AZOR Dosage & Rx Info | Uses, Side Effects

Azor Generic Name & Formulations

Legal Class

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

Cosette Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

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

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.

Administration

May be administered with other antihypertensives.

Nursing Considerations

May be administered with other antihypertensives. Patients should be asked to report pregnancies to their physicians as soon as possible.

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

Metabolism

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

Elimination

Renal (primary); fecal.

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