Reactions ▾
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Olmesartan medoxomil has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year.
Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse reactions similar to placebo. Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil. The overall frequency of adverse reactions was not dose-related.
Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with olmesartan medoxomil and 2.7% (i.e., 32/1179) of control patients. In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with olmesartan medoxomil and at a higher incidence versus placebo was dizziness (3% vs.
1%). The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with olmesartan medoxomil, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis. The incidence of cough was similar in placebo (0.7%) and olmesartan medoxomil (0.9%) patients.
Other potentially important adverse reactions that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3100 hypertensive patients treated with olmesartan medoxomil monotherapy in controlled or open-label trials are listed below. Body as a Whole: chest pain, peripheral edema Central and Peripheral Nervous System: vertigo Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, nausea Heart Rate and Rhythm Disorders: tachycardia Metabolic and Nutritional Disorders: hypercholesterolemia, hyperlipemia, hyperuricemia Musculoskeletal: arthralgia, arthritis, myalgia Skin and Appendages: rash Facial edema was reported in five patients receiving olmesartan medoxomil.
Angioedema has been reported with angiotensin II antagonists. Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of olmesartan medoxomil. Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to olmesartan medoxomil and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five olmesartan medoxomil patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.
Pediatric Hypertension No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to 16 years and that previously reported for adult patients.
6.2Post-Marketing Experience The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is n…
🔄 Drug Interactions ▾
No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH) 3/Mg(OH) 2]. Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected.
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 olmesartan medoxomil and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see CONTRAINDICATIONS (4)].
Avoid use of aliskiren with olmesartan medoxomil tablets in patients with renal impairment (GFR <60 ml/min). 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 [see CLINICAL PHARMACOLOGY (12.3)] . Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including olmesartan medoxomil tablets. Monitor serum lithium levels during concomitant use.
👥 Use in Specific Populations ▾
8.1Pregnancy Pregnancy Category D 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. 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 olmesartan medoxomil tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment.
If oligohydramnios is observed, discontinue olmesartan medoxomil tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to olmesartan medoxomil for hypotension, oliguria, and hyperkalemia [see USE IN SPECIFIC POPULATIONS (8.4)] .
8.3Nursing Mothers 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.
8.4Pediatric Use Neonates with a history of in utero exposure to olmesartan medoxomil: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. The antihypertensive effects of olmesartan medoxomil were evaluated in one randomized, double-blind clinical study in pediatric patients 1 to 16 years of age [see CLINICAL STUDIES (14.2)] .
The pharmacokinetics of olmesartan medoxomil was evaluated in pediatric patients 1 to 16 years of age [see CLINICAL PHARMACOLOGY (12.3)] . Olmesartan medoxomil was generally well tolerated in pediatric patients, and the adverse experience profile was similar to that described for adults. Olmesartan medoxomil has not been shown to be effective for hypertension in children <6 years of age.
Children <1 year of age must not receive olmesartan medoxomil for hypertension [see WARNINGS AND PRECAUTIONS (5.2)]. The renin-angiotensin aldosterone system (RAAS) plays a critical role in kidney development. RAAS blockade has been shown to lead to abnormal kidney development in very young mice.
Administering drugs that act directly on the renin- angiotensin aldosterone system (RAAS) can alter normal renal development.
8.5Geriatric Use Of the total number of hypertensive patients receiving olmesartan medoxomil in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences in effectiveness or safety were observed between elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [se…
🆘 Overdosage ▾
Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.
🧬 Clinical Pharmacology ▾
12.1Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in vascular smooth muscle.
Its action is, therefore, independent of the pathways for angiotensin II synthesis. An AT 2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT 1 receptor than for the AT 2 receptor.
Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is a mechanism of many drugs used to treat hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan medoxomil does not inhibit ACE (kininase II), it does not affect the response to bradykinin.
Whether this difference has clinical relevance is not yet known. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of olmesartan on blood pressure.
12.2Pharmacodynamics Olmesartan medoxomil doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of olmesartan medoxomil >40 mg giving >90% inhibition at 24 hours. Plasma concentrations of angiotensin I and angiotensin II and plasma renin activity (PRA) increase after single and repeated administration of olmesartan medoxomil to healthy subjects and hypertensive patients.
Repeated administration of up to 80 mg olmesartan medoxomil had minimal influence on aldosterone levels and no effect on serum potassium.
12.3Pharmacokinetics Absorption Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Olmesartan medoxomil tablets and the suspension formulation prepared from Olmesartan medoxomil tablets are bioequivalent [see DOSAGE AND ADMINISTRATION (2.2)] . The absolute bioavailability of olmesartan is approximately 26%.
After oral administration, the peak plasma concentration (C max) of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan. Distribution The volume of distribution of olmesartan is approximately 17 L.
Olmesartan is highly bound to plasma proteins (99%) and does not penetrate red blood cells. The protein binding is constant at plasma olmesartan concentrations well above the range achieved with recommended doses. In rats, olmesartan crossed the blood-brain barrier poorly, if at all.
Olmesartan passed across the placental barrier in rats and was distributed to the fetus. Olmesartan was distributed to milk at low levels in rats. Metabolism and Excretion Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan.
Total plasma clearance of olmesartan is
1.3 L/h, with a renal clearance of
0.6L/h. Approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile. Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours.
Olmesartan shows linear pharmacokinetics following single oral doses of up to 320 mg and multiple oral doses of up to 80 mg. Steady-state levels of olmesartan are achieved within 3 to 5 days and no accumulation i…
📦 How Supplied / Storage and Handling ▾
Olmesartan medoxomil tablets USP are supplied as light yellow, round, biconvex, film coated non-scored tablets containing 5 mg of olmesartan medoxomil, as white to off white, round, biconvex, film coated non-scored tablets containing 20 mg of olmesartan medoxomil, and as white to off white, oval, biconvex, film coated non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with “FS1”, “FS2” or ‘FS3” on one side of 5, 20, and 40 mg tablets, respectively and are plain on other side. Tablets are supplied as follows: 5 mg 20 mg 40 mg Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[ p-( o- 1H-tetrazol-5-ylphenyl)benzyl]imidazole-5 carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C 29H 30N 6O 6 and its structural formula is: [Structural formula for olmesartan medoxomil] Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, purified talc, titanium dioxide, and (5 mg only) iron oxide yellow.