ZESTORETIC

). Patients in whom lisinopril and diuretic are initiated simultaneously can develop symptomatic hypotension (see 9 DRUG INTERACTIONS). ZESTORETIC is not indicated for the treatment of renovascular hypertension (see 7 WARNINGS AND PRECAUTIONS, Hypotension).

3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS ZESTORETIC (lisinopril and hydrochlorothiazide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see

4 Drug-Drug Interactions) 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • When used in pregnancy, ACE inhibitors can cause injury or even death of the developing fetus. 1 Pregnant Women). 1 Dosing Considerations • Dosage must be individualized.

The fixed combination is not for initial therapy. The dose of ZESTORETIC (lisinopril and hydrochlorothiazide) should be determined by the titration of the individual components. • Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily, particularly when combined with antihypertensive agents.

2 Recommended Dose and Dosage Adjustment Patients should be titrated on the individual drugs. If the fixed combination represents the dosage determined by this titration, the use of ZESTORETIC may be more convenient in the management of patients.

If during maintenance therapy dosage adjustment is necessary, it is advisable to use individual drugs. 5 mg or 20 mg / 25 mg tablets once daily may be substituted if the titrated doses are the same as those in the fixed combination (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS).

Lisinopril monotherapy For lisinopril monotherapy the recommended initial dose in patients not on diuretics is 10 mg of lisinopril once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range of lisinopril is 10 to 40 mg administered in a single daily dose.

The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours.

If it is not, an increase in dose should be considered. The maximum dose used in long-term controlled clinical trials was 80 mg/day. ZESTORETIC® Product Monograph Page 6 of 53 If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added.

, Hypotension). 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS ZESTORETIC (lisinopril and hydrochlorothiazide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

1 Pregnant Women and

ZESTORETIC (lisinopril and hydrochlorothiazide) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. 4 Drug-Drug Interactions)