Lisinopril-HCTZ 10/12.5mg Tablets

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Lisinopril and Hydrochlorothiazide(lyse IN oh pril & hye droe klor oh THYE a zide) Pronunciation LYS-in-oh-pril & HYE-droe-KLOR-oh-THYE-a-zide
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin-converting enzyme (ACE) inhibitor / Thiazide diuretic
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Pregnancy Category
D
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FDA Approved
Aug 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lisinopril-HCTZ is a combination medicine used to treat high blood pressure (hypertension). Lisinopril helps relax blood vessels, and hydrochlorothiazide helps your body get rid of extra salt and water. Together, they help lower your blood pressure, which can reduce your risk of heart attack and stroke.
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How to Use This Medicine

Taking Your Medication Correctly

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg Lisinopril / 12.5 mg Hydrochlorothiazide orally once daily
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

initialTherapy: May be used as initial therapy if a patient is likely to require multiple drugs to achieve blood pressure goals. Starting dose typically 10/12.5 mg once daily.
notControlledOnMonotherapy: For patients not adequately controlled on Lisinopril monotherapy, switch to combination with 10/12.5 mg once daily. Dose can be titrated up to a maximum of 40/50 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment for CrCl > 30 mL/min. Monitor renal function closely.
Moderate: Use with caution. Consider lower starting doses or alternative agents. Monitor renal function and electrolytes frequently.
Severe: Contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) due to the hydrochlorothiazide component becoming ineffective and potential for worsening renal function.
Dialysis: Not recommended. Lisinopril is dialyzable, but HCTZ is not effectively removed by dialysis. Consider alternative agents.

Hepatic Impairment:

Mild: Use with caution. No specific dose adjustment, but monitor for signs of hepatic dysfunction.
Moderate: Use with caution. Thiazides can precipitate hepatic coma in patients with severe liver impairment. Monitor fluid and electrolyte balance closely.
Severe: Contraindicated or not recommended due to risk of hepatic coma with hydrochlorothiazide.

Pharmacology

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Mechanism of Action

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, reduced aldosterone secretion, increased plasma renin activity, and decreased total peripheral resistance. It also inhibits the degradation of bradykinin, a vasodilator. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This results in reduced plasma volume and peripheral vascular resistance.
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Pharmacokinetics

Absorption:

Bioavailability: Lisinopril: Approximately 25-30% (variable); Hydrochlorothiazide: Approximately 65-75%
Tmax: Lisinopril: 6-8 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Lisinopril: Absorption is not affected by food; Hydrochlorothiazide: Absorption is not significantly affected by food.

Distribution:

Vd: Lisinopril: Not extensively distributed to tissues; Hydrochlorothiazide: Approximately 0.8-1.7 L/kg
ProteinBinding: Lisinopril: Approximately 25% (to ACE); Hydrochlorothiazide: Approximately 40-68%
CnssPenetration: Lisinopril: Limited; Hydrochlorothiazide: Limited

Elimination:

HalfLife: Lisinopril: Functional half-life ~12 hours (due to slow dissociation from ACE); Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Lisinopril: Primarily renal; Hydrochlorothiazide: Primarily renal
ExcretionRoute: Lisinopril: Urine (unchanged); Hydrochlorothiazide: Urine (unchanged)
Unchanged: Lisinopril: 100%; Hydrochlorothiazide: >95%
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Pharmacodynamics

OnsetOfAction: Lisinopril: ~1 hour; Hydrochlorothiazide: ~2 hours; Combination: ~1-2 hours
PeakEffect: Lisinopril: 6-8 hours; Hydrochlorothiazide: 4-6 hours; Combination: 4-8 hours
DurationOfAction: Lisinopril: ~24 hours; Hydrochlorothiazide: 6-12 hours; Combination: ~24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Lisinopril-HCTZ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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Side Effects

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:

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.
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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).
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Before Using This Medicine

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 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.
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Precautions & Cautions

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
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.
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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

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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)
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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)
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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)
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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

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide therapy.

Timing: Before initiation of therapy

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

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

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline renal function, as both components are renally cleared and can affect kidney function.

Timing: Before initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, as thiazides can precipitate hepatic coma in severe liver impairment.

Timing: Before initiation of therapy

Serum Uric Acid

Rationale: Thiazides can increase uric acid levels, potentially precipitating gout.

Timing: Before initiation of therapy

Blood Glucose

Rationale: Thiazides can impair glucose tolerance.

Timing: Before initiation of therapy

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Routine Monitoring

Blood Pressure (BP)

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

Serum Electrolytes (Potassium, Sodium)

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

Renal Function (BUN, Serum Creatinine, eGFR)

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

Serum Uric Acid

Frequency: Periodically, especially in patients with history of gout or hyperuricemia

Target: Within normal limits

Action Threshold: Significant increase or symptoms of gout

Blood Glucose

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

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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

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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:

First Trimester: Limited human data, but potential for major congenital malformations (cardiovascular, CNS) has been suggested with ACE inhibitor exposure. Thiazides are generally considered low risk in the first trimester.
Second Trimester: Significant risk of fetal injury and death (e.g., fetal hypotension, anuria, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, premature birth, intrauterine growth restriction).
Third Trimester: Significant risk of fetal injury and death, similar to second trimester risks, plus potential for neonatal renal failure, hypotension, hyperkalemia, and oligohydramnios-related complications.
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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.

Infant Risk: Risk of hypotension, hyperkalemia (from Lisinopril), and electrolyte disturbances, jaundice, thrombocytopenia (from HCTZ) in the infant. HCTZ may also reduce milk supply.
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Pediatric Use

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

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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

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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.
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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)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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General Drug Facts

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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.