This information is not for clinical use. These highlights do not include all the information needed to use Olmesartan Medoxomil safely and effectively. Before taking Olmesartan Medoxomil please consult with your doctor. See full prescribing information for Olmesartan Medoxomil.

Warning

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Olmesartan Medoxomil Tablets as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING:FETAL TOXICITY Seefull prescribing information for complete boxed warning. When pregnancy is detected, discontinue Olmesartan Medoxomil Tablets as soon as possible (5.1). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1).

Indications And Usage

1 INDICATIONS & 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 is 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.

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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

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

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.

Warning and Cautions

· Avoid fetal (in utero) exposure (5.1). · Children <1 year of age must not receive Olmesartan Medoxomil Tablets 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 Tablets in cases where no other etiology is found (5.5). 5.1 Fetal toxicity Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Olmesartan Medoxomil Tablets as soon as possible [see Use in specific Populations (8.1)]. 5.2 Morbidity in Infants Children <1 year of age must not receive Olmesartan Medoxomil Tablets 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)]. 5.3 Hypotension 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. 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. 5.4 Impaired 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), 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. 5.5 Sprue-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 Tablets in cases where no other etiology is identified. 5.6 Electrolyte Imbalances Olmesartan Medoxomil Tablet 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

The most common adverse reaction in adults was dizziness (3%) (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Treatment with Olmesartan Medoxomil Tablets 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 Tablets . The overall frequency of adverse reactions was not dose-related. 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%). The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with Olmesartan Medoxomil Tablets , 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 Tablets (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 Tablets 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 Tablets . 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 Tablets . 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 Tablets 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 Tablets patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued. Pediatric Hypertension No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to 16 years and that previously reported for adult patients. 6.2 Post-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 (5.6)] Metabolic and Nutritional Disorders: Hyperkalemia Musculoskeletal: Rhabdomyolysis Urogenital System: Acute renal failure, increased blood creatinine levels Skin and Appendages: Alopecia, pruritus, urticaria Data from onecontrolled trial and an epidemiologic study have suggested that high-doseolmesartan may increase cardiovascular (CV) risk in diabetic patients, but theoverall data are not conclusive. The randomized, placebo-controlled,double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuriaPrevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs.placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and atleast one additional risk factor for CV disease. The trial met its primaryendpoint, delayed onset of microalbuminuria, but olmesartan had no beneficialeffect on decline in glomerular filtration rate (GFR). There was a finding ofincreased CV mortality (adjudicated sudden cardiac death, fatal myocardialinfarction, fatal stroke, revascularization death) in the olmesartan groupcompared 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 myocardialinfarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18). The epidemiologic studyincluded patients 65 years and older with overall exposure of > 300,000patient-years. In the sub-group of diabetic patients receiving high-doseolmesartan (40 mg/d) for > 6 months, there appeared to be an increased riskof death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking otherangiotensin receptor blockers. In contrast, high-dose olmesartan use innon-diabetic patients appeared to be associated with a decreased risk of death(HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking otherangiotensin receptor blockers. No differences were observed between the groupsreceiving lower doses of olmesartan compared to other angiotensin blockers orthose receiving therapy for < 6 months. Overall,these data raise a concern of a possible increased CV risk associated with theuse of high-dose olmesartan in diabetic patients. There are, however, concernswith the credibility of the finding of increased CV risk, notably theobservation in the large epidemiologic study for a survival benefit innon-diabetics of a magnitude similar to the adverse finding in diabetics.

Drug Interactions

No significant drug interactions were reported in studies in which Olmesartan Medoxomil Tablets was coadministered 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 Benicar and other agents that affect the RAS. Do not co-administer aliskiren with Olmesartan Medoxomil Tablets in patients with diabetes [see Contraindications (4)]. Avoid use of aliskiren with Olmesartan Medoxomil Tablets in patients with renal impairment (GFR <60 ml/min). Colesevelam hydrochloride Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology (12.3)]. Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Olmesartan Medoxomil Tablets. Monitor serum lithium levels during concomitant use. 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

· 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). 8.1 Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Olmesartan Medoxomil Tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Olmesartan Medoxomil Tablets , unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Olmesartan Medoxomil Tablets for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)]. 8.3 Nursing 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. 8.4 Pediatric Use Neonates with a history of in utero exposure to Olmesartan Medoxomil Tablets : 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 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 <6 years of age. Children <1 year of age must not receive Olmesartan Medoxomil Tablets for hypertension [see Warnings and Precautions (5.2)]. The renin-angiotensin aldosterone system (RAAS) plays a critical role in kidney development. RAAS blockade has been shown to lead to abnormal kidney development in very young mice. Administering drugs that act directly on the renin- angiotensin aldosterone system (RAAS) can alter normal renal development. 8.5 Geriatric 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 Dosage and Administration (2.1) and Clinical Pharmacology (12.3)]. 8.6 Hepatic Impairment Increases in AUC0-a and Cmax were observed in patients with moderate hepatic impairment compared to those in matched controls, with an increase in AUC of about 60%. No initial dosage adjustment is recommended for patients with moderate to marked hepatic dysfunction [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)]. 8.7 Renal Impairment Patients with renal insufficiency have elevated serum concentrations of olmesartan 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). No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance < 40 mL/min) [see Dosage and Administration (2.1), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. 8.8 Black Patients The antihypertensive effect of Olmesartan Medoxomil Tablets was smaller in black patients (usually a low-renin population), as has been seen with ACE inhibitors, beta-blockers and other angiotensin receptor blockers.