Amlodipine And Olmesartan Medoxomil (Amlodipine And Olmesartan Medoxomil)

Trade Name : Amlodipine and Olmesartan Medoxomil

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 520 mg/1mg/1

Storage and handling for Amlodipine and Olmesartan Medoxomil

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 Teva Pharmaceuticals USA, Inc.. 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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WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

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

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.
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.
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.
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.
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.
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.

Amlodipine 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. ().
Amlodipine 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 of amlodipine and olmesartan medoxomil tablets is 5 mg/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10 mg/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 mg/40 mg.

Recommended starting dose: 5 mg/20 mg once daily ().
Titrate 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 coadminister aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [].

Do not coadminister aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes ().

The 10 mg/20 mg amlodipine and olmesartan medoxomil tablets contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Hypotension in volume- or salt-depleted patients with treatment initiation may be anticipated. Start treatment under close supervision ().
Increased angina or myocardial infarction may occur upon dosage initiation or increase ().
Impaired renal function: changes in renal function may be anticipated in susceptible individual ().
Sprue-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 u2265 3%) is edema ().
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or .

Amlodipine ():
Olmesartan medoxomil ():

No data

Geriatric: Not recommended for initial therapy in patients u2265 75 years old ()
Hepatic Impairment: Not recommended for initial therapy ()

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.
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.
Arrayn- Olmesartan medoxomil.

Amlodipine and olmesartan medoxomil is provided as a tablet for oral administration and is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.
The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets is chemically described as 3-Ethyl 5-methyl (u00b1)-2-[(2-aminoethoxy)methyl]-4-(-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate.
Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.
The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil 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.
The structural formula for amlodipine besylate, USP is:
CHClNOu2022CHOS M.W. 567.1
The structural formula for olmesartan medoxomil, USP is:
CHNO M.W. 558.59
Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP a white to off-white crystalline powder. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.
Each amlodipine and olmesartan medoxomil tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. Additionally, the 5 mg/40 mg strength contains iron oxide black, iron oxide red, and iron oxide yellow; the 10 mg/20 mg strength contains FD&C yellow #5 tartrazine aluminum lake, FD&C yellow #6 sunset yellow FCF aluminum lake, and iron oxide yellow; and the 10 mg/40 mg strength contains FD&C red #40 allura red aluminum lake, FD&C yellow #6 sunset yellow FCF aluminum lake, and iron oxide red.

No data

Amlodipine.
Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.
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).
Olmesartan medoxomil.
Both olmesartan medoxomil and olmesartan tested negative in the Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames (bacterial mutagenicity) test. However, both were shown to induce chromosomal aberrations in cultured cells (Chinese hamster lung) and tested positive for thymidine kinase mutations in the mouse lymphoma assay. Olmesartan medoxomil tested negative for mutations in the MutaMouse intestine and kidney and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2000 mg/kg (olmesartan not tested).
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 are supplied for oral administration and contain amlodipine besylate, USP at a dose equivalent to 5 mg or 10 mg amlodipine and olmesartan medoxomil, USP in the strengths described below.
5 mg/20 mg: White, film-coated, modified capsule shaped tablet, debossed with u201cTVu201d on one side of the tablet and with u201c7027u201d on the other side of the tablet, in bottles of 30 (NDC 0093-7027-56) and 90 (NDC 0093-7027-98).
5 mg/40 mg: Light-yellow to yellow, film-coated, modified capsule shaped tablet, debossed with u201cTEVAu201d on one side of the tablet and with u201c7028u201d on the other side of the tablet, in bottles of 30 (NDC 0093-7028-56) and 90 (NDC 0093-7028-98).
10 mg/20 mg: Light-orange to orange, film-coated, modified capsule shaped tablet, debossed with u201cTEVAu201d on one side of the tablet and with u201c7029u201d on the other side of the tablet, in bottles of 30 (NDC 0093-7029-56) and 90 (NDC 0093-7029-98).
10 mg/40 mg: Red-brown, film-coated, modified capsule shaped tablet, debossed with u201cTEVAu201d on one side of the tablet and with u201c7030u201d on the other side of the tablet, in bottles of 30 (NDC 0093-7030-56) and 90 (NDC 0093-7030-98).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Arrayn- Pregnancy:
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. C 1/2017

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