benazepril/hydrochlorothiazide (Rx)

Brand and Other Names:Lotensin HCT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

benazepril/hydrochlorothiazide

tablet

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

Administration

Food decreases absorption; manufacturer recommends administering 1 hr before meal

<18 years: Safety/efficacy not established

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Interactions

Interaction Checker

and benazepril/hydrochlorothiazide

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            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
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            Warnings

            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

            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

            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)

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excreted in breast milk, use caution

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Pharmacokinetics

            Benazepril

            • 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

            Hydrochlorothiazide

            • 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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            Formulary

            FormularyPatient Discounts

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            Tier Description
            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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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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