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olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

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Overview

What is olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

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-[1-tetrazol-5- ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C H NO .

The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C H CINO•CHOS.

The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C HCIN OS .

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.



What does olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide look like?



What are the available doses of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Tablets: (olmesartan medoxomil, amlodipine and hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg and 40/10/25 mg (3)

What should I talk to my health care provider before I take olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling

How should I use olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is 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, 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.

This fixed combination drug is not indicated for the initial therapy of hypertension .

General Considerations

Dose once daily.

Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is 40/10/25 mg.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be taken with or without food.

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

Renal Impairment

The usual regimens of therapy with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets .

Elderly

Patients ≥ 75 years of age should start amlodipine at 2.5 mg, which is not available with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.

Hepatic Impairment

Patients with severe hepatic impairment should start amlodipine at 2.5 mg, which is not available with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets

Replacement Therapy

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be substituted for its individually titrated components.

Add-on/Switch Therapy

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets may be switched to olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets containing a lower dose of that component to achieve similar blood pressure reductions.


What interacts with olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Sorry No Records found


What are the warnings of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Sorry No Records found


What are the precautions of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Sorry No Records found


What are the side effects of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Sorry No records found


What should I look out for while using olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine and  hydrochlorothiazide tablets is contraindicated in patients with anuria 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)].

WARNING: FETAL TOXICITY


What might happen if I take too much olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

There is no information on overdosage with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in humans.

Olmesartan medoxomil.

Amlodipine.

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.


How should I store and handle olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide?

Olmesartan medoxomil, amlodipine besylate 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: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Olmesartan medoxomil, amlodipine besylate 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: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Olmesartan medoxomil, amlodipine besylate 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: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

An AT 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 ATreceptor than for the AT 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.

in vitro

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.

The mechanism of the antihypertensive effect of thiazides is not fully understood.

Non-Clinical Toxicology
Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine and  hydrochlorothiazide tablets is contraindicated in patients with anuria 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)].

WARNING: FETAL TOXICITY

Fexmid may have life-threatening interactions with MAO inhibitors (see ).  Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Fexmid and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).

Fexmid may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.

____________________________________________________________________ ULTRAM (tramadol HCl tablets, PriCar, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) ULTRACET (tramadol HCl and acetaminophen tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc.)_____________________________________________________________________

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, amlodipine and hydrochlorothiazide tablets as soon as possible see

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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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Tips

Tips

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Interactions

Interactions

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