Benazepril

Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. …

• Adult Patients: Initiate with 10 mg once daily (or 5 mg if patient is on diuretic)
• Titrate to 40 mg daily based on blood pressure response. • Pediatric patients age 6 years and above with glomerular filtration rate (GFR) >30 mL/min/1.73 m 2 : Initiate with 0.2 mg/kg once daily
• Maximum dose is 0.6 mg/kg once daily. • Renal Impairment: Initiate with 5 mg once daily in patients with GFR 3 mg/dL) Recommended Dosage
• ADULTS The recommended initial dose for patients not receiving a diuretic is 10 mg once a day
• The usual maintenance dosage range is 20 to 40 mg per day administered as a single dose or in two equally divided doses
• A dose of 80 mg gives an increased response, but experience with this dose is limited
• The divided regimen was more effective in controlling trough (pre-dosing) blood pressure than the same dose given as a once-daily regimen
• Use with diuretics
• In adults The recommended starting dose of benazepril hydrochloride tablets in a patient on a diuretic is 5 mg once daily
• If blood pressure is not controlled with benazepril hydrochloride alone, a low dose of diuretic may be added
• PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER The recommended starting dose for pediatric patients is 0.2 mg/kg once per day
• Titrate as needed to 0.6 mg/kg once per day
• Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied
• In pediatric patients. …

Tablets: 5 mg, 10 mg, 20 mg, and 40 mg • Each 5 mg tablet is white with “S” on one side and “341” on the other • Each 10 mg tablet is red with “S” on one side and “342” on the other • Each 20 mg tablet is grey with “S” on one side and “343” on the other • Each 40 mg tablet is blue with “S” on one side and “344” on the other • Tablets: 5 mg, 10 mg, 20 mg, 40 mg

• Pregnancy : Tell female patients of childbearing age about the consequences of exposure to benazepril hydrochloride during pregnancy
• Discuss treatment options with women planning to become pregnant
• Instruct patients to report pregnancies to their physicians as soon as possible
• Angioedema : Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors
• Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to take no more drugs until they have consulted with the prescribing physician. …

Benazepril hydrochloride tablets are contraindicated in patients: • who are hypersensitive to benazepril or to any other ACE inhibitor • with a history of angioedema with or without previous ACE inhibitor treatment Benazepril hydrochloride tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). …

• Diuretics: Excessive drop in blood pressure ( 7.1 ) • Antidiabetics: Increased risk of hypoglycaemia ( 7.2 ) • NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) • Lithium: Symptoms of lithium toxicity ( 7.6 ) • Neprilysin Inhibitor: Increased risk of angioedema ( Error! Hyperlink reference not valid. …

• Angioedema: Discontinue benazepril hydrochloride and treat appropriately. ( 5.2 ) • Monitor renal function periodically. ( 5.3 ) • Monitor blood pressure after initiation. ( 5.4 ) • Hyperkalemia: Monitor serum potassium periodically. ( 5.5 ) • Hepatic toxicity: Monitor for jaundice or signs of liver failure. ( 5.6 ) 5.1 Fetal Toxicity PREGNANCY CATEGORY D Benazepril hydrochloride tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Benazepril hydrochloride has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in benazepril hydrochloride and placebo patients. …

IN SPECIFIC POPULATIONS • Pediatrics: Safety and effectiveness have not been established in patients < 6 years of age or with GFR < 30 mL/min/1.73 m2 ( Error! Hyperlink reference not valid. ) • Race: Less antihypertensive effect in Blacks as monotherapy ( 8.5 ) 8.1 Pregnancy Risk Summary Benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. …

Single oral doses of 3 g/kg benazepril were associated with significant lethality in mice. Rats, however, tolerated single oral doses of up to 6 g/kg. Reduced activity was seen at 1 g/kg in mice and at 5 g/kg in rats. Human overdoses of benazepril have not been reported, but the most common manifestation of human benazepril overdosage is likely to be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Hypotension can be associated with electrolyte disturbances and renal failure. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.