Metoprolol HCT 50/25mg 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-1 Selective Adrenergic Blocker / Thiazide Diuretic
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Pregnancy Category
Category D
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FDA Approved
Jun 1985
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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 to slow your heart rate and relax blood vessels, 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 (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 well. This medication may increase the frequency of urination, so try to avoid taking it too close to bedtime to minimize sleep disturbances.

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 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 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 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 slowly reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly at home as advised by your doctor.
  • Limit sodium (salt) intake in your diet as recommended by your doctor.
  • Maintain a healthy weight, engage in regular physical activity, and limit alcohol consumption.
  • Avoid standing up too quickly from a sitting or lying position to prevent dizziness.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

hypertension: Initial dose is typically 50/25 mg once daily. May be increased to 100/25 mg or 100/50 mg if needed, up to a maximum of 200 mg metoprolol and 50 mg HCTZ 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 specific adjustment for mild impairment (CrCl > 50 mL/min).
Moderate: Use with caution. Consider lower doses or alternative agents if CrCl 30-50 mL/min due to HCTZ component. Thiazides become less effective below CrCl 30 mL/min.
Severe: Contraindicated if anuria or severe renal dysfunction (CrCl < 30 mL/min) due to HCTZ component.
Dialysis: Not recommended. HCTZ is not effectively removed by dialysis. Metoprolol is minimally dialyzable.

Hepatic Impairment:

Mild: Use with caution. No specific dose adjustment usually required.
Moderate: Consider lower starting doses and careful titration due to metoprolol component. Monitor for increased beta-blocker effects.
Severe: Use with extreme caution or avoid due to metoprolol component. Significant reduction in metoprolol clearance may occur.

Pharmacology

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Mechanism of Action

Metoprolol is a cardioselective beta-1 adrenergic receptor blocker. It reduces heart rate, myocardial contractility, and cardiac output, and inhibits renin release. 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, water, and potassium. This reduces plasma volume and peripheral vascular resistance.
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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: Food increases metoprolol bioavailability by 20-40%; HCTZ absorption is not significantly affected by food.

Distribution:

Vd: Metoprolol: 3.2-5.6 L/kg; HCTZ: 0.8-1.7 L/kg
ProteinBinding: Metoprolol: 10-12%; HCTZ: 40-68%
CnssPenetration: Metoprolol: Limited (lipophilic enough to cross BBB); HCTZ: Limited

Elimination:

HalfLife: Metoprolol: 3-7 hours; HCTZ: 5.6-14.8 hours
Clearance: Metoprolol: ~1 L/min; HCTZ: 2.5-3 mL/min/kg
ExcretionRoute: Metoprolol: Renal (95% as metabolites, <5% unchanged); HCTZ: Renal (95% 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: 12-24 hours; HCTZ: 6-12 hours

Safety & Warnings

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BLACK BOX WARNING

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. 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

Serious 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
Difficulty getting or maintaining an erection

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 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 and follow your doctor's recommendations for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor immediately.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical attention if you notice any of the following:

Feeling dizzy, sleepy, tired, or weak
Headache
Diarrhea
* Flu-like symptoms

If you're concerned about side effects or have questions, 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 swelling in your ankles/feet (signs of worsening heart failure)
  • Unusual muscle weakness or cramps (signs of electrolyte imbalance)
  • Persistent nausea or vomiting
  • Yellowing of skin or eyes (jaundice)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any existing health problems

This information is crucial to ensure your safety while taking this medication. Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
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Precautions & Cautions

Important Warnings and Cautions

It is crucial that you inform all of 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, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor, and discuss the results with them.

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

Interactions with Other Substances
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.

Discontinuing the 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.

Masking Low Blood Sugar Symptoms
This medication may conceal signs of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This is particularly concerning for 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.

Monitoring Blood Sugar Levels
If you have high blood sugar (diabetes), it is essential to closely monitor your blood sugar levels.

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

Heat and Fluid Loss
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 can lead to low blood pressure.

Gout and Lupus
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.

Thyroid Function
This medication may make it more challenging to detect signs of an overactive thyroid, such as a 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 for an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult with your doctor, as its effectiveness may be reduced 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
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)
  • Hypotension (very low blood pressure)
  • Cardiogenic shock
  • Heart failure
  • Bronchospasm
  • Hypoglycemia
  • Electrolyte imbalances (e.g., severe hypokalemia, hyponatremia)
  • Dehydration
  • Lethargy, confusion

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including IV fluids, vasopressors, atropine, glucagon, and potentially pacing for bradycardia.

Drug Interactions

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Contraindicated Interactions

  • Anuria
  • Hypersensitivity to sulfonamide-derived drugs
  • Cardiogenic shock
  • Sinus bradycardia (severe)
  • Second- or third-degree AV block (without a pacemaker)
  • Overt cardiac failure
  • Sick sinus syndrome (without a pacemaker)
  • Pheochromocytoma (untreated)
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Major Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, AV block, heart failure
  • Digoxin - increased risk of bradycardia
  • MAO inhibitors - risk of significant hypertension or bradycardia
  • Clonidine - risk of rebound hypertension upon withdrawal of clonidine if beta-blocker is not tapered first
  • Lithium - increased lithium levels due to reduced renal clearance by HCTZ
  • NSAIDs (e.g., ibuprofen, naproxen) - reduced antihypertensive effect of both components
  • Corticosteroids - enhanced electrolyte depletion (hypokalemia) by HCTZ
  • Cholestyramine, Colestipol - reduced absorption of HCTZ
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Moderate Interactions

  • Other antihypertensives - additive hypotensive effects
  • Insulin and oral hypoglycemics - beta-blockers may mask symptoms of hypoglycemia; HCTZ may increase blood glucose
  • Muscle relaxants (non-depolarizing) - enhanced effect due to HCTZ
  • Barbiturates, narcotics, alcohol - additive orthostatic hypotension
  • Pressor amines (e.g., norepinephrine) - diminished response to pressor amines
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased metoprolol plasma concentrations
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Minor Interactions

  • Antacids - may decrease metoprolol absorption (separate administration)
  • Sulfonylureas - HCTZ may reduce hypoglycemic effect

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia.

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, especially important for HCTZ excretion.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: Metoprolol is metabolized by the liver; assess for pre-existing hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

Blood Glucose

Rationale: HCTZ can cause hyperglycemia; metoprolol can mask hypoglycemia symptoms.

Timing: Prior to initiation (especially in diabetics)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly/quarterly

Target: <130/80 mmHg (or individualized target)

Action Threshold: If BP remains elevated despite maximum dose, or if symptomatic hypotension occurs.

Heart Rate (HR)

Frequency: Regularly, e.g., weekly after initiation/dose change, then monthly/quarterly

Target: 50-90 bpm (avoiding symptomatic bradycardia)

Action Threshold: If HR < 50 bpm or symptomatic bradycardia.

Serum Electrolytes (Potassium, Sodium)

Frequency: 1-2 weeks after initiation/dose change, then every 3-6 months

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

Action Threshold: If potassium < 3.0 mEq/L or > 5.5 mEq/L; if sodium < 130 mEq/L.

Renal Function (BUN, Serum Creatinine)

Frequency: 1-2 weeks after initiation/dose change, then every 3-6 months

Target: Stable within normal limits

Action Threshold: Significant increase in creatinine (>30% from baseline) or eGFR decline.

Blood Glucose

Frequency: Periodically, especially in diabetics or those at risk

Target: Individualized for diabetics; non-diabetics within normal range

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

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or lethargy
  • Shortness of breath or worsening of asthma/COPD symptoms
  • Swelling in ankles, feet, or hands (edema)
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Nausea or vomiting
  • Cold hands and feet
  • Depression or mood changes

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential risks.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia with metoprolol. HCTZ can cause fetal/neonatal adverse effects.
Third Trimester: Increased risk of fetal/neonatal bradycardia, hypoglycemia, and respiratory depression with metoprolol. HCTZ can cause neonatal jaundice, thrombocytopenia, and electrolyte disturbances.
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Lactation

Both metoprolol and hydrochlorothiazide are excreted in breast milk. Metoprolol is generally considered compatible with breastfeeding with monitoring for infant bradycardia or hypoglycemia. HCTZ can reduce milk supply and may cause adverse effects in the infant (e.g., electrolyte imbalance). Use with caution; monitor infant for adverse effects.

Infant Risk: L3 (Moderate risk) - potential for bradycardia, hypoglycemia (metoprolol), and electrolyte disturbances, reduced milk supply (HCTZ).
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Pediatric Use

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

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Take with or immediately after food to enhance metoprolol absorption and reduce GI upset.
  • Do not crush or chew tablets; swallow whole.
  • Educate patients on the importance of not abruptly discontinuing the medication due to the risk of rebound hypertension or cardiac events.
  • Monitor for signs of electrolyte imbalance (e.g., muscle cramps, weakness, fatigue) and advise patients to report them.
  • Caution patients about orthostatic hypotension, especially at the start of therapy or with dose increases.
  • This combination is often used when monotherapy with either a beta-blocker or a diuretic is insufficient to control blood pressure.
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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., loop diuretics, potassium-sparing diuretics)
  • Other beta-blockers (e.g., carvedilol, nebivolol)
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Cost & Coverage

Average Cost: $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 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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.