Drugplain

Lotensin HCT 20 mg/1

benazepril hydrochloride and hydrochlorothiazide · TABLET · Validus Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage
Plain English

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

Key Facts

Brand Name
Lotensin HCT
Generic Name
benazepril hydrochloride and hydrochlorothiazide
NDC Code (Product)
30698-453
Manufacturer
Validus Pharmaceuticals LLC
Strength
20 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA020033
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
05/30/1992

Recall History

No Recall History

Side Effects Reported to FDA

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

dizziness30 reports
diarrhoea24 reports
nausea23 reports
headache21 reports
pain19 reports
fatigue18 reports
hypertension18 reports
blood glucose increased17 reports
dyspnoea17 reports
vomiting16 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Lotensin HCT USP is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension ( see DOSAGE AND ADMINISTRATION ).

Dosage & Administration

DOSAGE AND ADMINISTRATION Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg. Switch Therapy: A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with Lotensin HCT. The usual recommended starting dose is 10/12.5 mg once daily to control blood pressure. Replacement Therapy: The combination may be substituted for the titrated individual components.

Warnings

WARNINGS 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) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: 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. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with Lotensin HCT should be discontinued and appropriate therapy instituted immediately. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine injection 1:1000 (0.3 - 0.5 mL) should be promptly administered ( see PRECAUTIONS and ADVERSE REACTIONS ). Black patients receiving AC…

Contraindications

CONTRAINDICATIONS Lotensin HCT is contraindicated in patients who are anuric. Lotensin HCT is also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Lotensin HCT is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Lotensin HCT is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin HCT within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin HCT in patients with diabetes.

Drug Interactions

Drug Interactions Neprilysin Inhibitors: Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema. Interactions Common for Both Benazepril and Hydrochlorothiazide Potassium Supplements and Potassium -Sparing Diuretics: Concomitant use with Lotensin HCT may effect potassium levels. Monitor potassium periodically. mTOR (mammalian target of rapamycin) inhibitor s : Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema ( see WARNINGS ). Lithium: Renal clearance of lithium is reduced by thiazides and increase the risk of lithium toxicity. Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. Monitor lithium levels when used concomitantly with Lotensin HCT. Dual Blockade of the Renin-Angiotensin System (RAS): Dual Blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypertension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most p…

Adverse Reactions

ADVERSE REACTIONS Lotensin HCT has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year. The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with Lotensin HCT and in 4% of patients treated with placebo. The most common reasons for discontinuation of therapy with Lotensin HCT in U.S. studies were cough (1.0%; see PRECAUTIONS ) , “dizziness” (1.0%), headache (0.6%), and fatigue (0.6%). 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 Lotensin HCT are shown in the table below. Reactions Possibly or Probably Drug Related Patients in U.S. Placebo-Controlled Studies LOTENSIN HCT N = 665 Placebo N = 235 N % N % “Dizziness” 41 6.3 8 3.4 Fatigue 34 5.2 6 2.6 Postural Dizziness 23 3.5 1 0.4 Headache 20 3.1 10 4.3 Cough 14 2.1 3 1.3 Hypertonia 10 1.5 3 1.3 …

Frequently Asked Questions

What is Lotensin HCT used for?

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

Is Lotensin HCT a controlled substance?

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

What is the generic name for Lotensin HCT?

The generic name for Lotensin HCT is benazepril hydrochloride and hydrochlorothiazide. There are 10 other brand versions of benazepril hydrochloride and hydrochlorothiazide.

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

The NDC (National Drug Code) for Lotensin HCT 20 mg/1 is 30698-453, listed by Validus Pharmaceuticals LLC.

Product NDC

30698-453

Package NDC

30698-453-01

Other Lotensin HCT Dosages

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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