Adult Dosing

Hypertension

Initial therapy

• Start: 5 mg/20 mg PO qd
• Increase after 1-2 wks to max. 10/40 mg PO qd PRN

Add-On therapy

• For patients not adequately controlled on amlodipine or olmesartan
• Max: 10 mg/40 mg PO qd

Replacement therapy

• May be substituted for individually titrated components. When substituting for individual components, the dose of one or both components can be increased if BP control is not satisfactory
• Max: 10 mg/40 mg PO qd

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Hypertension, alone or with other antihypertensive agents
• Initial therapy with other antihypertensive agents to maintain BP

• Hypersensitivity to any of the ingredients of the product
• Pregnancy (Third trimester)
• Concomitant use with angiotensin receptor blockers (ARBs) or ACE inhibitors (ACEIs) in patients with diabetes

• If pregnancy is detected during the therapy, suspend the drug as early as possible
• It can cause injury or death to the developing fetus when used during second or third trimester of pregnancy

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Initial therapy is not recommended

See Supplemental Patient Information

• If pregnancy is detected during the therapy, suspend the drug as early as possible [US Black Box warning]
• It can cause injury or death to the developing fetus when used during second or third trimester of pregnancy [US Black Box warning]
• Symptomatic hypotension has been reported after administration of olmesartan medoxomil especially in volume or salt-depleted patients. Monitor closely for hypotension and place in supine position and give intravenous normal saline infusion to the patient if hypotension occurs
• Use with caution in patients with severe aortic stenosis as acute hypotension has been reported with amlodipine therapy
• Amlodipine may develop increased frequency, duration, or severity of angina or acute myocardial infarction particularly in patients with severe obstructive coronary artery disease
• Amlodipine and olmesartan used in combination may decrease hemoglobin and hematocrit count
• Intestinal problems (ie, sprue-like enteropathy) reported; symptoms may include severe, chronic diarrhea with substantial weight loss, hence consider discontinuation of therapy in cases where no other etiology is identified

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Severe aortic stenosis
• Renal artery stenosis
• CHF
• Severe CAD
• Post-MI
• Elderly patients (75 yrs)

Supplemental Patient Information

• Female patients of childbearing age should be warned about the effects of the drug on the fetus; discuss other treatment options with female patients planning to become pregnant

Pregnancy Category:C (First trimester); D (Second and third trimester )

Breastfeeding: Safety unknown; prefer an alternative drug during breastfeeding as appropriate literature on the use of amlodipine as well as olmesartan is unavailable. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 December 2010). According to the manufacturer data, it is not known whether amlodipine or olmesartan are excreted in human milk, but olmesartan is secreted at low concentration in rat milk, decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

• CV: Severe hypotension, angina exacerbation, myocardial infarction, palpitations, orthostatic hypotension
• CNS: Dizziness, somnolence, asthenia
• GU: Renal impairment/failure, fetal/neonatal harm or death, frequent micturition, nocturia
• GI: Jaundice, elevated hepatic enzymes
• METABOLIC: Hyperkalemia
• DERM: Rash, pruritus, flushing
• MISC: Edema, asthenia, agioedema

Amlodipine

• Calcium channel blocker; inhibits the transmembrane influx of calcium ions into coronary vascular smooth muscle and cardiac muscle
• Absolute bioavailability: 64-90%
• Extensively metabolized by liver
• Excreted in urine as 60% metabolite, 10% unchanged
• Half life: 30-50 hrs; 56 hrs in impaired hepatic function

Olmesartan

• Angiotensin II receptor antagonist; blocks vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle
• Bioavailability: Approx. 26%
• Excreted in urine 35-50%, bile/feces
• Half life: Apprx. 13 hrs

US Trade Name(s)

• Azor

US Availability

Azor (amlodipine/olmesartan)

• TABS:
• 5 mg/20 mg
• 5 mg/40 mg
• 10 mg/20 mg
• 10 mg/40 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Sevikar

UK Availability

Sevikar (amlodipine/atorvastatin)

• TABS:
• 5 mg/20 mg
• 5 mg/40 mg
• 10 mg/40 mg

Australian Trade Name(s)

• Sevikar

Australian Availability

Sevikar (amlodipine/atorvastatin)

• TABS:
• 5 mg/20 mg
• 5 mg/40 mg
• 10 mg/40 mg

[Outline]

Cardiovascular

Antihypertensive Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Azor 10-20 MG TABS [Bottle] (SANKYO)
  30 mg = $117.76
  90 mg = $340.05
• Azor 5-20 MG TABS [Bottle] (SANKYO)
  30 mg = $121.06
  90 mg = $349.97
• Azor 10-40 MG TABS [Bottle] (SANKYO)
  90 mg = $442.99
  270 mg = $1299.02
• Azor 5-40 MG TABS [Bottle] (SANKYO)
  30 mg = $154.35
  90 mg = $450.93

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.