Alprazolam 0.5mg 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
Sep 2000
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Alprazolam is a medication in the benzodiazepine class, often prescribed to treat anxiety disorders and panic disorder. It works by calming the brain and nerves, helping to reduce feelings of anxiety and panic. The ODT (Orally Disintegrating Tablet) form dissolves quickly in the 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 tablets, do not push them out of the foil blister pack. Instead, use dry hands to remove the tablet from the foil. Place the tablet on your tongue and let it dissolve completely. You do not need to drink water with it. It's essential to let the tablet dissolve and not swallow it whole, chew, break, or crush it.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe and secure location where children cannot see or reach it, and other people cannot access it. Consider using a locked box or area to store your medication. Keep all medications away from 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. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.

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 continue with 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 CNS depressants (e.g., opioids, sedating antihistamines) as they can increase drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Do not stop taking this medication suddenly, especially if you have been taking it regularly for a long time. This can lead to serious withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort or grapefruit juice, as they can interact with alprazolam.
  • Store medication safely to prevent misuse or abuse by others.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 0.25 mg to 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 TID, titrate to maximum 4 mg/day in divided doses.
panic_initial: 0.5 mg TID, titrate by no more than 1 mg/day every 3-4 days to maximum 10 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in patients under 18 years of age).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution, monitor for increased effects.
Dialysis: Not significantly dialyzable; no specific recommendations, use with caution.

Hepatic Impairment:

Mild: Consider lower starting dose (e.g., 0.25 mg once daily or BID).
Moderate: Consider lower starting dose (e.g., 0.25 mg once daily or BID).
Severe: Contraindicated or use with extreme caution; significantly reduced clearance, increased risk of adverse effects including encephalopathy. Initial dose 0.25 mg once daily or BID.

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 (CNS). 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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90%
Tmax: 1-2 hours (for ODT, similar to conventional tablets)
FoodEffect: Food can delay Tmax by about 25% but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.7-1.2 L/kg
ProteinBinding: Approximately 80% (primarily to albumin)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 11.2 hours (range 6.3-26.9 hours)
Clearance: Approximately 0.9-1.2 mL/min/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours (clinical effects, though half-life is longer)

Safety & Warnings

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BLACK BOX WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND WITHDRAWAL REACTIONS

Concomitant use of benzodiazepines, including alprazolam, 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 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 and throughout treatment, assess each patient’s risk of abuse, misuse, and addiction.

The continued use of benzodiazepines, including alprazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can 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
Sudden change in balance
Shortness of breath
Severe dizziness or fainting
Confusion
Memory problems or loss
Difficulty speaking
Trouble urinating
Loss of control over 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 mild 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, contact your doctor for advice:

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 not mentioned here. 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:

  • Severe drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Extreme dizziness or lightheadedness
  • Confusion or disorientation
  • Slurred speech
  • Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
  • Yellowing of skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Symptoms of withdrawal if stopped abruptly (e.g., seizures, tremors, severe anxiety, insomnia, muscle cramps, vomiting, sweating)
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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 symptoms you experienced.
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 concurrently 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 whether it is safe to take this medication in conjunction with your other medications and health issues. Do not initiate, discontinue, 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 (OTC) 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. Individuals with phenylketonuria (PKU) should also consult their doctor, as some products contain phenylalanine.

If you start or stop smoking, inform your doctor, as this may require an adjustment to your medication dosage.

Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects.

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

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Flumazenil may be used as an antidote in severe cases, but it carries risks (e.g., precipitating withdrawal seizures).

Drug Interactions

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Contraindicated Interactions

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

  • Opioids (increased risk of respiratory depression, profound sedation, coma, death)
  • Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, antipsychotics, tricyclic antidepressants, muscle relaxants) - additive CNS depression
  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice) - increased alprazolam levels
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Moderate Interactions

  • Oral contraceptives (may decrease alprazolam clearance)
  • Digoxin (may increase digoxin levels)
  • Imipramine, desipramine (may increase plasma levels of these antidepressants)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: Alprazolam is primarily metabolized by the liver; assess baseline hepatic function, especially in patients with pre-existing liver disease.

Timing: Prior to initiation, if clinically indicated.

Renal function tests (RFTs)

Rationale: Metabolites are renally excreted; assess baseline renal function, especially in patients with pre-existing kidney disease.

Timing: Prior to initiation, if clinically indicated.

Mental status and psychiatric history

Rationale: Assess baseline anxiety/panic symptoms, history of substance abuse, and risk for suicidal ideation.

Timing: Prior to initiation.

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Routine Monitoring

Efficacy (reduction in anxiety/panic symptoms)

Frequency: Regularly during titration and maintenance, typically at follow-up visits (e.g., weekly initially, then monthly).

Target: Symptom reduction to a tolerable or absent level.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

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

Frequency: Regularly, especially during initiation and dose changes.

Target: Minimal to no intolerable side effects.

Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.

Signs of tolerance, dependence, or withdrawal

Frequency: At each follow-up visit, particularly with long-term use.

Target: Absence of signs of tolerance (requiring higher doses for same effect), dependence, or withdrawal symptoms upon dose reduction.

Action Threshold: Presence of these signs necessitates careful re-evaluation of treatment plan, including slow tapering if discontinuation is desired.

Respiratory status (especially with concomitant opioid use)

Frequency: Closely monitor during co-administration, particularly at initiation or dose changes.

Target: Normal respiratory rate and depth.

Action Threshold: Bradypnea, hypoventilation, or signs of respiratory depression require immediate medical attention.

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Lightheadedness
  • Confusion
  • Memory impairment
  • Slurred speech
  • Lack of coordination
  • Difficulty concentrating
  • Paradoxical excitement or agitation
  • Depressed mood or suicidal thoughts
  • Signs of withdrawal (e.g., seizures, tremors, muscle cramps, vomiting, sweating, anxiety, insomnia) upon abrupt discontinuation.

Special Patient Groups

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Pregnancy

Alprazolam is classified as Pregnancy Category D. It should not be used during pregnancy due to evidence of fetal risk. Use only 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) based on some studies, though data are conflicting.
Second Trimester: Not well-studied, but continued exposure may lead to neonatal effects.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, hypothermia (floppy infant syndrome), and withdrawal symptoms (e.g., irritability, tremors, hypertonia, seizures) if used late in pregnancy.
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Lactation

Alprazolam is excreted into breast milk. Due to the 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: Risk level: Moderate (L3 - Moderately safe, but close monitoring of infant is required).
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more sensitive to the effects of benzodiazepines, including alprazolam, and may experience increased risk of sedation, dizziness, ataxia, and falls. Lower starting doses (e.g., 0.25 mg two or three times daily) and careful titration are recommended. Monitor closely for cognitive impairment and falls.

Clinical Information

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Clinical Pearls

  • Alprazolam ODT offers convenience for patients who have difficulty swallowing pills or prefer not to use water. It dissolves rapidly on the tongue.
  • Due to its relatively short half-life and high potency, alprazolam has a significant potential for physical dependence and withdrawal symptoms, even with therapeutic doses. Tapering is crucial.
  • The Black Box Warning regarding concomitant opioid use and risks of abuse/dependence/withdrawal is critical for prescribers and patients.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric, elderly, or psychiatric patients.
  • Patients should be advised to avoid grapefruit juice as it can inhibit CYP3A4 and increase alprazolam levels, leading to enhanced effects and toxicity.
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Alternative Therapies

  • Other benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam, Oxazepam)
  • SSRIs (Selective Serotonin Reuptake Inhibitors) for anxiety/panic disorders (e.g., Sertraline, Paroxetine, Escitalopram)
  • SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., Venlafaxine, Duloxetine)
  • Buspirone (for generalized anxiety disorder)
  • Hydroxyzine (for anxiety)
  • Beta-blockers (e.g., Propranolol for performance anxiety or somatic symptoms)
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (0.5mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it'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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.