Lisinopril and Hydrochlorothiazide

International Labs, Inc.

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP - PACKAGE LABELS

FULL PRESCRIBING INFORMATION: CONTENTS*

• LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• LISINOPRIL AND HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE
• LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS
• OVERDOSAGE
• LISINOPRIL AND HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• USE IN PREGNANCY
• LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP 20 25 mg

FULL PRESCRIBING INFORMATION

LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION

CLINICAL PHARMACOLOGY

LISINOPRIL AND HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE

Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.) In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.)

LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS

Lisinopril and hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin
converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. 

WARNINGS

PRECAUTIONS

LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS

OVERDOSAGE

No specific information is available on the treatment of overdosage with lisinopril and hydrochlorothiazide. Treatment is symptomatic and supportive. Therapy with lisinopril and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include induction of emesis and/ or gastric lavage, and correction of dehydration, electrolyte imbalance and hypotension by established procedures.
Lisinopril
Following a single oral dose of 20 mg/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis. (See WARNINGS, Anaphylactoid reactions during membrane exposure.)
Hydrochlorothiazide
Oral administration of a single oral dose of 10 mg/kg to mice and rats was not lethal. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia,  hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

LISINOPRIL AND HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION

Lisinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component. The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and doseindependent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics. 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 either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg. 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 or greater blood pressure control with less potassium loss if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.
Replacement Therapy
The combination may be substituted for the titrated individual components.
Use in Renal Impairment
The usual regimens of therapy with lisinopril and hydrochlorothiazide tablets need not be adjusted as long as the patient’s creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine approximately ≤3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).

HOW SUPPLIED

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP 20 25 mg

Lisinopril HCTZ Tablets USP 20 25 mg