Olmesartan Medoxomil and Hydrochlorothiazide

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Overview

What is Olmesartan Medoxomil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[- (-1-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.

Its molecular formula is CHNOand its structural formula is:

Olmesartan medoxomil USP is a white to off-white, crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is CHClNOS and its structural formula is:

Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.

Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

What does Olmesartan Medoxomil and Hydrochlorothiazide look like?

What are the available doses of Olmesartan Medoxomil and Hydrochlorothiazide?

Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20 mg/12.5 mg; 40 mg/12.5 mg; 40 mg/25 mg ().

What should I talk to my health care provider before I take Olmesartan Medoxomil and Hydrochlorothiazide?

How should I use Olmesartan Medoxomil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen 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 and hydrochlorothiazide tablets.

Control of high blood pressure should be part 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 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.

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. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.

The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 40 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 mg/25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 20 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with hydrochlorothiazide monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 mg/25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide tablets.

What interacts with Olmesartan Medoxomil and Hydrochlorothiazide?

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What are the warnings of Olmesartan Medoxomil and Hydrochlorothiazide?

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What are the precautions of Olmesartan Medoxomil and Hydrochlorothiazide?

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What are the side effects of Olmesartan Medoxomil and Hydrochlorothiazide?

Sorry No records found

What should I look out for while using Olmesartan Medoxomil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated:

What might happen if I take too much Olmesartan Medoxomil and Hydrochlorothiazide?

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How should I store and handle Olmesartan Medoxomil and Hydrochlorothiazide?

Product: 63629-7570NDC: 63629-7570-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-7570-2 60 TABLET, FILM COATED in a BOTTLEProduct: 63629-7570NDC: 63629-7570-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-7570-2 60 TABLET, FILM COATED in a BOTTLEProduct: 63629-7570NDC: 63629-7570-1 30 TABLET, FILM COATED in a BOTTLENDC: 63629-7570-2 60 TABLET, FILM COATED in a BOTTLE

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Olmesartan medoxomil

Hydrochlorothiazide

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Non-Clinical Toxicology

Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated:

Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride tablets concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride tablets (see ).

Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics:

Beta-blockers:

Administration of diltiazem hydrochloride tablets concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).

Buspirone:

5.5-fold and C 4.1-fold compared to placebo. The T and T of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

Carbamazepine:

Cimetidine:

Clonidine:

Cyclosporine:

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Ivabradine:

Quinidine:

Rifampin:

Statins:

In a healthy volunteer crossover study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14-day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open-label, 4-way crossover study, coadministration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cduring diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

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 and hydrochlorothiazide as soon as possible Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia

The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide are described elsewhere:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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