Prescription Drug Information: Lisinopril with Hydrochlorothiazide (Page 5 of 5)

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.

DOSAGE AND ADMINISTRATION

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.

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 10/12.5 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.

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 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).

HOW SUPPLIED

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.

Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724

This Product was Repackaged By:

H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
United States

Label Image for 20/25mg

Label Image for 20/25mg
(click image for full-size original)
LISINOPRIL WITH HYDROCHLOROTHIAZIDE
lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-997(NDC:0143-1264)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL) LISINOPRIL 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
STARCH, CORN
FD&C BLUE NO. 2
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color RED (RED) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code WW;64
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-997-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:52959-997-60 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:52959-997-90 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:52959-997-02 120 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076265 01/01/2010
Labeler — H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company, Inc. 147681894 repack

Revised: 01/2010 H.J. Harkins Company, Inc.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.