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Azor Generic Name & Formulations
Legal Class
Rx
General Description
Amlodipine (as besylate), olmesartan medoxomil; 5mg/20mg, 10mg/20mg, 5mg/40mg, 10mg/40mg; tabs.
Pharmacological Class
Calcium channel blocker (CCB) + angiotensin II receptor blocker (ARB).
How Supplied
Tabs—30, 90, 100, 1000
Manufacturer
Generic Availability
NO
Azor Indications
Indications
Hypertension.
Azor Dosage and Administration
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.
Azor Contraindications
Contraindications
Concomitant aliskiren in patients with diabetes.
Azor Boxed Warnings
Boxed Warning
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Azor Warnings/Precautions
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: monitor. Nursing mothers: not recommended.
Azor Pharmacokinetics
See Literature
Azor Interactions
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.
Azor Adverse Reactions
Adverse Reactions
Edema, dizziness; headache, hypotension, rash, pruritus, palpitation, urinary frequency, nocturia, hepatic or renal dysfunction, decreased hematocrit, decreased hemoglobin, hyperkalemia (rare).
Azor Clinical Trials
See Literature
Azor Note
Not Applicable
Azor Patient Counseling
See Literature
