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Amlodipine besylate and Olmesartran medoxomil

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Overview

What is Amlodipine besylate and Olmesartran medoxomil?

Amlodipine and olmesartan medoxomil tablets 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.

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

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

The olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet is chemically described as 2,3dihydroxy-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. 

The structural formula for amlodipine besylate is:

The structural formula for olmesartan medoxomil is

Amlodipine and olmesartan medoxomil tablet contains amlodipine besylate, a white or almost white powder, and olmesartan medoxomil, white to off-white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is freely soluble in methanol, sparingly soluble in alcohol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil is sparingly soluble in methanol, practically insoluble in water.

Each amlodipine and olmesartan medoxomil tablet also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (5/40 mg, 10/20 mg and 10/40 mg tablets), and iron oxide black (5/40 mg, 10/20 mg and 10/40 mg tablets).



What does Amlodipine besylate and Olmesartran medoxomil look like?



What are the available doses of Amlodipine besylate and Olmesartran medoxomil?

Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg; 10/20 mg; 5/40 mg; and 10/40 mg (3).

What should I talk to my health care provider before I take Amlodipine besylate and Olmesartran medoxomil?

• Geriatric: Not recommended for initial therapy in patients ≥75 years old (8.5) • Hepatic Impairment: Not recommended for initial therapy (8.6)

How should I use Amlodipine besylate and Olmesartran medoxomil?

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 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. 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 patient’s risk.

Data from an 8-week, placebo-controlled, parallel-group factorial study see Clinical Studies (14.1) 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. 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.

  

The usual starting dose of amlodipine and olmesartan medoxomil tablet  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 tablet is 10/40 mg.


What interacts with Amlodipine besylate and Olmesartran medoxomil?

Sorry No Records found


What are the warnings of Amlodipine besylate and Olmesartran medoxomil?

Sorry No Records found


What are the precautions of Amlodipine besylate and Olmesartran medoxomil?

Sorry No Records found


What are the side effects of Amlodipine besylate and Olmesartran medoxomil?

Sorry No records found


What should I look out for while using Amlodipine besylate and Olmesartran medoxomil?

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

 


What might happen if I take too much Amlodipine besylate and Olmesartran medoxomil?

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

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.

Olmesartan medoxomil.


How should I store and handle Amlodipine besylate and Olmesartran medoxomil?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Amlodipine and Olmesartan Medoxomil Tablets are supplied as follows:5 mg/20 mg: Bottles of 30                                                      NDC# 46708-212-30                          Bottles of 90                                                      NDC# 46708-212-90Bottles of 1000                                                  NDC# 46708-212-915 mg/40 mg: Bottles of 30                                                      NDC# 46708-213-30                          Bottles of 90                                                      NDC# 46708-213-90Bottles of 1000                                                  NDC# 46708-213-9110 mg/20 mg: Bottles of 30                                                       NDC# 46708-214-30                          Bottles of 90                                                       NDC# 46708-214-90Bottles of 1000                                                   NDC# 46708-214-9110 mg/40 mg: Bottles of 30                                                        NDC# 46708-215-30                          Bottles of 90                                                        NDC# 46708-215-90Bottles of 1000                                                    NDC# 46708-215-91Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Amlodipine and Olmesartan Medoxomil Tablets.

Amlodipine and olmesartan medoxomil tablet is a combination of two antihypertensive drugs: a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), amlodipine besylate, and an angiotensin II receptor blocker, olmesartan medoxomil. The amlodipine component of amlodipine and olmesartan medoxomil tablet inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, and the olmesartan medoxomil component of amlodipine and olmesartan medoxomil tablet blocks the vasoconstrictor effects of angiotensin II.

 

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.

 

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 AT receptor 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. ACE 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.

Non-Clinical Toxicology
Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes s).

 

Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.

Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.

During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of levonorgestrel and ethinyl estradiol tablets. If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.

Some substances may increase plasma ethinyl estradiol concentrations. These include:

Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see ).

Pregnancy 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 amlodipine and olmesartan medoxomil tablets as soon as possible

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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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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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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).