Alprazolam 2mg ODT Tablets

Manufacturer PAR Active Ingredient Alprazolam Orally Disintegrating Tablets(al PRAY zoe lam) Pronunciation al PRAY zoe lam
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 treat anxiety.It is used to treat panic attacks.
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Drug Class
Anxiolytic, Sedative-Hypnotic
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category D
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FDA Approved
Jan 2005
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Alprazolam ODT is a medication used to treat anxiety and panic attacks. It belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves. The ODT (Orally Disintegrating Tablet) dissolves quickly in your mouth without water.
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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.

When taking the medication, make sure to handle the tablets carefully. If they come in a foil blister pack, do not push the tablet out of the foil. Instead, use dry hands to remove it from the packaging. Place the tablet on your tongue and let it dissolve completely. You do not need to drink water with it. It's essential to avoid swallowing the tablet whole, chewing, breaking, or crushing it.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep it in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Remember to keep all medications out of reach of pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular 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 sedating medications while taking alprazolam, as this can increase drowsiness and dangerous side effects.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Do not stop taking this medication suddenly without consulting your doctor, as this can lead to withdrawal symptoms.
  • Store the ODT tablets in their original blister packaging and do not open until ready to use. Handle with dry hands.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially opioids.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 0.25-0.5 mg orally disintegrating tablet (ODT) three times daily. Panic Disorder: 0.5 mg ODT three times daily.
Dose Range: 0.25 - 10 mg

Condition-Specific Dosing:

anxiety: Initial: 0.25-0.5 mg ODT TID. Max: 4 mg/day in divided doses.
panicDisorder: Initial: 0.5 mg ODT TID. May increase by no more than 1 mg/day every 3-4 days. Max: 10 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for patients <18 years)
Adolescent: Not established (Safety and efficacy not established for patients <18 years)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for increased sedation.
Dialysis: Not significantly dialyzable. No specific dose adjustment, but monitor for increased effects.

Hepatic Impairment:

Mild: Consider lower doses.
Moderate: Reduce initial dose by 50-75% (e.g., 0.25 mg ODT once daily or twice daily). Titrate slowly based on response and tolerability.
Severe: Contraindicated or significantly reduced dose (e.g., 0.25 mg ODT once daily). Use with extreme caution due to impaired clearance and increased risk of adverse effects.

Pharmacology

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Mechanism of Action

Alprazolam, a benzodiazepine, binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA)-A receptor complex in the central nervous system. This binding enhances the inhibitory effects of GABA by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuronal membrane and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1-2 hours (for ODT formulation, may be slightly faster than conventional tablets)
FoodEffect: Food may delay Tmax but does not significantly affect bioavailability.

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: Approximately 80% (primarily to albumin)
CnssPenetration: Yes

Elimination:

HalfLife: 11.2-15.3 hours (mean 12.5 hours)
Clearance: 0.66-1.04 mL/min/kg
ExcretionRoute: Renal (urine)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours (clinical effects)

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 concomitant use of benzodiazepines, including alprazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined. Warn patients against concomitant ingestion of alcohol and other CNS depressant drugs. The use of benzodiazepines, including alprazolam, exposes patients to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing alprazolam, assess each patient’s risk for abuse, misuse, and addiction. The use of benzodiazepines, including alprazolam, even at recommended dosages, exposes patients to the risks of physical dependence and withdrawal reactions. Withdrawal reactions, particularly when alprazolam is discontinued abruptly, may be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Change in balance
Shortness of breath
Severe dizziness or fainting
Confusion
Memory problems or loss
Difficulty speaking
Trouble urinating
Difficulty controlling body movements
Muscle twitching
Rapid heartbeat
Blurred vision
Changes in menstrual period (in women)

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 or any other unusual symptoms that bother you or do not go away, contact your doctor:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Changes in appetite
Constipation, diarrhea, vomiting, or stomach upset
Changes in sex drive
Sexual problems
Weight gain or loss
Sleep disturbances
Headache
Excessive sweating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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:

  • Extreme drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Unusual dizziness or lightheadedness
  • Confusion or disorientation
  • Slurred speech
  • Memory problems
  • Paradoxical reactions (e.g., increased agitation, aggression, hallucinations)
  • 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. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with glaucoma.
* If you are currently taking any of the following medications: clarithromycin, itraconazole, or ketoconazole. Your doctor or pharmacist can provide guidance on other medications that should not be taken in combination with this drug.

Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
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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.

If you have been using this drug for an extended period or at high doses, you may develop tolerance, which means it may not be as effective, and you may require higher doses to achieve the same effect. If you notice this medication is no longer working as well as it should, contact your doctor. Do not exceed the prescribed dose.

Until you understand how this medication affects you, avoid driving and other activities that require alertness. Additionally, refrain from consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or prescription and over-the-counter medications that can cause drowsiness, consult with your doctor.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your medication.

If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, consult with your doctor, as some products may contain phenylalanine.

If you start or stop smoking, inform your doctor, as this may affect your dosage.

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

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, contact your doctor immediately. Taking this medication late in pregnancy may increase the risk of breathing or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Impaired coordination (ataxia)
  • Diminished reflexes
  • Slurred speech
  • Hypotension (low blood pressure)
  • Respiratory depression
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may reverse opioid-induced respiratory depression but is not effective for benzodiazepine overdose alone. Flumazenil may be used in severe cases but carries risks (e.g., seizures).

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, ritonavir, nelfinavir, indinavir)
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Major Interactions

  • Opioids (increased risk of respiratory depression, profound sedation, coma, and death)
  • Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, antipsychotics, tricyclic antidepressants, general anesthetics)
  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice)
  • Digoxin (may increase digoxin levels)
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Moderate Interactions

  • Oral contraceptives (may increase alprazolam levels)
  • Cimetidine (may increase alprazolam levels)
  • Fluoxetine (may increase alprazolam levels)
  • Propoxyphene (may increase alprazolam levels)
  • Imipramine, desipramine (may increase levels of these antidepressants)
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Minor Interactions

  • Theophylline (may decrease alprazolam effects)
  • Rifampin (may decrease alprazolam levels)

Monitoring

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Baseline Monitoring

Mental Status Examination

Rationale: To assess baseline anxiety/panic symptoms and cognitive function.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

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

Timing: Prior to initiation, particularly if hepatic impairment is suspected or present.

Renal Function Tests (RFTs)

Rationale: Although renal excretion of unchanged drug is minimal, metabolites are renally cleared. Important for overall patient assessment.

Timing: Prior to initiation, particularly if renal impairment is suspected or present.

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Routine Monitoring

Efficacy (Anxiety/Panic Symptom Severity)

Frequency: Regularly, at each follow-up visit (e.g., weekly initially, then monthly/quarterly)

Target: Reduction in symptom severity, improved functional status.

Action Threshold: Lack of improvement, worsening symptoms, or development of new symptoms may require dose adjustment or re-evaluation of therapy.

Adverse Effects (e.g., sedation, dizziness, cognitive impairment, paradoxical reactions)

Frequency: Regularly, at each follow-up visit

Target: Minimal to no intolerable side effects.

Action Threshold: Significant or intolerable side effects warrant dose reduction, change in dosing schedule, or discontinuation.

Signs of Abuse, Misuse, or Dependence

Frequency: Regularly, at each follow-up visit

Target: Absence of drug-seeking behavior, escalating doses, or withdrawal symptoms.

Action Threshold: Evidence of abuse or dependence requires careful re-evaluation of treatment plan, potential referral for addiction treatment, and consideration of tapering off the medication.

Respiratory Status (especially with concomitant opioid use)

Frequency: Closely monitor, especially during initiation or dose escalation of either drug.

Target: Normal respiratory rate and depth.

Action Threshold: Bradypnea, shallow breathing, or signs of hypoventilation require immediate medical attention.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Ataxia
  • Confusion
  • Slurred speech
  • Memory impairment
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations)
  • Signs of withdrawal (e.g., rebound anxiety, insomnia, seizures, tremors, muscle cramps, vomiting) upon discontinuation or dose reduction.

Special Patient Groups

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Pregnancy

Alprazolam is classified as Pregnancy Category D, indicating positive evidence of human fetal risk. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting. Avoidance is generally recommended.
Second Trimester: Continued risk of fetal exposure. Potential for adverse effects on fetal development.
Third Trimester: Use during the third trimester or near delivery can lead to 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties, hypothermia, respiratory depression) and neonatal withdrawal symptoms (irritability, hypertonia, tremors, feeding difficulties) after birth.
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Lactation

Alprazolam is excreted into breast milk. Due to potential for sedation, feeding difficulties, and withdrawal symptoms in the infant, use is generally not recommended during breastfeeding. If use is necessary, monitor the infant closely for adverse effects.

Infant Risk: Sedation, lethargy, poor feeding, weight loss, and potential for withdrawal symptoms upon discontinuation of maternal drug.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients (<18 years of age). Use is generally not recommended due to lack of data and potential for adverse effects.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased risk of sedation, dizziness, falls, and cognitive impairment. Initial doses should be lower (e.g., 0.25 mg ODT two or three times daily) and titrated slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Alprazolam ODT offers a faster onset of action compared to conventional tablets for some patients due to rapid dissolution, which can be beneficial for acute anxiety or panic attacks.
  • Due to its relatively short half-life and high potency, alprazolam carries a higher risk of physical dependence and withdrawal symptoms compared to longer-acting benzodiazepines. Tapering is crucial upon discontinuation.
  • The ODT formulation is useful for patients who have difficulty swallowing pills or for situations where water is not readily available.
  • Educate patients thoroughly about the risks of concomitant use with opioids, alcohol, and other CNS depressants.
  • Monitor for paradoxical reactions, especially in pediatric, geriatric, or psychiatrically unstable patients.
  • Assess for a history of substance abuse before initiating therapy, as alprazolam has a high abuse potential.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, clonazepam, diazepam)
  • SSRIs (Selective Serotonin Reuptake Inhibitors) for long-term anxiety/panic disorder management (e.g., escitalopram, sertraline, paroxetine)
  • SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., venlafaxine, duloxetine)
  • Buspirone (for generalized anxiety disorder)
  • Beta-blockers (e.g., propranolol for performance anxiety or physical symptoms of anxiety)
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (2mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.