Amlodipine And Olmesartan Medoxomil (Amlodipine And Olmesartan Medoxomil)

Trade Name : AMLODIPINE and OLMESARTAN medoxomil

Macleods Pharmaceuticals Limited

TABLET, FILM COATED

Strength 520 mg/1mg/1

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amlodipine And Olmesartan Medoxomil (Amlodipine And Olmesartan Medoxomil) which is also known as AMLODIPINE and OLMESARTAN medoxomil and Manufactured by Macleods Pharmaceuticals Limited. It is available in strength of 5; 20 mg/1; mg/1 per ml. Read more

Amlodipine And Olmesartan Medoxomil (Amlodipine And 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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Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 11/2016

u2022u00a0When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ().u2022u00a0Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ().n
WARNING: FETAL TOXICITYn
See full prescribing information for complete boxed warning.n

Amlodipine and olmesartan medoxomil 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 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 amlodipine and olmesartan medoxomil tablets.n n
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).n n
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.n n
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.n n
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.n n
Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.n n
Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patientu2019s risk.n n
Data from an 8-week, placebo-controlled, parallel-group factorial study provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10 mg/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.
The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5 mg/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg.n n
For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5 mg/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10 mg/40 mg.
u2022u00a0Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product 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. ().
u2022u00a0Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals ().

The usual starting dose ofu00a0amlodipine and olmesartan medoxomil tablets is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [].
Dosage may be increased after 2 weeks. The maximum recommended dose of amlodipine and olmesartan medoxomil tablets is 10/40 mg.
u2022u00a0Recommended starting dose: 5 mg/20 mg once daily (). u2022u00a0Titrate as needed in two week intervals up to a maximum of 10 mg/40 mg once daily ().

Amlodipine and olmesartan medoxomil tablets are formulated for oral administration in the following strength combinations:
Tablets: (amlodipine/olmesartan medoxomil content) 5 mg/20 mg; 10 mg/20 mg; 5 mg/40 mg; and 10 mg/40 mg ().

Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes n
u2022u00a0Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes ().n

u2022u00a0Hypotension in volume-or salt-depleted patients with treatment initiation may be anticipated. Start treatment under close supervision ().u2022u00a0Increased angina or myocardial infarction may occur upon dosage initiation or increase ().u2022u00a0Impaired renal function: changes in renal function may be anticipated in susceptible individual ().u2022u00a0Sprue-like enteropathy has been reported. Consider discontinuation of amlodipine and olmesartan medoxomil tablets in cases where no other etiology is found ().

Most common adverse reaction (incidence u22653%) is edema ().n n n n n

Amlodipine ():u2022u00a0If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin. u2022u00a0Increased exposure of cyclosporin and tacrolimus. u2022u00a0Increased exposure of amlodipine when coadminstred with CYP3A inhibitors. Olmesartan medoxomil ():u2022u00a0Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect.u2022u00a0Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia.u2022u00a0Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride doseu2022u00a0Lithium: Increases in serum lithium concentrations and lithium toxicity.

u2022u00a0Geriatric: Not recommended for initial therapy in patients u226575 years old () u2022u00a0Hepatic Impariment: Not recommended for initial therapy (n n

There is no information on overdosage with amlodipine and olmesartan medoxomil tablets in humans.
Arrayn- 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.n n
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.n n
Arrayn- Olmesartan medoxomil

Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.n n
The amlodipine besylate component, USP of amlodipine and olmesartan medoxomil tabletsu00a0is chemically described as 3-ethyl-5-methyl (u00b1)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is CHClNOu2022CHOS.n n
Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.n n
The olmesartan medoxomil, USPu00a0component of amlodipine and olmesartan medoxomil tabletsu00a0is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[-(o-1-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is CHNO.n n
The structural formula for amlodipine besylate, USPu00a0is:n n n n n The structural formula for olmesartan medoxomil, USPu00a0is:n n n
Amlodipine and olmesartan medoxomil tablets contains amlodipine besylate, USP a white to off-white crystalline powder, and olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate, USPu00a0is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil, USPu00a0is practically insoluble in water and sparingly soluble in methanol.n n
Each tablet of amlodipine and olmesartan medoxomil tablets also contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, pregelatinized maize starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg tablets), iron oxide red (10 mg/20 mg and 10 mg/40 mg tablets).

No data

Amlodipine
Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.n n
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of amlodipine up to 10 mg/kg/day (about 10 times the MRHD of 10 mg/day on a mg/m basis).n n
in vitro
in vitro
in vitro
in vivo
Fertility of rats was unaffected by administration of olmesartan at dose levels as high as 1000 mg/kg/day (240 times the MRHD) in a study in which dosing was begun 2 (female) or 9 (male) weeks prior to mating.

No data

Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.
Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].

Arrayn- Pregnancy
Manufactured for :n Plainsboro, NJ 08536n n
Manufactured by :n Baddi, Himachal Pradesh, INDIAn n
Revised : January 2017
Trademarks are the property of their respective owners.PM02269203

R OnlyNDC 33342-190-07Amlodipine and Olmesartan Medoxomil Tablets5 mg / 20 mg30 tablets
R OnlyNDC 33342-190-10Amlodipine and Olmesartan Medoxomil Tablets5 mg / 20 mg90 tablets
R OnlyNDC 33342-191-07Amlodipine and Olmesartan Medoxomil Tablets5 mg / 40 mg30 tablets
R OnlyNDC 33342-191-10Amlodipine and Olmesartan Medoxomil Tablets5 mg / 40 mg90 tablets
R OnlyNDC 33342-192-07Amlodipine and Olmesartan Medoxomil Tablets10u00a0mg / 20 mg30 tablets
R OnlyNDC 33342-192-10Amlodipine and Olmesartan Medoxomil Tablets10u00a0mg / 20 mg90 tablets
R OnlyNDC 33342-193-07Amlodipine and Olmesartan Medoxomil Tablets10u00a0mg / 40 mg30 tablets
R OnlyNDC 33342-193-10Amlodipine and Olmesartan Medoxomil Tablets10u00a0mg / 40 mg90 tablets

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Amlodipine And Olmesartan Medoxomil (Amlodipine And Olmesartan Medoxomil)

Trade Name : AMLODIPINE and OLMESARTAN medoxomil

TABLET, FILM COATED

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Amlodipine And Olmesartan Medoxomil (Amlodipine And Olmesartan Medoxomil)

Trade Name : AMLODIPINE and OLMESARTAN medoxomil

TABLET, FILM COATED

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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)

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