Lisinopril-HCTZ 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 decreased sympathetic activity. It also inhibits the degradation of bradykinin, a vasodilator. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion. The combination provides additive antihypertensive effects and helps mitigate some of the electrolyte imbalances (e.g., hypokalemia from HCTZ, hyperkalemia from Lisinopril).

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Chest pain
Persistent cough
Severe stomach pain
Eye problems, such as changes in vision or eye pain, which can lead to permanent vision loss if left untreated
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Changes in skin, such as new or changing moles, lumps, or growths, which can be a sign of skin cancer
Signs of infection, such as fever, chills, or sore throat, which can be a sign of low white blood cell count

Other Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, tired, or weak
Headache
Cough

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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, such as foods or drugs. Describe the allergic reaction you experienced, including the 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 existing treatments and health status. Never start, stop, or adjust the dose of any medication without consulting your doctor.

Important Warnings and Precautions

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
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.

Interactions with Other Substances
Discuss with your doctor before consuming alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness.

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 healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

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

Over-the-Counter Product Interactions
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, and certain natural products or aids, consult with your doctor.

Interactions with Other Medications
If you are taking cholestyramine or colestipol, consult with 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, be cautious and 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 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Aliskiren (in patients with diabetes or renal impairment)
• Sacubitril/valsartan (Entresto) - concurrent use or within 36 hours of ACE inhibitor

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• Lithium - increased lithium levels and toxicity (due to reduced renal clearance by both components)
• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment (especially in elderly, volume-depleted, or renally impaired patients)
• Other antihypertensives - additive hypotensive effects
• Insulin and oral antidiabetic agents - may enhance hypoglycemic effect of antidiabetics (HCTZ can cause hyperglycemia, Lisinopril can enhance insulin sensitivity)

• Corticosteroids - may antagonize diuretic effect of HCTZ
• Cholestyramine and colestipol resins - may impair absorption of HCTZ
• Digitalis glycosides - increased risk of digitalis toxicity with HCTZ-induced hypokalemia
• Muscle relaxants, non-depolarizing - enhanced effect
• Allopurinol - increased risk of hypersensitivity reactions with HCTZ
• Cyclosporine - increased risk of hyperkalemia and renal dysfunction

• Alcohol - additive hypotensive effect
• Barbiturates, narcotics - additive hypotensive effect

• Dizziness or lightheadedness (especially upon standing)
• Persistent dry cough
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or swallowing
• Unusual fatigue or weakness
• Muscle cramps or weakness (electrolyte imbalance)
• Signs of dehydration (excessive thirst, dry mouth)
• Symptoms of hyperkalemia (palpitations, muscle weakness, paresthesias)
• Symptoms of hyponatremia (headache, confusion, nausea, seizures)
• Symptoms of gout (joint pain, swelling)

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Use during the first trimester is generally discouraged due to potential risks, though less severe than later trimesters. If pregnancy is detected, discontinue as soon as possible.

Use with caution. Both Lisinopril and Hydrochlorothiazide are excreted in breast milk. The American Academy of Pediatrics considers Lisinopril compatible with breastfeeding, but HCTZ is considered to have a potential for adverse effects on the infant (e.g., electrolyte disturbances, dehydration) and may decrease milk supply. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

Use with caution, generally starting with lower doses. Elderly patients may be more sensitive to the hypotensive and electrolyte effects (e.g., hyponatremia, hyperkalemia) and may have age-related decline in renal function, requiring closer monitoring of renal function and electrolytes.

• This combination is often used when monotherapy with an ACE inhibitor or a diuretic alone is insufficient to control blood pressure.
• The 20/25mg strength is a higher dose combination, typically for patients who require more aggressive blood pressure control.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but life-threatening side effect of ACE inhibitors.
• Monitor for orthostatic hypotension, especially at initiation, with dose increases, or in volume-depleted patients.
• Counsel patients on avoiding potassium supplements or salt substitutes unless specifically instructed by their physician due to the Lisinopril component.
• Thiazide diuretics can increase blood glucose and uric acid levels, requiring monitoring in diabetic or gout-prone patients.

• Other classes of antihypertensives (e.g., Calcium Channel Blockers, Beta-blockers, ARBs, direct vasodilators)
• Monotherapy with an ACE inhibitor (e.g., Lisinopril) or a thiazide diuretic (e.g., Hydrochlorothiazide) if blood pressure is adequately controlled.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.