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Benazepril HCl
Overview
What is Benazepril HCl?
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 benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is
Structure
Its empirical formula is C 24H 28N 2O 5•HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor.
Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2.
Please review the manufacturer's complete drug information available from the FDA at
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What does Benazepril HCl look like?
What are the available doses of Benazepril HCl?
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
What should I talk to my health care provider before I take Benazepril HCl?
8.1 Pregnancy
Pregnancy Category D
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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue benazepril hydrochloride as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue benazepril hydrochloride, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to benazepril hydrochloride for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations ( 8.4)].
8.3 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.
8.4 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 Clinical Pharmacology ( 12.3)]. The pharmacokinetics of benazepril hydrochloride have been evaluated in pediatric patients 6 to 16 years of age [see Clinical Pharmacology ( 12.3)].
Infants below the age of 1 year should not be given benazepril hydrochloride because of the risk of effects on kidney development.
Safety and effectiveness of benazepril hydrochloride have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate <30 mL/min/1.73m² [see Dosage and Administration ( 2.1) and Clinical Pharmacology 12.3)].
Neonates with a history of in utero exposure to benazepril hydrochloride:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a 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.
8.5 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 [see Dosage and Administration ( 2.2)] .
8.6 Race
ACE inhibitors, including benazepril hydrochloride, as monotherapy, have an effect on blood pressure that is less in black patients than in non-blacks.
8.7 Renal Impairment
Dose adjustment of benazepril hydrochloride is required in patients undergoing hemodialysis or whose creatinine clearance is ≤30 mL/min. No dose adjustment of benazepril hydrochloride is required in patients with creatinine clearance >30 mL/min [see Dosage and Administration ( 2.2) and Clinical Pharmacology ( 12.3)] .
Please review the manufacturer's complete drug information available from the FDA at
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How should I use Benazepril HCl?
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.
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.
www.fda.gov
2.1 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 mg 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.
Benazepril hydrochloride tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with GFR less than 30 mL/min/1.73 m 2[see Use in Specific Populations ( 8.4)].
2.2 Dose Adjustment for Renal Impairment
For adults with a GFR <30 mL/min/1.73 m 2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablets once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg. Benazepril hydrochloride tablets can also worsen renal function [see Warnings and Precautions ( 5.3)].
2.3 Preparation of Suspension (for 150 mL of a 2 mg/mL Suspension)
Add 75 mL of Ora-Plus®* oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril hydrochloride 20 mg tablets, and shake for at least two minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of one additional minute. Add 75 mL of Ora-Sweet®* oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days in the PET bottle with a child-resistant screw-cap closure. Shake the suspension before each use.
*Ora-Plus® and Ora-Sweet® are registered trademarks of Paddock Laboratories, Inc. Ora Plus® contains carrageenan, citric acid, methylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, potassium sorbate, simethicone, sodium phosphate monobasic, xanthan gum, and water. Ora-Sweet® contains citric acid, berry citrus flavorant, glycerin, methylparaben, potassium sorbate, sodium phosphate monobasic, sorbitol, sucrose, and water.
What interacts with Benazepril HCl?
Sorry No Records found
What are the warnings of Benazepril HCl?
Sorry No Records found
What are the precautions of Benazepril HCl?
Sorry No Records found
What are the side effects of Benazepril HCl?
Sorry No records found
What should I look out for while using Benazepril HCl?
Benazepril hydrochloride tablets are contraindicated in patients:
who are hypersensitive to benazapril or to any other ACE inhibitor
with a history of angioedema with or without previous ACE inhibitor treatment
Do not co-administer aliskiren with benazepril hydrochloride tablets in patients with diabetes [see Drug Interactions ( 7.4)] .
Please review the manufacturer's complete drug information available from the FDA at
Permanent Link:
What might happen if I take too much Benazepril HCl?
Benazepril is only slightly dialyzable, but consider dialysis to support patients with severely impaired renal function [see Warnings and Precautions ( 5.3)].
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.).
Please review the manufacturer's complete drug information available from the FDA at
Permanent Link:
How should I store and handle Benazepril HCl?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by:Carlsbad Technology, Inc.5922 Farnsworth Court Suite 102 Carlsbad, CA 92008Distributed by:McKesson Packaging Servicesa business unit of McKesson Corporation7101 Weddington Rd., Concord, NC 28027Repackaged By:Cardinal HealthZanesville, OH 43701L50720040715IS-4014571August 2014Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link: Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows:NDC 43547-335-10 bottle of 100 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows:NDC 43547-336-10 bottle of 100 tablets (with desiccant)NDC 43547-336-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows:NDC 43547-337-10 bottle of 100 tablets (with desiccant)NDC 43547-337-50 bottle of 500 tablets (with desiccant)Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “S” on one side and “344” on the other side, packaged as follows:NDC 43547-338-10 bottle of 100 tablets (with desiccant)NDC 43547-338-50 bottle of 500 tablets (with desiccant)Distributed by:Solco Healthcare US, LLCCranbury, NJ 08512, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 12/201507713-04Please review the manufacturer's complete drug information available from the FDA at Permanent Link:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1 Mechanism of Action
Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. Benazeprilat has much greater ACE inhibitory activity than does benazepril. 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.
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.
12.2 Pharmacodynamics
Single and multiple doses of 10 mg or more of benazepril hydrochloride cause inhibition of plasma ACE activity by at least 80%-90% for at least 24 hours after dosing. Pressor responses to exogenous angiotensin I were inhibited by 60%-90% (up to 4 hours post-dose) at the 10-mg dose.
Drug interactions
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
12.3 Pharmacokinetics
The pharmacokinetics of benazepril are approximately dose-proportional within the dosage range of 10-80 mg.
Following oral administration of benazepril hydrochloride, peak plasma concentrations of benazepril, and its active metabolite benazeprilat are reached within 0.5-1.0 hours and 1-2 hours, respectively. While the bioavailability of benazepril is not affected by food, time to peak plasma concentrations of benazeprilat is delayed to 2 – 4 hours.
The serum protein binding of benazepril is about 96.7% and that of benazeprilat about 95.3%, as measured by equilibrium dialysis; on the basis of in vitro studies, the degree of protein binding should be unaffected by age, hepatic dysfunction, or concentration (over the concentration range of 0.24-23.6 μmol/L).
Benazepril is almost completely metabolized to benazeprilat by cleavage of the ester group (primarily in liver). Both benazepril and benazeprilat undergo glucuronidation.
Benazepril and benazeprilat are cleared predominantly by renal excretion. About 37% of an orally administered dose was recovered in urine as benazeprilat (20%), benazeprilat glucuronide (8%), benazepril glucuronide (4%) and as trace amounts of benazepril. Nonrenal (i.e., biliary) excretion accounts for approximately 11%-12% of benazeprilat excretion.. The effective half-life of benazeprilat following once daily repeat oral administration of benazepril hydrochloride is 10-11 hours. Thus, steady-state concentrations of benazeprilat should be reached after 2 or 3 doses of benazepril hydrochloride given once daily.
Accumulation ratio based on AUC of benazeprilat was 1.19 following once daily administration.
Specific Populations
Renal impairment
The pharmacokinetics of/ systemic exposure to benazepril and benazeprilat in patients with mild-to-moderate renal insufficiency (creatinine clearance >30 mL/min) is similar to that in patients with normal renal function. In patients with creatinine clearance ≤30 mL/min, peak benazeprilat levels and the initial (alpha phase) half-life increase, and time to steady state may be delayed (see DOSAGE AND ADMINISTRATION ( 2).
When dialysis was started 2 hours after ingestion of 10 mg of benazepril, approximately 6% of benazeprilat was removed in 4 hours of dialysis. The parent compound, benazepril, was not detected in the dialysate.
Hepatic impairment
In patients with hepatic insufficiency (due to cirrhosis) , the pharmacokinetics of benazeprilat are essentially unaltered.
Drug Interactions
The pharmacokinetics of benazepril are not affected by the following drugs: hydrochlorothiazide, furosemide, chlorthalidone, digoxin, propranolol, atenolol, nifedipine, amlodipine, naproxen, acetylsalicylic acid, or cimetidine. Likewise the administration of benazepril does not substantially affect the pharmacokinetics of these medications (cimetidine kinetics were not studied)
Pediatrics
The pharmacokinetics of benazaprilat, evaluated in pediatric patients with hypertension following oral administration of a single dose is presented in table below.
Age group
Cmax
(ng/mL)
Tmax*
(h)
AUC 0-inf
(ng/mL*h)
CL/F/wt
(L/h/Kg)
T 1/2
(h)
>1 to ≤ 24 months
n=5
277
(192, 391)
1
(0.6, 2)
1328
(773, 2117)
0.26
(0.18, 0.4)
5.0
(4, 5.8)
>2 to ≤ 6 years
n=7
200
(168, 244)
2
(1.4, 2.4)
978
(842, 1152)
0.36
(0.31, 0.42)
5.5
(4.7, 6.5)
>6 to ≤ 12 years
n=7
221
(194, 258)
2
(1.2, 2.2)
1041
(855, 1313)
0.25
(0.21, 0.31)
5.5
(4.7, 6.5)
>12 to ≤ 17 years
n=8
287
(217, 420)
2
(1.3, 2.3)
1794
(1478, 2340)
0.16
(0.13, 0.21)
5.1
(4.2, 5.7)
Please review the manufacturer's complete drug information available from the FDA at
Permanent Link:
Non-Clinical Toxicology
Benazepril hydrochloride tablets are contraindicated in patients:who are hypersensitive to benazapril or to any other ACE inhibitor
with a history of angioedema with or without previous ACE inhibitor treatment
Do not co-administer aliskiren with benazepril hydrochloride tablets in patients with diabetes [see Drug Interactions ( 7.4)] .
Please review the manufacturer's complete drug information available from the FDA at Permanent Link:
Drug Interactions:
Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see ).
Should lidocaine and prilocaine cream, 2.5%/2.5% be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
5.1 Fetal Toxicity
PREGNANCY CATEGORY D
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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible [see Use in Specific Populations ( 8.1)] .
5.2 Angioedema and Anaphylactoid Reactions
Angioedema
Head and Neck Angioedema
Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx including some fatal reactions, have occured in patients treated with benazepril hydrochloride. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Benazepril hydrochloride should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor [see Contraindications ( 4)] . ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients.
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
Intestinal Angioedema
Intestinal angioedema has occurred 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. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.
Anaphylactoid Reactions
Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.
Anaphylactoid Reactions During Dialysis
Sudden and potentially life threatening anaphylactoid reactions have occured in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
5.3 Impaired Renal Function
Monitor renal function periodically in patients treated with benazepril hydrochloride. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin sytem. Patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction, or volume depletion) may be at particular risk of developing acute renal failure on benazepril hydrochloride. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on benazepril hydrochloride.
5.4 Hypotension
Benazepril hydrochloride can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia acute renal failure or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology.
In such patients, follow closely for the first 2 weeks of treatment and whenever the dose of benazepril or diuretic is increased. Avoid use of benazepril hydrochloride in patients who are hemodynamically unstable after acute MI.
Surgery/Anesthesia
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, benazepril hydrochloride may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs, correct by volume expansion.
5.5 Hyperkalemia
Serum potassium should be monitored periodically in patients receiving benazepril hydrochloride. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. 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 [see Drug Interactions ( 7.1)] .
5.6 Hepatic Failure
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.
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.
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):
Dermatologic: Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.
Gastrointestial: Nausea, pancreatitis, constipation, gastritis, vomiting, and melena.
Hematologic: Thrombocytopenia and hemolytic anemia.
Neurologic/Psychiatric: Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia
Other: Fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, sweating.
Laboratory Abnormalities:
Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes [see Adverse Reactions ( 5)] have been reported, as have incidents of hyponatremia, electrocardiographic changes, eosinophilia, and proteinuria.
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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Interactions
Interactions
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).