Lotensin 20 mg/1

benazepril hydrochloride · TABLET · Validus Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage

Plain English

Lotensin is a tablet containing benazepril hydrochloride at 20 mg/1, taken oral. Manufactured by Validus Pharmaceuticals LLC.

Key Facts

Brand Name: Lotensin
Generic Name: benazepril hydrochloride
NDC Code (Product): 30698-449
Manufacturer: Validus Pharmaceuticals LLC
Strength: 20 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA019851
Marketing Start: 06/21/1991

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea465 reports

fatigue427 reports

drug ineffective418 reports

dizziness411 reports

dyspnoea398 reports

diarrhoea384 reports

pain380 reports

headache367 reports

myocardial infarction322 reports

hypertension311 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE Lotensin ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, …

Dosage & Administration

2. DOSAGE AND ADMINISTRATION Adult Patients: Initiate with 10 mg once daily (or 5 mg if patients is on diuretic). Titrate to 40 mg daily based on blood pressure response. ( 2.1 ) Pediatric patients age 6 years and above with glomerular filtration rate (GFR) >30 mL/min/1.73 m 2 : Initiate with 0.2 mg/kg once daily. Maximum dose is 0.6 mg/kg once daily. Renal Impairment: Initiate with 5 mg once daily in patients with GFR <30 mL/min/1.73 m 2 (serum creatinine >3 mg/dL) ( 2.2 ) 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 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 Lotensin in a patient on a diuretic is 5 mg once daily. If blood pressure is not controlled with Lotensin alone, a low dose of diuretic may be added. PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER …

Contraindications

4. CONTRAINDICATIONS Lotensin is contraindicated in patients: who are hypersensitive to benazepril or to any other ACE inhibitor with a history of angioedema with or without previous ACE inhibitor treatment Lotensin is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2) ]. Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin in patients with diabetes [see Drug Interactions (7.4) ] . Angioedema or history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Coadministration with aliskiren in patients with diabetes ( 4 )

Drug Interactions

7 . DRUG INTERACTIONS Diuretics: Excessive drop in blood pressure ( 7.1 ) Antidiabetics: Increased risk of hypoglycemia ( 7.2 ) NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.6 ) Neprilysin Inhibitor: Increased risk of angioedema ( 7.7 ) Gold: Nitritoid reactions ( 7.8 ) 7.1 Diuretics Hypotension 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 Lotensin. The possibility of hypotensive effects with Lotensin can be minimized by either discontinuing or decreasing the dose of diuretic prior to initiation of treatment with Lotensin [see Dosage and Administration (2.1) ]. Hyperkalemia Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently. Lotensin attenuates potassium loss c…

Adverse Reactions

6 . ADVERSE REACTIONS 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. Lotensin 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 Lotensin 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 Lotensin 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 Lotensin than placebo were headache (6% vs. 4%), dizziness (4% vs. 2%), somnolence (2% vs. 0%) and postural dizziness (2% vs. 0%). Adverse reactions reporte…

Frequently Asked Questions

What is Lotensin used for?

Lotensin contains benazepril hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Lotensin a controlled substance?

Lotensin is not classified as a controlled substance by the DEA.

What is the generic name for Lotensin?

The generic name for Lotensin is benazepril hydrochloride. There are 12 other brand versions of benazepril hydrochloride.

What is the NDC code for Lotensin 20 mg/1?

The NDC (National Drug Code) for Lotensin 20 mg/1 is 30698-449, listed by Validus Pharmaceuticals LLC.

Product NDC

30698-449

Package NDC

30698-449-01

Other Benazepril Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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