Classes
DEA Class; Rx
Common Brand Names; Monopril
- ACE Inhibitors
Description
Oral ACE inhibitor; prodrug metabolized to active fosinoprilat; used once daily or in divided doses for both HTN and CHF; also has been used post-MI, but not FDA-approved; does not require dosage adjustment in renal failure, hepatic impairment, or dialysis.
Indications
Indicated for the treatment of hypertension
Contraindications
Hypersensitivity
History of hereditary or angioedema associated with previous ACE inhibitor treatment
Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan
Bilateral renal artery stenosis
Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)
Adverse Effects
- Dizziness (1.6-11.9%)
- Cough (2.2-9.7%)
- Headache (3.2%)
- Hyperkalemia (2.6%)
- Diarrhea (2.2%)
- Orthostatic hypotension (1.4-1.9%)
- Fatigue (1-2%)
- Angioedema
- ARF if renal artery stenosis
- Aplastic anemia
- Neutropenia
- Arthralgia
- Interstitial nephritis
- Vasculitis
- Rash
Warnings
Renal impairment, hepatic impairment, volume depletion, electrolyte abnormalities
Risk of hyperkalemia, especially with renal impairment, DM, or those taking concomitant K+-elevating drugs
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
ACE inhibition also causes increased bradykinin levels which putatively mediates angioedema
Coadministration with mTOR inhibitors (eg, temsirolimus) may increased risk for angioedema
Discontinue STAT if pregnant (see Contraindications and Black Box Warnings)
Less effective in blacks
Renal impairment may occur
Neutropenia/agranulocytosis reported
Cough may occur within the first few months
Cholestatic jaundice may occur
Use caution in severe aortic stenosis
Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia
Pregnancy and Lactation
Pregnancy Category: D
Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
Lactation: excreted in breast milk; not recommended
Maximum Dosage
80 mg/day PO for hypertension; 40 mg/day PO for heart failure.
80 mg/day PO for hypertension; 40 mg/day PO for heart failure.
40 mg/day PO for hypertension.
6 to 12 years: 40 mg/day PO for hypertension.
1 to 5 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fosinopril
tablet
- 10mg
- 20mg
- 40mg