y controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen may achieve similar or greater blood-pressure control without electrolyte disturbance if they are switched to lisinopril/HCTZ 10/12.5.
In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). If the patient's blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg of lisinopril should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).
Concomitant administration of ZESTORETIC with potassium supplements, potassium salt substitutes or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).
Replacement Therapy: The combination may be substituted for the titrated individual components.
Use in Renal Impairment: Regimens of therapy with lisinopril/HCTZ need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.7m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril/HCTZ is not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).
HOW SUPPLIED
ZESTORETIC 10-12.5 Tablets (NDC 0310-0141) Peach, round, biconvex, uncoated tablets identified with "141" debossed on one side and "ZESTORETIC" on the other side are supplied in bottles of 100 tablets.
ZESTORETIC 20-12.5 Tablets (NDC 0310-0142) White, round, biconvex, uncoated tablets identified with "142" debossed on one side and "ZESTORETIC" on the other side are supplied in bottles of 100 tablets.
ZESTORETIC 20-25 Tablets (NDC 0310-0145) Peach, round, biconvex, uncoated tablets identified with “145” debossed on one side and "ZESTORETIC" on the other side are supplied in bottles of 100 tablets.
Storage
Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from excessive light and humidity.
*AN69 is a registered trademark of Hospal Ltd.
ZESTORETIC is a trademark of the AstraZeneca group of companies.
© AstraZeneca 2009
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Rev. 02/2011
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ZESTORETIC
lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL and HYDROCHLOROTHIAZIDE) LISINOPRIL 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL &nb
