Olmesartan Medoxomil (Olmesartan Medoxomil)

Trade Name : olmesartan medoxomil

REMEDYREPACK INC.

TABLET, FILM COATED

Strength 40 mg/1

OLMESARTAN MEDOXOMIL Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olmesartan Medoxomil (Olmesartan Medoxomil) which is also known as olmesartan medoxomil and Manufactured by REMEDYREPACK INC.. It is available in strength of 40 mg/1 per ml. Read more

Olmesartan Medoxomil (Olmesartan Medoxomil) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Olmesartan Medoxomil Tablets

WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

Arrayn- When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible n n n n n n n n n n n n .n n n n n n n n n n n n
Arrayn- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus n n n n n n n n n n n n .n n n n n n n n n n n n

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.
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 Programu2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.

Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions n n n n n n n n n n n n .n n n n n n n n n n n n

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Olmesartan medoxomil tablets may be administered with or without food.
If blood pressure is not controlled by olmesartan medoxomil alone, a diuretic may be added. Olmesartan medoxomil tablets may be administered with other antihypertensive agents.

Tablets: 5 mg, 20 mg, and 40 mg n n n n n n n n n n n n .n nn n nn n nn n nn

n Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes n n n n n n n n n n n n n
Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes n n n n n n n n n n n n .n nn n nn n nn n nn

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Avoid fetal (in utero) exposure n n n n n n n n n n n n .n n n n n n n n n n n n
Children <1 year of age must not receive olmesartan medoxomil for hypertension n n n n n n n n n n n n .n n n n n n n n n n n n
Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation n n n n n n n n n n n n .n n n n n n n n n n n n
Monitor for worsening renal function in patients with renal impairment n n n n n n n n n n n n .n n n n n n n n n n n n
Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil tablets in cases where no other etiology is found n n n n n n n n n n n n .n n n n n n n n n n n n

The most common adverse reaction in adults was dizziness (3%) n n n n n n n n n n n n .n nn n nn n nn n nn
To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare, Inc. at 1-866-941-7875 or n n n n n n n n n n n n or FDA at 1-800-FDA-1088 or n n n n n n n n n n n n .n n n n n n n n n n n n

No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with digoxin or warfarin in healthy volunteers.
The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH)n n n n n n n n n n n n /Mg(OH)n n n n n n n n n n n n ].n nn n nn n nn n nn
Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil and other agents that affect the RAS.
Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes n n n n n n n n n n n n Avoid use of aliskiren with olmesartan medoxomil tablets in patients with renal impairment (GFR <60 ml/min).n nn n nn n nn n nn
Arrayn- Array
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 n n n n n n n n n n n n .n nn n nn n nn n nn
Lithium

NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect n n n n n n n n n n n n .n n n n n n n n n n n n
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia n n n n n n n n n n n n .n n n n n n n n n n n n
Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose n n n n n n n n n n n n .n n n n n n n n n n n n
Lithium: Increases in serum lithium concentrations and lithium toxicity n n n n n n n n n n n n .n n n n n n n n n n n n

No data

Nursing mothers: Choose to discontinue nursing or drug n n n n n n n n n n n n .n n n n n n n n n n n n
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 (n n n n n n n n n n n n , n n n n n n n n n n n n ).n n n n n n n n n n n n
Geriatrics: No overall difference in efficacy or safety vs. younger adult patients, but greater sensitivity of some older individuals cannot be ruled out n n n n n n n n n n n n .n n n n n n n n n n n n

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective ATn n n n n n n n n n n n subtype angiotensin II receptor antagonist.n nn n nn n nn n nn
Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[n n n n n n n n n n n n -(n n n n n n n n n n n n -n n n n n n n n n n n n -tetrazol-5-ylphenyl)benzyl]imidazole-5 carboxylate, cyclic 2,3-carbonate.n nn n nn n nn n nn
Its empirical formula is Cn n n n n n n n n n n n Hn n n n n n n n n n n n Nn n n n n n n n n n n n On n n n n n n n n n n n and its structural formula is:n nn n nn n nn n nn
Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, purified talc, titanium dioxide, and (5 mg only) iron oxide yellow.

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Olmesartan medoxomil tablets USP are supplied as white to off white, oval, biconvex, film coated non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with u201cFS1u201d, u201cFS2u201d or u2018FS3u201d on one side of 5, 20, and 40 mg tablets, respectively and are plain on other side.
NDC: 70518-2127-00
NDC: 70518-2127-01
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 90 in 1 BOTTLE PLASTIC
Storage
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [see USP Controlled Room Temperature].
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Arrayn- Pregnancy:
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762

DRUG: olmesartan medoxomil
GENERIC: olmesartan medoxomil
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-2127-0
NDC: 70518-2127-1
COLOR: white
SHAPE: OVAL
SCORE: No score
SIZE: 15 mm
IMPRINT: FS3
PACKAGING: 90 in 1 BOTTLE, PLASTIC
PACKAGING: 90 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
INACTIVE INGREDIENT(S):

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Olmesartan Medoxomil (Olmesartan Medoxomil)

Trade Name : olmesartan medoxomil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Olmesartan Medoxomil (Olmesartan Medoxomil)

Trade Name : olmesartan medoxomil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

Browse from other international pharmaceuticals

General

US NDC

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