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.
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.)
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 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. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10-80 mg and hydrochlorothiazide doses of 6.25-50 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 dose-independent 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.
A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to Lisinopril and Hydrochlorothiazide Tablets 10/12.5 mg or Lisinopril and Hydrochlorothiazide Tablets 20/12.5 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 10/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.
The combination may be substituted for the titrated individual components.
The usual regimens of therapy with lisinopril and hydrochlorothiazide need not be adjusted as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (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 is not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).
Lisinopril and Hydrochlorothiazide Tablets, 10/12.5 mg are Blue with White Mottling, Round, Unscored Tablet; Embossed “WW 62”.
Lisinopril and Hydrochlorothiazide Tablets, 20/12.5 mg are Yellow with White Mottling, Round, Unscored Tablet; Embossed “WW 63”.
Lisinopril and Hydrochlorothiazide Tablets, 20/25 mg are Peach-Red with White Mottling, Round, Unscored Tablet; Embossed “WW 64”.
They are supplied by H.J. Harkins Company, Inc. as follows:
|NDC||Strength||Quantity/Form||Color||Source Prod. Code|
|52959-997-30||20 mg / 25 mg||30 Tablets in a Plastic Bottle||RED||0143-1264|
|52959-997-60||20 mg / 25 mg||60 Tablets in a Plastic Bottle||RED||0143-1264|
|52959-997-90||20 mg / 25 mg||90 Tablets in a Plastic Bottle||RED||0143-1264|
|52959-997-02||20 mg / 25 mg||120 Tablets in a Plastic Bottle||RED||0143-1264|
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from excessive light and humidity.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
This Product was Repackaged By:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
| LISINOPRIL WITH HYDROCHLOROTHIAZIDE |
lisinopril and hydrochlorothiazide tablet
|Labeler — H.J. Harkins Company, Inc. (147681894)|
|H.J. Harkins Company, Inc.||147681894||repack|
Revised: 01/2010 H.J. Harkins Company, Inc.
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