Zestoretic (lisinopril/hydrochlorothiazide)

Dosage of hydrochlorothiazide should be individualized according to the patient's requirements and response. The lowest dosage necessary to produce the desired clinical effect should be used. If hydrochlorothiazide is added to the regimen of a patient stabilized on a potent hypotensive agent, dosage of the hypotensive agent should initially be reduced to avoid the possibility of severe hypotension.

Hydrochlorothiazide is administered orally.

Lisinopril is administered orally as tablets or an oral solution. Lisinopril is also commercially available in fixed-combination tablets containing lisinopril and hydrochlorothiazide (Zestoretic(R)); see the full prescribing information for administration of this combination product.

Food does not alter the bioavailability of lisinopril tablets.

Store lisinopril tablets at controlled room temperature at 20--25degreesC. Protect from moisture, freezing, and excessive heat. Dispense in a tight container.

Store lisinopril oral solution at controlled room temperature at 20--25degreesC in a tight container. Protect from freezing and excessive heat.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of angioedema or hypersensitivity related to previous angiotensin-converting enzyme (ACE) inhibitor treatment.

*Hereditary or idiopathic angioedema.

*Concomitant use of lisinopril and aliskiren in patients with diabetes mellitus.

*Use in combination with a neprilysin inhibitor (e.g., sacubitril); do not administer lisinopril within 36 hours of switching to or from sacubitril/valsartan.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in >2% of patients receiving lisinopril for the management of hypertension and more frequently than with placebo include headache, dizziness, and cough.

Adverse effects reported in >2% of patients receiving lisinopril for the management of heart failure and more frequently than with placebo include hypotension and chest pain.

Adverse effects reported in >2% of patients receiving lisinopril for the management of acute MI and more frequently than with placebo include hypotension.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of lisinopril have been established in pediatric patients 6--16 years of age for treatment of hypertension. No important differences were observed in the adverse reaction profile between pediatric and adult patients.

Safety and efficacy of lisinopril have not been established in children <6 years of age or in pediatric patients with glomerular filtration rate <30 mL/minute per 1.73 m2.

If oliguria or hypotension occurs in neonates with a history of in utero exposure to lisinopril, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be necessary in order to reverse hypotension and/or substitute for disordered renal function.

Lisinopril can cause fetal harm when administered to pregnant females.

Use of medications that impact the RAS, such as lisinopril, during the second and third trimesters of pregnancy decreases fetal renal function and increases fetal/neonatal morbidity and mortality. Oligohydramnios caused by medications that act on the RAS can result in fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), anuria, hypotension, renal failure, and death.

Discontinue lisinopril as soon as possible when pregnancy is detected. In the rare case that there is no appropriate alternative to therapy with drugs affecting the RAS, apprise the mother of the potential hazard to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. Based on the week of pregnancy, fetal testing may be appropriate. However, patients and clinicians should be aware that oligohydramnios may not manifest until after the fetus has sustained irreversible injury. Closely observe neonates with a history of in utero exposure to lisinopril for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. To reverse hypotension and substitute for disordered renal function, exchange transfusions or dialysis may be required.

There are maternal and embryofetal risks associated with untreated hypertension during pregnancy. Hypertension in pregnancy increases the mother's risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications; hypertension also increases the fetal risk for intrauterine growth restriction and intrauterine death. Monitor pregnant females with hypertension carefully and manage accordingly.

Lisinopril is distributed into milk in rats; it is not known whether the drug is distributed into milk in humans. The effects of lisinopril on the breast-fed infant or on milk production are also unknown.

Because of the potential for serious adverse reactions in breastfeeding infants, advise women not to breast-feed during treatment with lisinopril.

The manufacturer makes no specific dosage recommendations for geriatric patients.

In a clinical study of lisinopril in patients with MI, 47% of patients were >=65 years of age, and 18% were >=75 years of age. In this study, 4.8% of patients >=75 years of age discontinued lisinopril because of renal dysfunction compared to 1.3% of patients <75 years of age. No other differences in safety or effectiveness were observed between geriatric and younger patients; however, greater sensitivity of some older individuals cannot be excluded.