Olmesartan Medoxomil 40 mg Tablet, 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 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 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 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 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 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 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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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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.
9 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 mgthis 71335-2749-02 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Olmesartan Medoxomil 40 mg 72189-0138-30 | direct | 30 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 |
|---|---|---|---|
| 71335-2749-01 | 30 TABLET, COATED in 1 BOTTLE (71335-2749-1) | 2025-10-03 | Active |
| 71335-2749-02 You're viewing this | 90 TABLET, COATED in 1 BOTTLE (71335-2749-2) | 2025-10-03 | Active |
| 71335-2749-03 | 28 TABLET, COATED in 1 BOTTLE (71335-2749-3) | 2025-10-03 | Active |
You're viewing the largest of 3 pack sizes for this product.
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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 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Olmesartan medoxomil tablets are indicated for the treatment of 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. 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 tablets. 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. • Olmesartan medoxomil tablets is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older,alone or with other antihypertensive agents, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Indication Starting Dose Dose Range Adult Hypertension (2.1) 20 mg once daily 20 to 40 mg once daily Pediatric Hypertension (6 years of age and older) ( 2.2 ) 20 to <35 kg 10 mg once daily ≥35 kg 20 mg once daily 20 to <35 kg 10 to 20 mg once daily ≥35 kg 20 to 40 mg once daily.
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 tablets 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 olmesartan medoxomil tablets under close medical supervision and give consideration to use of a lower starting dose [see Warnings and Precautions ( 5.3 )]
2.2Pediatric Hypertension (6 Years of Age and Older) 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 tablets 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 olmesartan medoxomil tablets in children less than 1 year of age is not recommended [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.4 )] . 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 tablets 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 tablets 20 mg 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 ® and 50 mL of ORA-Plus ®* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2 to 8°C (36 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. * ORA-Sweet ® and ORA-Plus ® are registered trademarks of Paddock Laboratories, Inc.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS · 5 mg yellow coloured round shape film coated tablets debossed with OLM on one side & 5 on other side. · 20 mg white to off-white coloured, round shape film coated tablets debossed with OLM on one side & 20 on other side. · 40 mg white to off-white coloured,oval shape film coated tablets debossed with OLM on one side & 40 on other side. Tablets: 5 mg, 20 mg, and 40 mg
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions ( 7.3 ) ]. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS · Avoid fetal (in utero) exposure ( 5.1 ). · Use of olmesartan medoxomil tablets in children less than 1 year of age is not recommended.( 5.2 ). · Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation ( 5.3 ). · Monitor for worsening renal function in patients with renal impairment ( 5.4 ). · Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found ( 5.5 ).
5.1Fetal Toxicity Olmesartan medoxomil tablets 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 olmesartan medoxomil tablets as soon as possible [see Use in Specific Populations ( 8.1 ) ].
5.2Morbidity in Infants Use of olmesartan medoxomil tablets in children less than 1 year of age is not recommended. 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 tablets . Initiate treatment under close medical supervision and consider starting at a lower dose. 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 tablets . 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 tablets [see Dosage and Administration ( 2.1 ) , Drug Interactions (7.3), 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 tablets 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 alternative antihypertensive therapy in cases where no other etiology is identified.
5.6Hyperkalemia Serum potassium should be monitored in patients receiving olmesartan medoxomil tablets. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the de…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction in adults was dizziness (3%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 tablets 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.
Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil tablets. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil tablets 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 tablets 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 tablets and at a higher incidence versus placebo was dizziness (3% vs. 1%). Facial edema was reported in five patients receiving olmesartan medoxomil tablets.
Angioedema has been reported with angiotensin II antagonists. 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 not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole : Asthenia, angioedema, anaphylactic reactions Gastrointestinal : Vomiting, sprue-like enteropathy [see Warnings and Precautions ( 5.5 )] Metabolic and Nutritional Disorders : Hyperkalemia Musculoskeletal : Rhabdomyolysis Urogenital System : Acute renal failure, increased blood creatinine levels Skin and Appendages : Alopecia, pruritus, urticaria Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.
The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs.
3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers.
In contrast, high-dose olmesartan use in non-diabetic patients appear…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ).
Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7.4 ). Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ).
7.1Agents 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.
7.2Non-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.
7.3Dual 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 tablets 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 less than 60 ml/min).
7.4Lithium 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.
7.5Colesevelam 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)] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Choose to discontinue nursing or drug (8.2 ).
8.1Pregnancy Risk Summary Olmesartan medoxomil tablets 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. 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.
In animal reproduction studies, olmesartan medoxomil tablets treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In patients taking olmesartan medoxomil tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.
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 tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to olmesartan medoxomil tablets, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function. Data Animal Data No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose (MRHD) on a mg/m 2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m 2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does).
In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day.
8.2Lactation Risk Summary There is no information regarding the presence of olmesartan in human milk, th…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Olmesartan medoxomil tablets 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. 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.
In animal reproduction studies, olmesartan medoxomil tablets treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In patients taking olmesartan medoxomil tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.
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 tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to olmesartan medoxomil tablets, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function. Data Animal Data No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose (MRHD) on a mg/m 2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the MRHD on a mg/m 2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does).
In rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD of 40 mg/day.
🧒 Pediatric Use ▾
8.4Pediatric Use The antihypertensive effects of olmesartan medoxomil tablets 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 tablets were evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology (12.3)] . Olmesartan medoxomil tablets was generally well tolerated in pediatric patients, and the adverse experience profile was similar to that described for adults.
Olmesartan medoxomil tablets has not been shown to be effective for hypertension in children less than 6 years of age. Use of olmesartan medoxomil tablets in children less than 1 year of age is not recommended [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.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of hypertensive patients receiving olmesartan medoxomil tablets 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 [see Clinical Pharmacology ( 12.3 ) ].
🆘 Overdosage ▾
10 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 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 AT1 receptor in vascular smooth muscle.
Its action is, therefore, independent of the pathways for angiotensin II synthesis. An AT2 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 AT1 receptor than for the AT2 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 tablets 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 Tablets >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 tablets to healthy subjects and hypertensive patients.
Repeated administration of up to 80 mg olmesartan medoxomil tablets 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 (Cmax) of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan. Olmesartan medoxomil tablets may be administered with or without food.
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 an…
🧬 Mechanism of Action ▾
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 AT1 receptor in vascular smooth muscle.
Its action is, therefore, independent of the pathways for angiotensin II synthesis. An AT2 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 AT1 receptor than for the AT2 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING lmesartan medoxomil tablets, USP is supplied as white to off-white coloured,oval shape film coated tablets containing 40 mg of olmesartan medoxomil USP. Tablets are debossed with OLM40 on the other side 40 mg tablets, respectively. NDC: 71335-2749-1: 30 Tablets in a BOTTLE NDC: 71335-2749-2: 90 Tablets in a BOTTLE NDC: 71335-2749-3: 28 Tablets in a BOTTLE Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Olmesartan medoxomil,USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 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]imidazole5-carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil, USP is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and in heptanes,slightly soluble in ethanol (96%),sparingly soluble in methanol. Olmesartan medoxomil tablets, USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil,USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxy propyl cellulose ,stearic acid,magnesium stearate, talc, titanium dioxide, and (5 mg only) yellow iron oxide.
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 6.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Pregnancy : Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
Lactation : Advise nursing women not to breastfeed during treatment with olmesartan medoxomil tablets [see Use in Specific Populations (8.2)]. Hyperkalemia : Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider [see Drug Interactions (7.1)]. Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA.
Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Revised: March 2025 Rx Only PT 2245-04