Diazepam 2mg Tablets

Manufacturer MYLAN Active Ingredient Diazepam Tablets(dye AZ e pam) Pronunciation dye-AZ-e-pam
WARNING: This drug is a benzodiazepine. The use of a benzodiazepine drug along with opioid drugs has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and death. Opioid drugs include drugs like codeine, oxycodone, and morphine. Opioid drugs are used to treat pain and some are used to treat cough. Talk with the doctor.If you are taking this drug with an opioid drug, get medical help right away if you feel very sleepy or dizzy; if you have slow, shallow, or trouble breathing; or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Benzodiazepines can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose or death, especially when used along with certain other drugs, alcohol, or street drugs. Drug use disorder can happen even if you take this drug as your doctor has told you. Get medical help right away if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.You will be watched closely to make sure you do not misuse this drug or develop drug use disorder.Benzodiazepines may cause dependence. Lowering the dose or stopping this drug all of a sudden may cause withdrawal. This can be life- threatening. The risk of dependence and withdrawal are raised the longer you take this drug and the higher the dose. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor's instructions. Get medical help right away if you have trouble controlling body movements, seizures, new or worse behavior or mood changes like depression or thoughts of suicide, thoughts of harming someone, hallucinations (seeing or hearing things that are not there), losing contact with reality, moving around or talking a lot, or any other bad effects.Sometimes, withdrawal signs can last for several weeks to more than 12 months. Tell your doctor if you have anxiety; trouble with memory, learning, or focusing; trouble sleeping; burning, numbness, or tingling; weakness; shaking; muscle twitching; ringing in the ears; or any other bad effects. @ COMMON USES: It is used to relax muscles.It is used to treat alcohol withdrawal.It is used to treat anxiety.It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anxiolytic, Sedative-hypnotic, Anticonvulsant, Skeletal muscle relaxant
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category D
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FDA Approved
Nov 1963
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Diazepam is a medication that belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves. It is used to treat anxiety, muscle spasms, and seizures, and also for alcohol withdrawal symptoms. It can make you feel sleepy or relaxed.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.

Storing and Disposing of Your Medication

Store this medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. To ensure safety, store this medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication. When you're finished with the medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.

Missing a Dose

If you take this medication on a regular schedule, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid alcohol and other sedatives: Combining diazepam with alcohol or other drugs that make you sleepy can be very dangerous and lead to severe breathing problems or coma.
  • Do not drive or operate machinery: Diazepam can cause drowsiness, dizziness, and impaired coordination. Avoid activities requiring mental alertness until you know how the medication affects you.
  • Take exactly as prescribed: Do not take more or less than your prescribed dose, and do not take it more often than directed. Do not stop taking it suddenly without talking to your doctor, as this can cause withdrawal symptoms.
  • Risk of dependence: Long-term use can lead to physical and psychological dependence. Your doctor will help you taper off the medication slowly if it needs to be stopped.
  • Store safely: Keep out of reach of children and pets, and in a secure place to prevent misuse.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg to 10 mg, 2 to 4 times daily (for anxiety)
Dose Range: 2 - 40 mg

Condition-Specific Dosing:

anxiety: 2 mg to 10 mg, 2 to 4 times daily
acutealcoholwithdrawal: 10 mg 3 to 4 times during the first 24 hours, then 5 mg 3 to 4 times daily as needed
skeletalmusclespasm: 2 mg to 10 mg, 3 to 4 times daily
status epilepticus (IV): 5 mg to 10 mg, repeated every 10-15 minutes up to a maximum of 30 mg
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Pediatric Dosing

Neonatal: Not established (contraindicated due to risk of 'gasping syndrome' with benzyl alcohol preservative in IV formulations; oral use generally avoided due to prolonged half-life)
Infant: Not established (oral use generally avoided due to prolonged half-life)
Child: 0.12 mg/kg to 0.8 mg/kg per day orally, divided 3 or 4 times daily (for anxiety/muscle spasm); 0.04 mg/kg to 0.2 mg/kg IV for status epilepticus (max 0.6 mg/kg over 8 hours)
Adolescent: Similar to adult dosing, but start with lowest effective dose and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed, but monitor for increased sedation.
Moderate: No specific adjustment generally needed, but monitor for increased sedation.
Severe: Use with caution; consider lower doses and extended dosing intervals due to potential accumulation of active metabolites. Not significantly dialyzable.
Dialysis: Not effectively removed by hemodialysis. Use with caution, monitor for prolonged effects.

Hepatic Impairment:

Mild: Use with caution; consider lower initial doses.
Moderate: Significant dose reduction (e.g., 50%) and careful titration required due to impaired metabolism and prolonged half-life. Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dose reduction. Risk of hepatic encephalopathy. Monitor closely.

Pharmacology

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Mechanism of Action

Diazepam is a benzodiazepine that binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA)-A receptor complex in the central nervous system. This binding enhances the affinity of GABA for its receptor, leading to an increased frequency of chloride channel opening. The influx of chloride ions hyperpolarizes the neuronal membrane, thereby inhibiting neuronal excitability and producing anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100% (oral)
Tmax: 1-1.5 hours (oral)
FoodEffect: Food can delay the rate of absorption (increase Tmax) but generally does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.8-1.0 L/kg (adults), higher in children and elderly
ProteinBinding: 98-99% (primarily to albumin)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: Diazepam: 20-100 hours (highly variable); Desmethyldiazepam: 30-100 hours
Clearance: 0.2-0.5 mL/min/kg
ExcretionRoute: Renal (primarily as conjugated metabolites)
Unchanged: <1% (urine)
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Pharmacodynamics

OnsetOfAction: 15-60 minutes (oral); 1-5 minutes (IV)
PeakEffect: 1-2 hours (oral); 5-10 minutes (IV)
DurationOfAction: 6-8 hours (clinical effects); however, accumulation of active metabolites leads to prolonged effects, especially with chronic use.

Safety & Warnings

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BLACK BOX WARNING

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The risks of abuse, misuse, and addiction with benzodiazepines can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions. Continued use of benzodiazepines, including diazepam, may lead to physical dependence. The risks of withdrawal reactions, including seizures, may be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Change in balance
Feeling confused
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Severe dizziness or fainting
Muscle spasms
Twitching
Trouble sleeping
Changes in eyesight
Slurred speech
Severe upset stomach, vomiting, or loss of appetite that persists or worsens
Suicidal thoughts or actions (see below for more information)

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, particularly in people who have had suicidal thoughts or actions in the past. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions

contact your doctor immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:

Feeling sleepy
Feeling tired or weak
Muscle weakness

This is not an exhaustive list of possible 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 drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Extreme dizziness or lightheadedness
  • Unusual confusion or disorientation
  • Slurred speech
  • Loss of coordination or balance (ataxia)
  • Paradoxical reactions (e.g., increased agitation, aggression, hallucinations, restlessness)
  • 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, including:
+ Breathing problems
+ Glaucoma
+ Liver disease
+ Myasthenia gravis
+ Sleep apnea
A history of psychosis
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or pain relievers like oxycodone

Additionally, if you are:

Breastfeeding or planning to breastfeed, as you may need to avoid nursing while taking this medication
Considering giving this medication to a child, note that it is not recommended for infants under 6 months of age

This medication may interact with other drugs or health conditions. Therefore, it is crucial to:

Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking
Discuss your health problems with your doctor to ensure it is safe to take this medication
* Avoid starting, stopping, or changing the dose of any medication without consulting your doctor first
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Precautions & Cautions

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

Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.

Refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.

Prior to using marijuana, other cannabis products, or prescription and over-the-counter medications that may impair your reactions, consult with your doctor.

If you experience a change in the frequency or severity of seizures after initiating this medication, promptly discuss this with your doctor.

This medication may cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, consult with your doctor.

Do not alter the dosage or discontinue this medication without consulting your doctor, as this may trigger seizures.

If you are taking this medication long-term, schedule regular blood tests and discuss the results with your doctor.

Prolonged use or high doses of this medication may lead to tolerance, reducing its effectiveness and potentially requiring increased doses to achieve the same effect. If you notice a decrease in the medication's efficacy, contact your doctor. Do not exceed the prescribed dosage.

Adults 65 years and older should exercise caution when taking this medication, as they may be more susceptible to side effects.

When administering this medication to children, use caution, as they may be at a higher risk for certain side effects.

If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may harm the unborn baby.

Taking this medication during late pregnancy may increase the risk of respiratory or feeding problems, hypothermia, or withdrawal symptoms in the newborn. Discuss this with your doctor to understand the potential risks and benefits.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Ataxia (loss of coordination)
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow breathing)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Flumazenil (a benzodiazepine receptor antagonist) may be used in severe cases, but it carries risks, including precipitating acute withdrawal seizures in dependent patients.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4/CYP2C19 inhibitors (e.g., ketoconazole, itraconazole, fluvoxamine) in patients with severe respiratory depression or coma.
  • Other CNS depressants (especially opioids) in patients with severe respiratory compromise or history of substance abuse (relative contraindication due to Black Box Warning).
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Major Interactions

  • Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for patients for whom alternative treatment options are inadequate.
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics): Additive CNS depressant effects.
  • Strong CYP3A4 inhibitors (e.g., clarithromycin, ritonavir, grapefruit juice): Significantly increase diazepam levels, leading to increased sedation and respiratory depression.
  • Strong CYP2C19 inhibitors (e.g., omeprazole, fluoxetine): Significantly increase diazepam levels.
  • Sodium oxybate: Potentiates CNS depression.
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Moderate Interactions

  • Moderate CYP3A4/CYP2C19 inhibitors (e.g., cimetidine, erythromycin, diltiazem, verapamil, isoniazid): May increase diazepam levels.
  • Antacids: May delay absorption but not extent.
  • Digoxin: May increase digoxin serum concentrations.
  • Phenytoin: May alter phenytoin levels (increase or decrease).
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Minor Interactions

  • Theophylline: May antagonize the sedative effects of diazepam.
  • Levodopa: May reduce the therapeutic effect of levodopa.

Monitoring

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Baseline Monitoring

Mental Status/Cognitive Function

Rationale: To assess baseline anxiety/sedation level and identify pre-existing cognitive impairment.

Timing: Prior to initiation

Respiratory Rate and Effort

Rationale: To establish baseline respiratory status, especially important before concomitant use with opioids or in patients with respiratory compromise.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Diazepam is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

Renal Function (CrCl)

Rationale: To assess kidney function, as metabolites are renally excreted and accumulation can occur in severe impairment.

Timing: Prior to initiation (if clinically indicated)

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Routine Monitoring

Sedation Level/Alertness

Frequency: Daily or as needed, especially during dose titration or with concomitant CNS depressants.

Target: Awake, alert, able to respond appropriately; minimal sedation.

Action Threshold: Excessive drowsiness, lethargy, difficulty arousing, slurred speech, ataxia. Reduce dose or discontinue.

Respiratory Rate and Depth

Frequency: Regularly, especially with higher doses or concomitant opioids.

Target: Normal for patient.

Action Threshold: Bradypnea (<10-12 breaths/min), shallow breathing, hypoventilation. Consider naloxone if opioid co-administration, respiratory support.

Efficacy (Anxiety, Seizure Control, Muscle Spasm)

Frequency: Regularly, based on clinical response.

Target: Reduction in target symptoms.

Action Threshold: Lack of therapeutic effect. Re-evaluate diagnosis, dose, or consider alternative therapy.

Signs of Dependence/Withdrawal

Frequency: Periodically, especially with long-term use or during dose reduction/discontinuation.

Target: Absence of withdrawal symptoms (e.g., rebound anxiety, insomnia, tremors, seizures).

Action Threshold: Emergence of withdrawal symptoms. Taper dose slowly.

Paradoxical Reactions

Frequency: Monitor throughout therapy.

Target: Absence of agitation, aggression, hallucinations.

Action Threshold: Occurrence of paradoxical reactions. Discontinue diazepam.

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Symptom Monitoring

  • Excessive drowsiness
  • Dizziness
  • Confusion
  • Ataxia (loss of coordination)
  • Slurred speech
  • Blurred vision
  • Respiratory depression (slow, shallow breathing)
  • Paradoxical reactions (agitation, aggression, hallucinations, restlessness)
  • Memory impairment (anterograde amnesia)
  • Signs of tolerance or withdrawal (if discontinuing)

Special Patient Groups

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Pregnancy

Diazepam is classified as Pregnancy Category D, meaning there is positive evidence of human fetal risk. It should only be used if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations, particularly cleft lip and palate, although data are conflicting and the absolute risk is low.
Second Trimester: Risk of fetal CNS depression if used close to term.
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties, hypothermia, respiratory depression) and withdrawal symptoms (irritability, hypertonia, tremors) in the neonate if used during late pregnancy or labor.
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Lactation

Diazepam and its active metabolites are excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on nursing infants is unknown but may be of concern. Use with caution, monitor infant for sedation, poor feeding, and weight gain.

Infant Risk: Moderate risk (L3). Potential for sedation, lethargy, poor feeding, and weight loss in the infant due to accumulation of active metabolites. Long half-life in infants. Avoid if possible, or use lowest effective dose for shortest duration, and monitor infant closely.
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Pediatric Use

Use with caution, especially in neonates and infants, due to prolonged half-life and potential for accumulation. Dosage must be carefully individualized based on age, weight, and clinical response. Not recommended for long-term use in children due to potential for developmental effects and dependence.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased sedation, dizziness, ataxia, and cognitive impairment. Start with the lowest effective dose (e.g., 2 mg 1-2 times daily) and titrate slowly. Increased risk of falls. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diazepam has a very long half-life and active metabolites, leading to significant accumulation with chronic dosing, especially in the elderly or those with hepatic impairment.
  • Due to its rapid onset of action, diazepam is often preferred for acute anxiety, status epilepticus (IV), and acute alcohol withdrawal.
  • Physical dependence and withdrawal symptoms can occur with prolonged use, even at therapeutic doses. Tapering is crucial upon discontinuation.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in children, the elderly, and patients with psychiatric disorders.
  • Concomitant use with opioids carries a Black Box Warning due to the risk of profound sedation, respiratory depression, coma, and death. Avoid unless absolutely necessary and monitor closely.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, alprazolam, clonazepam for anxiety; midazolam for acute seizures)
  • SSRIs (e.g., escitalopram, sertraline) or SNRIs (e.g., venlafaxine, duloxetine) for long-term anxiety management
  • Buspirone (for generalized anxiety disorder)
  • Hydroxyzine (for short-term anxiety/sedation)
  • Anticonvulsants (e.g., phenytoin, levetiracetam) for seizure disorders
  • Skeletal muscle relaxants (e.g., cyclobenzaprine, tizanidine) for muscle spasms
  • Non-pharmacological therapies (e.g., cognitive behavioral therapy, psychotherapy, relaxation techniques)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (2mg)
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.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.