Propranolol 10mg Tablets

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Propranolol Tablets(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.
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Drug Class
Antihypertensive, Antiarrhythmic, Antianginal, Antimigraine
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Pharmacologic Class
Non-selective beta-adrenergic blocker
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Pregnancy Category
Category C
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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 slowing down your heart rate and relaxing blood vessels, which helps to lower blood pressure, reduce chest pain (angina), prevent migraines, and treat certain heart rhythm problems. It can also help with tremors and anxiety.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. 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.

Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's crucial to complete the full course of treatment to ensure the best possible outcome.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from extreme heat, cold, and light. Keep the lid tightly closed to prevent moisture and other environmental factors from affecting the medication. Do not freeze your medication, as this can alter its composition and potency.

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 the missed one, as this can increase the risk of adverse effects.
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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 pulse regularly as instructed by your doctor. Report if your pulse is too slow (e.g., below 50-60 beats per minute) or irregular.
  • Avoid alcohol, as it can increase the effects of propranolol and cause dizziness.
  • If you have diabetes, monitor your blood sugar levels closely, as propranolol can mask the signs of low blood sugar.
  • Avoid activities requiring mental alertness, such as driving, until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • Maintain a healthy diet and exercise routine as advised by your doctor for conditions like high blood pressure or heart disease.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For hypertension: 40 mg orally twice daily initially.
Dose Range: 10 - 640 mg

Condition-Specific Dosing:

hypertension: Initial: 40 mg BID; usual maintenance: 120-240 mg/day in 2-3 divided doses. Max: 640 mg/day.
anginaPectoris: Initial: 80 mg/day in 2-4 divided doses; usual maintenance: 160-320 mg/day.
arrhythmias: 10-30 mg orally 3-4 times daily.
migraineProphylaxis: Initial: 80 mg/day in divided doses; usual maintenance: 160-240 mg/day.
essentialTremor: Initial: 40 mg BID; usual maintenance: 120-320 mg/day.
hypertrophicSubaorticStenosis: 20-40 mg 3-4 times daily.
pheochromocytoma: 60 mg/day in divided doses for 3 days prior to surgery, or 30 mg/day in divided doses for non-operable tumors.
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Pediatric Dosing

Neonatal: Not established for general use. Used off-label for specific conditions (e.g., infantile hemangioma, arrhythmias) with highly individualized dosing.
Infant: Not established for general use. Used off-label for specific conditions (e.g., infantile hemangioma, arrhythmias) with highly individualized dosing.
Child: Hypertension: Initial 0.5 mg/kg/day in 2 divided doses; usual range 1-2 mg/kg/day. Max 4 mg/kg/day or 60 mg/day. Infantile Hemangioma: 0.5-1 mg/kg/day divided BID, titrated up to 2-3 mg/kg/day.
Adolescent: Dosing similar to adult for some indications, but individualized based on weight and condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased effects.
Severe: Use with caution. Consider lower initial doses and careful titration due to potential for accumulation of active metabolites. Monitor heart rate and blood pressure closely.
Dialysis: Propranolol is not significantly removed by hemodialysis. No specific supplemental dose needed, but monitor for increased effects due to potential accumulation of metabolites.

Hepatic Impairment:

Mild: Use with caution. Consider lower initial doses.
Moderate: Significant reduction in dose may be required due to extensive hepatic metabolism. Start with lower doses (e.g., 50% of usual) and titrate slowly.
Severe: Contraindicated or use with extreme caution. Significant dose reduction (e.g., 75% or more) is necessary. Monitor closely for adverse effects.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks both beta-1 (β1) and beta-2 (β2) adrenergic receptors. Blocking β1 receptors in the heart leads to decreased heart rate, decreased myocardial contractility, and decreased cardiac output, thereby lowering blood pressure and reducing myocardial oxygen demand. Blocking β2 receptors in the bronchi and peripheral vasculature can lead to bronchoconstriction and vasoconstriction, respectively. It also has membrane-stabilizing activity (quinidine-like effect) at high doses and lacks intrinsic sympathomimetic activity (ISA). Its antihypertensive effect is also attributed to reduction of renin release from the kidneys, and central nervous system effects.
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Pharmacokinetics

Absorption:

Bioavailability: 25-50% (highly variable 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 (lipophilic, readily crosses blood-brain barrier)

Elimination:

HalfLife: 3-6 hours (immediate release)
Clearance: Not available (highly variable)
ExcretionRoute: Urine (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30 minutes (oral)
PeakEffect: 1-1.5 hours (oral)
DurationOfAction: 6-12 hours (immediate release)

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 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 propranolol 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 immediate 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 low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ A rash on the cheeks or other body parts
+ Easy sunburning
+ 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 or irregular heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion or hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or other 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, such as red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or 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, tiredness, or 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 (bradycardia)
  • Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
  • Swelling of ankles or feet
  • Unusual weight gain
  • New or worsening chest pain
  • Coldness, numbness, or pain in fingers or toes
  • Symptoms of depression (e.g., persistent sadness, loss of interest)
  • Signs of low blood sugar (e.g., sweating, hunger, confusion) if you are diabetic, as typical symptoms like rapid heartbeat may be masked.
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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 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

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

To ensure your safety, always verify with your doctor that it is safe to take this medication with your existing health conditions and other medications. Never start, stop, or change 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
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring and Lab Tests
Follow your doctor's instructions for checking your blood pressure and heart rate. Be aware that this medication may affect certain laboratory 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 hypoglycemia, especially in people with diabetes, children, and those who are fasting or have undergone surgery.

Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.

Stopping the Medication
Do not stop taking this medication abruptly, as this can lead to worsening chest pain or even a heart attack, especially if you have certain types of heart disease. To avoid side effects, your doctor will instruct 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.

Thyroid Conditions
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 with your doctor if you have any concerns.

Interactions with Other Medications
If you have high blood pressure, consult with your doctor before taking over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Allergic Reactions
If you have a history of severe allergic reactions, discuss with your doctor the potential risks of anaphylaxis. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

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 to ensure the best possible outcome for 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
  • Heart failure
  • Bronchospasm
  • Hypoglycemia
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include atropine for bradycardia, 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 (within 14 days of use) - risk of severe hypertension.
  • Diazoxide (IV) - risk of severe hypotension.
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Major Interactions

  • Other antiarrhythmics (e.g., amiodarone, quinidine, flecainide) - increased risk of bradycardia, heart block, and myocardial depression.
  • Digoxin - increased risk of bradycardia.
  • Alpha-1 blockers (e.g., prazosin, doxazosin) - risk of profound first-dose hypotension.
  • Insulin and oral hypoglycemics - can mask symptoms of hypoglycemia (tachycardia, tremors) and prolong hypoglycemic episodes.
  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce the antihypertensive effect of propranolol.
  • Clonidine - risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first.
  • Ergot alkaloids (e.g., ergotamine) - increased peripheral vasoconstriction and ischemia.
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Moderate Interactions

  • Cimetidine - increases propranolol plasma levels (inhibits metabolism).
  • Alcohol - may increase propranolol levels and enhance hypotensive effects.
  • Phenytoin, phenobarbital, rifampin - decrease propranolol plasma levels (induce metabolism).
  • Theophylline - propranolol may decrease theophylline clearance.
  • Lidocaine - propranolol may decrease lidocaine clearance.
  • Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may decrease propranolol absorption.
  • SSRIs (e.g., fluoxetine, paroxetine) - may increase propranolol levels (CYP2D6 inhibition).
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Minor Interactions

  • Not available (interactions are generally categorized as moderate or higher due to clinical significance).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

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

Timing: Prior to initiation, particularly in patients with cardiac history.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation.

Liver Function Tests (ALT, AST, Bilirubin)

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

Timing: Prior to initiation.

Blood Glucose (in diabetic patients)

Rationale: Propranolol can mask symptoms of hypoglycemia.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then every 3-6 months).

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

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic), or inadequate BP control.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then every 3-6 months).

Target: Typically >50-60 bpm (unless specific therapeutic goal for lower HR).

Action Threshold: Bradycardia (<50 bpm or symptomatic), or significant drop from baseline.

Symptoms of Bronchospasm/Dyspnea

Frequency: Regularly, especially in patients with history of asthma/COPD.

Target: Absence of symptoms.

Action Threshold: New or worsening shortness of breath, wheezing.

Blood Glucose (in diabetic patients)

Frequency: More frequent monitoring, especially when initiating or adjusting dose.

Target: Individualized glycemic targets.

Action Threshold: Hypoglycemia (especially if masked symptoms).

Peripheral Perfusion (e.g., cold extremities)

Frequency: Periodically.

Target: Normal perfusion.

Action Threshold: Worsening claudication or cold extremities.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Wheezing
  • Cold hands/feet
  • Bradycardia (slow pulse)
  • Depression
  • Sleep disturbances
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol is classified as Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause fetal growth restriction, bradycardia, and hypoglycemia. Neonates exposed to beta-blockers in utero may be at risk for hypoglycemia, bradycardia, and respiratory depression at birth.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed due to potential for fetal effects.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia. Close monitoring of fetal growth and heart rate is recommended.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate for several days after birth.
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Lactation

Propranolol is excreted into breast milk. The American Academy of Pediatrics considers propranolol to be 'compatible with breastfeeding' with caution. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypotension, drowsiness, hypoglycemia).

Infant Risk: Low to moderate risk. While present in milk, the amount is generally small. However, infants, especially neonates or those with underlying conditions, should be monitored for adverse effects.
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Pediatric Use

Dosing is highly individualized and often off-label for specific conditions like infantile hemangioma, hypertension, or certain arrhythmias. Close monitoring of heart rate, blood pressure, and blood glucose is essential. Pediatric patients may be more sensitive to the effects of beta-blockade.

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Geriatric Use

Elderly patients may be more sensitive to the effects of propranolol, particularly bradycardia and hypotension. Start with lower doses and titrate slowly. Monitor for adverse effects and drug interactions more closely.

Clinical Information

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Clinical Pearls

  • Propranolol is a highly lipophilic beta-blocker, meaning it readily crosses the blood-brain barrier, which contributes to its efficacy in conditions like migraine prophylaxis, essential tremor, and anxiety.
  • Due to its non-selective nature (blocking both beta-1 and beta-2 receptors), it should be used with extreme caution or avoided in patients with bronchospastic diseases (e.g., asthma, COPD) as it can cause bronchoconstriction.
  • It is important to educate patients about the black box warning regarding abrupt discontinuation, especially in those with ischemic heart disease.
  • Food significantly increases the bioavailability of propranolol, so consistent administration with meals is recommended to maintain stable drug levels.
  • Propranolol can mask the signs of hypoglycemia (e.g., tachycardia, tremors) in diabetic patients, making blood glucose monitoring crucial.
  • It is often used off-label for performance anxiety due to its ability to reduce physical symptoms like palpitations and tremors.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-blockers (e.g., prazosin, terazosin)
  • Central alpha-agonists (e.g., clonidine)
  • For migraine prophylaxis: Topiramate, Valproic acid, CGRP inhibitors
  • For essential tremor: Primidone
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (10mg)
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.