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Benazepril Hydrochloride (Benazepril Hydrochloride)

Trade Name : Benazepril Hydrochloride

Eon Labs, Inc.

TABLET, FILM COATED

Strength 10 mg/1

BENAZEPRIL HYDROCHLORIDE Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Benazepril Hydrochloride (Benazepril Hydrochloride) which is also known as Benazepril Hydrochloride and Manufactured by Eon Labs, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Benazepril Hydrochloride (Benazepril Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus n n- ]
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue benazepril hydrochloride as soon as possible. ()
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()
  • Benazepril hydrochloride tablets, USP 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. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programu2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
  • Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
  • Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
  • Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
  • It may be used alone or in combination with thiazide diuretics.
  • Benazepril hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor 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. ()
  • No data
  • Tablets: 5 mg, 10 mg, 20 mg, and 40 mg
  • u2022
  • Benazepril hydrochloride is contraindicated in patients:
  • Benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor n n
  • Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride in patients with diabetes n .
  • No data
  • 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 6,000 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.
  • The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg.
  • Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with benazepril hydrochloride and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%).
  • Adverse reactions seen in at least 1% greater frequency in patients treated with benazepril hydrochloride than placebo were headache (6% vs 4%), dizziness (4% vs 2%), somnolence (2% vs 0%) and postural dizziness (2% vs 0%).
  • Adverse reactions reported in controlled clinical trials (less than 1% more on benazepril than on placebo), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):
  • Arrayn- Dermatologic
  • Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.
  • Arrayn- Gastrointestinal
  • Nausea, pancreatitis, constipation, gastritis, vomiting, and melena.
  • Arrayn- Hematologic
  • Thrombocytopenia and hemolytic anemia.
  • Arrayn- Neurologic/Psychiatric
  • Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.
  • Arrayn- Other
  • Fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, sweating.
  • Arrayn- Laboratory Abnormalities
  • Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes have been reported, as have incidents of hyponatremia, electrocardiographic changes, eosinophilia, and proteinuria.
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The most common adverse reactions leading to discontinuation were headache (0.6%) and cough (0.5%) ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n
  • No data
  • No data
  • 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.
  • Benazepril is only slightly dialyzable, but consider dialysis to support patients with severely impaired renal function n
  • If ingestion is recent, consider activated charcoal. Consider gastric decontamination (e.g., vomiting, gastric lavage) in the early period after ingestion.
  • Monitor for blood pressure and clinical symptoms. Supportive management should be employed to ensure adequate hydration and to maintain systemic blood pressure.
  • In the case of marked hypotension, infuse physiological saline solution; as needed, consider vasopressors (e.g., catecholamines i.v.).
  • Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:
  • Its molecular formula is CHNOu2022HCl, and its molecular weight is 460.96.
  • Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor.
  • Benazepril hydrochloride tablets, USP contain 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn), hydrogenated castor oil, crospovidone, colloidal silicon dioxide, zinc stearate, hypromellose, titanium dioxide, polyethylene glycol 400 and polysorbate 80. The and tablets also contain D&C yellow No. 10 and FD&C yellow No. 6. The tablets also contain FD&C red No. 40 and FD&C yellow No. 6. The tablets also contain FD&C red No. 40.
  • No data
  • No evidence of carcinogenicity was found when benazepril was administered to rats and mice for up to two years at doses of up to 150 mg/kg/day. When compared on the basis of body weights, this dose is 110 times the maximum recommended human dose. When compared on the basis of body surface areas, this dose is 18 and 9 times (rats and mice, respectively) the maximum recommended human dose (calculations assume a patient weight of 60 kg). No mutagenic activity was detected in the Ames test in bacteria (with or without metabolic activation), in an test for forward mutations in cultured mammalian cells, or in a nucleus anomaly test. In doses of 50 to 500 mg/kg/day (6 to 60 times the maximum recommended human dose based on mg/m comparison and 37 to 375 times the maximum recommended human dose based on a mg/kg comparison), benazepril hydrochloride had no adverse effect on the reproductive performance of male and female rats.
  • Hypertension
  • Arrayn- Adult Patients
  • In single-dose studies, benazepril hydrochloride lowered blood pressure within 1 hour, with peak reductions achieved between 2 and 4 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. In multiple-dose studies, once-daily doses of between 20 mg and 80 mg decreased seated pressure 24 hours after dosing by about 6 to 12 mmHg systolic and 4 to 7 mmHg diastolic. The trough values represent reductions of about 50% of that seen at peak.
  • Four dose-response studies using once-daily dosing were conducted in 470 mild-to-moderate hypertensive patients not using diuretics. The minimal effective once-daily dose of benazepril hydrochloride was 10 mg; but further falls in blood pressure, especially at morning trough, were seen with higher doses in the studied dosing range (10 to 80 mg). In studies comparing the same daily dose of benazepril hydrochloride given as a single morning dose or as a twice-daily dose, blood pressure reductions at the time of morning trough blood levels were greater with the divided regimen.
  • The antihypertensive effects of benazepril hydrochloride were not appreciably different in patients receiving high-or low-sodium diets.
  • In normal human volunteers, single doses of benazepril caused an increase in renal blood flow but had no effect on glomerular filtration rate.
  • Use of benazepril hydrochloride in combination with thiazide diuretics gives a blood-pressure-lowering effect greater than that seen with either agent alone. By blocking the renin-angiotensin-aldosterone axis, administration of benazepril hydrochloride tends to reduce the potassium loss associated with the diuretic.
  • Arrayn- Pediatric Patients
  • In a clinical study of 107 pediatric patients, 7 to 16 years of age, with either systolic or diastolic pressure above the 95th percentile, patients were given 0.1 or 0.2 mg/kg then titrated up to 0.3 or 0.6 mg/kg with a maximum dose of 40 mg once daily. After four weeks of treatment, the 85 patients whose blood pressure was reduced on therapy were then randomized to either placebo or benazepril and were followed up for an additional two weeks. At the end of two weeks, blood pressure (both systolic and diastolic) in children withdrawn to placebo rose by 4 to 6 mmHg more than in children on benazepril. No dose-response was observed.
  • Benazepril Hydrochloride Tablets, USP, for oral administration, are packaged with a desiccant and available as
  • Arrayn- 5 mg
  • Yellow-orange, round, biconvex, film-coated tablets, debossed u201cu201d over u201c5u201d on one side and plain on the other side and supplied as:
  • NDC 0185-0505-09 bottles of 90
  • NDC 0185-0505-01 bottles of 100
  • NDC 0185-0505-05 bottles of 500
  • Arrayn- 10 mg
  • Orange, round, biconvex, film-coated tablets, debossed u201cu201d over u201c53u201d on one side and plain on the other side and supplied as:
  • NDC 0185-0053-09 bottles of 90
  • NDC 0185-0053-01 bottles of 100
  • NDC 0185-0053-05 bottles of 500
  • Arrayn- 20 mg
  • Pink, round, biconvex, film-coated tablets, debossed u201cu201d over u201c82u201d on one side and plain on the other side and supplied as:
  • NDC 0185-0820-09 bottles of 90
  • NDC 0185-0820-01 bottles of 100
  • NDC 0185-0820-05 bottles of 500
  • Arrayn- 40 mg
  • Red, round, biconvex, film-coated tablets, debossed u201cu201d over u201c48u201d on one side and plain on the other side and supplied as:
  • NDC 0185-0048-09 bottles of 90
  • NDC 0185-0048-01 bottles of 100
  • NDC 0185-0048-05 bottles of 500
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.
  • Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
  • KEEP TIGHTLY CLOSED.
  • KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
  • 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.
  • Symptomatic Hypotension
  • Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patients to discontinue the drug until they have consulted with the prescribing physician.
  • Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of a reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.
  • Hyperkalemia
  • Tell patients not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
  • Hypoglycemia
  • Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use.
  • Distributed bySandoz Inc.Princeton, NJ 08540
  • Rev. January 2019MF0505REV01/19
  • NDC 0185-0505-01
  • Benazepril Hydrochloride Tablets, USP
  • 5 mg
  • Contains FD&C Yellow No. 6 as a color additive.
  • 100 Tablets
  • Rx only
  • Sandoz
  • NDC 0185-0053-01
  • Benazepril Hydrochloride Tablets USP
  • 10 mg
  • Contains FD&C Yellow No. 6 as a color additive.
  • 100 Tablets
  • Rx only
  • Sandoz
  • NDC 0185-0820-01
  • Benazepril Hydrochloride Tablets USP
  • 20 mg
  • Contains FD&C Yellow No. 6 as a color additive.
  • 100 Tablets
  • Rx only
  • Sandoz
  • NDC 0185-0048-01
  • Benazepril Hydrochloride Tablets USP
  • 40 mg
  • Rx only
  • 100 Tablets
  • Sandoz

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