Azilsartan Medoxomil

Indications

Hypertension, alone or in combination w/ other antihypertensive agents.

Adult Dose

Adult: Initially 40 mg once daily. May be increased to a max of 80 mg once daily as necessary.

Renal Dose

Renal Impairment No dose adjustment is required with mild-to-severe renal impairment or end-stage renal disease. Patients with moderate-to-severe renal impairment are more likely to report high serum creatinine values.

Elderly Dose

No dose adjustment is necessary in elderly patients Abnormally high serum creatinine values were more likely to be reported for patients aged 75 or older Hypertension 80 mg PO once daily Coadministration with high-dose diuretics: 40 mg PO once daily

Hepatic Dose

Hepatic Impairment Dose adjustment not necessary with mild-to-moderate hepatic impairment; monitor in severe impairment (data not available)

Administration

May be taken with or without food.

Contra Indications

Hypersensitivity. Pregnancy.

Precautions

Abnormally high serum creatinine values more likely reported in patients aged 75 or older Caution with hyperkalemia NSAIDs may attenuate antihypertensive response Coadministration with NSAIDs increase risk of renal impairment including acute renal failure Hypotension in volume- or salt-depleted patients In patients with an activated renin-angiotensin system, such as volume-and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment Impaired renal function As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals receiving therapy In patients whose renal function may depend on activity of renin-angiotensin system (eg, patients with severe congestive heart failure, renal artery stenosis, or volume depletion) Monitoring Parameters Monitor for worsening renal function in patients with renal impairment. Monitoring Monitor closely in mild to moderate hepatic impairment (limited information available).

Pregnancy-Lactation

C+D Pregnancy Category: C (1st trimester); D (2nd and 3rd trimesters) Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death Lactation: unknown whether distributed in breast milk, decide on alternate antihypertensive therapy or do not breastfeed

Interactions

In patients who are elderly, volume-depleted (including those on diuretic therapy), or who have compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, may result in deterioration of renal function, including possible acute renal failure; these effects are usually reversible Monitor renal function periodically in patients receiving azilsartan and NSAID therapy; the antihypertensive effect of angiotensin II receptor antagonists may be attenuated by NSAIDs, including selective COX-2 inhibitors Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy Most patients receiving combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; in general, avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function and electrolytes in patients receiving therapy and other agents that affect the RAS Do not coadminister aliskiren with azilsartan in patients with diabetes; avoid use of aliskiren with azilsartan in patients with renal impairment (GFR <60 mL/min) Contraindicated (2) aliskiren sparsentan Serious - Use Alternative (14) aliskiren benazepril captopril enalapril fosinopril lisinopril lithium lofexidine moexipril perindopril potassium phosphates, IV quinapril ramipril trandolapril

Adverse Effects

1-10% Diarrhea (2%) <1% Nausea,Asthenia,Fatigue,Muscle spasm,Dizziness,Postural hypotension,Cough

Mechanism of Action

Angiotensin II blocker; displaces angiotensin II from AT1 receptor and may lower blood pressure by antagonizing AT1-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water absorption, and hypertrophic responses. May induce more complete inhibition of renin-angiotensin system compared with ACE inhibitors; does not affect response to bradykinin. Inhibits the pressor effects of an angiotensin II infusion in a dose-related manner.