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AZOR
Hypertension
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Drug Name:

AZOR Rx

Generic Name and Formulations:
Amlodipine (as besylate), olmesartan medoxomil; 5mg/20mg, 10mg/20mg, 5mg/40mg, 10mg/40mg; tabs.

Company:
Daiichi Sankyo

Therapeutic Use:

Indications for AZOR :

Hypertension.

Adult:

Individualize. Initially 5/20mg once daily; may increase after 1–2 weeks up to max 10/40mg daily. ≥75yrs or hepatic impairment: initial therapy not recommended.

Children:

Not established.

Contraindications:

Concomitant aliskiren in patients with diabetes.

Boxed Warning:

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Volume/salt depleted. Severe obstructive coronary disease. Severe aortic stenosis. Severe hepatic or renal impairment. Renal artery stenosis. Consider discontinuing if sprue-like enteropathy develops and no other etiology is identified. Monitor electrolytes periodically. Elderly (may need lower initial dose of amlodipine). Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Pharmacological Class:

Calcium channel blocker (CCB) + angiotensin II receptor blocker (ARB).

Interactions:

See Contraindications. Potentiates simvastatin; limit simvastatin dose to 20mg/day. May potentiate cyclosporine, tacrolimus, lithium; monitor levels. Potentiated by CYP3A4 inhibitors; may need dose reduction. Antagonized by NSAIDs (including selective COX-2 inhibitors); may impair renal function (monitor). Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Consider taking at least 4hrs before colesevelam HCl dose. Monitor BP with CYP3A4 inducers.

Adverse Reactions:

Edema, dizziness; headache, hypotension, rash, pruritus, palpitation, urinary frequency, nocturia, hepatic or renal dysfunction, decreased hematocrit, decreased hemoglobin, hyperkalemia (rare).

Metabolism:

Amlodipine: hepatic; 93% protein bound. Olmesartan: 99% protein bound.

Elimination:

Renal (primary); fecal.

Generic Availability:

NO

How Supplied:

Tabs—30, 90, 100, 1000


Data provided by MPR.

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