olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 40 mg; 5 mg; 25 mg Tablet, Film Coated, 90-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.
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🩺 Clinical
Amlodipine is used to treat high blood pressure and certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have ches...
Read the full MedlinePlus article ↗- Yes, it's very common. High blood pressure often needs more than one medicine to reach a safe target, and combining them into a single tablet makes it much easier to take consisten...
- Why am I taking three medicines in one pill? Is that normal?
- This is a really important one. You should not take this medicine if you are pregnant, and if you discover you're pregnant while taking it, stop it right away and call your doctor...
- Can I take this medicine if I'm pregnant or trying to get pregnant?
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🧪 Inactive Ingredients / Excipients
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
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A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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UNII 949E52Z6MY
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It acts as a binder to hold tablet ingredients together and as a film-former in coatings that control how fast the medicine dissolves.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.915 | $82.36 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.52 | $137.24 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.45 | $130.92 / 90 tablets |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 49884-0788-09 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (49884-788-09) | $0.9151 / ea | $82.36 | 2016-10-26 | Active |
| 49884-0788-11 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-788-11) | $0.9151 / ea | $27.45 | 2016-10-26 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.9151 NADAC).
This pack accounts for about 2.5% of this product's recent Medicaid fills; most go to the 30 tablets pack. See all packs ↓
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What quantity is in NDC 49884-0788-09?
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What NDC number is used to bill for this package of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 40 mg; 5 mg; 25 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are 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 (CV) 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, amlodipine and hydrochlorothiazide 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. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is a combination of olmesartan medoxomil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic, 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. Limitations of Use Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are not indicated for initial therapy.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2 week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is 40/10/25 mg.
Dose selection should be individualized based on previous therapy. Dose once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 /10 /25 mg once daily ( 2 ).
Dose selection should be individualized based on previous therapy ( 2 ).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are available in the following strength combinations: 20/5/12.5 40/5/12.5 40/5/25 40/10/12.5 40/10/25 Olmesartan medoxomil (mg) 20 40 40 40 40 Amlodipine equivalent (mg) 5 5 5 10 10 Hydrochlorothiazide (mg) 12.5 12.5 25 12.5 25 Tablets: (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) 20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, 40 /10 /25 mg
⛔ Contraindications ▾
4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions ( 7.2 )]. Anuria: Hypersensitivity to sulfonamide-derived drugs (4).
Do not coadminister aliskiren with Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in patients with diabetes (4).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ). Monitor renal function and potassium in susceptible patients Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase ( 5.3 ).
Observe for signs of fluid or electrolyte imbalance ( 5.6 ). Exacerbation or activation of systemic lupus erythematosus ( 5.8 ). Acute angle-closure glaucoma ( 5.9 ).
Sprue-like enteropathy has been reported. Consider discontinuation of Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in cases where no other etiology is found ( 5.10 )
5.1Fetal Toxicity olmesartan medoxomil . Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
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, amlodipine and hydrochlorothiazide tablets as soon as possible [see Use in specific Populations ( 8.1 )].
Hydrochlorothiazide. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations ( 8.1 )].
5.2Hypotension in Volume-or Salt-Depleted Patients Olmesartan medoxomil. In patients with an activated renin-angiotensin 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 with Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
5.3Increased Angina and/or Myocardial Infarction Amlodipine. Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction upon starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.
5.4Impaired Renal Function Olmesartan medoxomil, amlodipine and hydrochlorothiazide. Impaired renal function was reported in 2.1% of subjects receiving olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets compared to 0.2% to 1.3% of subjects receiving dual combination therapy of olmesartan medoxomil and amlodipine, olmesartan medoxomil and hydrochlorothiazide or amlodipine and hydrochlorothiazide. If progressive renal impairment becomes evident consider withholding or discontinuing olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
Olmesartan medoxomil. Changes in renal function occur in some individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system. 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 ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death.
Similar effects may occur in pat…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Olmesartan medoxomil, amlodipine and hydrochlorothiazide In the controlled trial of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, patients were randomized to olmesartan medoxomil, amlodipine and hydrochlorothiazide 40/10/25 mg, olmesartan medoxomil/ amlodipine 40/10 mg, olmesartan medoxomil/ hydrochlorothiazide 40/25 mg, or amlodipine/ hydrochlorothiazide 10/25 mg.
Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combination therapies. Safety data from this study were obtained in 574 patients with hypertension who received olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets for 8 weeks. The frequency of adverse reactions was similar between men and women, patients <65 years of age and patients ≥65 years of age, patients with and without diabetes, and Black and non-Black patients.
Discontinuations because of adverse events occurred in 4% of patients treated with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 40/10/25 mg compared to 1% of patients treated with olmesartan medoxomil/amlodipine 40/10 mg, 2% of patients treated with olmesartan medoxomil/hydrochlorothiazide 40/25 mg, and 2% of patients treated with amlodipine/hydrochlorothiazide 10/25 mg. The most common reason for discontinuation with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets was dizziness (1%).
Dizziness was one of the most frequently reported adverse reactions with incidence of 1.4% to 3.6% in subjects continuing on dual combination therapy compared to 5.8% to 8.9% in subjects who switched to olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. The other most frequent adverse reactions that occurred in at least 2% of subjects are presented in the table below: Table 1 Adverse Reaction OM40/ AML10/ HCTZ25 mg (N = 574) n (%) OM40/ AML10 mg (N = 596) n (%) OM40/ HCTZ25 mg (N = 580) n (%) AML10/ HCTZ25 mg (N = 552) n (%) Edema peripheral 44 (7.7) 42 (7.0) 6 (1.0) 46 (8.3) Headache 37 (6.4) 42 (7.0) 38 (6.6) 33 (6.0) Fatigue 24 (4.2) 34 (5.7) 31 (5.3) 36 (6.5) Nasopharyngitis 20 (3.5) 11 (1.8) 20 (3.4) 16 (2.9) Muscle spasms 18 (3.1) 12 (2.0) 14 (2.4) 13 (2.4) Nausea 17 (3.0) 12 (2.0) 22 (3.8) 12 (2.2) Upper respiratory tract infection 16 (2.8) 26 (4.4) 18 (3.1) 14 (2.5) Diarrhea 15 (2.6) 14 (2.3) 12 (2.1) 9 (1.6) Urinary tract infection 14 (2.4) 8 (1.3) 6 (1.0) 7 (1.3) Joint swelling 12 (2.1) 17 (2.9) 2 (0.3) 16 (2.9) Syncope was reported by 1% of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets subjects compared to 0.5% or less for the other treatment groups.
Olmesartan medoxomil 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 treated for at least 1 year. Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse reactions similar to that seen with placebo.
Adverse reactions were generally mild, transient, and without relationship to the dose of olmesartan medoxomil. Amlodipine Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials.
6.2 Post-Marketing Expe…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Olmesartan medoxomil (7.1 ): Nonsteroidal anti-inflammatory drugs (NSAIDS): May lead to increased risk of renal impairment and loss of antihypertensive effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before Colesevelam hydrochloride dose.
Lithium: Increases in serum lithium concentrations and lithium toxicity. Amlodipine ( 7.2 ): Limit simvastatin to 20 mg daily when coadministered. Increased exposure to cyclosporin and tacrolimus Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): Antidiabetic drugs: Dosage adjustment of antidiabetic may be required.
Cholestyramine and colestipol: Reduced absorption of thiazides. NSAIDs: Can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics.
7.1Drug Interactions with Olmesartan Medoxomil 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, coadministration 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, amlodipine and hydrochlorothiazide tablets and other agents that affect the RAS.
Do not coadminister aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in patients with diabetes [see Contraindications ( 4 )] . Avoid use of aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 ml/min). Use with 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 with concomitant use of olmesartan or thiazide diuretics.
Monitor lithium levels in patients receiving olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets and lithium.
7.2Drug Interactions with Amlodipine Simvastatin Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. [see Clinical Pharmacology ( 12.3 )]. Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered.
Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology ( 12.3 )] . CYP3A Inhibitors Coadministration of amlodipine with CYP3A…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8.2 ). Renal Impairment: Avoid use in patients with creatinine clearance ≤30 mL/min ( 8.7)
8.1Pregnancy Risk Summary Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations ] . 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.
When pregnancy is detected, discontinue Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Olmesartan medoxomil Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.
Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to olmesartan, if oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function [see Use in Specific Populations ( 8.4 )].
Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times that in umbilical vein plasma.
Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of preeclampsia, these drugs should not be used to treat hypertension in pregnant women. The use of HCTZ for other indications (e.g., heart disease) in pregnancy should be avoided.
Data Animal Data No reproductive studies have been conducted with the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide. However, these studies have been conducted for olmesartan medoxomil, amlodipine and hydrochlorothiazide alone, and olmesartan medoxomil and hydrochlorothiazide together. Olmesartan medoxomil.
No teratogenic effects were observed when olmesartan medoxomil was administ…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations ] . 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.
When pregnancy is detected, discontinue Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Olmesartan medoxomil Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.
Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to olmesartan, if oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function [see Use in Specific Populations ( 8.4 )].
Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times that in umbilical vein plasma.
Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of preeclampsia, these drugs should not be used to treat hypertension in pregnant women. The use of HCTZ for other indications (e.g., heart disease) in pregnancy should be avoided.
Data Animal Data No reproductive studies have been conducted with the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide. However, these studies have been conducted for olmesartan medoxomil, amlodipine and hydrochlorothiazide alone, and olmesartan medoxomil and hydrochlorothiazide together. Olmesartan medoxomil.
No teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) or pregnant rabbits at oral doses up t…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. In a controlled clinical trial, 123 hypertensive patients treated with olmesartan medoxomil, amlodipine and hydrochlorothiazide were ≥65 years of age and 18 patients were ≥75 years of age. No overall differences in the efficacy or safety of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets were observed in these patient populations; however, greater sensitivity of some older individuals cannot be ruled out.
The recommended initial dose of amlodipine in patients ≥ 75 years of age is 2.5 mg, a dose not available with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
🆘 Overdosage ▾
10 OVERDOSAGE There is no information on overdosage with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in humans. Olmesartan medoxomil. 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 should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown.
Amlodipine. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted.
Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output.
Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Hydrochlorothiazide.
The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats, more than 1000-fold the highest recommended human dose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The active ingredients of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets target three separate mechanisms involved in blood pressure regulation. Specifically, amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; olmesartan medoxomil blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume.
For a more detailed description of the mechanisms of action for each individual component, see below. Olmesartan medoxomil. Angiotensin II is formed from angiotensin I in a reaction catalyzed by 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.
Angiotensin-converting enzyme inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan 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. Amlodipine . Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Experimental data suggests that amlodipine binds to both dihydropyridine and nonhydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Hydrochlorothiazide . Hydrochlorothiazide is a thiazide diuretic.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and de…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The active ingredients of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets target three separate mechanisms involved in blood pressure regulation. Specifically, amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; olmesartan medoxomil blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume.
For a more detailed description of the mechanisms of action for each individual component, see below. Olmesartan medoxomil. Angiotensin II is formed from angiotensin I in a reaction catalyzed by 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.
Angiotensin-converting enzyme inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan 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. Amlodipine . Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Experimental data suggests that amlodipine binds to both dihydropyridine and nonhydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Hydrochlorothiazide . Hydrochlorothiazide is a thiazide diuretic.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassiu…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide in the strengths described below. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are supplied for oral administration in the following strength and package configurations: Tablet Strength (OM/AML equivalent/HCTZ) Package Configuration NDC# Tablet Color 20/5/12.5 mg Bottle of 30 Bottle of 90 49884-786-11 49884-786-09 White, film coated, round shaped biconvex tablet, debossed with “p” on one side and “786” on the other 40/5/12.5 mg Bottle of 30 Bottle of 90 49884-787-11 49884-787-09 Pink, film coated, round shaped biconvex tablet, debossed with “p” on one side and “787” on the other 40/5/25 mg Bottle of 30 Bottle of 90 49884-788-11 49884-788-09 White, film coated, oval shaped biconvex tablet, debossed with “p” on one side and “788” on the other 40/10/12.5 mg Bottle of 30 Bottle of 90 49884-789-11 49884-789-09 Orange, film coated, round shaped biconvex tablet, debossed with “p” on one side and “789” on the other 40/10/25 mg Bottle of 30 Bottle of 90 49884-790-11 49884-790-09 Pink, film coated, oval shaped biconvex tablet, debossed with “p” on one side and “790” on the other Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described 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 empirical formula is C 29 H 30 N 6 O 6 . The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S.
The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 CIN 3 O 4 S 2 . The structural formula for olmesartan medoxomil is: The structural formula for amlodipine besylate is: The structural formula for hydrochlorothiazide is: Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder, amlodipine besylate, a white to off-white crystalline powder, and hydrochlorothiazide, a white or practically white, crystalline powder.
The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol.
Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each 20/5/12.5 mg tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/5/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide.
Each 40/5/25 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 25 mg of hydrochlorothiazide. Each 40/10/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/10/25 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 25 mg of hydrochlorothiazide.
Each tablet of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating for 20 /5 /12.5 mg, 40 /5 /25 mg tablets contains titanium dioxide, hypromellose, polyethylene glycol and polysorbate, the color coating for 40/10/25 mg and 40/5/12.5 mg tablets contains polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc and iron oxide red and the color coating for 40 /10 /12.5 mg tablets polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc iron oxide yellow and FD&C #6.
Olmesartan medoxomil Amlodipine besylate Hydrochlorothiazide
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [ see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] .
Lactation : Advise nursing women not to breastfeed during treatment with Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets [ see Use in Specific Populations (8.2)] . Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets should be discontinued until the physician has been consulted.
Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope . Non-melanoma Skin Cancer : Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.
Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [ see Warnings and Precautions (5.9)]. Manufactured for: Endo USA Malvern, PA 19355 U.S.A. Made in India © 2024 Endo, Inc. or one of its affiliates.
Issued: 08/2024