Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: Use not recommended
Hepatic Dose Adjustment
- Hepatic impairment or progressive liver diseases: Use with caution; dose adjustments not defined
See Supplemental Patient Information
- ACE inhibitors can cause fetal/neonatal morbidity/mortality when administered to a pregnant woman [US Black Box Warning]
- Anaphylactoid reactions including head, neck, and intestinal angioedema have been reported in patients receiving ACE inhibitors. Angioedema involving the tongue, glottis, or larynx may lead to airway obstruction and can be fatal. Discontinue therapy and immediately provide emergency treatment such as administration of subcutaneous epinephrine injection 1:1000 (0.3-0.5 mL)
- Life-threatening anaphylactoid reactions have been reported in patients undergoing desensitizing therapy with hymenoptera venom while receiving ACE inhibitors. Patients dialyzed with high-flux membranes and concomitantly treated with an ACE inhibitor and patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption are prone to anaphylactoid reactions
- Agranulocytosis and bone marrow depression have been reported with ACE inhibitor therapy, particularly in patients with renal impairment, especially those who also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Monitor WBC counts in such patients prior to starting treatment and at approximately two-week intervals for about three months, then periodically
- Fosinopril should be used cautiously after an assessment of benefit and risk in patients with collagen vascular disease or who are exposed to other drugs known to affect the white cells or immune response, particularly when there is impaired renal function
- Symptomatic hypotension can occur with fosinopril/hydrochlorothiazide therapy, especially in patients who are volume- and/or salt-depleted or receiving high doses of diuretics. Correct the volume depletion prior to administration of fosinopril/hydrochlorothiazide; if excessive hypotension occurs, place the patient in a supine position and give an intravenous infusion of physiological saline if required
- Closely monitor the infants with histories of in utero exposure to ACE inhibitors for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion
- A syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death has been reported rarely with ACE inhibitors. Discontinue therapy and provide appropriate medical treatment
- Thiazide diuretics may exacerbate or activate systemic lupus erythematosus
- Fosinopril/hydrochlorothiazide should be used cautiously in patients with severe renal disease, as thiazides may precipitate azotemia in such patients
- ACE inhibitors may cause nonproductive cough, possibly due to the inhibition of the degradation of endogenous bradykinin, which resolves on discontinuation of therapy
- Hypertensive patients with renal artery stenosis may experience increases in blood urea nitrogen and serum creatinine with fosinopril therapy; these increases were reversible upon discontinuation of ACE inhibitor therapy or concomitant diuretic therapy. Monitor renal function in these patients during the first few weeks of therapy
- Use fosinopril/hydrochlorothiazide cautiously in patients with impaired hepatic function or progressive liver disease, as minor alterations of fluid and electrolyte balance may precipitate hepatic coma
- Fosinopril monotherapy may cause hyperkalemia; conversely, treatment with thiazide diuretics has been associated with hypokalemia. The opposite effects of fosinopril and hydrochlorothiazide on serum potassium will balance each other in many patients; while, in some patients, one or the other effect may be dominant. Periodically monitor serum electrolytes to detect possible electrolyte imbalance
- Prolonged use of thiazides can cause hypercalcemia, hypophosphatemia, and hypomagnesemia
- As thiazide diuretics tend to reduce glucose tolerance and raise serum levels of cholesterol, triglycerides, and uric acid, it can precipitate frank gout or overt diabetes in susceptible patients
- Elevated BUN and serum creatinine levels were observed during therapy; dosage reduction of fosinopril/hydrochlorothiazide may be required
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Severe congestive heart failure
- CAD
- Diabetes mellitus
- Post-sympathectomy
- Hyponatremia
- Black patients
- Surgery/Anesthesia
- History of gout
- Asthma
- Geriatric patients
Supplemental Patient Information
- Instruct patients to promptly report any signs or symptoms suggesting angioedema to their physicians
- Inform patients that lightheadedness or syncope can occur, particularly during the first days of therapy and should be told to report to the physician
- Advise patients receiving therapy not to use potassium supplements or salt substitutes containing potassium without consulting their physician
- Instruct patients to promptly report any signs or symptoms suggestive of infection, which could be a sign of neutropenia
Pregnancy Category:C (first trimester) and D (second and third trimesters)
Breastfeeding: An alternate drug may be preferred, especially while nursing a newborn or preterm infant, because no information is available on the use of fosinopril during breastfeeding. During lactation, hydrochlorothiazide at a dose of 50 mg daily or less is acceptable. Intense diuresis with large doses may decrease breastmilk production. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 June 2011). As per manufacturer's data, both fosinopril and hydrochlorothiazide are excreted in human milk. Because of the potential for serious adverse reactions from hydrochlorothiazide and fosinopril in nursing infants, a decision should be made whether to discontinue nursing or to discontinue fosinopril/hydrochlorothiazide, analyzing the importance of the drug to the mother.
US Trade Name(s)
US Availability
fosinopril/hydrochlorothiazide (generic)
- TABS:
- 10 mg/12.5 mg
- 20 mg/12.5 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
fosinopril/hydrochlorothiazide (generic)
- TABS:
- 10 mg/12.5 mg
- 20 mg/12.5 mg
Fosetic (fosinopril/hydrochlorothiazide)
Hyforil, Monoplus (fosinopril/hydrochlorothiazide)
- TABS:
- 10 mg/12.5 mg
- 20 mg/12.5 mg
[Outline]
