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Lotensin Hct

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Lotensin Hct

Indications
Dosage
How Supplied

INDICATIONS

Lotensin HCT is indicated for the treatment of hypertension.

This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

In using Lotensin HCT, 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 does not have a similar risk (see WARNINGS, Neutropenia/ Agranulocytosis).

Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks.

DOSAGE AND ADMINISTRATION

Benazepril is an effective treatment of hypertension in once-daily doses of 10-80 mg, while hydrochlorothiazide is effective in doses of 12.5-50 mg per day. In clinical trials of benazepril/hydrochlorothiazide combination therapy using benazepril doses of 5-20 mg and hydrochlorothiazide doses of 6.25-25 mg, the antihypertensive effects increased with increasing dose of either component.

The side effects (see WARNINGS) of benazepril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of benazepril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens in which benazepril is combined with low doses of hydrochlorothiazide produce minimal effects on serum potassium. In clinical trials of Lotensin HCT, the average change in serum potassium was near zero in subjects who received 5/6.25 mg or 20/12.5 mg, but the average subject who received 10/12.5 mg or 20/25 mg experienced a mild reduction in serum potassium, similar to that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Dose Titration Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with benazepril monotherapy may be switched to Lotensin HCT 10/12.5 or Lotensin HCT 20/12.5. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar blood-pressure control without electrolyte disturbance if they are switched to Lotensin HCT 5/6.25.

Replacement Therapy

The combination may be substituted for the titrated individual components.

Use in Renal Impairment

Regimens of therapy with Lotensin HCT need not take account of renal function as long as the patient's creatinine clearance is > 30 mL/min/1.73m2 (serum creatinine roughly ≤ 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Lotensin HCT is not recommended (see WARNINGS).

HOW SUPPLIED

Lotensin HCT is available in tablets of four different strengths:

Benazepril Hydrochlorothiazide Tablet Color
5 mg
6.25 mg
white
10 mg
12.5 mg
light pink
20 mg
12.5 mg
grayish-violet
20 mg
25 mg
red

Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets.

The National Drug Codes for the various packages are

Dose Bottle of 100 Tablet Imprint
5/6.25
NDC 0078-0451-05
57
10/12.5
NDC 0078-0452-05
72
20/12.5
NDC 0078-0453-05
74
20/25
NDC 0078-0454-05
75

Tablets are oblong and scored, with “Lotensin HCT” on one side and appropriate number imprinted on the other side.

Storage

Do not store above 30°C (86°F). Protect from moisture and light. Dispense in tight, light-resistant container (USP).

Manufactured by: Novartis Pharmaceuticals Corporation Suffern, New York 10901. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: 01/2012

Last reviewed on RxList: 1/27/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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