Lopressor HCT 50/25 Tablets

Manufacturer VALIDUS PHARMACEUTICALS Active Ingredient Metoprolol and Hydrochlorothiazide Tablets(me toe PROE lole & hye droe klor oh THYE a zide) Pronunciation MEE-toe-PROE-lole and 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, Cardioselective; Thiazide Diuretic
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Pregnancy Category
Category D
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FDA Approved
Aug 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lopressor HCT is a combination medicine containing two drugs: metoprolol and hydrochlorothiazide. Metoprolol is a beta-blocker that helps to slow your heart rate and relax blood vessels, lowering your blood pressure. Hydrochlorothiazide is a 'water pill' (diuretic) that helps your body get rid of extra salt and water, which also helps to lower blood pressure. Together, they work to treat high blood pressure (hypertension).
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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 better. Be aware that this medication may increase your urine production. To minimize sleep disturbances, try to avoid taking your medication too close to bedtime.

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. If you are taking cholestyramine or colestipol, consult with your pharmacist about the best way to take these medications in combination with your current prescription.

Before using any over-the-counter (OTC) products, including cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, or certain natural products or aids that may increase blood pressure, consult with your doctor.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a safe and secure 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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once daily. Do not stop taking it suddenly without talking to your doctor, especially if you have heart disease, as this can worsen your condition.
  • Monitor your blood pressure and heart rate regularly at home as advised by your doctor.
  • Avoid sudden changes in position (e.g., standing up quickly from sitting or lying down) to prevent dizziness or lightheadedness.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effect and dizziness.
  • Follow a low-sodium diet as recommended by your doctor or dietitian.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Protect yourself from the sun, as hydrochlorothiazide can increase sun sensitivity (use sunscreen, wear protective clothing).
  • 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: Initial dose: 50 mg metoprolol / 25 mg hydrochlorothiazide once daily.
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

hypertension: May be increased to 100 mg metoprolol / 25 mg hydrochlorothiazide once daily after 1-2 weeks if needed for blood pressure control.
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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 specific adjustment for metoprolol. Hydrochlorothiazide may require caution.
Moderate: Use with caution. Hydrochlorothiazide efficacy may decrease. Consider lower doses or alternative agents if CrCl < 30 mL/min.
Severe: Contraindicated if anuria. Use with extreme caution or avoid if CrCl < 30 mL/min due to hydrochlorothiazide component.
Dialysis: Metoprolol is not significantly removed by hemodialysis. Hydrochlorothiazide is not dialyzable. Use with caution, monitor fluid and electrolyte balance.

Hepatic Impairment:

Mild: No specific adjustment for hydrochlorothiazide. Metoprolol may require dose reduction.
Moderate: Metoprolol dose reduction may be necessary due to decreased metabolism. Hydrochlorothiazide use with caution due to risk of hepatic coma.
Severe: Significant dose reduction for metoprolol may be required. Hydrochlorothiazide use with extreme caution or avoid due to risk of hepatic coma.

Pharmacology

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Mechanism of Action

Metoprolol is a cardioselective beta-1 adrenergic receptor blocker, reducing heart rate, cardiac output, and blood pressure. 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.
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Pharmacokinetics

Absorption:

Bioavailability: Metoprolol: ~50% (due to first-pass metabolism); Hydrochlorothiazide: ~65-75%
Tmax: Metoprolol: 1.5-2 hours; Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Food increases metoprolol absorption and reduces first-pass metabolism, leading to higher plasma concentrations. Food does not significantly affect hydrochlorothiazide absorption.

Distribution:

Vd: Metoprolol: 3.2-5.6 L/kg; Hydrochlorothiazide: 0.8 L/kg
ProteinBinding: Metoprolol: ~10-12%; Hydrochlorothiazide: ~40-68%
CnssPenetration: Metoprolol: Limited; Hydrochlorothiazide: Limited

Elimination:

HalfLife: Metoprolol: 3-7 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Metoprolol: ~1 L/min; Hydrochlorothiazide: Renal clearance is proportional to GFR
ExcretionRoute: Metoprolol: Renal (primarily metabolites); Hydrochlorothiazide: Renal (unchanged)
Unchanged: Metoprolol: <5% (renal); Hydrochlorothiazide: >95% (renal)
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Pharmacodynamics

OnsetOfAction: Metoprolol: ~1 hour; Hydrochlorothiazide: ~2 hours
PeakEffect: Metoprolol: 2-4 hours; Hydrochlorothiazide: 4-6 hours
DurationOfAction: Metoprolol: 10-20 hours (dose-dependent); Hydrochlorothiazide: 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 Lopressor HCT, 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, Lopressor HCT administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina pectoris should be taken. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Lopressor HCT 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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Changes in urine production or dry mouth
+ Dry eyes or severe stomach upset
Signs of kidney problems, including:
+ Inability to urinate or changes in urine production
+ Blood in the urine or significant weight gain
New or worsening chest pain
Slow heartbeat
Depression
Confusion or memory problems
Shortness of breath, significant weight gain, or swelling in the arms or legs
Erectile dysfunction

Eye Problems:

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

Changes in vision or eye pain (usually occurring within hours to weeks of starting the medication)

Skin Cancer Risk:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize this risk, protect your skin from the sun and follow your doctor's instructions for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lumps or growths, contact your doctor right away.

Other 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 symptoms or if they persist or worsen, contact your doctor:

Dizziness, drowsiness, fatigue, or weakness
Headache
Diarrhea
* Flu-like symptoms

Reporting Side Effects:

If you have questions or concerns about side effects, 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 spells
  • Very slow heart rate (e.g., less than 50 beats per minute) or irregular heartbeat
  • Shortness of breath, swelling in ankles or feet, or unusual weight gain (signs of worsening heart failure)
  • Persistent muscle cramps, weakness, or unusual tiredness (signs of electrolyte imbalance, especially low potassium)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
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 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 use of dofetilide

Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when using stairs.

Regularly monitor your blood pressure and heart rate as directed by your doctor. Additionally, have blood work checked as recommended by your doctor, and discuss the results with them. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

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

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

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, especially in individuals with diabetes, children, and those who are fasting or undergoing surgery. If you have questions or concerns, discuss them with your doctor. If you have diabetes, closely monitor your blood sugar levels.

High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, consult with your doctor.

In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these can lead to low blood pressure.

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

This medication may make it more challenging to recognize signs 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.

If you have a history of severe allergic reactions, inform your doctor, as you may be at increased risk of a more severe reaction. If you use epinephrine to treat severe allergic reactions, consult with your doctor, as epinephrine may be less effective while taking this medication.

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

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Cardiogenic shock
  • Bronchospasm (difficulty breathing)
  • Cardiac arrest
  • Hypoglycemia (low blood sugar)
  • Electrolyte imbalances (e.g., severe hypokalemia, hyponatremia)
  • Dehydration
  • Lethargy, confusion, coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including IV fluids, vasopressors, atropine for bradycardia, glucagon, and potentially hemodialysis in severe cases.

Drug Interactions

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Contraindicated Interactions

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

  • Lithium (hydrochlorothiazide can increase lithium levels and toxicity)
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (may reduce antihypertensive effect of both components)
  • Other antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers, direct renin inhibitors) (additive hypotensive effects)
  • Digitalis glycosides (increased risk of bradycardia and AV block with metoprolol; hypokalemia from HCTZ can potentiate digitalis toxicity)
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, propafenone, ritonavir, bupropion) (can significantly increase metoprolol plasma concentrations)
  • Barbiturates, narcotics, alcohol (potentiate orthostatic hypotension)
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Moderate Interactions

  • Antidiabetic agents (insulin, oral hypoglycemics) (metoprolol may mask symptoms of hypoglycemia; HCTZ may increase blood glucose)
  • Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
  • Norepinephrine, epinephrine (beta-blockers may blunt pressor response)
  • Skeletal muscle relaxants, non-depolarizing (prolonged effect)
  • Cholestyramine, colestipol resins (may impair absorption of hydrochlorothiazide)
  • Pressor amines (e.g., norepinephrine) (reduced response to pressor amines)
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Minor Interactions

  • Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
  • Amantadine (increased risk of amantadine toxicity)
  • Diazoxide (enhanced hyperglycemic and hypotensive effects)
  • Loop diuretics (additive diuretic/hypotensive effects)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline cardiovascular status and guide initial dosing.

Timing: Prior to initiation of therapy

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: Hydrochlorothiazide can cause electrolyte imbalances (hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia).

Timing: Prior to initiation of therapy

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney function, as hydrochlorothiazide is renally cleared and its efficacy/safety are affected by renal impairment.

Timing: Prior to initiation of therapy

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: Metoprolol is metabolized by the liver; hepatic impairment can affect its clearance. Hydrochlorothiazide should be used with caution in severe hepatic impairment.

Timing: Prior to initiation of therapy

Blood Glucose

Rationale: Hydrochlorothiazide can cause hyperglycemia; metoprolol can mask symptoms of hypoglycemia.

Timing: Prior to initiation of therapy

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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 (or individualized target); HR: 50-90 bpm (avoiding symptomatic bradycardia)

Action Threshold: BP persistently above target, HR < 50 bpm or symptomatic bradycardia, or significant orthostatic hypotension.

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated)

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L; Magnesium: 1.7-2.2 mg/dL; Calcium: 8.5-10.2 mg/dL

Action Threshold: Significant deviations from normal range, especially hypokalemia (<3.5 mEq/L) or hyponatremia (<135 mEq/L).

Renal Function (BUN, Serum Creatinine, eGFR)

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months, or as clinically indicated)

Target: Stable within patient's baseline or normal limits

Action Threshold: Significant increase in BUN/creatinine or decrease in eGFR.

Blood Glucose

Frequency: Periodically (e.g., every 3-6 months, or as clinically indicated, especially in diabetic patients)

Target: Individualized based on patient's diabetic status

Action Threshold: Persistent hyperglycemia or difficulty controlling blood glucose in diabetic patients.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or lethargy
  • Bradycardia (slow heart rate)
  • Shortness of breath or worsening of asthma/COPD symptoms
  • Cold hands and feet
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Nausea, vomiting, or excessive thirst (signs of electrolyte imbalance)
  • Swelling in ankles, feet, or hands (edema)
  • Changes in vision (rare, but possible with HCTZ)

Special Patient Groups

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Pregnancy

Category D. Not recommended during pregnancy, especially during the second and third trimesters, due to the hydrochlorothiazide component. Thiazides can cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions seen in adults. Metoprolol has also been associated with fetal growth restriction and bradycardia.

Trimester-Specific Risks:

First Trimester: Limited data for metoprolol, generally considered Category C. Hydrochlorothiazide is Category B. Overall risk is lower than later trimesters, but combination is still generally avoided.
Second Trimester: Increased risk of fetal growth restriction, bradycardia, and other adverse effects due to metoprolol. Hydrochlorothiazide can cause fetal/neonatal jaundice, thrombocytopenia, and electrolyte disturbances.
Third Trimester: Highest risk of adverse fetal/neonatal effects, including fetal growth restriction, bradycardia, hypoglycemia, and respiratory depression from metoprolol. Hydrochlorothiazide can cause neonatal jaundice, thrombocytopenia, and electrolyte imbalances. Use is generally contraindicated.
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Lactation

Both metoprolol and hydrochlorothiazide are excreted into breast milk. Use is generally not recommended due to potential for adverse effects in the infant (e.g., bradycardia, hypotension, hypoglycemia from metoprolol; electrolyte disturbances, jaundice from hydrochlorothiazide) and potential to suppress lactation (hydrochlorothiazide).

Infant Risk: L3 (Moderate risk - potential for adverse effects; monitor infant for bradycardia, hypotension, hypoglycemia, jaundice, and electrolyte imbalances).
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more sensitive to the effects of metoprolol (e.g., bradycardia, hypotension) and hydrochlorothiazide (e.g., electrolyte imbalances, dehydration, renal impairment). Start with lower doses and titrate carefully. Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • Lopressor HCT is a fixed-dose combination and may not be suitable for initial therapy in all patients. Individual titration of metoprolol and hydrochlorothiazide may be preferred.
  • Abrupt discontinuation of beta-blockers can precipitate angina, myocardial infarction, or ventricular arrhythmias, especially in patients with ischemic heart disease. Taper dose gradually over 1-2 weeks.
  • Monitor for signs of electrolyte imbalance, particularly hypokalemia, which can be exacerbated by the hydrochlorothiazide component. Potassium supplementation or potassium-sparing diuretics may be needed.
  • Caution in patients with bronchospastic disease (e.g., asthma, COPD) as metoprolol, even cardioselective, can cause bronchoconstriction at higher doses.
  • May mask signs of hyperthyroidism (tachycardia) and hypoglycemia (tremor, palpitations) in diabetic patients.
  • Hydrochlorothiazide can increase serum uric acid levels and may precipitate gout attacks in susceptible individuals.
  • Hydrochlorothiazide can cause photosensitivity reactions; advise patients to use sun protection.
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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, Chlorthalidone)
  • Other Beta-blockers (e.g., Carvedilol, Nebivolol)
  • Alpha-1 Blockers (e.g., Doxazosin)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 overdose, including the medication taken, the amount, and the time it occurred.