benazepril/amlodipine (Rx)

Brand and Other Names:Lotrel
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

benazepril/amlodipine

capsule

  • 10mg/2.5mg
  • 10mg/5mg
  • 20mg/5mg
  • 20mg/10mg
  • 40mg/5mg
  • 40mg/10mg
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Hypertension

1 tablet (2.5-10 mg amlodipine; 10-40mg benazepril) PO qDay; titrate with appropriate dosage combination to control BP; not to exceed 10 mg/day amlodipine, 80 mg/day benazepril

Dosage Modifications

Renal impairment: Decrease dose if CrCl <30 mL/min, severe liver impairment, or coadministered with diuretic

Hepatic impairment: 2.5 mg based on amlodipine initially

Safety and efficacy not established

The recommended initial dose of amlodipine in elderly patients is 2.5 mg

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Interactions

Interaction Checker

and benazepril/amlodipine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Amlodipine

            • Peripheral edema (2-15%)
            • Pulmonary edema (7-15%)

            Benazepril

            • None indicated

            1-10%

            Amlodipine

            • Abdominal pain (1.6%)
            • Dizziness (1.1-3.4%)
            • Dyspepsia (1-2%)
            • Fatigue (4.5%)
            • Flushing (0.7-2.6%)
            • Headache (7.3%)
            • Male sexual dysfunction (1-2%)
            • Muscle cramps (1-2%)
            • Nausea (2.9%)
            • Palpitation (0.7-4.5%)
            • Rash (1-2%)
            • Somnolence (1-2%)
            • Weakness (1-2%)

            Benazepril

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

            Postmarketing Reports

            Amlodipine

            • Gingival hyperplasia
            • Tachycardia
            • Jaundice
            • Hepatic enzyme elevations
            • Diplopia
            • Gynecomastia
            • Cholestasis
            • Acute interstitial nephritis
            • Depression
            • Leukopenia

            Benazepril

            • Stevens-Johnson syndrome
            • Pancreatitis
            • Hemolytic anemia
            • Pemphigus
            • Thrombocytopenia
            • Arthralgia
            • ECG changes
            • Gastritis
            • Flushing
            • Hemolytic anemia
            • Neutropenia
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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

            History of angioedema with or without previous ACE inhibitor therapy

            Hereditary or idiopathic angioedema

            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

            Concomitant use with Aliskiren in patients with diabetes mellitus

            Cautions

            Use with caution in CHF

            Use with caution in patients with aortic stenosis, ischemic heart disease or cerebrovascular disease

            Use with caution in patients with unstented unilateral/bilateral renal artery stenosis; avoid use due to elevated risk of deterioration in renal function

            Persistent, progressive dermatologic reactions

            Exacerbation of angina (during initiation of treatment, after dose increase, or withdrawal of beta blocker)

            Use caution in hepatic impairment (may require lower starting dose)

            Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia

            Risk of hyperkalemia, especially with renal impairment or DM or in patients taking concomitant K+-elevating drugs; assess for hypotension and hyperkalemia

            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 with monotherapy; most patients receiving combination of two renin-angiotensin system (RAS) inhibitors do not obtain additional benefit compared to monotherapy; in general, avoid combined use of RAS inhibitors

            Black patients receiving ACE inhibitors have higher incidence of angioedema compared with nonblacks

            Titrate slowly with hepatic impairment; amlodipine extensively metabolized by liver (half-life is 56 hr with hepatic impairment)

            Rare reports of cholestatic hepatitis and acute liver failure (some fatal)

            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

            Myocardial infarction or increased angina in patients with obstructive coronary artery disease may occur

            Avoid with severe renal impairment (ie, CrCl <30 mL/min); avoid in patients with severe heart failure, whose renal function may depend on the activity of the renin-angiotensin-aldosterone system; treatment with ACE inhibitor causes oliguria or progressive azotemia and (rarely) with acute renal failure and/or death

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            Pregnancy & Lactation

            Pregnancy category: D

            Lactation: Minimal amounts of benazepril enters milk, but excretion of amlodipine is not known; not recommended

            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

            Amlodipine: Ca channel blocker; inhibits the transmembrane influx of extracellular Ca ions across the membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations, resulting in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating the main coronary and systemic arteries

            Benazepril: Competitively inhibits angiotensin-converting enzymes, resulting in decreased plasma angiotensin II concentrations; consequently, blood pressure may be reduced in part through decreased vasoconstriction, increased renin activity, and decreased aldosterone secretion

            Absorption

            Bioavailability: Benazepril (37%); amlodipine (64-90%)

            Peak plasma time: Benazepril (0.5-2 hr); amlodipine (6-12 hr)

            Distribution

            Protein bound: >90% for each component

            Vd: Benazepril (0.7 L/kg); amlodipine (21 L/kg)

            Metabolism

            Benazepril by hepatic metabolism to active metabolite (benazeprilat)

            Amlodipine is extensively metabolized in liver

            Elimination

            Half-life, elimination: Benazeprilat (10-11 hr); amlodipine (~48 hr)

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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.
            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.
            Code Definition
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