Metoprolol HCT 100/25mg Tablets

Manufacturer ALEMBIC PHARMACEUTICALS Active Ingredient Metoprolol and Hydrochlorothiazide Tablets(me toe PROE lole & hye droe klor oh THYE a zide) Pronunciation me toe PROE lole & hye droe klor oh THYE a zide
It is used to treat high blood pressure.
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Drug Class
Antihypertensive
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Pharmacologic Class
Beta-adrenergic Blocker, Selective; Thiazide Diuretic
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Pregnancy Category
Category D
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a combination of two drugs: metoprolol and hydrochlorothiazide. Metoprolol is a beta-blocker that helps relax blood vessels and slow your heart rate, lowering blood pressure. Hydrochlorothiazide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water, which also helps lower blood pressure. Together, they work to treat high blood pressure.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with or immediately after a meal.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. It's essential to maintain your treatment regimen to achieve the best results.

Managing Potential Side Effects

This medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking your medication too close to bedtime. Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Interactions with Other Medications

If you take cholestyramine or colestipol, consult with your pharmacist about the best way to take these medications with your prescribed drug. Before using any over-the-counter (OTC) products, talk to your doctor if they may increase your blood pressure. These products include:

Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once daily with or immediately following a meal.
  • Do not stop taking this medication suddenly, especially if you have heart disease, as it can worsen your condition. Your doctor will tell you how to gradually reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly at home as advised by your doctor.
  • Limit your intake of sodium (salt) as directed by your doctor.
  • Maintain a healthy diet rich in fruits and vegetables, especially those high in potassium (e.g., bananas, oranges, potatoes) to help prevent low potassium levels, unless advised otherwise by your doctor.
  • Engage in regular physical activity as recommended by your doctor.
  • Avoid excessive alcohol consumption, as it can lower blood pressure and increase dizziness.
  • Be aware of symptoms of low blood pressure (dizziness, lightheadedness) and stand up slowly from a sitting or lying position.
  • Inform your doctor or dentist that you are taking this medication before any surgery or dental procedures.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet (Metoprolol 100 mg / HCTZ 25 mg) orally once daily
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

hypertension: Initial dose typically 50 mg metoprolol / 12.5 mg HCTZ once daily, titrate as needed up to 200 mg metoprolol / 50 mg HCTZ 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 adjustment needed for Metoprolol. Caution with HCTZ.
Moderate: Metoprolol: Consider dose reduction if CrCl < 30 mL/min. HCTZ: Use with caution, may be less effective.
Severe: Metoprolol: Significant dose reduction (e.g., 25% of usual dose) if CrCl < 10 mL/min. HCTZ: Contraindicated in anuria; generally not recommended if CrCl < 30 mL/min.
Dialysis: Metoprolol: Not significantly removed by hemodialysis. HCTZ: Not removed by hemodialysis. Avoid use.

Hepatic Impairment:

Mild: Metoprolol: No specific adjustment. HCTZ: No specific adjustment.
Moderate: Metoprolol: Consider dose reduction due to reduced metabolism. HCTZ: Use with caution, may precipitate hepatic coma.
Severe: Metoprolol: Significant dose reduction (e.g., 50% or more) due to extensive hepatic metabolism. HCTZ: Contraindicated or avoid use due to risk of hepatic coma.

Pharmacology

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Mechanism of Action

Metoprolol: A selective beta-1 adrenergic receptor blocker that decreases cardiac output, reduces sympathetic outflow from the CNS, and suppresses renin release. Hydrochlorothiazide: 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, and to a lesser extent, potassium and magnesium.
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Pharmacokinetics

Absorption:

Bioavailability: Metoprolol: ~50% (due to first-pass metabolism); HCTZ: 65-75%
Tmax: Metoprolol: 1-2 hours; HCTZ: 1-2.5 hours
FoodEffect: Metoprolol: Food increases bioavailability by 20-40%; HCTZ: Food may increase absorption slightly but not clinically significant.

Distribution:

Vd: Metoprolol: 5.6 L/kg; HCTZ: 0.8 L/kg
ProteinBinding: Metoprolol: 10-12%; HCTZ: 40-68%
CnssPenetration: Metoprolol: Limited; HCTZ: Limited

Elimination:

HalfLife: Metoprolol: 3-7 hours; HCTZ: 5.6-14.8 hours
Clearance: Metoprolol: ~1 L/min; HCTZ: ~300 mL/min
ExcretionRoute: Metoprolol: Renal (primarily metabolites); HCTZ: Renal (unchanged)
Unchanged: Metoprolol: <5%; HCTZ: >95%
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Pharmacodynamics

OnsetOfAction: Metoprolol: ~1 hour; HCTZ: ~2 hours
PeakEffect: Metoprolol: 2-4 hours; HCTZ: 4-6 hours
DurationOfAction: Metoprolol: 10-20 hours; HCTZ: 6-12 hours

Safety & Warnings

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BLACK BOX WARNING

Ischemic Heart Disease: Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina pectoris should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol therapy abruptly even in patients treated only for hypertension.
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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 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 fluid and electrolyte problems, such as:
+ 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 throwing up
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
New or worsening chest pain
Slow heartbeat
Depression
Feeling confused
Memory problems or loss
Shortness of breath
Significant weight gain
Swelling in the arms or legs
Erectile dysfunction

Eye Problems:

This medication can cause certain eye problems, which can lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:

Changes in vision
Eye pain

These symptoms usually occur within hours to weeks of starting the medication.

Skin Cancer Risk:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk:

Protect your skin from the sun
Follow your doctor's recommendations for skin checks
Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

Other Side Effects:

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness
Sleepiness
Fatigue
Weakness
Headache
Diarrhea
* Flu-like symptoms

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (less than 50 beats per minute)
  • Shortness of breath, especially with exertion or lying down
  • Swelling in your ankles, feet, or hands
  • Unusual weight gain
  • Muscle cramps or weakness, irregular heartbeat (signs of low potassium)
  • Extreme thirst, dry mouth, nausea, vomiting (signs of dehydration or electrolyte imbalance)
  • Yellowing of skin or eyes (jaundice)
  • Unusual bleeding or bruising
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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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A known sulfa allergy.
Certain heart conditions, including:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems
Inability to urinate.
Current treatment with dofetilide.

Additionally, provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

This information will help your doctor determine if it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

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
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 down position and exercise caution when climbing stairs.

Monitoring and Follow-up
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor. Discuss any concerns or questions with your doctor.

Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances
Consult your doctor before consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that may cause drowsiness.

Discontinuation of Medication
Do not stop taking this medication abruptly, as this may lead to worsened chest pain or even a heart attack, particularly if you have certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Risk of Low Blood Sugar
This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This risk is higher in individuals with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, discuss them with your doctor.

Blood Sugar Monitoring
If you have diabetes, it is crucial to closely monitor your blood sugar levels.

Cholesterol and Triglyceride Levels
This medication may cause elevated cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, consult your doctor.

Fluid Loss and Dehydration
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Gout and Lupus
Be aware of the risk of gout attacks, and if you have lupus, this medication may exacerbate your condition. Notify your doctor immediately if you experience new or worsening symptoms.

Thyroid Function
This medication may make it more challenging to detect symptoms of an overactive thyroid, such as rapid heartbeat. If you have an overactive thyroid and stop taking this medication abruptly, your condition may worsen and become life-threatening. Discuss this with your doctor.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. You may be at risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult your doctor, as epinephrine may be less effective while taking this medication.

Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Cardiogenic shock
  • Heart failure
  • Bronchospasm
  • Hypoglycemia
  • Loss of consciousness
  • Electrolyte imbalances (e.g., severe hypokalemia, hyponatremia)
  • Dehydration

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive and symptomatic, and may include IV fluids, vasopressors, atropine, glucagon, and correction of electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Anuria (due to HCTZ)
  • Cardiogenic shock (due to Metoprolol)
  • Sinus bradycardia (due to Metoprolol)
  • Second- or third-degree AV block (due to Metoprolol)
  • Overt cardiac failure (due to Metoprolol)
  • Sick sinus syndrome (due to Metoprolol, unless permanent pacemaker is in place)
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Major Interactions

  • Non-dihydropyridine Calcium Channel Blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and hypotension.
  • Digoxin: Increased risk of bradycardia.
  • Lithium: Increased lithium levels and toxicity (due to HCTZ).
  • NSAIDs (e.g., ibuprofen, naproxen): May reduce antihypertensive and diuretic effects (due to HCTZ).
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, propafenone): May increase metoprolol plasma concentrations.
  • Other antihypertensives (e.g., ACE inhibitors, ARBs, direct renin inhibitors): Additive hypotensive effects.
  • Alpha-1 blockers (e.g., prazosin, doxazosin): Increased risk of first-dose hypotension.
  • Fingolimod: Potentiates bradycardia (due to Metoprolol).
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Moderate Interactions

  • Corticosteroids: Increased risk of hypokalemia (due to HCTZ).
  • Antidiabetic agents (insulin, oral hypoglycemics): May mask symptoms of hypoglycemia (due to Metoprolol); HCTZ may decrease glucose tolerance.
  • Cholestyramine, Colestipol: May reduce absorption of HCTZ.
  • Muscle relaxants (e.g., tubocurarine): Enhanced effect (due to HCTZ).
  • Barbiturates, Opioids, Alcohol: Additive orthostatic hypotension (due to HCTZ).
  • Pressor amines (e.g., norepinephrine): Decreased arterial responsiveness (due to HCTZ).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: HCTZ can cause hypokalemia, hyponatremia, hypomagnesemia, and hypercalcemia.

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney function, as both drugs are renally eliminated and HCTZ is contraindicated in severe renal impairment.

Timing: Prior to initiation

Blood Glucose

Rationale: HCTZ can impair glucose tolerance; Metoprolol can mask hypoglycemia symptoms.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Metoprolol is hepatically metabolized; HCTZ should be used with caution in severe hepatic impairment.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: BP: <130/80 mmHg (individualized); HR: 50-90 bpm

Action Threshold: BP persistently above target, HR < 50 bpm or symptomatic bradycardia

Serum Electrolytes (Potassium, Sodium)

Frequency: Every 1-2 weeks initially, then every 1-3 months, or as clinically indicated

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L

Action Threshold: Potassium < 3.0 mEq/L or > 5.5 mEq/L; Sodium < 130 mEq/L or symptomatic hyponatremia

Renal Function (BUN, Serum Creatinine)

Frequency: Every 1-3 months, or as clinically indicated

Target: Within normal limits for age/sex

Action Threshold: Significant increase in BUN/Creatinine, or eGFR decline

Blood Glucose (HbA1c for diabetics)

Frequency: Periodically, more frequently in diabetics

Target: Individualized

Action Threshold: Persistent hyperglycemia or difficulty controlling blood glucose

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Shortness of breath
  • Swelling in ankles/feet (edema)
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Dry mouth
  • Increased thirst
  • Nausea/vomiting
  • Unusual weight gain or loss

Special Patient Groups

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Pregnancy

Category D. Hydrochlorothiazide can cross the placenta and may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions seen in adults. Metoprolol can cause bradycardia, hypoglycemia, and growth restriction in the fetus/neonate. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for adverse effects on fetal development cannot be excluded, especially with HCTZ.
Second Trimester: Risk of fetal growth restriction, bradycardia, and hypoglycemia (Metoprolol). Risk of electrolyte disturbances, jaundice, thrombocytopenia (HCTZ).
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression (Metoprolol). Increased risk of neonatal jaundice, thrombocytopenia, and electrolyte disturbances (HCTZ). May reduce plasma volume and uteroplacental perfusion.
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Lactation

Both metoprolol and hydrochlorothiazide are excreted into breast milk. While metoprolol is generally considered compatible with breastfeeding by some sources, HCTZ can reduce milk supply. Monitor breastfed infants for signs of bradycardia, hypoglycemia, and dehydration. Use with caution, or consider an alternative.

Infant Risk: Low to moderate risk. Potential for bradycardia and hypoglycemia (Metoprolol); potential for dehydration, electrolyte imbalance, and reduced milk supply (HCTZ).
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Pediatric Use

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

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of both metoprolol (e.g., bradycardia, hypotension) and hydrochlorothiazide (e.g., electrolyte imbalances, dehydration). Start with lower doses and titrate slowly. Renal function should be monitored closely.

Clinical Information

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Clinical Pearls

  • This combination is useful for patients whose blood pressure is not adequately controlled by monotherapy with either a beta-blocker or a diuretic.
  • Take with or immediately following a meal to enhance metoprolol absorption and reduce gastrointestinal upset.
  • Patients should be advised to report any signs of electrolyte imbalance (e.g., muscle cramps, weakness, excessive thirst).
  • Educate patients on the importance of not abruptly discontinuing the medication due to the metoprolol component's black box warning.
  • Monitor for signs of worsening heart failure, especially in patients with pre-existing cardiac conditions.
  • Caution in patients with asthma or COPD, as even selective beta-1 blockers can cause bronchospasm at higher doses or in susceptible individuals.
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Alternative Therapies

  • ACE inhibitors (e.g., Lisinopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan)
  • Calcium Channel Blockers (e.g., Amlodipine)
  • Other diuretics (e.g., Furosemide, Spironolactone)
  • Other beta-blockers (e.g., Carvedilol, Nebivolol)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.