ALTACE Rx

Indications for ALTACE:

Treatment of CHF in stabilized patients after MI, to reduce mortality, hospitalizations, and progression to severe/resistant heart failure.

Adult:

Swallow whole or may open caps and sprinkle contents on applesauce or mix in 4oz of water or apple juice, then consume entire mixture. Adjust at 3-week intervals. Initially 2.5mg twice daily, if hypotension occurs may reduce to 1.25mg twice daily; usual maintenance: 5mg twice daily. CrCl <40mL/min: initially 1.25mg once daily; may increase up to max 2.5mg twice daily. If volume depletion or renal artery stenosis present: initially 1.25mg once daily; adjust according to BP response.

Children:

Not established.

Contraindications:

History of ACEI-associated angioedema. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril): avoid within 36hrs of switching to or from sacubitril/valsartan.

Boxed Warning:

Fetal toxicity.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Discontinue if angioedema or laryngeal stridor occurs. Renal or hepatic impairment (discontinue if jaundice or marked increases in hepatic enzymes occur). Severe CHF. Dialysis (esp. high-flux membrane). Monitor WBCs in collagen vascular disease. Correct salt/volume depletion prior to initiation. Monitor renal function in severe CHF, hypertension, or renal artery stenosis. Monitor for hyperkalemia in diabetes or renal insufficiency. Surgery. Black patients: increased risk of angioedema, possibly less effective. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Pharmacological Class:

ACE inhibitor.

Interactions:

See Contraindications. Concomitant telmisartan: not recommended. Concomitant K+ supplements, K+-sparing diuretics, K+-containing salt substitutes may cause hyperkalemia; monitor serum levels. Excessive hypotension with diuretics (reduce diuretic dose if possible). May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors; monitor renal function periodically in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor BP, renal function and electrolytes closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Increased risk of angioedema with concomitant mTOR inhibitor (eg, temsirolimus) or neprilysin inhibitor. Monitor serum lithium. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Adverse Reactions:

Hypotension, cough, dizziness, angina, nausea, vomiting, diarrhea, postural hypotension, syncope, vertigo, hyperkalemia, oliguria, azotemia; rare: neutropenia, agranulocytosis (monitor).

How Supplied:

Caps—100

Indications for ALTACE:

Hypertension, alone or in combination with thiazide diuretics. To reduce risk of MI, stroke, or death from cardiovascular causes in high-risk patients ≥55yrs old (see full labeling).

Adult:

Swallow whole or may open caps and sprinkle contents on applesauce or mix in 4oz of water or apple juice, then consume entire mixture. Hypertension: initially 2.5mg once daily; maintenance: 2.5–20mg daily in single or 2 divided doses. May add a diuretic if BP is not controlled. Cardiovascular risk reduction: initially 2.5mg once daily for 1 week, then 5mg once daily for 3 weeks; maintenance 10mg once daily or in 2 divided doses. For both: (CrCl <40mL/min): 1.25mg once daily; max 5mg/day. If volume depletion or renal artery stenosis present: initially 1.25mg once daily; adjust according to BP response.

Children:

Not established.

Contraindications:

History of ACEI-associated angioedema. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril): avoid within 36hrs of switching to or from sacubitril/valsartan.

Boxed Warning:

Fetal toxicity.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Discontinue if angioedema or laryngeal stridor occurs. Renal or hepatic impairment (discontinue if jaundice or marked increases in hepatic enzymes occur). Severe CHF. Dialysis (esp. high-flux membrane). Monitor WBCs in collagen vascular disease. Correct salt/volume depletion prior to initiation. Monitor renal function in severe CHF, hypertension, or renal artery stenosis. Monitor for hyperkalemia in diabetes or renal insufficiency. Surgery. Black patients: increased risk of angioedema, possibly less effective. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Pharmacological Class:

ACE inhibitor.

Interactions:

See Contraindications. Concomitant telmisartan: not recommended. Concomitant K+ supplements, K+-sparing diuretics, K+-containing salt substitutes may cause hyperkalemia; monitor serum levels. Excessive hypotension with diuretics (reduce diuretic dose if possible). May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors; monitor renal function periodically in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor BP, renal function and electrolytes closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Increased risk of angioedema with concomitant mTOR inhibitor (eg, temsirolimus) or neprilysin inhibitor. Monitor serum lithium. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Adverse Reactions:

Headache, dizziness, fatigue, cough, hypotension, hyperkalemia; rare: neutropenia, agranulocytosis (monitor).

How Supplied:

Caps—100