Benazepril Hydrochlorothiazide

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and benazepril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and benazepril. You may need to stop using the medicine for a short time.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked. Your blood and urine may also be tested if you have been vomiting or are dehydrated.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Dosage Forms & Strengths

benazepril/hydrochlorothiazide

tablet

• 5mg/6.25mg
• 10mg/12.5mg
• 20mg/12.5mg
• 20mg/25mg

Hypertension

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

Dosage Modifications

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

Renal impairment

• CrCl  ≥30 mL/min: No dosage adjustment
• CrCl  <30 mL/min: Not recommended; loop diuretics preferred

Dosing Considerations

Less effective in African-Americans

Black patients receiving ACE inhibitors have been reported to have higher incidence of angioedema compared to nonblacks

<18 years: Safety and efficacy not established

Benazepril

1-10%

• Cough (1-10%)
• Dizziness (4%)
• Fatigue (2%)
• Headache (6%)
• Nausea (1%)
• Postural dizziness (2%)
• Serum creatinine increased (2%)
• Somnolence (2%)

<1%

• 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

Hydrochlorothiazide

Frequency Not Defined

• Anorexia
• Epigastric distress
• Hypotension
• Orthostatic hypotension
• Photosensitivity

<1%

• 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

Contraindications

Hypersensitivity to either component or sulfonamides

History of hereditary or angioedema associated with or without 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

Bilateral renal artery stenosis or anuria

Do not coadminister with aliskiren in patients with diabetes

Cautions

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

Myelosuppression

Renal impairment may occur

Neutropenia/agranulocytosis reported

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)