Amlodipine besylate; olmesartan medoxomil

What is Amlodipine besylate; olmesartan medoxomil?

Amlodipine besylate; olmesartan medoxomil (Azor) is a combination of amlodipine besylate, a dihydropyridine calcium channel blocker, and olmesartan medoxomil, an angiotensin II receptor blocker used to treat high blood pressure.

• Azor may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Amlodipine

Olmesartan

What are the uses of this medicine?

• Amlodipine besylate; olmesartan medoxomil (Azor) is used 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 (CV) events, primarily strokes and myocardial infarctions.

How does this medicine work?

• Azor 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 Azor inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, and the olmesartan medoxomil component of Azor blocks the vasoconstrictor effects of angiotensin II.

Amlodipine:

• Amlodipine (am loe' di peen) belongs to the dihydropyridine class of calcium channel blockers and is used in the treatment of both hypertension and angina pectoris.
• Like other calcium channel blockers, amlodipine acts by blocking the influx of calcium ions into vascular smooth muscle and cardiac muscle cells during membrane depolarization.
• This action causes relaxation of vascular and arterial smooth muscle cells, resulting in arterial vasodilation and a decrease in cardiac work and oxygen consumption.

Olmesartan: Olmesartan (ol" me sar' tan) is an angiotensin II receptor blocker (ARB) used alone or in combination of other agents for therapy of hypertension. Olmesartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its antihypertensive activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• diabetes who use aliskiren.

What drug interactions can this medicine cause?

Amlodipine drug interactions:

• If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin.
• Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.
• Increased exposure of amlodipine when coadministered with CYP3A inhibitors.

Olmesartan medoxomil drug interactions:

• Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect.
• 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.
• Do not co-administer aliskiren with Azor in patients with diabetes.
• Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose.
• Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including AZOR.

Is this medicine FDA approved?

• The patent is held by Daiichi Sankyo Pharmaceuticals.
• Daiichi Sankyo filed a supplemental New Drug Application (sNDA) for Azor with the United States Food and Drug Administration on September 17, 2008.

How should this medicine be used?

Recommended dosage:

• The usual starting dose of Azor 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg

This medicine is available in fallowing brand namesː

• Azor

What side effects can this medication cause?

The most common side effects of this medicine include:

• edema

What special precautions should I follow?

• Anticipate hypotension in volume- or salt-depleted patients with treatment initiation. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
• Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
• Changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system.
• Patients with hepatic impairment have decreased clearance of amlodipine. The lowest dose of Azor is 5/20 mg; therefore, initial therapy with Azor is not recommended in hepatically impaired patients.
• Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Consider discontinuation of Azor in cases where no other etiology is identified.
• Azor contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.
• Azor can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue Azor as soon as possible.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no information on overdosage with Azor in humans.

Amlodipine overdose may cause:

• peripheral vasodilation
• hypotension
• tachycardia

Management of overdosage:

• If massive overdose should occur, active cardiac and respiratory monitoring should be instituted.
• Frequent blood pressure measurements are essential.
• 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 overdose may cause:

• hypotension
• tachycardia
• bradycardia

Management of overdose:

• If symptomatic hypotension should occur, supportive treatment should be initiated.
• The dialyzability of olmesartan is unknown.

Can this medicine be used in pregnancy?

• Azor can cause fetal harm when administered to a pregnant woman.
• 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.
• When pregnancy is detected, discontinue Azor as soon as possible.
• Consider alternative antihypertensive therapy during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Azor in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• AMLODIPINE BESYLATE
• OLMESARTAN MEDOXOMIL

Inactive ingredients:

• MICROCRYSTALLINE CELLULOSE
• STARCH, CORN
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• POLYVINYL ALCOHOL, UNSPECIFIED
• POLYETHYLENE GLYCOL
• TITANIUM DIOXIDE
• TALC

Who manufactures and distributes this medicine?

• Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ
• Manufactured by Daiichi Sankyo Europe GmbH, Germany

What should I know about storage and disposal of this medication?

• Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF).

• Dailymed label info on Amlodipine besylate; olmesartan medoxomil
• FDA Amlodipine besylate; olmesartan medoxomil

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