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SOLCO HEALTHCAR
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43547033650

benazepril hcl 10 mg tablet (generic lotesin)

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Uses

Benazepril hydrochloride is used alone or in combination with other classes of antihypertensive agents (e.g., thiazide diuretics) in the management of hypertension.

Because captopril, another angiotensin-converting enzyme (ACE) inhibitor, may cause serious adverse effects (e.g., neutropenia, agranulocytosis), particularly in patients with renal impairment (especially those with collagen vascular disease) or in patients receiving immunosuppressive therapy, the possibility that similar adverse effects may occur with benazepril should be considered since current evidence is insufficient to rule out such risk.)

Hypertension

Benazepril is used alone or in combination with other classes of antihypertensive agents in the management of hypertension. ACE inhibitors are considered one of several preferred antihypertensive drugs for the initial management of hypertension; other options include angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics. While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes. ACE inhibitors may be particularly useful in the management of hypertension in patients with certain coexisting conditions such as heart failure, ischemic heart disease, diabetes mellitus, chronic kidney disease, or cerebrovascular disease or following myocardial infarction. and in

In general, black hypertensive patients tend to respond better to monotherapy with thiazide diuretics or calcium-channel blockers than to monotherapy with ACE inhibitors. Although ACE inhibitors have lowered blood pressure in all races studied, monotherapy with these agents has produced a smaller reduction in blood pressure in black hypertensive patients, a population associated with low renin hypertension; however, this population difference in response does not appear to occur during combined therapy with an ACE inhibitor and a thiazide diuretic or calcium-channel blocker. In addition, ACE inhibitors appear to produce a higher incidence of angioedema in black patients than in other races. (See Race under Hypertension: Other Special Considerations for Antihypertensive Therapy, in and in .)

For additional information on the role of ACE inhibitors in the management of hypertension, and in .

Heart Failure

ACE inhibitors have been used in the management of heart failure, usually in conjunction with other agents such as cardiac glycosides, diuretics, and β-adrenergic blocking agents (β-blockers).

Current guidelines for the management of heart failure in adults generally recommend a combination of drug therapies to reduce morbidity and mortality, including neurohormonal antagonists (e.g., ACE inhibitors, angiotensin II receptor antagonists, angiotensin receptor-neprilysin inhibitors [ARNIs], β-blockers, aldosterone receptor antagonists) that inhibit the detrimental compensatory mechanisms in heart failure. Additional agents (e.g., cardiac glycosides, diuretics, sinoatrial modulators [i.e., ivabradine]) added to a heart failure treatment regimen in selected patients have been associated with symptomatic improvement and/or reduction in heart failure-related hospitalizations. Experts recommend that all asymptomatic patients with reduced left ventricular ejection fraction (LVEF) (American College of Cardiology Foundation [ACCF]/American Heart Association [AHA] stage B heart failure) receive therapy with an ACE inhibitor and β-blocker to prevent symptomatic heart failure and to reduce morbidity and mortality. If ACE inhibitors are not tolerated, then an angiotensin II receptor antagonist is recommended as alternative therapy. In patients with prior or current symptoms of chronic heart failure with reduced LVEF (ACCF/AHA stage C heart failure), ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend inhibition of the renin-angiotensin-aldosterone (RAA) system with an ACE inhibitor, angiotensin II receptor antagonist, or ARNI in conjunction with a β-blocker, and an aldosterone antagonist in selected patients, to reduce morbidity and mortality. While ACE inhibitors have been the preferred drugs for inhibition of the RAA system because of their established benefits in patients with heart failure and reduced ejection fraction, some evidence indicates that therapy with sacubitril/valsartan, an ARNI, may be more effective than ACE inhibitor therapy (enalapril) in reducing cardiovascular death and heart failure-related hospitalization in such patients. ACCF, AHA, and HFSA recommend that patients with chronic symptomatic heart failure and reduced LVEF (New York Heart Association [NYHA] class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality. However, in patients in whom an ARNI is not appropriate, continued use of an ACE inhibitor for all classes of heart failure with reduced ejection fraction remains strongly advised. In patients in whom an ARNI or ACE inhibitor is not appropriate, an angiotensin II receptor antagonist may be used. For additional information on the use of ACE inhibitors in the management of heart failure, see Uses: Heart Failure, in and in .

Diabetic Nephropathy

Both ACE inhibitors and angiotensin II receptor antagonists have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria, and use of a drug from either class is recommended in such patients with modestly elevated (30-300 mg/24 hours) or higher (exceeding 300 mg/24 hours) levels of urinary albumin excretion. The usual precautions of ACE inhibitor or angiotensin II receptor antagonist therapy in patients with substantial renal impairment should be observed. For additional information on the use of ACE inhibitors in the treatment of diabetic nephropathy, see

Dosage and Administration

Administration

Benazepril hydrochloride is administered orally.

For adult or pediatric patients unable to swallow tablets or those children for whom the daily dose does not correspond exactly to the strength of commercially available tablets, benazepril hydrochloride may be administered orally as an extemporaneously prepared suspension.

An extemporaneous suspension containing benazepril hydrochloride 2 mg/mL can be prepared in the following manner. First, 75 mL of suspending vehicle (Ora-Plus) is added to an amber polyethylene terephthalate (PET) bottle containing fifteen 20-mg tablets of benazepril hydrochloride, and the contents are shaken for at least 2 minutes. The concentrated suspension should be allowed to stand for at least 60 minutes following reconstitution, and then should be shaken for an additional minute. The concentrated suspension of benazepril hydrochloride should be diluted with 75 mL of syrup (Ora-Sweet), and the container then shaken to disperse the ingredients. The suspension should be shaken before dispensing each dose. The extemporaneous suspension is stable for 30 days when stored at 2-8°C.

Dosage

Dosage of benazepril hydrochloride must be adjusted according to patient tolerance and response. Because of the risk of inducing hypotension, initiation of benazepril therapy requires consideration of recent antihypertensive therapy, the extent of blood pressure elevation, sodium intake, fluid status, and other clinical circumstances. If therapy is initiated in a patient already receiving a diuretic, symptomatic hypotension may occur following the initial dose of the angiotensin-converting enzyme (ACE) inhibitor. To minimize the possibility of hypotension, especially in patients in whom diuretic therapy was recently initiated, it is recommended that diuretic therapy be discontinued, if possible, 2-3 days before initiating benazepril. If blood pressure is not controlled adequately with the ACE inhibitor alone, diuretic therapy may be resumed cautiously. If diuretic therapy cannot be discontinued, sodium intake can be increased prior to initiating benazepril to minimize the risk of hypotension, and benazepril should be initiated under close medical supervision at a dose of 5 mg in adults to determine the magnitude of hypotensive effect. Dosage also should be adjusted carefully under close medical supervision in patients with heart failure, with or without associated renal impairment, because of the risk of hypotension; such patients should be followed closely for at least 2 weeks after initiation of benazepril or diuretic therapy or dosage adjustment of either drug. Hypotension does not preclude the administration of subsequent doses of benazepril-containing therapy, provided the hypotension has been managed effectively.

Hypertension

Benazepril Therapy

For the management of hypertension in adults not receiving a diuretic, the usual initial dosage of benazepril hydrochloride is 10 mg once daily. In patients currently receiving a diuretic, an initial benazepril hydrochloride dosage of 5 mg daily is recommended; however, discontinuance of the diuretic is preferred.(See the introductory discussion under Dosage and Administration: Dosage.) Dosage of the drug should be adjusted according to the patient's peak (2-6 hours after dosing) and trough blood pressure responses. If the blood pressure response diminishes toward the end of the dosing interval during once-daily administration, increasing the dosage or giving the drug in divided doses daily should be considered.

The usual maintenance dosage in adults is 20-40 mg daily, given as a single dose or in 2 divided doses daily. Higher dosages (i.e., 80 mg daily) reportedly have resulted in increased response; however, experience with such dosages has been limited. The safety and efficacy of dosages exceeding 80 mg daily have not been established. If blood pressure is not controlled with benazepril alone, a second antihypertensive agent (e.g., diuretic) may be added.

For the management of hypertension in children 6 years of age or older, the usual initial dosage of benazepril hydrochloride is 0.2 mg/kg (up to 10 mg) once daily. Dosage may be adjusted until the desired blood pressure goal is achieved. The safety and efficacy of dosages exceeding 0.6 mg/kg or in excess of 40 mg daily have not been established.

The panel members appointed to the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8 expert panel) state that evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) should be used when available to determine target dosages of antihypertensive agents. Target dosages of antihypertensive agents generally can be achieved within 2-4 weeks, but it may take up to several months.

Antihypertensive therapy should be titrated until goal blood pressure is achieved. If an adequate blood pressure response is not achieved with benazepril monotherapy, another antihypertensive agent with demonstrated benefit may be added; if goal blood pressure is still not achieved with the use of 2 antihypertensive agents at optimal dosages, a third drug may be added. In patients who experience intolerable adverse effects with benazepril, dosage reduction should be considered; if adverse effects worsen or fail to resolve, it may be necessary to discontinue the ACE inhibitor and initiate another class of antihypertensive agent.

Benazepril/Amlodipine Fixed-combination Therapy

The manufacturer states that therapy with the commercially available preparations containing benazepril hydrochloride in fixed combination with amlodipine should only be initiated in adults after an adequate response is not achieved with benazepril (or another ACE inhibitor) or amlodipine (or another dihydropyridine-derivative calcium-channel blocking agent) alone. Alternatively, such fixed combinations may be used if amlodipine dosages necessary for adequate response have been associated with development of edema. The fixed combination containing benazepril with amlodipine also may be used in patients who have been receiving the drugs separately, provided that the optimum dosage corresponds to the ratio in the commercial fixed-combination preparation. Dosage of the fixed combination containing benazepril and amlodipine should be adjusted according to the patient's response; it should be taken into consideration that steady-state plasma concentrations of benazepril and amlodipine are reached after approximately 2 and 7 days of initiating therapy, respectively. The addition of benazepril to amlodipine therapy usually does not provide additional antihypertensive effects in black patients; however, benazepril appears to reduce the development of amlodipine-associated edema regardless of race. To avoid an excessive antihypertensive response in patients maintained on amlodipine monotherapy, the dosage of amlodipine usually should be reduced in nonblack patients when benazepril therapy is initiated. The manufacturer states that when the fixed combinations containing 2.5-10 mg of amlodipine with 10-40 mg of benazepril hydrochloride have been used, the antihypertensive effects of these combinations have increased with increasing dosages of amlodipine regardless of race; in addition, antihypertensive effects increased with increasing dosages of benazepril in nonblack patients. In geriatric patients and small, frail individuals, preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage (2.5 mg daily) of amlodipine.

Benazepril/Hydrochlorothiazide Fixed-combination Therapy

The manufacturers state that therapy with the commercially available preparations containing benazepril hydrochloride in fixed combination with hydrochlorothiazide should only be initiated in adults after an adequate response is not achieved with benazepril or hydrochlorothiazide monotherapy. Alternatively, the fixed combination containing benazepril with hydrochlorothiazide may be used in patients who had been receiving the drugs separately and in whom dosage of the individual drugs has been adjusted. Such fixed combinations also may be used to prevent benazepril-induced increases of serum potassium or hydrochlorothiazide-induced potassium loss. Patients whose blood pressure is not adequately controlled with benazepril monotherapy may receive the fixed combination containing 10 mg of benazepril hydrochloride and 12.5 mg of hydrochlorothiazide or, alternatively, the preparation containing 20 mg of benazepril hydrochloride and 12.5 mg of hydrochlorothiazide. Further increases of either or both drugs depend on clinical response; however, dosage of hydrochlorothiazide generally should not be increased for about 2-3 weeks after initiation of therapy. In addition, patients whose blood pressure has been adequately controlled with a hydrochlorothiazide dosage of 25 mg daily, but who experienced potassium loss, may achieve similar response if they are switched to therapy with the fixed combination preparation containing 5 mg of benazepril hydrochloride and 6.25 mg of hydrochlorothiazide. The manufacturer states that when the fixed combinations containing 5-20 mg of benazepril hydrochloride with 6.25-25 mg of hydrochlorothiazide have been used, antihypertensive effects increased with increasing dosage of either drug.

Blood Pressure Monitoring and Treatment Goals

Careful monitoring of blood pressure during initial titration or subsequent upward adjustment in dosage of benazepril is recommended.

The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure; specific target levels of blood pressure should be individualized based on consideration of multiple factors, including patient age and comorbidities, and the currently available evidence from clinical studies.

Special Populations

If benazepril is used in patients with impaired renal function, dosage must be modified in response to the degree of renal impairment, and, as with other ACE inhibitors, the theoretical risk of neutropenia must be considered. In adults with creatinine clearances less than 30 mL/minute per 1.73 m or serum creatinine concentrations exceeding 3 mg/dL, the recommended initial dosage of benazepril hydrochloride is 5 mg once daily. If an adequate response is not achieved, dosage may be increased gradually until blood pressure is controlled or a maximum benazepril hydrochloride dosage of 40 mg daily is reached. There are insufficient data to date to make recommendations regarding dosage of benazepril in children with creatinine clearances less than 30 mL/minute per 1.73 m, and the manufacturer recommends that benazepril therapy not be used in such patients. If concomitant diuretic therapy is required in patients with severe renal impairment (creatinine clearances less than 30 mL/minute per 1.73 m or serum creatinine concentrations exceeding 3 mg/dL), a loop diuretic is preferred to a thiazide diuretic. Therefore, use of the commercially available preparation containing benazepril in combination with hydrochlorothiazide is not recommended for patients with severe renal impairment. Use of the commercially available preparation containing benazepril in combination with amlodipine also is not recommended for patients with severe renal impairment.

Because of the greater frequency of decreased renal function in geriatric patients, the manufacturer states that dosage selection should be made with care and that it may be useful to monitor renal function in such patients receiving benazepril.

Preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the recommended initial dosage of amlodipine (2.5 mg daily) in geriatric patients and patients with hepatic impairment.

Cautions

Contraindications

Known hypersensitivity to benazepril, other angiotensin-converting enzyme (ACE) inhibitors, or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use of Fixed Combinations

When hydrochlorothiazide is used in fixed combination with benazepril, the usual cautions, precautions, and contraindications associated with hydrochlorothiazide must be considered in addition to those associated with benazepril. When amlodipine is used in fixed combination with benazepril, the usual cautions, precautions, and contraindications associated with amlodipine must be considered in addition to those associated with benazepril.

Cardiovascular Effects

Like other ACE inhibitors, benazepril rarely is associated with hypotension in patients with uncomplicated hypertension. Symptomatic hypotension may occur; patients at particular risk include those with severe volume and/or salt depletion secondary to prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume and/or salt depletion should be corrected before starting benazepril therapy.

Marked hypotension may occur in patients with heart failure (with or without associated renal impairment), which may be associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death. In patients with heart failure, benazepril therapy should be started under close medical supervision and patients should be followed closely for at least 2 weeks after initiation of benazepril or diuretic therapy or dosage adjustment of either drug. (See Dosage and Administration: Dosage.)

If hypotension occurs, the patient should be placed in the supine position, and if necessary, an IV infusion of 0.9% sodium chloride injection to expand fluid volume may be administered. Benazepril therapy usually may be continued following restoration of blood pressure and volume.

Hematologic Effects

Neutropenia/agranulocytosis, particularly in patients with renal impairment (especially those with concomitant collagen vascular disease), reported with captopril. Data insufficient to rule out similar incidence of agranulocytosis with benazepril in patients without prior reactions with other ACE inhibitors. Monitoring of leukocytes in patients with collagen vascular disease, especially if renal impairment exists, should be considered.

Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and mortality when used in pregnancy. Such potential risks of these drugs occur throughout pregnancy, especially during the second and third trimesters. ACE inhibitors also increase the risk of major congenital malformations when administered during the first trimester of pregnancy. Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving. Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy. For additional information on the risk of ACE inhibitors during pregnancy, and in .

Hepatic Effects

Rare ACE inhibitor-associated clinical syndrome manifested initially by cholestatic jaundice; may progress to fulminant hepatic necrosis and is potentially fatal. Patients receiving an ACE inhibitor, including benazepril, who develop jaundice or marked elevations of hepatic enzymes should discontinue the drug and receive appropriate monitoring.

Sensitivity Reactions

Sensitivity reactions, including anaphylactoid reactions and angioedema (including laryngeal angioedema and tongue edema) are potentially fatal. Head and neck angioedema involving the tongue, glottis, or larynx may cause airway obstruction. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, benazepril should be discontinued and appropriate therapy (e.g., epinephrine) should be initiated immediately.

Intestinal angioedema (occasionally without a prior history of facial angioedema or elevated serum levels of complement 1 [C1] esterase inhibitor) also has been reported in patients receiving ACE inhibitors. Intestinal angioedema, which frequently presents as abdominal pain (with or without nausea or vomiting), usually is diagnosed by abdominal CT scan, ultrasound, or surgery; symptoms usually have resolved after discontinuance of the ACE inhibitor. Intestinal angioedema should be considered in the differential diagnosis of patients who develop abdominal pain during therapy with an ACE inhibitor.

Life-threatening anaphylactoid reactions have been reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom. When ACE inhibitors were temporarily discontinued before desensitization with the venom, anaphylactoid reactions did not recur; however, such reactions recurred after inadvertent rechallenge. Anaphylactoid reactions have been reported following initiation of hemodialysis that used a high-flux membrane in patients receiving an ACE inhibitor. In addition, anaphylactoid reactions have been reported in patients undergoing low-density lipoprotein (LDL) apheresis with dextran sulfate absorption.

General Precautions

Renal Effects

Inhibition of the renin-angiotensin-aldosterone (RAA) system may cause renal impairment and rarely renal failure and/or death in susceptible patients (e.g., those whose renal function depends on the activity of the RAA system such as patients with severe heart failure).

Deterioration of renal function, manifested as transient increases in BUN and serum creatinine concentrations, may occur following administration of ACE inhibitor therapy, particularly in hypertensive patients with unilateral or bilateral renal artery stenosis, preexisting renal impairment, or concomitant diuretic therapy. This effect usually was reversible following discontinuance of ACE inhibitor and/or diuretic therapy. Renal function should be monitored closely during the first few weeks of therapy and periodically thereafter in such patients.

Effects on Potassium

Hyperkalemia can develop, especially in those with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).

Cough

Persistent and nonproductive; resolves after drug discontinuance.

Surgery/Anesthesia

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension. Hypotension in such patients may be corrected by volume expansion.

Specific Populations

Pregnancy

Category D.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Lactation

Because benazepril or benazeprilat alone and hydrochlorothiazide alone are distributed into human milk and potentially may cause serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or benazepril (either alone or in fixed combination with hydrochlorothiazide), taking into account the importance of the drug(s) to the woman. It is not known whether amlodipine is distributed into human milk. The manufacturer recommends that women receiving benazepril in fixed combination with amlodipine discontinue nursing.

Pediatric Use

Safety and efficacy of benazepril not established in children younger than 6 years of age and in pediatric patients with creatinine clearances of less than 30 mL/minute. Safety and efficacy of benazepril in fixed combination with amlodipine or hydrochlorothiazide not established in children. The long-term effects of benazepril on growth and development in children have not been studied. Although safety profile of the drug in pediatric patients is similar to that in adults, because of the potential for adverse effects on kidney development, ACE inhibitors should not be administered to pediatric patients younger than 1 year of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Because geriatric patients are more likely to have decreased renal function, dosage should be selected cautiously; it may be useful to monitor renal function in such patients.

Renal Impairment

Renal function may decrease with ACE inhibitor therapy in susceptible patients. Use with caution in those with renal impairment. (See Dosage and Administration: Special Populations and also Renal Effects under Warnings/Precautions: General Precautions, in Cautions.)

Black Patients

ACE inhibitors not as effective.(See Uses: Hypertension.)

Common Adverse Effects

Adverse effects reported in greater than 1% of patients receiving benazepril include headache, dizziness, fatigue, somnolence, postural dizziness, nausea, and cough. Adverse effects reported in greater than 1% of patients receiving benazepril in fixed combination with hydrochlorothiazide include dizziness, fatigue, postural dizziness, headache, cough, hypertonia, vertigo, nausea, impotence, and somnolence. Adverse effects reported in greater than 1% of patients receiving benazepril in fixed combination with amlodipine include cough, headache, dizziness, and edema.

Drug Interactions

Antidiabetic Agents

Hypoglycemia has been reported rarely in diabetic patients receiving angiotensin-converting enzyme (ACE) inhibitors, including benazepril, concomitantly with insulin or oral antidiabetic agents. Patients receiving these drugs concomitantly should be informed of the possibility of hypoglycemia and monitored appropriately.

Diuretics

Potential pharmacokinetic and pharmacologic interaction (hypotensive effect).

Drugs Increasing Serum Potassium Concentration

Potential pharmacologic interaction (additive hyperkalemic effect). Includes potassium-sparing diuretics, potassium supplements, and other drugs that can cause hyperkalemia.

Lithium

Potential pharmacokinetic interaction (increased lithium concentrations and clinical toxicity).

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