benazepril hydrochloride


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benazepril hydrochloride

Apo-Benazepril (CA), Lotensin

Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

Pregnancy risk category C (first trimester), D (second and third trimesters)

FDA Box Warning

• When used during second or third trimester of pregnancy, drug may cause fetal injury and death. Discontinue as soon as possible when pregnancy is detected.

Action

Inhibits conversion of angiotensin I to angiotensin II, a vasoconstrictor that stimulates adrenal glands and promotes aldosterone secretion, thereby reducing sodium and water reabsorption and ultimately decreasing blood pressure. Decreased angiotensin also causes increased potassium level and fluid loss.

Availability

Tablets: 5 mg, 10 mg, 20 mg, 40 mg

Indications and dosages

Hypertension

Adults: Initially, 5 to 10 mg/day P.O. as a single dose. Increase gradually to a maintenance dosage of 20 to 40 mg/day as a single dose or in two divided doses. (Start with 5 mg/day in patients receiving diuretics.)

Dosage adjustment

• Renal impairment

Off-label uses

• Myocardial infarction
• Nephropathy

Contraindications

• Hypersensitivity to drug or to other ACE inhibitors
• Angioedema with or without previous ACE inhibitor treatment

Precautions

Use cautiously in:
• renal or hepatic impairment, hypovolemia, hyponatremia, aortic stenosis, hypertrophic cardiomyopathy, cerebrovascular or cardiac insufficiency
• patients receiving concurrent diuretics
• black patients
• elderly patients
• pregnant patients (use not recommended, particularly in second and third trimesters)
• breastfeeding patients
• children.

Administration

Use extreme caution if patient has family history of angioedema.
• When giving concurrently with diuretics, know that drug may cause excessive hypotension. If possible, stop diuretic therapy 2 to 3 days before starting benazepril.
• Give with or without food.
• Know that drug may be used alone or in conjunction with other antihypertensives.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, syncope, light-headedness, headache, insomnia

CV: angina pectoris, hypotension, tachycardia

EENT: sinusitis

GI: diarrhea, nausea, anorexia

GU: proteinuria, erectile dysfunction, decreased libido, renal failure

Hematologic: agranulocytosis

Metabolic: hyperkalemia

Respiratory: cough, dyspnea, bronchitis, asthma, eosinophilic pneumonitis

Skin: rash, angioedema

Other: fever, altered taste

Interactions

Drug-drug.Allopurinol: increased risk of hypersensitivity reaction

Antacids: decreased benazepril absorption

Antihypertensives, diuretics, general anesthetics, nitrates, phenothiazines: excessive hypotension

Cyclosporine, indomethacin, potassium-sparing diuretics, potassium supplements: hyperkalemia

Lithium: increased lithium blood level, greater risk of lithium toxicity

Nonsteroidal anti-inflammatory drugs: blunting of antihypertensive response

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, potassium: increased levels

Antinuclear antibodies: positive result

Sodium: decreased level

Drug-food.Salt substitutes containing potassium: hyperkalemia

Drug-herbs.Capsaicin: cough

Drug-behaviors.Acute alcohol ingestion: increased hypotension

Patient monitoring

Monitor for signs and symptoms of angioedema, including laryngeal edema and shock.
• Measure blood pressure regularly.
• Monitor CBC, electrolyte levels, kidney and liver function test results, and urinary protein level.

Patient teaching

Tell patient to immediately report change in urination pattern, difficulty breathing, or swelling of throat or lips.
• Instruct patient to record blood pressure at various intervals daily.
• Tell patient to report dizziness, fainting, or light-headedness during initial therapy.
• Advise patient to increase fluid intake during exercise and in hot weather.
• Caution patient to avoid salt substitutes, which may cause hyperkalemia.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

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References in periodicals archive ?
The UV spectrum in mobile phase exhibits a relative absorption maximum at 240 nm for benazepril hydrochloride, benazepril impurity-E, benazepril impurity-4, benazepril impurity-C, benazepril impurity-F, benazepril impurity-2, benazepril impurity-B, benazepril impurity-D and benazepril impurity-G while at 217 nm for methyl benzenesulfonate, amlodipine impurity-D benazepril impurity-3 and amlodipine impurity-A.
Reddy's Laboratories (NYSE:RDY) revealed on Thursday the launch of its Amlodipine Besylate and Benazepril Hydrochloride capsules (5 mg/40 mg and 10 mg/40 mg) in the US market on 5 July 2011.
The company added the Amlodipine Besylate and Benazepril Hydrochloride capsules (5 mg/40 mg and 10 mg/40 mg) is the bio equivalent generic version of LOTREL capsules.
The findings show that initial fixed-dose combination therapy with amlodipine besylate and benazepril hydrochloride is preferable to monotherapy in this population, Dr.
The company said the amlodipine besylate and benazepril hydrochloride capsules are a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and benazepril, an angiotension converting enzyme (ACE) inhibitor.
These amlodipine besylate and benazepril hydrochloride capsules are reportedly the generic version of Novartis' Lotrel.
Benazepril Hydrochloride Tablets are the AB-rated generic equivalent of Novartis' antihypertensive agent Lotensin(R) Tablets.
Additionally, the FDA granted final approval for Mylan's ANDA for Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 5 mg/6.
Mylan is prepared to launch Benazepril Hydrochloride Tablets and Benazepril Hydrochloride and Hydrochlorothiazide Tablets beginning today.
Food and Drug Administration has granted tentative approval for the company's ANDA for Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg.