Propranolol 20mg/5ml Solution

Manufacturer ROXANE Active Ingredient Propranolol Oral Solution(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat high blood pressure.It is used to treat chest pain or pressure. It is used to help certain heart problems.It is used to prevent migraine headaches.It is used to treat tremor (essential).It is used after a heart attack to help prevent future heart attacks and lengthen life.It is used to treat pheochromocytoma. It is used to treat certain types of abnormal heartbeats.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal, Migraine Prophylaxis
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Pharmacologic Class
Non-selective beta-adrenergic blocker
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Pregnancy Category
Not available
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FDA Approved
Nov 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a type of medicine called a beta-blocker. It works by blocking certain natural chemicals in your body, like adrenaline, from affecting your heart and blood vessels. This helps to slow down your heart rate, relax your blood vessels, and lower your blood pressure. It can also help with conditions like tremors, migraines, and certain heart rhythm problems.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you 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. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

When taking a liquid medication, measure your dose accurately using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device to ensure you take the correct dose.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that your condition is properly managed.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from heat, cold, and light. Keep the lid tightly closed to protect the medication. Do not freeze your medication.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Do not stop taking this medication suddenly, especially if you have heart disease. Your doctor will tell you how to slowly reduce the dose.
  • Take your medication exactly as prescribed by your doctor. Do not skip doses.
  • Measure the liquid solution carefully with the provided measuring device, not a household spoon.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the effects of propranolol.
  • If you are diabetic, monitor your blood sugar levels closely, as propranolol can mask the signs of low blood sugar.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • Avoid activities requiring mental alertness until you know how the medication affects you, as it can cause dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For hypertension, initial 40 mg twice daily, maintenance 120-240 mg/day in 2-3 divided doses. For angina, initial 80 mg/day in 2-4 divided doses, maintenance 160-320 mg/day. Oral solution 20mg/5ml is less common for adult chronic use but can be used for titration or specific needs.
Dose Range: 20 - 320 mg

Condition-Specific Dosing:

Hypertension: Initial 40 mg twice daily, maintenance 120-240 mg/day in 2-3 divided doses.
Angina Pectoris: Initial 80 mg/day in 2-4 divided doses, maintenance 160-320 mg/day.
Migraine Prophylaxis: Initial 80 mg/day in divided doses, maintenance 160-240 mg/day.
Essential Tremor: Initial 40 mg twice daily, maintenance 120-320 mg/day.
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Pediatric Dosing

Neonatal: Not established for general use. Specific dosing for Infantile Hemangioma (Hemangeol brand, different concentration) is 0.6 mg/kg/day, titrated up to 1.7 mg/kg/day.
Infant: For Infantile Hemangioma (Hemangeol brand, different concentration): Initial 0.6 mg/kg/day (0.2 mg/kg given 3 times daily), titrated up to 1.7 mg/kg/day (0.57 mg/kg given 3 times daily). For other indications (e.g., hypertension, arrhythmias), typically 0.5-1 mg/kg/day in 2-4 divided doses, max 2 mg/kg/day or 60 mg/day.
Child: For hypertension/arrhythmias: Initial 0.5-1 mg/kg/day in 2-4 divided doses, max 2 mg/kg/day or 60 mg/day. Titrate to response. Max 4 mg/kg/day or 160 mg/day.
Adolescent: Dosing similar to adult low-end dosing, titrated based on indication and response. Typically 1-2 mg/kg/day in divided doses, max 4 mg/kg/day or 160 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed, but monitor for increased effects.
Severe: Use with caution. Consider lower initial doses and slower titration due to potential accumulation of active metabolites. Monitor closely.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis, but monitor for increased effects due to potential metabolite accumulation.

Hepatic Impairment:

Mild: Consider lower initial doses and slower titration.
Moderate: Significant reduction in dose may be required (e.g., 50% reduction). Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 75% reduction). Propranolol is extensively metabolized by the liver.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 and beta-2 adrenergic receptors. This blockade leads to decreased heart rate, decreased myocardial contractility, reduced cardiac output, and lowered blood pressure. It also inhibits renin release from the kidneys. Beta-2 blockade can cause bronchoconstriction and inhibit glycogenolysis.
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Pharmacokinetics

Absorption:

Bioavailability: 25-50% (due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (immediate release)
FoodEffect: Food increases bioavailability and reduces peak plasma concentrations variability.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes

Elimination:

HalfLife: 3-6 hours
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: 30 minutes (oral)
PeakEffect: 60-90 minutes (oral)
DurationOfAction: 6-12 hours

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Exacerbation of angina pectoris and, in some cases, myocardial infarction and ventricular arrhythmia have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Therefore, when discontinuing chronically administered propranolol, 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, propranolol 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 to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease.
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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 immediate medical attention:

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Severe dizziness or fainting
New or worsening chest pain
Slow heartbeat
Abnormal heartbeat
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or mood changes
Unusual burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red)
Changes in eyesight
Unexplained bruising or bleeding
Fever, chills, or sore throat
Erectile dysfunction
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes

Other Possible 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 discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Sleep disturbances
* Vivid or unusual dreams

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
  • Very slow heart rate (less than 50 beats per minute)
  • Shortness of breath, wheezing, or difficulty breathing (especially if new or worsening)
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • Chest pain (especially if new or worsening after stopping the medication)
  • Coldness, numbness, or tingling in your fingers or toes
  • Signs of depression (e.g., persistent sadness, loss of interest)
  • Severe 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 and its symptoms.
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

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history

Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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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
Until you know 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 be cautious when climbing stairs.

Monitoring and Lab Tests
Follow your doctor's instructions for checking blood pressure and heart rate. Be aware that this medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances
Discuss with your doctor before consuming alcohol. If you smoke, talk to your doctor about the potential risks. 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, particularly in people with diabetes, children, and those who are fasting or have undergone surgery.

Special Considerations
If you have diabetes, closely monitor your blood sugar levels. Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, especially 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. Seek immediate medical attention if you experience new or worsening chest pain or other heart problems.

Thyroid and Blood Pressure Considerations
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult your doctor before using over-the-counter 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, and certain natural products or aids.

Allergic Reactions and Epinephrine
If you have a history of severe allergic reactions, discuss with your doctor the potential risks of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as epinephrine may be less effective while taking this medication. Ensure you have the correct strength of epinephrine.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor 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)
  • Severe hypotension (very low blood pressure)
  • Cardiogenic shock
  • Congestive heart failure
  • Bronchospasm
  • Hypoglycemia
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call 911. For advice, call a poison control center at 1-800-222-1222. Treatment is supportive and symptomatic, and may include atropine, glucagon, IV fluids, vasopressors, and bronchodilators.

Drug Interactions

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Contraindicated Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, heart block, and hypotension.
  • MAO inhibitors (e.g., phenelzine, selegiline) - risk of severe hypertension.
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Major Interactions

  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first).
  • Other antiarrhythmics (e.g., amiodarone, disopyramide, quinidine) - additive negative inotropic/chronotropic effects.
  • Insulin and oral hypoglycemics - may mask signs of hypoglycemia (tachycardia, tremors) and prolong hypoglycemic episodes.
  • Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) - risk of severe hypertension and bradycardia due to unopposed alpha-adrenergic stimulation.
  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce the antihypertensive effect of propranolol.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of peripheral ischemia.
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Moderate Interactions

  • CYP450 inhibitors (e.g., cimetidine, fluoxetine, paroxetine, ritonavir) - may increase propranolol plasma levels.
  • CYP450 inducers (e.g., rifampin, phenobarbital, phenytoin) - may decrease propranolol plasma levels.
  • Alcohol - may increase propranolol plasma levels and enhance hypotensive effects.
  • Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of first-dose hypotension.
  • Digoxin - additive bradycardic effects.
  • Lidocaine - propranolol may reduce lidocaine clearance, increasing toxicity risk.
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Minor Interactions

  • Antacids (aluminum hydroxide, magnesium hydroxide) - may decrease propranolol absorption (separate administration by 2 hours).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide titration for antihypertensive effect.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and conduction, especially if pre-existing cardiac conditions.

Timing: Prior to initiation (if clinically indicated)

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as metabolites are renally excreted.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess baseline hepatic function, as propranolol is extensively metabolized by the liver.

Timing: Prior to initiation

Blood Glucose (in diabetic patients)

Rationale: Propranolol can mask signs of hypoglycemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration, then periodically (e.g., monthly to quarterly)

Target: Individualized based on indication (e.g., <130/80 mmHg for hypertension)

Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension; inadequate BP control

Heart Rate (HR)

Frequency: Regularly, especially during dose titration, then periodically (e.g., monthly to quarterly)

Target: Typically >50-60 bpm (adults), individualized for children

Action Threshold: HR <50 bpm (adults) or symptomatic bradycardia; new onset arrhythmia

Blood Glucose (in diabetic patients)

Frequency: More frequently than usual, especially during dose changes

Target: Individualized

Action Threshold: Hypoglycemia without typical warning signs

Symptoms of Bronchospasm/Dyspnea

Frequency: Ongoing

Target: Not applicable

Action Threshold: New or worsening shortness of breath, wheezing

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Shortness of breath
  • Wheezing
  • Cold extremities
  • Depression
  • Insomnia
  • Masked signs of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are reports of adverse effects on the fetus/neonate including bradycardia, hypoglycemia, and intrauterine growth restriction. Neonates of mothers treated with propranolol should be carefully monitored for signs of beta-blockade for several days after birth.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly indicated due to potential for fetal effects.
Second Trimester: Potential for fetal bradycardia, growth restriction, and hypoglycemia. Close monitoring recommended.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression at birth. Withdrawal symptoms (e.g., irritability, tremors) may occur in neonates.
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Lactation

Propranolol is excreted into breast milk. The amount is generally low, but there is a potential for adverse effects in the breastfed infant (e.g., bradycardia, hypotension, hypoglycemia). Monitor the infant for signs of beta-blockade. Use with caution, especially in preterm or unstable infants. Consider alternative agents if possible.

Infant Risk: Low to moderate risk (L3 - Moderately Safe)
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Pediatric Use

Dosing must be carefully individualized and titrated based on weight, age, and indication. The 20mg/5ml oral solution is particularly useful for precise pediatric dosing. Close monitoring for adverse effects (especially bradycardia, hypotension, hypoglycemia, and bronchospasm) is crucial. Specific formulations (e.g., Hemangeol) are approved for infantile hemangioma.

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Geriatric Use

Geriatric patients may be more sensitive to the effects of beta-blockers and may have reduced renal or hepatic function, requiring lower initial doses and slower titration. Increased risk of bradycardia, hypotension, and CNS effects (e.g., dizziness, confusion). Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always taper propranolol slowly over 1-2 weeks when discontinuing, especially in patients with ischemic heart disease, to avoid rebound angina, myocardial infarction, or arrhythmias.
  • Propranolol can mask the signs of hypoglycemia (e.g., tachycardia, tremors) in diabetic patients. Educate patients to monitor blood glucose more closely.
  • Use with extreme caution in patients with bronchospastic diseases (e.g., asthma, COPD) due to non-selective beta-2 blockade, which can cause bronchoconstriction.
  • Avoid concomitant use with non-dihydropyridine calcium channel blockers (verapamil, diltiazem) due to risk of severe bradycardia and heart block.
  • The oral solution is particularly useful for precise dose titration, especially in pediatric patients or those requiring very low doses.
  • Patients may experience cold extremities due to peripheral vasoconstriction; advise on appropriate clothing.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, labetalol)
  • Calcium channel blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin receptor blockers (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • Central alpha-agonists (e.g., clonidine)
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Cost & Coverage

Average Cost: Varies widely, typically low per 5ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure 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.