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Aceon (perindopril erbumine)

BOXED WARNING

D/C if pregnancy is detected. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury/death to the developing fetus.

THERAPEUTIC CLASS

ACE inhibitor

DEA CLASS

RX

INDICATIONS

Treatment of essential HTN alone or w/ other antihypertensives (eg, thiazide diuretics). Treatment of stable coronary artery disease (CAD) to reduce risk of cardiovascular mortality or nonfatal MI; may be used w/ conventional treatment for CAD (eg, antiplatelet, antihypertensive, or lipid-lowering therapy).

ADULT DOSAGE

Hypertension

Initial: 4mg qd
Titrate: May titrate prn to max of 16mg/day
Maint: 4-8mg/day given in 1 or 2 divided doses

Stable Coronary Artery Disease

Initial: 4mg qd for 2 weeks
Maint: Increase as tolerated to 8mg qd

DOSING CONSIDERATIONS

Concomitant Medications
Concomitant Diuretics:
Consider reducing diuretic dose prior to start of treatment

Renal Impairment
CrCl <30mL/min: Not recommended

CrCl ≥30mL/min:
Initial: 2mg/day
Max: 8mg/day

Elderly
HTN:
Initial: 4mg/day given in 1 or 2 divided doses
Monitor BP and titrate carefully w/ doses >8mg

>70 Years
Stable CAD:
Initial: 2mg qd in the 1st week, followed by 4mg qd in the 2nd week
Maint: 8mg qd if tolerated

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 2mg*, 4mg*, 8mg* *scored

CONTRAINDICATIONS

Hereditary or idiopathic angioedema. Coadministration w/ aliskiren in patients w/ diabetes.

WARNINGS/PRECAUTIONS

Higher incidence of angioedema in blacks than nonblacks. Angioedema of the face, extremities, lips, tongue, glottis, or larynx reported; d/c and administer appropriate therapy. Intestinal angioedema reported; monitor for abdominal pain. Symptomatic hypotension may occur and is most likely in patients w/ volume/salt depletion. Closely monitor patients at risk for excessive hypotension, especially during the first 2 weeks of treatment and whenever dose is increased. May cause agranulocytosis and bone marrow depression, most frequently in renal impairment patients, especially w/ collagen vascular disease (eg, systemic lupus erythematosus [SLE] or scleroderma). May cause changes in renal function. Oliguria, progressive azotemia, and (rarely) acute renal failure and death may occur in patients w/ severe CHF. May increase BUN and SrCr in patients w/ renal artery stenosis. May cause hyperkalemia; risk factors include renal insufficiency and diabetes mellitus (DM). Persistent nonproductive cough reported. Rarely, associated w/ syndrome that starts w/ cholestatic jaundice and progresses to fulminant necrosis and sometimes death; d/c if jaundice or marked elevations of hepatic enzymes develop. Hypotension may occur w/ major surgery or during anesthesia.

ADVERSE REACTIONS

Cough, headache, asthenia, dizziness, hypotension.

DRUG INTERACTIONS

See Contraindications and Dose modification. Dual blockade of the RAS is associated w/ increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure); avoid combined use of RAS inhibitors, or closely monitor BP, renal function, and electrolytes w/ concomitant agents that affect the RAS. Avoid w/ aliskiren in patients w/ renal impairment (GFR <60mL/min). Hypotension risk, increased BUN and SrCr, and reduced perindoprilat bioavailability w/ diuretics. Increased risk of hyperkalemia w/ K+-sparing diuretics, drugs that increase serum K+ (eg, indomethacin, heparin, cyclosporine), K+ supplements and/or K+-containing salt substitutes. May increase lithium levels and risk of toxicity; monitor lithium levels. Nitritoid reactions reported w/ injectable gold (sodium aurothiomalate). Caution w/ digoxin. Coadministration w/ NSAIDs, including selective COX-2 inhibitors, may attenuate antihypertensive effect of ACE inhibitors and may further deteriorate renal function.

PREGNANCY AND LACTATION

Category D, caution in nursing.

MECHANISM OF ACTION

ACE inhibitor; inhibits ACE activity, resulting in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity, and decreased aldosterone secretion.

PHARMACOKINETICS

Absorption: Absolute bioavailability (75%, 25% perindoprilat); Tmax=1 hr, 3-7 hrs (perindoprilat). Distribution: Plasma protein binding (approx 60%, 10-20% perindoprilat); crosses placenta. Metabolism: Hepatic (extensive); hydrolysis, glucuronidation, cyclization via dehydration; perindoprilat (active metabolite). Elimination: Urine (4-12%, unchanged); T1/2=approx 0.8-1 hr, 3-10 hrs (perindoprilat).

ASSESSMENT

Assess for hereditary or idiopathic angioedema, volume and/or salt depletion, CHF, renal artery stenosis, ischemic heart disease, cerebrovascular disease, hepatic/renal impairment, DM, collagen vascular disease (eg, SLE), previous hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of anaphylactoid reactions, head/neck/intestinal angioedema, hypotension, agranulocytosis, bone marrow depression, cholestatic jaundice, fulminant hepatic necrosis, hepatic failure, hyperkalemia, persistent nonproductive cough, hypersensitivity reactions, and neutropenia. Monitor hepatic/renal function, BP, and K+ levels.

PATIENT COUNSELING

Inform of pregnancy risks and discuss treatment options w/ women planning to become pregnant; advise to report pregnancy to physician as soon as possible. Instruct to d/c and immediately report to physician if any signs/symptoms of angioedema develop. Counsel to report any signs of infection (eg, sore throat, fever).

STORAGE

20-25°C (68-77°F). Protect from moisture.

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