azilsartan medoxomil potassium: clinical use

Prescribing considerations

• Licensed for essential hypertension in adults; not indicated for people under 18 years.
• Correct significant volume or salt depletion and assess hypotension risk before initiation.
• Use caution where renal function depends on the renin–angiotensin system, including severe renal impairment, renal artery stenosis or heart failure.
• Use is not recommended in severe hepatic impairment or primary hyperaldosteronism; experience after recent kidney transplantation is lacking.
• Use particular caution with aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, or ischaemic cardiac or cerebrovascular disease.
• Dual renin–angiotensin system blockade is generally not recommended and, if exceptionally necessary, requires specialist supervision.

Contraindications and cautions

• Hypersensitivity to azilsartan medoxomil or an excipient.
• Second or third trimester of pregnancy.
• Use with an aliskiren-containing product in diabetes mellitus or renal impairment with GFR below 60 mL/min/1.73 m².

Monitoring

• Check blood pressure, renal function, serum potassium and sodium before treatment.
• Recheck renal function and electrolytes after initiation or treatment changes, and sooner in people at increased risk.
• Continue periodic renal-function and electrolyte monitoring once stable; increase monitoring during acute illness or when interacting medicines are introduced.
• Investigate clinically important creatinine rises, declining eGFR, hyperkalaemia or symptomatic hypotension, including volume depletion and interacting medicines such as NSAIDs.

Clinical pharmacology

Azilsartan medoxomil is rapidly hydrolysed to active azilsartan, a selective AT1-receptor antagonist. It blocks angiotensin II-mediated vasoconstriction, aldosterone release and renal sodium reabsorption. Food does not materially affect azilsartan bioavailability, and the active compound is highly protein-bound.

Formulation and product differences

• The selected products are white, round oral tablets; tablet size and debossed markings distinguish the available strengths.
• The tablets contain azilsartan medoxomil as the potassium salt and are essentially sodium-free.
• Store in the original package to protect from light and moisture.