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Benazepril Hydrochloride
Overview
What is Benazepril Hydrochloride?
Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol and in methanol. Its chemical name is 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 CHNOHCl and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
Benazepril hydrochloride is supplied as tablets containing 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, 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.
What does Benazepril Hydrochloride look like?
What are the available doses of Benazepril Hydrochloride?
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What should I talk to my health care provider before I take Benazepril Hydrochloride?
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How should I use Benazepril Hydrochloride?
Benazepril hydrochloride tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
In using benazepril hydrochloride tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see ).
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.
What interacts with Benazepril Hydrochloride?
Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor.
What are the warnings of Benazepril Hydrochloride?
Anaphylactoid and Possibly Related Reactions
Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including benazepril hydrochloride) may be subject to a variety of adverse reactions, some of them serious.
Angioedema of the face, extremities, lips, tongue, glottis and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors. In U.S. clinical trials, symptoms consistent with angioedema were seen in none of the subjects who received placebo and in about 0.5% of the subjects who received benazepril hydrochloride. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, treatment with benazepril hydrochloride should be discontinued and appropriate therapy instituted immediately. see.
Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption (a procedure dependent upon devices not approved in the United States).
Hypotension
Benazepril hydrochloride can cause symptomatic hypotension. Like other ACE inhibitors, benazepril has been only rarely associated with hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been volume- and/or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. Volume- and/or salt-depletion should be corrected before initiating therapy with benazepril hydrochloride.
In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia and, rarely, with acute renal failure and death. In such patients, benazepril hydrochloride therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of benazepril or diuretic is increased.
If hypotension occurs, the patient should be placed in a supine position, and, if necessary, treated with intravenous infusion of physiological saline. Benazepril hydrochloride treatment usually can be continued following restoration of blood pressure and volume.
Neutropenia/Agranulocytosis
Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Available data from clinical trials of benazepril are insufficient to show that benazepril does not cause agranulocytosis at similar rates. Monitoring of white blood cell counts should be considered in patients with collagen-vascular disease, especially if the disease is associated with impaired renal function.
Fetal/Neonatal Morbidity and Mortality
ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, benazepril hydrochloride should be discontinued as soon as possible and monitoring of the fetal development should be performed on a regular basis.
The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE inhibitor exposure.
In addition, use of ACE inhibitors during the first trimester of pregnancy has been associated with a potentially increased risk of birth defects. In women planning to become pregnant, ACE inhibitors (including benazepril hydrochloride) should not be used. Women of child-bearing age should be made aware of the potential risk and ACE inhibitors (including benazepril hydrochloride) should only be given after careful counseling and consideration of individual risks and benefits.
Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.
If oligohydramnios is observed, benazepril should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of exposure to ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Benazepril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers with another ACE inhibitor, but experience is limited.
No teratogenic effects of benazepril hydrochloride were seen in studies of pregnant rats, mice and rabbits. On a mg/m basis, the doses used in these studies were 60 times (in rats), 9 times (in mice) and more than 0.8 times (in rabbits) the maximum recommended human dose (assuming a 50 kg woman). On a mg/kg basis these multiples are 300 times (in rats), 90 times (in mice) and more than 3 times (in rabbits) the maximum recommended human dose.
Hepatic Failure
Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
What are the precautions of Benazepril Hydrochloride?
General
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors, including benazepril hydrochloride, may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. In a small study of hypertensive patients with renal artery stenosis in a solitary kidney or bilateral renal artery stenosis, treatment with benazepril hydrochloride was associated with increases in blood urea nitrogen and serum creatinine; these increases were reversible upon discontinuation of benazepril hydrochloride or diuretic therapy, or both. When such patients are treated with ACE inhibitors, renal function should be monitored during the first few weeks of therapy. Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when benazepril hydrochloride has been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction of benazepril hydrochloride and/or discontinuation of the diuretic may be required. see.
In clinical trials, hyperkalemia (serum potassium at least 0.5 mEq/L greater than the upper limit of normal) occurred in approximately 1% of hypertensive patients receiving benazepril hydrochloride. In most cases, these were isolated values which resolved despite continued therapy. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with benazepril hydrochloride (see , ).
Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
In patients with hepatic dysfunction due to cirrhosis, levels of benazeprilat are essentially unaltered (see , ).
In patients undergoing surgery or during anesthesia with agents that produce hypotension, benazepril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion.
Information for Patients
Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors. Discuss other treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors. Patients should be so advised and told 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 drug until they have consulted with the prescribing physician.
Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to the prescribing physician. Patients should be told that if syncope occurs, benazepril hydrochloride tablets should be discontinued until the prescribing physician has been consulted.
All patients should be cautioned that inadequate fluid intake or excessive perspiration, diarrhea or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
Patients should be told to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.
Drug Interactions
Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with benazepril hydrochloride. The possibility of hypotensive effects with benazepril hydrochloride can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with benazepril hydrochloride. If this is not possible, the starting dose should be reduced (see ).
Benazepril hydrochloride can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene and others) or potassium supplements can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution, and the patient's serum potassium should be monitored frequently.
Interaction studies with warfarin and acenocoumarol failed to identify any clinically important effects on the serum concentrations or clinical effects of these anticoagulants.
Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors (including benazepril) during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.
In rare cases, diabetic patients receiving an ACE inhibitor (including benazepril) concomitantly with insulin or oral anti-diabetics may develop hypoglycemia. Such patients should therefore be advised about the possibility of hypoglycemic reactions and should be monitored accordingly.
No clinically important pharmacokinetic interactions occurred when benazepril hydrochloride was administered concomitantly with hydrochlorothiazide, chlorthalidone, furosemide, digoxin, propranolol, atenolol, naproxen or cimetidine.
Benazepril hydrochloride has been used concomitantly with beta-adrenergic-blocking agents, calcium-channel-blocking agents, diuretics, digoxin and hydralazine, without evidence of clinically important adverse interactions. Benazepril, like other ACE inhibitors, has had less than additive effects with beta-adrenergic blockers, presumably because both drugs lower blood pressure by inhibiting parts of the renin-angiotensin system.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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 mg/kg/day 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.
Pregnancy Category D
See , .
Nursing Mothers
Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. A newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat.
Geriatric Use
Of the total number of patients who received benazepril in U.S. clinical studies of benazepril hydrochloride, 18% were 65 or older while 2% were 75 or older. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Benazepril and benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Pediatric Use
The antihypertensive effects of benazepril hydrochloride have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age (see and). The pharmacokinetics of benazepril hydrochloride have been evaluated in pediatric patients 6 to 16 years of age (see ). Benazepril hydrochloride was generally well tolerated and adverse effects were similar to those described in adults. (See ).
Treatment with benazepril hydrochloride is not recommended in pediatric patients less than 6 years of age (see ), and in children with glomerular filtration rate <30 mL/min as there are insufficient data available to support a dosing recommendation in these groups. (See , and .)
What are the side effects of Benazepril Hydrochloride?
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 comparable 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 mg 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%) (see , ).
The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with benazepril hydrochloride are shown below.
Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):
| BENAZEPRIL HCl | PLACEBO | |||
| (N=964) | (N=496) | |||
| N | % | N | % | |
| Headache | 60 | 6.2 | 21 | 4.2 |
| Dizziness | 35 | 3.6 | 12 | 2.4 |
| Fatigue | 23 | 2.4 | 11 | 2.2 |
| Somnolence | 15 | 1.6 | 2 | 0.4 |
| Postural Dizziness | 14 | 1.5 | 1 | 0.2 |
| Nausea | 13 | 1.3 | 5 | 1.0 |
| Cough | 12 | 1.2 | 5 | 1.0 |
Cardiovascular
Symptomatic hypotension was seen in 0.3% of patients, postural hypotension in 0.4% and syncope in 0.1%; these reactions led to discontinuation of therapy in 4 patients who had received benazepril monotherapy and in 9 patients who had received benazepril with hydrochlorothiazide (see and ). Other reports included angina pectoris, palpitations and peripheral edema.
Renal
Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving benazepril hydrochloride, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine.
Fetal/Neonatal Morbidity and Mortality
See
Angioedema
Angioedema has been reported in patients receiving ACE inhibitors. During clinical trials in hypertensive patients with benazepril, 0.5% of patients experienced edema of the lips or face without other manifestations of angioedema. Angioedema associated with laryngeal edema and/or shock may be fatal. If angioedema of the face, extremities, lips, tongue or glottis and/or larynx occurs, treatment with benazepril hydrochloride should be discontinued and appropriate therapy instituted immediately (see).
Dermatologic
Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus or rash), photosensitivity and flushing.
Gastrointestinal
Pancreatitis, constipation, gastritis, vomiting and melena.
Hematologic
Thrombocytopenia and hemolytic anemia.
Neurologic and Psychiatric
Anxiety, decreased libido, hypertonia, insomnia, nervousness and paresthesia.
Other
Asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia and sweating.
Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.
The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis and neutropenia.
Pediatric Patients
The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients. Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development.
The long-term effects of benazepril on growth and development have not been studied.
Clinical Laboratory Test Findings
Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving benazepril hydrochloride, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis (see , ).
Since benazepril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient's serum potassium should be monitored frequently (see ).
Decreases in hemoglobin (a low value and a decrease of 5 g/dL) were rare, occurring in only 1 of 2,014 patients receiving benazepril hydrochloride alone and in 1 of 1,357 patients receiving benazepril hydrochloride plus a diuretic. No U.S. patients discontinued treatment because of decreases in hemoglobin.
Clinically important changes in standard laboratory tests were rarely associated with benazepril hydrochloride administration. Elevations of uric acid, blood glucose, serum bilirubin and liver enzymes (see ) have been reported, as have scattered incidents of hyponatremia, electrocardiographic changes, leukopenia, eosinophilia and proteinuria. In U.S. trials, less than 0.5% of patients discontinued treatment because of laboratory abnormalities.
What should I look out for while using Benazepril Hydrochloride?
Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor.
What might happen if I take too much Benazepril Hydrochloride?
Sorry No Records found
How should I store and handle Benazepril Hydrochloride?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815Benazepril Hydrochloride Tablets are available as:5 mg:10 mg:20 mg:40 mg: Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.Store at 20º to 25º C (68º to 77º F) [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.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.Sandoz Inc.Princeton, NJ 08540Rebel Distributors Corp.Thousand Oaks, CA 91320OS8016Rev. 01/09MF0005REV01/09MG #17815
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.
Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with benazepril hydrochloride alone for up to 52 weeks had elevations of serum potassium of up to 0.2 mEq/L. Similar patients treated with benazepril hydrochloride and hydrochlorothiazide for up to 24 weeks had no consistent changes in their serum potassium (see ).
Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. In animal studies, benazepril had no inhibitory effect on the vasopressor response to angiotensin II and did not interfere with the hemodynamic effects of the autonomic neurotransmitters acetylcholine, epinephrine and norepinephrine.
ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of benazepril hydrochloride remains to be elucidated.
While the mechanism through which benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, benazepril has an antihypertensive effect even in patients with low-renin hypertension (see ).
Non-Clinical Toxicology
Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor.Few systemic data have been collected on the metabolism of bupropion following concomitant administration with other drugs or, alternatively, the effect of concomitant administration of bupropion on the metabolism of other drugs.
Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between bupropion hydrochloride extended-release tablets (XL) and drugs that are substrates of or inhibitors/inducers of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, cyclophosphamide, ticlopidine, and clopidogrel). In addition, studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as nelfinavir and efavirenz inhibit the hydroxylation of bupropion. No clinical studies have been performed to evaluate this finding. The threohydrobupropion metabolite of bupropion does not appear to be produced by the cytochrome P450 isoenzymes. The effects of concomitant administration of cimetidine on the pharmacokinetics of bupropion and its active metabolites were studied in 24 healthy young male volunteers. Following oral administration of two 150 mg tablets of the sustained-release formulation of bupropion with and without 800 mg of cimetidine, the pharmacokinetics of bupropion and hydroxybupropion were unaffected. However, there were 16% and 32% increases in the AUC and C, respectively, of the combined moieties of threohydrobupropion and erythrohydrobupropion.
In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir (KALETRA) 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20% to 80%. This effect is thought to be due to the induction of bupropion metabolism. Patients receiving ritonavir may need increased doses of bupropion, but the maximum recommended dose of bupropion should not be exceeded (see CLINICAL PHARMACOLOGY: ).
While not systematically studied, certain drugs may induce the metabolism of bupropion (e.g., carbamazepine, phenobarbital, phenytoin).
Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 healthy volunteers.
Animal data indicated that bupropion may be an inducer of drug-metabolizing enzymes in humans. In one study, following chronic administration of bupropion, 100 mg 3 times daily to 8 healthy male volunteers for 14 days, there was no evidence of induction of its own metabolism. Nevertheless, there may be the potential for clinically important alterations of blood levels of coadministered drugs.
Therefore, coadministration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including certain antidepressants (e.g., nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving a drug metabolized by CYP2D6, the need to decrease the dose of the original medication should be considered, particularly for those concomitant medications with a narrow therapeutic index. Although citalopram is not primarily metabolized by CYP2D6, in one study bupropion increased the C and AUC of citalopram by 30% and 40%, respectively. Citalopram did not affect the pharmacokinetics of bupropion and its three metabolites.
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 comparable 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 mg 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%) (see , ).
The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with benazepril hydrochloride are shown below.
Other adverse experiences reported in controlled clinical trials (in less than 1% of benazepril patients), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).