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Altace (ramipril)

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, alone or in combination with thiazide diuretics. To reduce risk of MI, stroke, or death from cardiovascular (CV) causes in patients ≥55 yrs of age at high risk of developing a major CV event due to history of coronary artery disease, stroke, peripheral vascular disease, or diabetes with at least 1 other CV risk factor. For use in stable patients who have demonstrated signs of CHF within the 1st few days after sustaining acute MI.

ADULT DOSAGE

Hypertension

Not Receiving a Diuretic:
Initial: 2.5mg qd
Titrate: Adjust dose according to BP response
Maint: 2.5-20mg/day as single dose or in 2 equally divided doses
May add diuretic if BP is not controlled

Risk Reduction of Myocardial Infarction, Stroke, Cardiovascular Death

≥55 Years:
Initial: 2.5mg qd for 1 week
Titrate: Increase to 5mg qd for next 3 weeks, then increase as tolerated
Maint: 10mg qd
May be given as a divided dose if hypertensive or recently post-MI

Congestive Heart Failure Post-Myocardial Infarction

Initial: 2.5mg bid or may switch to 1.25mg bid if hypotensive at this dose
Titrate: If tolerated, increase to 5mg bid at 3-week intervals after 1 week of initial dose
After initial dose, observe for at least 2 hrs and until BP has stabilized for at least an additional hr

DOSING CONSIDERATIONS

Renal Impairment
CrCl ≤40mL/min:
HTN:
Initial: 1.25mg qd
Titrate: May increase dosage until BP is controlled
Max: 5mg/day

CHF Post MI:
Initial: 1.25mg qd
Titrate: May increase to 1.25mg bid
Max: 2.5mg bid

Other Important Considerations
Renal Artery Stenosis/Volume Depletion (eg, Past and Current Diuretic Use):
Initial: 1.25mg qd
Titrate: Adjust dosage according to BP response

ADMINISTRATION

Oral route

Swallow whole
May sprinkle contents on a small amount (about 4 oz) of applesauce or mix in 4 oz (120mL) of water or apple juice
Consume mixture in its entirety
May pre-prepare and store described mixtures for up to 24 hrs at room temperature or up to 48 hrs under refrigeration

HOW SUPPLIED

Cap: 1.25mg, 2.5mg, 5mg, 10mg

CONTRAINDICATIONS

History of ACE inhibitor-associated angioedema. Coadministration with aliskiren in patients with diabetes.

WARNINGS/PRECAUTIONS

Increased risk of angioedema in patients with history of angioedema unrelated to ACE inhibitor therapy. Head/neck angioedema reported; d/c and institute appropriate therapy if laryngeal stridor or angioedema of the face, tongue, or glottis occurs. Higher rate of angioedema in blacks than nonblacks. Intestinal angioedema reported; monitor for abdominal pain. Anaphylactoid reactions reported during desensitization with hymenoptera venom, dialysis with high-flux membranes, and LDL apheresis with dextran sulfate absorption. Rarely, associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death; d/c if jaundice or marked hepatic enzyme elevations develop. May cause changes in renal function. Excessive hypotension associated with oliguria or azotemia and, rarely, with acute renal failure and death may occur in patients with CHF; closely monitor during first 2 weeks of therapy and whenever the dose is increased. Increases in BUN and SrCr may occur in hypertensive patients with renal artery stenosis or without preexisting renal vascular disease; dosage reduction of therapy and/or discontinuation of diuretic may be required. Agranulocytosis, pancytopenia, bone marrow depression, and mild reductions in RBC count and Hgb content, blood cell, or platelet counts may occur; consider monitoring WBCs in patients with collagen vascular disease (eg, systemic lupus erythematosus, scleroderma), especially with renal impairment. Symptomatic hypotension may occur and is most likely in patients with volume and/or salt depletion; correct depletion prior to therapy. Hypotension may occur with surgery or during anesthesia. Hyperkalemia reported; risk factors include renal insufficiency and diabetes mellitus (DM). Persistent nonproductive cough reported.

ADVERSE REACTIONS

Hypotension, cough increased, dizziness, angina pectoris, headache, asthenia, fatigue.

DRUG INTERACTIONS

See Contraindications. 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). Hypotension risk, and increased BUN and SrCr with diuretics. Increased risk of hyperkalemia with K+-sparing diuretics, K+ supplements, and/or K+-containing salt substitutes; use with caution and frequently monitor serum K+. Not recommended with telmisartan; increased risk of renal dysfunction. Increased lithium levels and symptoms of lithium toxicity reported; frequently monitor serum lithium levels. Diuretics may further increase risk of lithium toxicity. Nitritoid reactions reported rarely with injectable gold (sodium aurothiomalate). Coadministration with NSAIDs, including selective COX-2 inhibitors, may deteriorate renal function and attenuate antihypertensive effect. Increased risk for angioedema with mammalian target of rapamycin inhibitor (eg, temsirolimus).

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: Absolute bioavailability (28%, 44% ramiprilat); Tmax=1 hr, 2-4 hrs (ramiprilat). Distribution: Plasma protein binding (73%, 56% ramiprilat); crosses placenta; found in breast milk. Metabolism: Cleavage of ester group (primarily in the liver); ramiprilat (active metabolite). Elimination: Urine (60%, <2% unchanged), feces (40%); T1/2>50 hrs (ramiprilat), 13-17 hrs (multiple daily doses, ramiprilat).

ASSESSMENT

Assess for history of angioedema, CHF, renal artery stenosis, collagen vascular disease, volume/salt depletion, DM, hepatic impairment, hypersensitivity to drug, pregnancy/nursing status, and possible drug interactions. Obtain baseline renal function.

MONITORING

Monitor for signs/symptoms of angioedema, abdominal pain, anaphylactoid reactions, jaundice, hypotension, hyperkalemia, cough, and other adverse reactions. Consider monitoring WBCs in patients with collagen vascular disease, especially with renal impairment. Monitor BP and renal/hepatic function.

PATIENT COUNSELING

Instruct to d/c therapy and to immediately report any signs/symptoms of angioedema. Advise to promptly report any indication of infection. Instruct to report lightheadedness, especially during 1st days of therapy; advise to d/c and consult with a physician if syncope occurs. Inform that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting may lead to an excessive fall in BP, with the same consequences of lightheadedness and possible syncope. Inform females of childbearing age about the consequences of exposure during pregnancy and discuss treatment options in women planning to become pregnant; instruct to report pregnancy to physician as soon as possible. Advise not to use salt substitutes containing K+ without consulting physician.

STORAGE

15-30°C (59-86°F). Pre-prepared Mixtures: Up to 24 hrs at room temperature or up to 48 hrs under refrigeration.

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