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Olmesartan Medoxomil 40 mg Tablet, Film Coated, 60-count — NDC 71205-0174-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Olmesartan Medoxomil 40 mg Tablet, Film Coated, 60-count — NDC 71205-174-60 (Billing 71205-0174-60)

by Proficient Rx LP · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Olmesartan Medoxomil 40 mg Tablet, Film Coated from Proficient Rx LP, marketed since Apr 2017 and currently FDA-listed.

NDC 71205-0174-60
🏷️ FDA NDC (as labeled) 71205-174-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2000/unit — full pricing hub ↓
Product page 71205-0174-30 Also comes in: 30 tablets 71205-174-30 90 tablets 71205-174-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-174-60
Product NDC 71205-174
11-digit billing NDC 71205017460
RxCUI 349401, 349405
UNII 6M97XTV3HD
Application # ANDA204798
SPL Set ID e210f962-9b91-46c6-af8f-9f9a9ae84245
Established class (EPC) Angiotensin 2 Receptor Blocker
Mechanism of action Angiotensin 2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-04-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance OLMESARTAN MEDOXOMIL
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36150055200360
GPI class Olmesartan Medoxomil
GCN Seq No 050290
GCN 17286
HICL code 023490
Ingredient (HICL) Olmesartan Medoxomil
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4F
Therapeutic class — specific (HIC3) Antihypertensives, Angiotensin Receptor Antagonist
AHFS code 24:32.08.00
AHFS class Angiotensin Ii Receptor Antagonists
FDB label name OLMESARTAN MEDOXOMIL 40 MG TAB
FDB brand name Olmesartan Medoxomil
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 050290
  • GCN: 17286
  • GPI-14 (Medi-Span): 36150055200360
  • HICL (First Databank): 023490
  • AHFS class code: 24:32.08.00
  • RxCUI (RxNorm): 349401
Why two NDCs? The FDA registers this code as 71205-174-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0174-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker
Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain
How it works Angiotensin 2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OLMESARTAN MEDOXOMIL 40 MG TAB Ingredient Olmesartan Medoxomil
📗 Our plain-language guide HelloPharmacist
  • Olmesartan is used to treat high blood pressure (hypertension) in adults and in kids as young as six years old. It works by relaxing your blood vessels so your heart doesn't have t...
  • No — this is one of the most important things to know about olmesartan. It can cause very serious harm to an unborn baby, including kidney failure and even death, especially after...
  • Can I take this if I'm pregnant or trying to get pregnant?
  • Dizziness is the most commonly reported side effect — it happens in about 3 out of 100 people in clinical trials. It's most likely when you first start the medicine, especially if...
📖 Read our full Olmesartan guide →
1
Nutrient depletion considerations

Olmesartan Medoxomil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Olmesartan Medoxomil nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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 $12.00 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0174-30 71205-174-30 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2018-12-01 — Active
71205-0174-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE 2018-12-01 — Active
71205-0174-90 71205-174-90 90 TABLET, FILM COATED in 1 BOTTLE 2018-12-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, film coated in 1 bottle.
How does this package differ from NDC 71205-0174-30?
Both are Olmesartan Medoxomil 40 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 60-count one, while NDC 71205-0174-30 is the 30 tablets package.
What NDC number is used to bill for this package of Olmesartan Medoxomil 40 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
olmesartan medoxomil 40 mg 16729-0322-10 Accord 30 tablets $0.110 AB Availability likely —
Olmesartan Medoxomil 40 mg 00527-2427-32 Lannett 30 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 31722-0854-30 Camber 30 tablets $0.111 AB Availability likely —
Olmesartan medoxomil 40 mg 33342-0180-07 Macleods 30 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 43547-0301-03 Solco 30 tablets $0.111 AB Availability likely —
olmesartan medoxomil 40 mg 50228-0341-10 ScieGen 1000 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 64980-0603-03 Rising 30 tablets $0.111 AB Availability likely —
Olmesartan medoxomil 40 mg 72205-0167-30 Novadoz 30 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 72241-0080-04 Modavar 90 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 72303-0850-01 HEC 30 tablets $0.111 AB Availability likely —
Olmesartan Medoxomil 40 mg 82009-0075-90 QUALLENT 90 tablets $0.111 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 mgthis 71205-0174-60 Proficient 60 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 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeOval
ImprintK;19
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA204798 (ANDA)
Labeler code71205
First marketedApr 2017
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 91 words ▾

WARNING : FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil as soon as possible [see Warnings and Precautions (5.1) ]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue olmesartan medoxomil 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 ~2 min read ▾

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 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 are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, 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 (1).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Adult Hypertension (2.1) 20 mg once daily 20 to 40 mg once daily Pediatric Hypertension (6 to 16 years) (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 • Olmesartan medoxomil tablets may be administered with or without food. • If blood pressure is not controlled by olmesartan medoxomil tablets alone, a diuretic may be added. Olmesartan medoxomil tablets may be administered with other antihypertensive agents.

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. 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 tablets 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 tablets 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 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.

Children <1 year of age must not receive olmesartan medoxomil tablets 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 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 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 ®* 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 87 words ▾

3 DOSAGE FORMS AND STRENGTHS • 5 mg tablets are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘16’ on the other side. • 20 mg tablets are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘18’ on the other side. • 40 mg tablets are white colored, oval shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘19’ on the other side. Tablets: 5 mg, 20 mg, and 40 mg (3) .

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions (7) ] . Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes (4) .

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Avoid fetal ( in utero ) exposure (5.1) . • Children <1 year of age must not receive olmesartan medoxomil for hypertension (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 discontinuation of olmesartan medoxomil in cases where no other etiology is found (5.5) .

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 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 contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reaction in adults was dizziness (3%) ( 6.1 ).To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-332-1088 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 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 r… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 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 in patients with diabetes [see Contraindications (4)] .

Avoid use of aliskiren with olmesartan medoxomil 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. Monitor serum lithium levels during concomitant use. • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect (7) . • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7) . • Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose (7) . • Lithium: Increases in serum lithium concentrations and lithium toxicity (7) .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Nursing mothers: Choose to discontinue nursing or drug (8.3) . • In patients with an activated renin-angiotensin system, such as volume- or salt-depletion, renin-angiotensin-aldosterone system (RAAS) blockers such as olmesartan medoxomil can cause excessive hypotension. In susceptible patients, e.g., with renal artery stenosis, RAAS blockers can cause renal failure (5.3 , 5.4) . • Geriatrics: No overall difference in efficacy or safety vs. younger adult patients, but greater sensitivity of some older individuals cannot be ruled out (8.5) .

8.1Pregnancy Teratogenic Effects 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 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, 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 were 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-angi… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects 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 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, 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) ].

🧒 Pediatric Use 199 words ▾

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 were 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.

🧓 Geriatric Use 90 words ▾

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 [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] .

🆘 Overdosage 44 words ▾

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 ~3 min read ▾

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 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… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

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.

📦 How Supplied / Storage and Handling 99 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Olmesartan Medoxomil Tablets, 20 mg are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘18’ on the other side. Bottles of 30 NDC 71205-172-30 Bottles of 60 NDC 71205-172-60 Bottles of 90 NDC 71205-172-90 Olmesartan Medoxomil Tablets, 40 mg are white colored, oval shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘19’ on the other side. Bottles of 30 NDC 71205-174-30 Bottles of 60 NDC 71205-174-60 Bottles of 90 NDC 71205-174-90 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 132 words ▾

11 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 -1 H -tetrazol-5-ylphenyl)benzyl]imidazole‑-5-carboxylate, cyclic 2,3-carbonate.

Its molecular 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 sparingly soluble in methanol. Olmesartan medoxomil 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: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.

Chemical Structure

💬 Information for Patients 80 words ▾

17 PATIENT COUNSELING INFORMATION Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to olmesartan medoxomil during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500 038, India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 07/2018

🍼 Nursing Mothers 62 words ▾

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.

🧬 Pharmacokinetics ~3 min read ▾

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 in plasma occurs with once-daily dosing. Geriatric The pharmacokinetics of olmesartan were studied in the elderly (≥65 years).

Overall, maximum plasma concentrations of olmesartan were similar in young adults and the elderly. Modest accumulation of olmesartan was observed in the elderly with repeated dosing; AUC ss , τ was 33% higher in elderly patients, corresponding to an approximate 30% reduction in CL R [see Dosage and Administration (2.1) and Use in Specific Populations (8.5) ] . Pediatric The pharmacokinetics of olmesartan were studied in pediatric hypertensive patients aged 1 to16 years.

The clearance of olmesartan in pediatric patients was similar to that in adult patients when adjusted by the body weight [see Use in Specific Populations (8.4) ] . Olmesartan pharmacokinetics have not been investigated in pediatric patients less than 1 year of age [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ]. Gender Minor differences were observed in the pharmacokinetics of olmesartan in women compared to men.

AUC and C max were 10 to 15% higher in women than in men. Hepatic Insufficiency Increases in AUC 0-∞ and C max were observed in patients with moderate hepatic impairment compared to those in matched controls, with an increase in AUC of about 60% [see Dosage and Administration (2.1) and Use in Specific Populations (8.6) ] . Renal Insufficiency In patients with renal insufficiency, serum concentrations of olmesartan were elevated compared to subjects with normal renal function.

After repeated dosing, the AUC was approximately tripled in patients with severe renal impairment (creatinine clearance <20 mL/min). The pharmacokinetics of olmesartan in patients undergoing hemodialysis has not been studied [see Dosage and Administration (2.1) , Warnings and Precautions (5.4) and Use in Specific Populations (8.7) ] . Drug Interaction Bile Acid Sequestering Agent Colesevelam Concomitant administration of 40 mg olmesartan medoxomil and 3750 mg colesevelam hydrochloride in healthy subjects resulted in 28% reduction in C max and 39% reduction in AUC of olmesartan.

Lesser effects, 4% and 15% reduction in C max and AUC respectively, were observed… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 91 words ▾

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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Hypertension The antihypertensive effects of olmesartan medoxomil have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 olmesartan medoxomil; 548 placebo) with essential hypertension were studied. Olmesartan medoxomil once daily lowered diastolic and systolic blood pressure.

The response was dose-related, as shown in the following graph. A olmesartan medoxomil dose of 20 mg daily produces a trough sitting BP reduction over placebo of about 10/6 mmHg and a dose of 40 mg daily produces a trough sitting BP reduction over placebo of about 12/7 mmHg. Olmesartan medoxomil doses greater than 40 mg had little additional effect.

The onset of the antihypertensive effect occurred within 1 week and was largely manifest after 2 weeks. Data above are from seven placebo-controlled studies (2145 olmesartan medoxomil patients, 548 placebo patients). The blood pressure lowering effect was maintained throughout the 24-hour period with olmesartan medoxomil once daily, with trough-to-peak ratios for systolic and diastolic response between 60 and 80%.

The blood pressure lowering effect of olmesartan medoxomil, with and without hydrochlorothiazide, was maintained in patients treated for up to 1 year. There was no evidence of tachyphylaxis during long-term treatment with olmesartan medoxomil or rebound effect following abrupt withdrawal of olmesartan medoxomil after 1 year of treatment. The antihypertensive effect of olmesartan medoxomil was similar in men and women and in patients older and younger than 65 years.

The effect was smaller in black patients (usually a low-renin population), as has been seen with ACE inhibitors, beta-blockers and other angiotensin receptor blockers. Olmesartan medoxomil had an additional blood pressure lowering effect when added to hydrochlorothiazide. There are no trials of olmesartan medoxomil demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

Olmesartan Medoxomil Dose Response Placebo-Adjusted Reduction in Blood Pressure (mmHg)

14.2Pediatric Hypertension The antihypertensive effects of olmesartan medoxomil in the pediatric population were evaluated in a randomized, double-blind study involving 302 hypertensive patients aged 6 to 16 years. The study population consisted of an all black cohort of 112 patients and a mixed racial cohort of 190 patients, including 38 blacks. The etiology of the hypertension was predominantly essential hypertension (87% of the black cohort and 67% of the mixed cohort).

Patients who weighed 20 to <35 kg were randomized to 2.5 or 20 mg of olmesartan medoxomil once daily and patients who weighed ≥35 kg were randomized to 5 or 40 mg of olmesartan medoxomil once daily. At the end of 3 weeks, patients were re-randomized to continuing olmesartan medoxomil or to taking placebo for up to 2 weeks. During the initial dose-response phase, olmesartan medoxomil significantly reduced both systolic and diastolic blood pressure in a weight-adjusted dose-dependent manner.

Overall, the two dose levels of olmesartan medoxomil (low and high) significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg from the baseline, respectively. These reductions in systolic blood pressure included both drug and placebo effect. During the randomized withdrawal to placebo phase, mean systolic blood pressure at trough was 3.2 mmHg lower and mean diastolic blood pressure at trough was 2.8 mmHg lower in patients continuing olmesartan medoxomil than in patients withdrawn to placebo.

These differences were statistically different. As observed in adult populations, the blood pressure reductions were smaller in black patients. In the same study, 59 patients aged 1 to 5 years who weighed ≥5 kg received 0.3 mg/kg of… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2000 mg/kg/day) was, on a mg/m 2 basis, about 480 times the maximum recommended human dose (MRHD) of 40 mg/day. Two carcinogenicity studies conducted in mice, a 6-month gavage study in the p53 knockout mouse and a 6-month dietary administration study in the Hras2 transgenic mouse, at doses of up to 1000 mg/kg/day (about 120 times the MRHD), revealed no evidence of a carcinogenic effect of olmesartan medoxomil.

Both olmesartan medoxomil and olmesartan tested negative in the in vitro Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames (bacterial mutagenicity) test. However, both were shown to induce chromosomal aberrations in cultured cells in vitro (Chinese hamster lung) and tested positive for thymidine kinase mutations in the in vitro mouse lymphoma assay. Olmesartan medoxomil tested negative in vivo for mutations in the MutaMouse intestine and kidney and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2000 mg/kg (olmesartan not tested).

Fertility of rats was unaffected by administration of olmesartan medoxomil at dose levels as high as 1000 mg/kg/day (240 times the MRHD) in a study in which dosing was begun 2 (female) or 9 (male) weeks prior to mating.

13.2Animal Toxicology and/or Pharmacology Reproductive Toxicology Studies 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] of olmesartan medoxomil 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2000 mg/kg/day) was, on a mg/m 2 basis, about 480 times the maximum recommended human dose (MRHD) of 40 mg/day. Two carcinogenicity studies conducted in mice, a 6-month gavage study in the p53 knockout mouse and a 6-month dietary administration study in the Hras2 transgenic mouse, at doses of up to 1000 mg/kg/day (about 120 times the MRHD), revealed no evidence of a carcinogenic effect of olmesartan medoxomil.

Both olmesartan medoxomil and olmesartan tested negative in the in vitro Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames (bacterial mutagenicity) test. However, both were shown to induce chromosomal aberrations in cultured cells in vitro (Chinese hamster lung) and tested positive for thymidine kinase mutations in the in vitro mouse lymphoma assay. Olmesartan medoxomil tested negative in vivo for mutations in the MutaMouse intestine and kidney and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2000 mg/kg (olmesartan not tested).

Fertility of rats was unaffected by administration of olmesartan medoxomil at dose levels as high as 1000 mg/kg/day (240 times the MRHD) in a study in which dosing was begun 2 (female) or 9 (male) weeks prior to mating.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.6 ) 11/2016

📄 Package Label / Principal Display Panel 44 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (30 Tablet Bottle) NDC 71205-172-30 Rx only Olmesartan Medoxomil Tablets 20 mg 30 Tablets 71205-172-30

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (30 Tablet Bottle) NDC 71205-174-30 Rx only Olmesartan Medoxomil Tablets 40 mg 30 Tablets 71205-174-30

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Olmesartan Medoxomil — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Olmesartan Medoxomil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$18.95M
Claims incl. refills
1M
Beneficiaries
847.8K
Spend / beneficiary
$22.35
Spend / claim
$18.14
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (71205-0174-30), 90 tablets (71205-0174-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71205-0172-30 · Proficient 71205-0176-30 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.