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Vasotec (enalapril maleate)

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 HTN, alone or with other antihypertensive agents (eg, thiazide-type diuretics). Treatment of symptomatic CHF, usually in combination with diuretics and digitalis. To decrease the rate of development of overt HF and decrease incidence of hospitalization for HF in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35%).

ADULT DOSAGE

Hypertension

Not Receiving Diuretics:
Initial: 5mg qd
Titrate: Adjust dose according to BP response
Usual Range: 10-40mg/day given in single dose or 2 divided doses

May add diuretic if BP not controlled

Receiving Diuretics:
If possible, d/c diuretic 2-3 days prior to therapy. If BP is not controlled w/ enalapril alone, then diuretic therapy may be resumed
Initial: 2.5mg

Heart Failure

Symptomatic CHF in Combination w/ Diuretics and Digitalis:
Initial: 2.5mg qd
Range: 2.5-20mg bid
Max: 40mg/day in divided doses

Asymptomatic Left Ventricular Dysfunction

Decreasing the Rate of Development of Overt Heart Failure (HF) and the Incidence of Hospitalization for HF in Clinically Stable Patients (Ejection Fraction ≤35%):
Initial: 2.5mg bid
Titrate: Increase as tolerated to 20mg/day (in divided doses)

PEDIATRIC DOSAGE

Hypertension

1 Month-16 Years:
Initial: 0.08mg/kg (up to 5mg) qd
Titrate: Adjust according to BP response
Max: 0.58mg/kg (or 40mg/day)

DOSING CONSIDERATIONS

Renal Impairment
HTN:
CrCl ≤30mL/min:
Initial: 2.5mg qd

Dialysis Patients:
Initial: 2.5mg qd on dialysis days
Titrate: Adjust dose based on BP on nondialysis days

HF:
SrCr >1.6mg/dL:
Initial: 2.5mg/day
Titrate: May increase to 2.5mg bid, then 5mg bid and higher prn, usually at intervals of 4 days or more
Max: 40mg/day

Other Important Considerations
HF:
Hyponatremia (Serum Na+ <130mEq/L):
Initial: 2.5mg/day
Titrate: May increase to 2.5mg bid, then 5mg bid and higher prn, usually at intervals of 4 days or more
Max: 40mg/day

ADMINISTRATION

Oral route

Preparation of Sus (200mL of a 1.0mg/mL Sus)
1. Add 50mL of Bicitra to a polyethylene terephthalate bottle containing ten 20mg tabs; shake for at least 2 min
2. Let concentrate stand for 60 min, then shake for additional 1 min
3. Add 150mL of Ora-Sweet SF to concentrate and shake sus to disperse ingredients
4. Refrigerate at 2-8°C (36-46°F) for 30 days
5. Shake sus before each use

HOW SUPPLIED

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

CONTRAINDICATIONS

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

WARNINGS/PRECAUTIONS

Head/neck angioedema reported; d/c and administer appropriate therapy if angioedema occurs. Higher incidence of angioedema reported in blacks than nonblacks. Intestinal angioedema reported; monitor for abdominal pain. BP effect that is less in blacks than nonblacks reported. Patients with history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema during therapy. Anaphylactoid reactions reported during desensitization with hymenoptera venom, dialysis with high-flux membranes, and LDL apheresis with dextran sulfate absorption. Excessive hypotension sometimes associated with oliguria and/or azotemia and rarely with acute renal failure, or death may occur; monitor during first 2 weeks of therapy and whenever dose of the drug and/or diuretic is increased. Consider dose reduction or d/c therapy or diuretic if symptomatic hypotension occurs. Neutropenia or agranulocytosis and bone marrow depression may occur; monitor WBCs in patients with renal disease and collagen vascular disease. Associated with syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis, and sometimes death; d/c if jaundice or marked elevations of hepatic enzymes develop. Caution with left ventricular outflow obstruction. May cause changes in renal function; may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure or death in severe HF patients whose renal function depends on the renin-angiotensin-aldosterone system. Increases in BUN and SrCr reported with renal artery stenosis; monitor renal function during the 1st few weeks of therapy. Increases in BUN and SrCr reported. Hyperkalemia may occur; caution with diabetes mellitus (DM) and renal insufficiency. Persistent nonproductive cough reported. Hypotension may occur with major surgery or during anesthesia; may be corrected by volume expansion. Avoid in neonates and children with GFR <30mL/min.

ADVERSE REACTIONS

Fatigue, headache, dizziness.

DRUG INTERACTIONS

See Contraindications. Dual blockade of the RAS is associated with increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure); avoid combined use of RAS inhibitors. 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). Hypotension risk and increased BUN and SrCr with diuretics. Coadministration with NSAIDs, including selective COX-2 inhibitors, may decrease antihypertensive effect of ACE inhibitors and may further deteriorate renal function. K+-sparing diuretics, K+-containing salt substitutes, or K+ supplements may increase serum K+ levels; use caution and monitor serum K+ frequently. Avoid K+-sparing agents in patients with HF. Antihypertensives that cause renin release (eg, diuretics) may augment antihypertensive effect. Lithium toxicity reported with lithium; monitor serum lithium levels frequently. Nitritoid reactions reported rarely with injectable gold (eg, sodium aurothiomalate).

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 decreased aldosterone secretion.

PHARMACOKINETICS

Absorption: Tmax=1 hr, 3-4 hrs (metabolite). Distribution: Crosses placenta; found in breast milk. Metabolism: Hydrolysis; enalaprilat (metabolite). Elimination: Urine and feces (94%); T1/2=11 hrs (metabolite).

ASSESSMENT

Assess for history of angioedema, hypersensitivity, volume/salt depletion, renal dysfunction/disease, collagen vascular disease, renal artery stenosis, ischemic heart disease, cerebrovascular disease, left ventricular outflow obstruction, DM, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for hypotension, anaphylactoid reactions, angioedema, and other adverse reactions. Monitor BP, renal/hepatic function, and serum K+ levels. Monitor WBCs periodically in patients with collagen vascular disease and/or renal disease.

PATIENT COUNSELING

Inform of pregnancy risks and instruct to notify physician as possible as soon if pregnant/planning to become pregnant; discuss treatment options in women planning to become pregnant. Instruct to d/c therapy and to immediately report signs/symptoms of angioedema. Caution about lightheadedness, especially during the 1st few days of therapy and advise to report to physician. Instruct to d/c and to consult physician if syncope occurs. Caution that excessive perspiration and dehydration may lead to excessive fall in BP; advise to consult with physician. Advise not to use K+ supplements or salt substitutes containing K+ without consulting physician. Advise patient to report any indication of infection.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

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