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Fosinopril/Hydrochlorothiazide

    DEA Class; Rx

    Common Brand Names; Monopril-HCT

    • ACEI/Diuretic Combos; 
    • ACEI/HCTZ Combos
     

    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

    Indicated for the treatment of hypertension.

    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)

    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

    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 category: B

    Lactation: Drug excreted in breast milk; use with caution (American Academy of Pediatrics states that it is “compatible with nursing”)

    Adults

    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.

    Elderly

    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.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Fosinopril Sodium/Hydrochlorothiazide

    tablet

    • 10mg/12.5mg
    • 20mg/12.5mg