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Amlodipine Besylate And Olmesartan Medoxomil (Amlodipine Besylate And Olmesartan Medoxomil)

Trade Name : Amlodipine besylate and Olmesartan medoxomil

Ajanta Pharma Limited

TABLET

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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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 Amlodipine Besylate And Olmesartan Medoxomil (Amlodipine Besylate And Olmesartan Medoxomil) which is also known as Amlodipine besylate and Olmesartan medoxomil and Manufactured by Ajanta Pharma Limited. It is available in strength of 5; 20 mg/1; mg/1 per ml. Read more

Amlodipine Besylate And Olmesartan Medoxomil (Amlodipine Besylate 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 11/2016
  • WARNING: FETAL TOXICITYu00a0
  • When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ().u00a0
  • 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.n Data from an 8-week, placebo-controlled, parallel-group factorial studyu00a0 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 10/40 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.n n n n n n n n
  • 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 5/20 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 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.
  • Amlodipine and olmesartanu00a0 medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and 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 ().n
  • The usual starting dose of amlodipine 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.n
  • Recommended starting dose: 5/20 mg once daily ().
  • Titrate as needed in two week intervals up to a maximum of 10/40 mg once daily ().
  • Amlodipine u00a0and olmesartan medoxomil tablets are formulated for oral administration in the u00a0following strength combinations:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • u00a0u00a0
  • Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg; 10/20 mg; 5/40 mg; and 10/40 mg .
  • Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes n n n n
  • Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes .
  • No data
  • 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 ().n n
  • Most common adverse reaction (incidence u22653%) is edema . n n n n
  • Amlodipine ():
  • Olmesartan medoxomil ():
  • No data
  • Geriatric: Not recommended for initial therapy in patients u226575 years old ()
  • Hepatic Impariment: Not recommended for initial therapy ()
  • There is no information on overdosage with amlodipine and olmesartan medoxomil tablets in humans.n n Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths.Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/mbasis) caused a marked peripheral vasodilation and hypotension.n 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 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 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 should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown.
  • Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USPu00a0and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.n The amlodipine besylate, USPu00a0component of amlodipine and olmesartan medoxomil tablets is 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 Olmesartan medoxomil, USPu00a0a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.n The olmesartan medoxomil, USPu00a0component 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. Its empirical formula is CHNO.n The structural formula for amlodipine besylate, USPu00a0is:
  • The structural formula for olmesartan medoxomil, USPu00a0is:
  • Amlodipine and olmesartan medoxomil tablets contains amlodipine besylate, USPu00a0a white or almost white powder, and olmesartan medoxomil, USPu00a0white to off-white crystalline powder. The molecular weights of amlodipine besylate, USPu00a0and olmesartan medoxomil, USPu00a0are 567.1 and 558.59, respectively. Amlodipine besylate, USPu00a0is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USPu00a0is practically insoluble in water and sparingly soluble in methanol.n Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets).
  • No data
  • No data
  • No data
  • Amlodipine and olmesartan medoxomil tablets contain amlodipine besylate, USPu00a0at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil, USPu00a0in the strengths described below.n 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 25u00b0C (77u00b0F); excursions permitted to 15u00b0C-30u00b0C (59u00b0F-86u00b0F) [see USP Controlled Room Temperature].
  • Arrayn- Pregnancy:
  • Marketed by:n n n n Bridgewater, NJ 08807.
  • Manufactured by:n n n n B-4/5/6, MIDC Area, Paithan 431 148, India.
  • Revised 11/2019
  • No data

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