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Zestril (lisinopril)

BOXED WARNING

D/C when 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 HTN in adult and pediatric patients ≥6 yrs of age alone or with other antihypertensive agents. To reduce signs and symptoms of systolic heart failure (HF). Reduction of mortality in treatment of hemodynamically stable patients within 24 hrs of acute myocardial infarction (AMI).

ADULT DOSAGE

Hypertension

Initial: 10mg qd
Titrate: Adjust dose according to BP response
Usual Range: 20-40mg qd
Max: 80mg

May add a low-dose diuretic if BP is not controlled

Heart Failure

Reduce Signs and Symptoms of Systolic Heart Failure (HF):
Adjunct w/ Diuretics and (Usually) Digitalis:

Initial: 5mg qd
Titrate: Increase as tolerated
Max: 40mg qd

Diuretic dose may need to be adjusted to help minimize hypovolemia

Acute Myocardial Infarction

Reduction of Mortality in Hemodynamically Stable Patients w/in 24 Hrs of Acute MI (AMI):
5mg w/in 24 hrs of onset of symptoms, followed by 5mg after 24 hrs, 10mg after 48 hrs, and then 10mg qd for at least 6 weeks

PEDIATRIC DOSAGE

Hypertension

≥6 Years:
GFR >30mL/min:

Initial: 0.07mg/kg qd (up to 5mg total)
Titrate: Adjust dose according to BP response
Max: 0.61mg/kg (up to 40mg) qd

DOSING CONSIDERATIONS

Concomitant Medications
HTN:
Initial Dose w/ Diuretics: 5mg qd

Renal Impairment
CrCl 10-30mL/min: Reduce initial dose to 1/2 the usual recommended dose (eg, HTN, 5mg; systolic HF/AMI, 2.5mg)
Up titrate as tolerated to a max of 40mg qd
Hemodialysis or CrCl <10mL/min:
Initial: 2.5mg qd

Other Important Considerations
HF:
W/ Hyponatremia (Serum Na+ <130mEq/L):
Initial: 2.5mg qd

Reduction of Mortality in AMI:
Low Systolic BP (SBP) (>100-120mmHg) During First 3 Days After Infarct:
Initial: 2.5mg
Maint: 5mg qd w/ temporary reductions to 2.5mg if needed, if SBP ≤100mmHg occurs
D/C if SBP <90mmHg for >1 hr occurs

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 2.5mg, 5mg*, 10mg, 20mg, 30mg, 40mg *scored

CONTRAINDICATIONS

History of ACE inhibitor-associated angioedema, hereditary or idiopathic angioedema. Coadministration with aliskiren in patients with diabetes.

WARNINGS/PRECAUTIONS

Not recommended in pediatric patients with GFR <30mL/min. Head/neck angioedema reported; d/c promptly and administer appropriate therapy. Intestinal angioedema reported; monitor for abdominal pain. Patients with history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema during therapy. Less effect on BP and more reports of angioedema in blacks than nonblacks. Anaphylactoid reactions reported during desensitization with hymenoptera venom, dialysis with high-flux membranes, and LDL apheresis with dextran sulfate absorption. May cause changes in renal function, including acute renal failure, especially in patients whose renal function depends on the RAS system; consider withholding or discontinuing therapy if a clinically significant decrease in renal function develops. May cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death; closely monitor patients at risk of excessive hypotension during first 2 weeks of treatment and whenever therapy and/or diuretic dose is increased. Symptomatic hypotension may occur in patients with severe aortic stenosis or hypertrophic cardiomyopathy. Increases in BUN and SrCr with renal artery stenosis reported. Hypotension may occur with major surgery or during anesthesia. Hyperkalemia reported. Associated with syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis, and sometimes death; d/c if jaundice or marked hepatic enzyme elevations occur.

ADVERSE REACTIONS

Dizziness, headache, hypotension, hyperkalemia, syncope, increased creatinine/BUN.

DRUG INTERACTIONS

See Contraindications. Hypotension risk and increased BUN and SrCr with diuretics. Increased hypoglycemic risk with insulin or oral hypoglycemics. NSAIDs, including selective COX-2 inhibitors, may cause deterioration of renal function. Antihypertensive effect may be attenuated by NSAIDs. Dual blockade of the RAS is associated with 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 with concomitant agents that also affect the RAS. Avoid with aliskiren in patients with renal impairment (GFR <60mL/min). Increased risk of hyperkalemia with K+-sparing diuretics, K+-containing salt substitutes, or K+ supplements; monitor serum K+ periodically. Lithium toxicity reported; monitor serum lithium levels during concurrent use. Nitritoid reactions reported with injectable gold.

PREGNANCY AND LACTATION

Category D, not for use in nursing.

MECHANISM OF ACTION

ACE inhibitor; decreases plasma angiotensin II, which leads to decreased vasopressor activity and aldosterone secretion.

PHARMACOKINETICS

Absorption: Tmax=7 hrs (adults), 6 hrs (pediatric patients). Elimination: Urine (unchanged); T1/2=12 hrs.

ASSESSMENT

Assess for hypersensitivity to the drug, history of ACE inhibitor-associated angioedema, hereditary/idiopathic angioedema, risk factors for hyperkalemia, risk for excessive hypotension, severe aortic stenosis or hypertrophic cardiomyopathy, renal impairment, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for angioedema, anaphylactoid reactions, and other adverse reactions. Monitor BP, LFTs, serum K+, and renal function.

PATIENT COUNSELING

Inform of pregnancy risks and discuss treatment options for women planning to become pregnant; instruct to report pregnancy to physician as soon as possible. Instruct to immediately report signs/symptoms of angioedema and to avoid drug until they have consulted with prescribing physician. Instruct to report lightheadedness, especially during 1st few days of therapy; if syncope occurs, advise to d/c therapy until physician is consulted. Advise that excessive perspiration, dehydration, and other causes of volume depletion may lead to excessive fall in BP; instruct to consult with a physician. Advise not to use salt substitutes containing K+ without consulting physician. Advise diabetic patients treated with oral antidiabetic agents or insulin to closely monitor for hypoglycemia, especially during the 1st month of combined use. Instruct to report promptly any indication of infection, which may be a sign of leukopenia/neutropenia.

STORAGE

20-25°C (68-77°F). Protect from moisture, freezing, and excessive heat.

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