Zestoretic 20/25mg Tablets

Lisinopril is an ACE inhibitor that prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption and increased potassium retention), and decreased sympathetic activity. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. The combination provides additive antihypertensive effects and helps mitigate some of the electrolyte imbalances (e.g., hypokalemia) that can occur with HCTZ monotherapy.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
High Blood Sugar: Confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or fruity-smelling breath.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Fluid and Electrolyte Imbalance: Mood changes, confusion, muscle pain or weakness, irregular heartbeat, severe dizziness or fainting, increased thirst, seizures, fatigue, weakness, decreased appetite, changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Chest Pain or Persistent Cough: Seek medical attention if you experience chest pain or a cough that does not subside.
Severe Stomach Pain: Contact your doctor if you experience severe stomach pain.
Eye Problems: This medication can cause eye problems that may lead to permanent vision loss if left untreated. If you notice changes in vision or eye pain, usually within hours to weeks of starting the medication, contact your doctor immediately.
Liver Problems: In rare cases, this medication can cause liver damage, which can be fatal. Seek medical help if you experience dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes.
Skin Cancer: Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. Protect your skin from the sun and follow your doctor's recommendations for skin checks. Contact your doctor if you notice any changes in the size or color of a mole, or any new or changing skin growths.
Low White Blood Cell Count: This medication can increase the risk of infection, particularly in people with kidney problems or other underlying health conditions. Seek medical help if you experience fever, chills, or sore throat.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

Dizziness, fatigue, or weakness
Headache
* Cough

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A known sulfa allergy.
A history of angioedema, a severe and potentially life-threatening reaction characterized by symptoms such as:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Breathing difficulties
+ Swallowing problems
+ Unusual hoarseness
Kidney disease or any kidney problems.
Inability to urinate.
Current or recent use of specific medications, including:
+ Dofetilide
+ Lithium
+ Aliskiren-containing drugs, especially if you have diabetes or kidney problems
+ Sacubitril-containing drugs within the last 36 hours

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult your doctor.

Monitoring and Laboratory Tests
If you have diabetes, closely monitor your blood sugar levels. Regularly undergo blood work, blood pressure checks, and other laboratory tests as advised by your doctor. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

Potassium and Salt Interactions
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Additionally, if you are on a low-salt or salt-free diet, consult your doctor before continuing.

OTC Medications and Blood Pressure
Before using OTC products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor.

Interactions with Other Medications
If you are taking cholestyramine or colestipol, consult your pharmacist about the proper administration of these medications with this drug. Be aware of the potential for gout attacks.

Lupus and Other Conditions
If you have lupus, this medication may exacerbate or reactivate the condition. Immediately inform your doctor if you experience any new or worsening symptoms. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.

High Cholesterol and Triglycerides
This medication may cause increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor.

Angioedema and Other Serious Reactions
A severe and potentially life-threatening reaction called angioedema has been associated with this medication, with a higher risk in Black patients.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult your doctor to discuss potential risks to your baby.

• Aliskiren (in patients with diabetes or renal impairment (GFR < 60 mL/min/1.73 m2))
• Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of switching due to increased risk of angioedema

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect and increase risk of renal impairment (including acute renal failure) and hyperkalemia
• Lithium - increased serum lithium concentrations and toxicity
• Other antihypertensives - additive hypotensive effects
• Diuretics (other) - additive hypotensive effects
• Insulin and oral antidiabetic agents - HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic dosage
• Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia
• Digitalis glycosides - hypokalemia/hypomagnesemia induced by HCTZ may predispose to digitalis toxicity

• Allopurinol - increased risk of hypersensitivity reactions to allopurinol
• Colestipol and Cholestyramine resins - may delay or decrease absorption of HCTZ
• Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant
• Alcohol, barbiturates, or narcotics - may potentiate orthostatic hypotension

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or swallowing
• Persistent dry cough
• Muscle cramps or weakness
• Unusual tiredness or weakness
• Nausea, vomiting, or diarrhea
• Signs of dehydration (e.g., dry mouth, decreased urination)
• Symptoms of hyperkalemia (e.g., fatigue, muscle weakness, paresthesias, bradycardia)
• Symptoms of hypokalemia (e.g., muscle weakness, cramps, irregular heartbeat)
• Symptoms of gout (e.g., acute joint pain, swelling, redness)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, anuria, hypotension, and death). Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks.

Both Lisinopril and Hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypotension, hyperkalemia from Lisinopril; electrolyte disturbances, jaundice from HCTZ), use is generally not recommended. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to the hypotensive effects and renal impairment. Start with lower doses and monitor renal function and electrolytes closely.

• Zestoretic is a fixed-dose combination and should not be used for initial therapy in patients requiring individualized titration of Lisinopril and HCTZ.
• Monitor for angioedema, especially in the first few weeks of therapy. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk.
• A persistent dry cough is a common side effect of ACE inhibitors and usually resolves upon discontinuation.
• Educate patients about orthostatic hypotension (dizziness upon standing) and advise them to rise slowly from a sitting or lying position.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored, due to the risk of hyperkalemia from Lisinopril.
• Thiazide diuretics can increase serum uric acid and glucose levels; monitor these parameters, especially in patients with gout or diabetes.
• Patients should be advised to inform their healthcare provider if they become pregnant or plan to become pregnant, as this medication is contraindicated in the 2nd and 3rd trimesters.

• Other classes of antihypertensives (e.g., ARBs, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Lisinopril monotherapy
• Hydrochlorothiazide monotherapy

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.