Lisinopril and Hydrochlorothiazide

Description

Lisinopril is chemically described as (S)-1-N2-(1-carboxy-3-phenylpropyl)-L-lysyl-L-proline dihydrate, with an empirical formula of C21H31N3O5 • 2H2O. It is a white to off-white, crystalline powder with a molecular weight of 441.52. Lisinopril is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is identified as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, with an empirical formula of C7H8ClN3O4S2. This compound is a white, or practically white, crystalline powder with a molecular weight of 297.73 and is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP, are available for oral use in three tablet combinations: 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. The inactive ingredients in the 10 mg/12.5 mg tablets include dibasic calcium phosphate dihydrate, magnesium stearate, mannitol, and pregelatinized starch. The 20 mg/12.5 mg tablets contain dibasic calcium phosphate dihydrate, magnesium stearate, mannitol, pregelatinized starch, and yellow ferric oxide. The 20 mg/25 mg tablets consist of dibasic calcium phosphate dihydrate, magnesium stearate, mannitol, pregelatinized starch, and red ferric oxide.

Uses and Indications

Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure. Effective management of high blood pressure is essential for reducing the risk of both fatal and non-fatal cardiovascular events, particularly strokes and myocardial infarctions.

Control of hypertension should be integrated into a comprehensive cardiovascular risk management strategy, which includes lipid control, diabetes management, antithrombotic therapy, smoking cessation, regular exercise, and limited sodium intake. It is important to note that many patients may require more than one antihypertensive agent to achieve their blood pressure goals.

Clinical evidence from randomized controlled trials has demonstrated that numerous antihypertensive medications can significantly reduce cardiovascular morbidity and mortality, with blood pressure reduction being a key factor in these benefits. The most substantial and consistent cardiovascular outcome associated with blood pressure reduction is a decreased risk of stroke, along with reductions in myocardial infarction and overall cardiovascular mortality.

Elevated systolic or diastolic blood pressure is linked to increased cardiovascular risk, and even modest reductions in severe hypertension can yield considerable health benefits. The relative risk reduction from lowering blood pressure is consistent across various populations, with patients at higher baseline risk—such as those with diabetes or hyperlipidemia—experiencing greater absolute benefits.

It is also noted that some antihypertensive medications may exhibit smaller blood pressure-lowering effects when used as monotherapy in black patients. Additionally, many of these agents have other approved indications and therapeutic effects, including those related to angina, heart failure, or diabetic kidney disease.

Dosage and Administration

Lisinopril monotherapy is indicated at once-daily doses ranging from 10 mg to 80 mg. Hydrochlorothiazide monotherapy is effective at daily doses between 12.5 mg and 50 mg.

For patients requiring combination therapy, clinical trials have demonstrated that lisinopril can be administered in doses from 10 mg to 80 mg, while hydrochlorothiazide can be given in doses from 6.25 mg to 50 mg. In cases where blood pressure is not adequately controlled with either monotherapy, a switch to lisinopril and hydrochlorothiazide tablets at dosages of 10 mg/12.5 mg or 20 mg/12.5 mg may be considered.

Further increases in the dosage of either or both components should be based on the clinical response of the patient. It is recommended that the hydrochlorothiazide dose not be increased until 2 to 3 weeks have elapsed to allow for adequate assessment of the patient's response.

Dosages exceeding 80 mg of lisinopril and 50 mg of hydrochlorothiazide are not recommended. The combination therapy may be substituted for the titrated individual components without necessitating adjustments to the usual regimens, provided the patient's creatinine clearance remains greater than 30 mL/min/1.73 m².

Contraindications

Lisinopril and hydrochlorothiazide tablets are contraindicated in patients with hypersensitivity to any component of the formulation. The use of this product is also contraindicated in individuals with a history of angioedema associated with prior treatment using an angiotensin-converting enzyme (ACE) inhibitor, as well as in those with hereditary or idiopathic angioedema.

Due to the presence of hydrochlorothiazide, this medication is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Additionally, the combination of lisinopril and hydrochlorothiazide is contraindicated with neprilysin inhibitors, such as sacubitril; administration should not occur within 36 hours of switching to or from sacubitril/valsartan. Furthermore, coadministration of aliskiren with lisinopril and hydrochlorothiazide is contraindicated in patients with diabetes.

Warnings and Precautions

Patients receiving ACE inhibitors, including lisinopril, may experience serious adverse reactions, including anaphylactoid and possibly related reactions. It is crucial for healthcare professionals to be vigilant for signs of these reactions, as they can be life-threatening.

Angioedema has been reported rarely in patients treated with lisinopril and may occur at any time during therapy. If angioedema occurs, particularly with involvement of the tongue, glottis, or larynx, immediate discontinuation of lisinopril is necessary, along with appropriate therapy, which may include subcutaneous epinephrine and measures to ensure a patent airway. Additionally, intestinal angioedema has been documented in patients receiving ACE inhibitors, with symptoms resolving upon cessation of the medication.

Hypotension is another significant concern, particularly in patients who are salt or volume-depleted. Excessive hypotension may occur, necessitating careful monitoring of blood pressure, especially during the initial stages of treatment.

Neutropenia and agranulocytosis have been reported in rare cases, warranting periodic monitoring of white blood cell counts in patients receiving lisinopril. Furthermore, there is a risk of hepatic failure, as ACE inhibitors have been associated with a syndrome that can progress to hepatic necrosis and death. Caution is advised when using lisinopril in patients with severe renal disease or impaired hepatic function, as the concomitant use of hydrochlorothiazide may precipitate azotemia and hepatic coma.

General precautions should be taken in patients with aortic stenosis or hypertrophic cardiomyopathy, as lisinopril may exacerbate outflow tract obstruction. Changes in renal function can occur, particularly during the first few weeks of therapy; therefore, monitoring of renal function is essential. Additionally, serum potassium levels should be monitored, especially in patients with renal insufficiency or those taking potassium-sparing diuretics, due to the risk of hyperkalemia. A persistent nonproductive cough may develop in some patients, which typically resolves after discontinuation of the medication.

During major surgery or anesthesia, lisinopril may inhibit the formation of angiotensin II, potentially leading to hypotension.

Laboratory tests should include periodic determination of serum electrolytes to detect possible imbalances, as well as evaluation of renal function, which is critical in the assessment of hypertensive patients.

In the event of pregnancy, lisinopril and hydrochlorothiazide tablets should be discontinued immediately, and the patient should contact their healthcare provider.

Side Effects

Patients receiving treatment with PRINZIDE may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

Common adverse reactions observed in clinical trials include dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%), and orthostatic effects (3.2%). Other frequently reported reactions include diarrhea (2.5%), nausea (2.2%), upper respiratory infection (2.2%), muscle cramps (2.0%), asthenia (1.8%), paresthesia (1.5%), hypotension (1.4%), vomiting (1.4%), dyspepsia (1.3%), rash (1.2%), and impotence (1.2%).

In addition to these common reactions, patients may experience a variety of additional adverse effects. These include chest pain, abdominal pain, syncope, chest discomfort, fever, and viral infections. Cardiovascular effects may manifest as palpitations and orthostatic hypotension. Digestive system reactions can include gastrointestinal cramps, dry mouth, constipation, and heartburn. Musculoskeletal complaints such as back pain, shoulder pain, knee pain, and myalgia have also been reported.

Nervous system and psychiatric effects may include decreased libido, vertigo, depression, and somnolence. Respiratory issues such as common cold, nasal congestion, influenza, bronchitis, and dyspnea have been noted, along with skin reactions like flushing, pruritus, and skin inflammation. Special senses may be affected, leading to blurred vision and tinnitus, while urogenital issues may include urinary tract infections.

Serious warnings associated with PRINZIDE include the risk of angioedema, which has been reported more frequently in Black patients. This condition can lead to laryngeal edema and may be fatal; therefore, immediate discontinuation of therapy and appropriate treatment are necessary if symptoms occur. Hypotension-related adverse effects were noted in clinical trials, with hypotension occurring in 1.4% of patients, orthostatic hypotension in 0.5%, and syncope in 0.8%. Additionally, a persistent nonproductive cough has been reported with all ACE inhibitors, resolving upon discontinuation of therapy.

Specific adverse reactions related to hydrochlorothiazide include weakness, anorexia, gastric irritation, jaundice, pancreatitis, and renal dysfunction. Hematologic reactions such as leukopenia, agranulocytosis, and thrombocytopenia have also been observed. Skin reactions can be severe, including erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis. Furthermore, hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer, particularly squamous cell carcinoma in white patients receiving large cumulative doses.

Patients should be monitored for these adverse reactions, and appropriate management strategies should be implemented as necessary.

Drug Interactions

Patients receiving lisinopril should be aware of several important drug interactions that may affect their treatment outcomes and safety.

Pharmacodynamic Interactions:

• Co-administration of non-steroidal anti-inflammatory drugs (NSAIDs) with lisinopril may lead to a deterioration in renal function, particularly in elderly or volume-depleted patients. It is advisable to monitor renal function closely in these individuals. Additionally, the antihypertensive effect of lisinopril may be diminished by NSAIDs.

• The use of diuretics in conjunction with lisinopril may result in hypotension upon initiation of lisinopril therapy. It is recommended to consider discontinuing the diuretic or increasing salt intake prior to starting lisinopril.

• Dual blockade of the renin-angiotensin system (RAS) with lisinopril and other agents can heighten the risk of hypotension, hyperkalemia, and alterations in renal function. Close monitoring is warranted in these cases.

• Patients taking neprilysin inhibitors or mTOR inhibitors (e.g., temsirolimus) alongside lisinopril may experience an increased risk of angioedema.

• Rare nitritoid reactions, characterized by facial flushing and hypotension, have been reported with the use of injectable gold in combination with lisinopril.

Pharmacokinetic Interactions:

• The concurrent use of aliskiren with lisinopril is contraindicated in diabetic patients and in individuals with renal impairment (GFR <60 ml/min).

• Lisinopril may elevate serum potassium levels when administered with potassium-sparing diuretics or potassium supplements; therefore, monitoring of serum potassium levels is recommended.

• Lithium toxicity may occur with the concurrent use of lisinopril, necessitating frequent monitoring of serum lithium levels.

Hydrochlorothiazide Interactions:

• When hydrochlorothiazide is used, patients should be cautious of potential interactions with alcohol, barbiturates, or narcotics, as these substances may enhance the risk of orthostatic hypotension.

• Adjustments to antidiabetic drug dosages may be required when hydrochlorothiazide is co-administered.

• The absorption of hydrochlorothiazide can be significantly impaired by cholestyramine and colestipol resins, potentially reducing absorption by up to 85% and 43%, respectively.

• Corticosteroids may exacerbate electrolyte depletion, particularly hypokalemia, when used in conjunction with hydrochlorothiazide.

• Non-steroidal anti-inflammatory drugs may diminish the effectiveness of diuretics, necessitating close monitoring of patient response.

Packaging & NDC

The table below lists all NDC Code configurations of Lisinopril and Hydrochlorothiazide (lisinopril and hydrochlorothiazide tablets), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly neonates with a history of in utero exposure to lisinopril and hydrochlorothiazide tablets, require careful monitoring. In cases where oliguria or hypotension is observed, it is essential to focus on supporting blood pressure and renal perfusion. Management may necessitate interventions such as exchange transfusions or dialysis to address hypotension and/or to compensate for impaired renal function.

Lisinopril, which is known to cross the placenta, has been effectively removed from neonatal circulation through peritoneal dialysis, demonstrating some clinical benefit. Although theoretically, exchange transfusion may also facilitate the removal of lisinopril, there is currently no clinical experience to support this procedure in practice.

Geriatric Use

Clinical studies of lisinopril and hydrochlorothiazide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience has not identified significant differences in responses between elderly patients and younger patients.

In general, dose selection for geriatric patients should be approached with caution. It is advisable to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies.

A multiple-dose pharmacokinetic study comparing elderly versus young hypertensive patients revealed that the area under the plasma concentration time curve (AUC) increased approximately 120% for lisinopril and approximately 80% for hydrochlorothiazide in older patients. This indicates that elderly patients may experience higher systemic exposure to these medications.

Given that this drug is substantially excreted by the kidneys, the risk of toxic reactions may be greater in patients with impaired renal function. Therefore, careful consideration should be given to dose selection in elderly patients, who are more likely to have decreased renal function. It is essential that the evaluation of hypertensive patients includes a thorough assessment of renal function to ensure safe and effective treatment.

Pregnancy

Lisinopril-Hydrochlorothiazide is not indicated for use during pregnancy due to the associated risks to the developing fetus. The use of lisinopril during pregnancy is contraindicated, as it may cause potential harm to fetal outcomes. Hydrochlorothiazide is also not recommended for use in pregnant patients.

While animal studies have not demonstrated adverse effects on reproductive performance, this does not ensure safety in human pregnancies. Therefore, the use of lisinopril and hydrochlorothiazide during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Healthcare professionals are advised to consider alternative treatments for managing hypertension in pregnant patients.

Lactation

It is not known whether lisinopril is excreted in human milk. However, studies in lactating rats have shown that the milk contains radioactivity following the administration of 14C lisinopril, with another study indicating that lisinopril was present in rat milk at levels comparable to plasma levels in the dams. Thiazides, which are components of the combination, do appear in human milk.

Due to the potential for serious reactions in breastfed infants from ACE inhibitors and hydrochlorothiazide, healthcare professionals should consider the importance of lisinopril and hydrochlorothiazide tablets to the mother when making a decision to either discontinue nursing or discontinue the medication.

Renal Impairment

Patients with renal impairment should be treated with caution, particularly when using thiazides, as these agents may precipitate azotemia and exhibit cumulative effects in individuals with reduced kidney function. In cases of severe renal disease, careful monitoring is essential.

The use of lisinopril in patients with renal impairment necessitates periodic monitoring of white blood cell counts, especially in those with collagen vascular diseases, due to the risk of neutropenia and agranulocytosis. Although clinical trial data for lisinopril are insufficient to definitively rule out similar rates of agranulocytosis as seen with captopril, marketing experience has indicated rare instances of neutropenia and bone marrow depression.

In patients with severe congestive heart failure, whether or not accompanied by renal insufficiency, there is a risk of excessive hypotension, which may lead to oliguria, progressive azotemia, and, in rare cases, acute renal failure or death. Therefore, initiation of therapy should occur under close medical supervision, with vigilant monitoring during the first two weeks of treatment and following any dose adjustments of lisinopril or diuretics.

Patients receiving concurrent therapy with an ACE inhibitor and mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) or neprilysin inhibitors may face an increased risk of angioedema. Additionally, while excessive hypotension is rarely observed in uncomplicated hypertensive patients, it can occur in those who are salt/volume-depleted, such as individuals undergoing vigorous diuretic treatment or those on dialysis.

In the event of hypotension, the patient should be positioned supine, and if necessary, an intravenous infusion of normal saline should be administered. A transient hypotensive response does not contraindicate further doses, which can typically be given without issue once blood pressure stabilizes following volume expansion.

Hepatic Impairment

Patients with hepatic impairment may experience an increased risk of adverse effects when treated with ACE inhibitors. Rarely, these medications have been associated with a syndrome that begins with cholestatic jaundice or hepatitis and can progress to fulminant hepatic necrosis, and in some cases, death. The underlying mechanism of this syndrome remains unclear.

In patients receiving ACE inhibitors, if jaundice or significant elevations in hepatic enzymes are observed, it is imperative to discontinue the ACE inhibitor immediately and ensure appropriate medical follow-up is provided.

Thiazide diuretics should be administered with caution in patients with impaired hepatic function or those with progressive liver disease. Minor alterations in fluid and electrolyte balance in these patients may precipitate hepatic coma, necessitating careful monitoring and potential dosage adjustments.

Overdosage

In cases of overdosage with lisinopril and hydrochlorothiazide tablets, specific treatment protocols are not established; therefore, management is primarily symptomatic and supportive.

Potential Symptoms The most significant manifestation of overdosage is likely to be hypotension. In such instances, the recommended intervention is the intravenous infusion of normal saline solution to restore hemodynamic stability.

Management Procedures Lisinopril can be effectively removed from the system through hemodialysis, which may be considered in severe cases of overdose.

While studies involving the oral administration of a single dose of 10 g/kg of hydrochlorothiazide in mice and rats did not result in lethality, it is important to note that excessive diuresis can lead to electrolyte depletion and dehydration.

Additionally, if digitalis has been co-administered, there is a risk that hypokalemia may exacerbate cardiac arrhythmias, necessitating careful monitoring and management of potassium levels.

Healthcare professionals are advised to provide supportive care and monitor the patient closely for any complications arising from overdosage.

Nonclinical Toxicology

There were no adverse effects on reproductive performance observed in male and female rats treated with lisinopril at doses up to 300 mg/kg/day, which is 33 times the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis. Similarly, hydrochlorothiazide did not adversely affect the fertility of mice and rats of either sex when administered via diet at doses of up to 100 mg/kg and 4 mg/kg, respectively, prior to conception and throughout gestation. These doses correspond to 9 times and 0.7 times the MRHDD based on body surface area.

No evidence of tumorigenic effects was noted when lisinopril was administered orally for 105 weeks to male and female rats at doses up to 90 mg/kg/day or for 92 weeks to male and female mice at doses up to 135 mg/kg/day, which are 10 times and 7 times the MRHDD, respectively, on a body surface area basis. Additionally, two-year feeding studies conducted by the National Toxicology Program (NTP) revealed no carcinogenic potential for hydrochlorothiazide in female mice at doses up to approximately 600 mg/kg/day (53 times the MRHDD) or in male and female rats at doses up to approximately 100 mg/kg/day (18 times the MRHDD). However, the NTP did find equivocal evidence for hepatocarcinogenicity in male mice.

Lisinopril in combination with hydrochlorothiazide was not found to be mutagenic in microbial mutagen tests using Salmonella typhimurium or Escherichia coli, with or without metabolic activation, nor in a forward mutation assay using Chinese hamster lung cells. Furthermore, this combination did not induce DNA single strand breaks in an in vitro alkaline elution assay using rat hepatocytes, nor did it result in increases in chromosomal aberrations in both in vitro tests in Chinese hamster ovary cells and in vivo studies in mouse bone marrow. Lisinopril alone also demonstrated a lack of mutagenicity in the Ames test and did not produce chromosomal aberrations in the aforementioned assays.

Hydrochlorothiazide was not genotoxic in in vitro assays, including the Ames mutagenicity assay with various strains of Salmonella typhimurium and the Chinese Hamster Ovary test for chromosomal aberrations, nor in in vivo assays involving mouse germinal cell chromosomes and Chinese hamster bone marrow chromosomes. Positive results were only observed in the in vitro CHO Sister Chromatid Exchange and Mouse Lymphoma Cell assays at specific concentrations, as well as in the Aspergillus nidulans non-disjunction assay at an unspecified concentration.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Angioedema has been documented in patients receiving PRINZIDE, with a higher incidence observed in Black patients compared to non-Black patients. This condition, particularly when associated with laryngeal edema, may be fatal. In cases of angioedema affecting the face, extremities, lips, tongue, glottis, and/or larynx, discontinuation of PRINZIDE and immediate initiation of appropriate therapy is recommended. Additionally, rare instances of intestinal angioedema have been reported in patients treated with angiotensin-converting enzyme (ACE) inhibitors, including lisinopril. These patients often presented with abdominal pain, with or without nausea or vomiting, and in some cases, there was no prior history of facial angioedema, and C-1 esterase levels were normal. Diagnosis of intestinal angioedema was made through abdominal CT scans, ultrasounds, or surgical procedures, with symptom resolution following the cessation of the ACE inhibitor.

Hypotension-related adverse effects were noted in clinical trials, with an incidence of hypotension at 1.4%, orthostatic hypotension at 0.5%, and other orthostatic effects at 3.2%. Syncope occurred in 0.8% of patients.

Rare cases of neutropenia, thrombocytopenia, and bone marrow depression have also been reported. Hemolytic anemia has been documented, although a causal relationship with lisinopril cannot be excluded.

Patients with a history of angioedema unrelated to ACE-inhibitor therapy may be at an increased risk of developing angioedema while receiving an ACE inhibitor. Furthermore, coadministration of an ACE inhibitor with mTOR inhibitors (such as temsirolimus, sirolimus, or everolimus) or a neprilysin inhibitor may elevate the risk of angioedema.

Patient Counseling

Healthcare providers should advise patients to discontinue lisinopril and hydrochlorothiazide tablets as soon as pregnancy is detected. It is important to inform patients that drugs acting directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Patients should be instructed to report immediately any signs or symptoms of angioedema, which may include swelling of the face, extremities, eyes, lips, or tongue, as well as difficulty in swallowing or breathing. They should be advised to refrain from taking any additional doses until they have consulted with their prescribing physician.

Caution patients to be aware of lightheadedness, particularly during the initial days of therapy. If they experience actual syncope, they should discontinue the medication and consult their physician before resuming.

All patients should be made aware that excessive perspiration and dehydration can lead to a significant drop in blood pressure due to reduced fluid volume. They should also be informed that other causes of volume depletion, such as vomiting or diarrhea, may similarly affect blood pressure, and they should consult their physician if these situations arise.

Patients should be advised against using salt substitutes that contain potassium without prior consultation with their physician. Additionally, they should be instructed to report any signs of infection, such as a sore throat or fever, as these may indicate neutropenia.

Female patients of childbearing age should be counseled on the potential consequences of exposure to lisinopril and hydrochlorothiazide tablets during pregnancy. It is essential to discuss treatment options with women who are planning to become pregnant, and they should be encouraged to report any pregnancies to their physicians as soon as possible.

For patients taking hydrochlorothiazide, it is important to instruct them to protect their skin from sun exposure and to undergo regular skin cancer screenings.

Patients experiencing any side effects are encouraged to report them to Solco Healthcare US, LLC at 1-866-257-2597 or to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied in a well-closed container to ensure integrity, particularly if the package has been subdivided. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F) as defined by USP Controlled Room Temperature guidelines. Additionally, it is essential to protect the product from excessive light and humidity to maintain its quality and efficacy.

Additional Clinical Information

Periodic determination of serum electrolytes is recommended to monitor for potential electrolyte imbalances in patients, particularly during episodes of excessive vomiting or when receiving parenteral fluids. Clinicians should be aware that thiazide diuretic therapy may lead to increases in cholesterol and triglyceride levels, and thiazides should be discontinued prior to conducting tests for parathyroid function.

Patients should be counseled on several important safety considerations. They must report any signs of angioedema, such as swelling of the face or difficulty breathing, and should not take additional medication until consulting their physician. Lightheadedness, especially in the initial days of therapy, should be reported, and if syncope occurs, patients should discontinue the drug and seek medical advice. Patients are also advised to be cautious of excessive perspiration and dehydration, which can lead to significant drops in blood pressure. Additionally, they should avoid potassium-containing salt substitutes without prior consultation. Signs of infection, such as sore throat or fever, should prompt immediate reporting due to the risk of neutropenia. Female patients of childbearing age should be informed about the risks associated with the use of lisinopril and hydrochlorothiazide during pregnancy and should report any pregnancies to their healthcare provider. Lastly, those taking hydrochlorothiazide should be instructed to protect their skin from sun exposure and to undergo regular skin cancer screenings.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Lisinopril and Hydrochlorothiazide as submitted by Solco Healthcare LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)