Lisinopril-Hydrochlorothiazide (lisinopril/hydrochlorothiazide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Hydrochlorothiazide is a thiazide diuretic and antihypertensive agent.
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor.
Lisinopril is an inhibitor of angiotensin-converting enzyme (ACE, bradykinase, kininase II), the peptidyl dipeptidase that catalyzes the conversion of angiotensin I to angiotensin II. Angiotensin II is a vasoconstrictor that also stimulates aldosterone secretion; inhibition of ACE results in decreased plasma angiotensin II, leading to reduced vasopressor activity and aldosterone secretion. ACE also degrades bradykinin, a potent vasodepressor, although it is unknown whether increased levels of bradykinin play a role in the therapeutic effects of lisinopril.
The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. However, lisinopril is antihypertensive even in patients with low-renin hypertension.
The onset of antihypertensive activity was observed at 1 hour following oral administration of a single dose of lisinopril, with peak reduction of blood pressure achieved by 6 hours. Although an antihypertensive effect was observed 24 hours after dosing with recommended single daily doses, the effect was more consistent and the mean effect was considerably larger in some studies with doses of >=20 mg than with lower doses. However, at all doses studied, the mean antihypertensive effect was substantially smaller 24 hours after dosing than at 6 hours after dosing.
In adults, peak serum concentrations occur within about 7 hours of oral administration of lisinopril tablets; there was a trend toward a small delay in time taken to reach peak serum concentrations in patients with acute myocardial infarction (MI). Based on urinary recovery, the mean extent of absorption of lisinopril is approximately 25%, with considerable intersubject variability (6--60%) at all doses tested (5--80 mg). In patients with stable New York Heart Association Class II--IV congestive heart failure, the absolute bioavailability of lisinopril is reduced to 16%.
In patients with acute MI, the oral bioavailability of lisinopril is similar to that in healthy volunteers. Food does not alter the bioavailability of lisinopril tablets. Lisinopril oral solution is bioequivalent to lisinopril tablets under fasted and fed conditions.
Declining serum concentrations of lisinopril exhibit a prolonged terminal phase, which likely represents saturable binding to ACE and is not proportional to dose. This terminal phase does not contribute to drug accumulation. Lisinopril does not appear to bind to serum proteins.
Studies in rats indicate that lisinopril crosses the blood brain barrier poorly. Lisinopril does not undergo metabolism; it is excreted unchanged entirely in the urine. The effective half-life of lisinopril after multiple dosing is 12 hours.
USES: This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications, lisinopril and hydrochlorothiazide.
Lisinopril belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is a "water pill" (diuretic) that causes you to make more urine.
This helps your body get rid of extra water and salt.
Generic name: lisinopril/hydrochlorothiazide
Pronunciation: (lye-SIN-oh-pril/HYE-droe-KLOR-oh-THYE-a-zide)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Lisinopril-Hydrochlorothiazide
Indications
The following indications are listed for Lisinopril-Hydrochlorothiazide:
- Hypertension
Also known as: Elevated Blood Pressure, Essential Hypertension, Hyperpiesia, Hyperpiesis, Hypertensive Disorder, Systemic Arterial Hypertension.
Dosing
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.
Drug interactions
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.
Contraindications
*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 reactions
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.
Precautions
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.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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