Lisinopril-HCTZ 10/12.5mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Important Considerations
This medication may increase your urine production, so it's essential to drink plenty of non-caffeinated fluids unless your doctor advises you to limit your fluid intake.
To minimize sleep disturbances, try to avoid taking your medication too close to bedtime.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture.
Keep your medication in a dry place, away from the bathroom.
Store all medications in a safe and secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking this medication without talking to your doctor, even if you feel well.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
- Limit alcohol intake, as it can increase the blood pressure-lowering effect and dizziness.
- Follow a low-sodium diet as recommended by your doctor.
- Engage in regular physical activity and maintain a healthy weight.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
- Inform your doctor or dentist that you are taking this medication before any surgery or dental procedures.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of 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.
Severe stomach pain.
Eye problems, such as changes in vision or eye pain, which can lead to permanent vision loss if left untreated. These symptoms usually occur within hours to weeks of starting the medication.
Liver problems, which can be life-threatening: dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes.
Skin cancer: rare cases have been reported in people taking hydrochlorothiazide. Protect your skin from the sun and follow your doctor's recommendations for skin checks. Report any changes in mole size or color, or new or changing skin growths to your doctor immediately.
Low white blood cell count, which can increase the risk of infection, particularly in people with kidney problems or other underlying health conditions. Seek medical attention if you experience fever, chills, or sore throat.
Other Possible Side Effects
Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, fatigue, or weakness.
Headache.
* Cough.
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
- Severe dizziness, fainting, or lightheadedness.
- Persistent dry cough.
- Signs of electrolyte imbalance: unusual muscle weakness, cramps, irregular heartbeat, extreme thirst, confusion.
- Signs of kidney problems: little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
- Signs of liver problems: nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
- Signs of high uric acid/gout: joint pain, swelling, redness.
- Blurred vision or eye pain (may be signs of acute angle-closure glaucoma, seek immediate medical attention).
Before Using This Medicine
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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & 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 understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 Considerations
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.
Over-the-Counter Medications and Natural Products
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, 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.
Cholesterol and Triglyceride Considerations
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.
Overdose Information
Overdose Symptoms:
- Severe hypotension (low blood pressure)
- Dizziness, lightheadedness, fainting
- Tachycardia (rapid heart rate) or bradycardia (slow heart rate)
- Electrolyte imbalances (e.g., severe hypokalemia, hyperkalemia, hyponatremia)
- Dehydration
- Renal failure
What to Do:
In case of suspected overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic, including intravenous fluid administration for hypotension, correction of electrolyte imbalances, and monitoring of vital signs and renal function.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment due to increased risk of hyperkalemia, hypotension, and renal impairment)
- Sacubitril/valsartan (Entresto) (due to increased risk of angioedema; must not be co-administered within 36 hours of the last dose of sacubitril/valsartan)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
- NSAIDs (e.g., ibuprofen, naproxen, celecoxib) (may reduce the antihypertensive effect of ACE inhibitors and diuretics, and increase the risk of renal impairment, especially in dehydrated or elderly patients)
- Lithium (increased serum lithium concentrations and toxicity due to reduced renal clearance by both components)
- Gold injections (e.g., sodium aurothiomalate) (rare nitritoid reactions including facial flushing, nausea, vomiting, and hypotension)
- Other antihypertensive agents (additive hypotensive effects)
- Insulin and oral antidiabetic agents (thiazides may decrease glucose tolerance, requiring adjustment of antidiabetic medication; Lisinopril may enhance insulin sensitivity, potentially leading to hypoglycemia)
Moderate Interactions
- Alcohol (may potentiate orthostatic hypotension)
- Corticosteroids (may increase electrolyte depletion, particularly hypokalemia)
- Cholestyramine and colestipol resins (may impair absorption of hydrochlorothiazide)
- Pressor amines (e.g., norepinephrine) (thiazides may decrease arterial responsiveness to pressor amines)
- Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) (thiazides may potentiate the effect of these agents)
- Allopurinol (increased risk of hypersensitivity reactions with ACE inhibitors)
- Cyclosporine (increased risk of hyperkalemia and renal dysfunction)
Minor Interactions
- Digitalis glycosides (hypokalemia induced by HCTZ may sensitize the myocardium to the toxic effects of digitalis)
- Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide therapy.
Timing: Before initiation of therapy
Rationale: To establish baseline and identify pre-existing imbalances; ACE inhibitors can cause hyperkalemia, thiazides can cause hypokalemia, hyponatremia, hypomagnesemia, and hypercalcemia.
Timing: Before initiation of therapy
Rationale: To assess baseline renal function, as both components are renally cleared and can affect kidney function.
Timing: Before initiation of therapy
Rationale: To assess baseline hepatic function, as thiazides can precipitate hepatic coma in severe liver impairment.
Timing: Before initiation of therapy
Rationale: Thiazides can increase uric acid levels, potentially precipitating gout.
Timing: Before initiation of therapy
Rationale: Thiazides can impair glucose tolerance.
Timing: Before initiation of therapy
Routine Monitoring
Frequency: Regularly, at each clinic visit or as directed by physician
Target: <130/80 mmHg or individualized target
Action Threshold: Persistent BP above target or symptomatic hypotension
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated
Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L
Action Threshold: Potassium <3.0 or >5.5 mEq/L; Sodium <130 or >150 mEq/L, or symptomatic changes
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated
Target: Stable, within normal limits or patient's baseline
Action Threshold: Increase in serum creatinine >30% from baseline, or significant decrease in eGFR
Frequency: Periodically, especially in patients with history of gout or hyperuricemia
Target: Within normal limits
Action Threshold: Significant increase or symptoms of gout
Frequency: Periodically, especially in diabetic patients or those at risk for diabetes
Target: Individualized target for blood glucose control
Action Threshold: Significant increase in blood glucose or loss of glycemic control
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Persistent dry cough
- Swelling of face, lips, tongue, or throat (signs of angioedema)
- Difficulty breathing or swallowing
- Muscle cramps or weakness (signs of electrolyte imbalance)
- Unusual fatigue or lethargy
- Signs of dehydration (e.g., excessive thirst, dry mouth)
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is also generally not recommended due to potential risks.
Trimester-Specific Risks:
Lactation
Not recommended during breastfeeding. Both Lisinopril and Hydrochlorothiazide are excreted in human milk. Hydrochlorothiazide can suppress lactation. Potential for serious adverse effects in the breastfed infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients, as they may be more sensitive to the effects of the drug, particularly hypotension and electrolyte imbalances. Start with lower doses and monitor renal function and electrolytes closely. Elderly patients are also at higher risk for NSAID-induced renal dysfunction when co-administered.
Clinical Information
Clinical Pearls
- This combination is often used when monotherapy with either an ACE inhibitor or a diuretic is insufficient to control blood pressure.
- The cough associated with ACE inhibitors (Lisinopril) is a common side effect and is typically dry and persistent. If bothersome, an alternative class of antihypertensive may be considered.
- Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as it can be life-threatening.
- Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in dehydrated patients.
- Educate patients on the importance of regular blood pressure monitoring at home.
- Avoid concomitant use with potassium supplements or salt substitutes unless specifically advised by a healthcare provider due to the risk of hyperkalemia from Lisinopril.
Alternative Therapies
- Other ACE inhibitors (e.g., enalapril, ramipril)
- Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
- Calcium Channel Blockers (e.g., amlodipine, nifedipine)
- Beta-blockers (e.g., metoprolol, carvedilol)
- Other diuretics (e.g., loop diuretics like furosemide, potassium-sparing diuretics like spironolactone)
- Direct Renin Inhibitors (e.g., aliskiren - limited use)