Dosing & Uses
Dosage Forms & Strengths
10 mg/12.5 mg PO qDay initially
Dosage range: 10-80 mg/12.5-50 mg per day PO
Combination therapy indicated for patients whose blood pressure is not adequately controlled with fosinopril or hydrochlorothiazide monotherapy
CrCl < 30 mL/min or serum creatinine ≥ 3 mg/dL: Use not recommended
CrCl ≥ 30 mL/min: Dose adjustment not necessary
Metabolism of active metabolite fosinoprilat will be reduced in progressive liver disease; use caution
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
- 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%)
Frequency Not Defined
- ARF if renal artery stenosis
- Aplastic anemia
- Interstitial nephritis
- 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
Frequency Not Defined
- Epigastric distress
- Orthostatic hypotension
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Hypersensitivity to ACE inhibitors, thiazides or sulfonamides
History of hereditary or angioedema associated with previous ACE inhibitor treatment
Pregnancy (2nd and 3rd trimesters): significant risk of fetal/neonatal morbidity and mortality (due to fosinopril)
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)
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
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 & Lactation
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)
Lactation: enters breast milk; contraindicated
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Competitively inhibits angiotensin-converting enzymes, resulting in decreased plasma angiotensin II concentrations; BP may be reduced in part through decreased vasoconstriction, increased renin activity, and decreased aldosterone secretion; increases renal blood flow
Protein bound: 99.4%
75% present as active fosinoprilat, 20-30% as a glucuronide conjugate of fosinoprilat, and 1-5% as a p-hydroxy metabolite of fosinoprilat
Half-life: 12 hr (fosinoprilat); 14 hr (heart failure)
Total body clearance: 26-39 mL/min
Excretion: 50% urine; 50% feces
Peritoneal dialysis: 7%
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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