Dosing & Uses
Dosage Forms & Strengths
Not for initial therapy
If BP not controlled with benazepril monotherapy: Initiate with 10 mg/12.5 mg OR 20 mg/12.5 mg PO qDay
Increase either or both components based on clinical response
Do not increase hydrochlorothiazide component more often than q2-3 wk
Controlled on hydrochorothiazide 25 mg/day with significant potassium loss: Initiate with 5 mg/6.25 mg
Hepatic impairment: Dosage adjustment not required
Lower doses may be required in geriatric patients
- CrCl ≥30 mL/min: No dosage adjustment
- CrCl <30 mL/min: Not recommended; loop diuretics preferred
Less effective in African-Americans
Black patients receiving ACE inhibitors have been reported to have higher incidence of angioedema compared to nonblacks
Food decreases absorption; manufacturer recommends administering 1 hr before meal
<18 years: Safety/efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
- Cough (1-10%)
- Dizziness (4%)
- Fatigue (2%)
- Headache (6%)
- Nausea (1%)
- Postural dizziness (2%)
- Serum creatinine increased (2%)
- Somnolence (2%)
- Angioedema, ARF if renal artery stenosis, neutropenia, photosensitivity, agranulocytosis,alopecia, anaphylactoid reaction, angina, angioedema, arthralgia, arthritis, asthma, dermatitis, dyspnea, ECG changes,eosinophilia, flushing, gastritis, hemolytic anemia, hyperglycemia, hyperkalemia, hyponatremia, hypotension, impotence, insomnia, leukopenia, neutropenia, palpitations,pancreatitis, postural hypotension, proteinuria, rash, Stevens-Johnson syndrome, syncope, thrombocytopenia, transaminases increased, uric acid increased, vomiting
Frequency Not Defined
- Epigastric distress
- Orthostatic hypotension
- Anaphylaxis, anemia, confusion, dizziness, erythema multiforme skin reactions including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, fatigue, hypomagnesemia, hyponatremia, hypochloremia, headache, hypercalcemia, hyperuricemia, hyperglycemia, hyperlipidemia, hypercholesterolemia, muscle weakness or cramps, nausea, purpura, rash, vertigo, vomiting
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 either component or sulfonamides
History of hereditary or angioedema associated with or without previous ACE inhibitor treatment
Bilateral renal artery stenosis or anuria
Do not coadminister with aliskiren in patients with diabetes
Pregnancy (2nd and 3rd trimesters): significant risk of fetal and neonatal morbidity and mortality
Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia
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
Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with Lotensin HCT should be discontinued and appropriate therapy instituted immediately
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
DM, fluid or electrolyte imbalance, hyperuricemia or gout, SLE, liver disease, renal disease
May aggravate digitalis toxicity
Sensitivity reactions may occur with or without history of allergy or asthma
Biliary cirrhosis or biliary obstruction
Renal impairment may occur
Cough may occur within the first few months
Cholestatic jaundice may occur
Risk of male sexual dysfunction
Avoid concomitant use with lithium
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Pregnancy & Lactation
Pregnancy Category: D
Lactation: excreted in breast milk, use caution
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
Benazepril/hydrochlorothiazide is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, benazepril, and a thiazide diuretic, hydrochlorothiazide
Benazepril prevents the conversion of angiotensin I to angiotensin II (a potent vasoconstrictor) through inhibition of ACE by competing with physiologic substrate (angiotensin I) for active site of ACE; inhibition of ACE initially results in decreased plasma angiotensin II concentrations & consequently, blood pressure may be reduced in part through decreased vasoconstriction, increased renin activity, & decreased aldosterone secretion
Hydrochlorothiazide is a thiazide diuretic that inhibits Na reabsorption in distal renal tubules resulting in increased excretion of Na+ and water, also K+ and H+ ions
- Half-Life: 10-11 hr
- Bioavailability: 37%
- Onset: 1-2 hr following 2-20 mg dose
- Duration: 24 hr following 2-20 mg dose
- Vd: 8.7 L
- Peak Plasma Time: 0.5-1 hr
- Protein Bound: 95-97%
- Metabolism: Primarily liver
- Metabolites: Benazeprilat (active)
- Clearance: Mostly renal
- Excretion: Mostly urine (32%); bile (11-12%)
- Dialyzable: Minimally
- Half-Life: 6-15 hr
- Bioavailability: 70%
- Onset: 2 hr (diuresis); 4-6 hr (peak effect)
- Duration: 6-12 hr (diuresis); 1 wk (HTN)
- Vd: 3.6-7.8 L/kg
- Peak Plasma:1.5-2.5 hr
- Protein Bound: 68%
- Metabolism: Minimally metabolized
- Clearance: 335 mL/min
- Excretion: Urine 50-70%
- Dialyzable: No
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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.|
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