Classes
DEA Class; Rx
Common Brand Names; Monopril-HCT
- ACEI/Diuretic Combos;
- ACEI/HCTZ Combos
Description
Oral combination of an angiotensin-converting enzyme inhibitor and a thiazide diuretic
Used for the treatment of hypertension
More effective than fosinopril monotherapy in Black patients
Indications
Indicated for the treatment of hypertension.
Contraindications
Hypersensitivity to ACE inhibitors, thiazides or sulfonamides
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
Anuria or 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
Fosinopril
- 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
Hydrochlorothiazide
- Anaphylaxis, anemia, confusion, erythema multiforme skin reactions including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, hypomagnesemia, hyponatremia, hypochloremia, dizziness, fatigue, headache, hypercalcemia, hyperuricemia, hyperglycemia, hyperlipidemia, hypercholesterolemia, muscle weakness or cramps, nausea, purpura, rash, vertigo, vomiting
- Anorexia
- Epigastric distress
- Hypotension
- Orthostatic hypotension
- Photosensitivity
Warnings
Begin combination therapy only after failed monotherapy
Severe renal impairment, hepatic impairment
Risk of hypotension, especially with CHF
Coadministration with mTOR inhibitors (eg, temsirolimus) may increased risk for angioedema
Renal impairment may occur
Neutropenia/agranulocytosis reported
Cough may occur within the first few months
Cholestatic jaundice may occur
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
Pregnancy and Lactation
Pregnancy category: B
Lactation: Drug excreted in breast milk; use with caution (American Academy of Pediatrics states that it is “compatible with nursing”)
Maximum Dosage
80 mg/day PO for fosinopril monotherapy and 50 mg/day PO for hydrochlorothiazide monotherapy. However, patients generally require lower doses of fosinopril and HCTZ when given in combination.
80 mg/day PO for fosinopril monotherapy and 50 mg/day PO for hydrochlorothiazide monotherapy. However, patients generally require lower doses of fosinopril and HCTZ when given in combination.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fosinopril Sodium/Hydrochlorothiazide
tablet
- 10mg/12.5mg
- 20mg/12.5mg