Alprazolam 1mg 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
Oct 2003
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Alprazolam is a medication used to treat anxiety and panic disorders. It works by calming the brain and nerves, helping to reduce feelings of anxiety and panic attacks. The ODT (Orally Disintegrating Tablet) form 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 it correctly. If the tablets 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 let the tablet dissolve and not swallow it whole, chew, break, or crush it.

Storing and Disposing of Your Medication

To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse. When you no longer need the medication or it has expired, 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. You can also check with your pharmacist about 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 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 medications that cause drowsiness (e.g., opioids, cold/allergy medicines) as this can increase the risk of serious side effects like severe drowsiness or breathing problems.
  • 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, especially if you have been taking it regularly for a while. Your doctor will tell you how to slowly reduce your dose to prevent withdrawal symptoms.
  • Store at room temperature, away from moisture and heat. Keep out of reach of children and pets.
  • Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: Initial 0.25-0.5 mg orally 3 times daily. Panic Disorder: Initial 0.5 mg orally 3 times daily.
Dose Range: 0.25 - 10 mg

Condition-Specific Dosing:

Anxiety Disorder: Usual effective dose 0.5-4 mg/day in divided doses. Max 4 mg/day.
Panic Disorder: Usual effective dose 0.5-10 mg/day in divided doses. Dose may be increased by no more than 1 mg/day every 3-4 days. Max 10 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; consider lower initial doses and careful titration due to potential for accumulation of active metabolites.
Dialysis: Not significantly dialyzable; no specific recommendations, but monitor for increased effects.

Hepatic Impairment:

Mild: Consider lower initial doses.
Moderate: Consider lower initial doses (e.g., 0.25 mg once daily or BID).
Severe: Significant dose reduction required (e.g., 0.25 mg once daily or BID) due to impaired clearance and increased sensitivity.

Pharmacology

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Mechanism of Action

Alprazolam, a benzodiazepine, binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron in the central nervous system. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the brain, leading to increased chloride ion influx, hyperpolarization of the neuron, and reduced neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1.5-2 hours (for ODT)
FoodEffect: Food may delay Tmax but does not significantly affect AUC or Cmax.

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: 80%
CnssPenetration: Yes

Elimination:

HalfLife: 11.2 hours (range 6.3-26.9 hours)
Clearance: Not available
ExcretionRoute: Urine (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours (anxiolytic effect)

Safety & Warnings

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BLACK BOX WARNING

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND PHYSICAL DEPENDENCE 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, assess each patient’s risk for abuse, misuse, and addiction. The use of benzodiazepines, including alprazolam, may lead to physical dependence. The risk of dependence and withdrawal increases with longer treatment duration and higher doses. 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 Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ 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 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, 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. If you have questions or concerns, 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:

  • Excessive drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Confusion or disorientation
  • Slurred speech
  • Unusual mood changes, agitation, or aggression (paradoxical reactions)
  • Yellowing of skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Thoughts of self-harm or suicide
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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 in conjunction 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 with your other medications and health conditions. Never start, stop, or adjust 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 medication 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 engaging in activities that require your full attention. Additionally, refrain from consuming alcohol while taking this medication.

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.

If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, talk to 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 while taking this medication, 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:

  • Severe drowsiness
  • Confusion
  • Impaired coordination (ataxia)
  • Diminished reflexes
  • Slurred speech
  • Slowed or shallow breathing
  • Hypotension (low blood pressure)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local Poison Control Center (1-800-222-1222 in the US). Flumazenil may be used to reverse benzodiazepine effects in a hospital setting, but it carries risks, including precipitation of acute withdrawal.

Drug Interactions

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Contraindicated Interactions

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

  • Opioids (e.g., morphine, oxycodone, hydrocodone) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, other anxiolytics, antipsychotics, tricyclic antidepressants) - additive CNS depression.
  • Moderate CYP3A4 inhibitors (e.g., fluoxetine, cimetidine, erythromycin, clarithromycin, diltiazem, verapamil) - increased alprazolam plasma concentrations.
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Moderate Interactions

  • Digoxin - may increase digoxin plasma concentrations.
  • Oral contraceptives - may increase alprazolam plasma concentrations.
  • Grapefruit juice - may inhibit CYP3A4 and increase alprazolam levels.
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Minor Interactions

  • Not typically listed as minor; most interactions are clinically significant due to CNS effects or metabolic inhibition.

Monitoring

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Baseline Monitoring

Mental status and cognitive function

Rationale: To assess baseline anxiety/panic symptoms and potential for cognitive adverse effects.

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess hepatic impairment, which necessitates dose adjustment.

Timing: Prior to initiation, especially in patients with suspected hepatic dysfunction.

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Routine Monitoring

Efficacy (anxiety/panic symptom reduction)

Frequency: Regularly during treatment, especially during dose titration.

Target: Reduction in symptom severity, improved functioning.

Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy; excessive sedation may require dose reduction.

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

Frequency: Regularly, especially during initial therapy and dose changes.

Target: Minimal to tolerable side effects.

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

Signs of tolerance, dependence, or abuse

Frequency: Periodically, especially with long-term use.

Target: Absence of signs of misuse or escalating dose requirements.

Action Threshold: Evidence of dependence or abuse requires re-evaluation of treatment plan and potential tapering.

Respiratory status (especially with concomitant opioid use)

Frequency: Closely monitor, particularly during initiation or dose changes of either drug.

Target: Normal respiratory rate and depth.

Action Threshold: Bradypnea, shallow breathing, or hypoxemia requires immediate medical intervention.

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Symptom Monitoring

  • Excessive sedation
  • Drowsiness
  • Confusion
  • Slurred speech
  • Ataxia (impaired coordination)
  • Memory impairment
  • Respiratory depression (slow, shallow breathing)
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations, disinhibition)
  • Signs of withdrawal upon discontinuation (e.g., rebound anxiety, insomnia, seizures, tremors, muscle cramps, vomiting, sweating)

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.
Second Trimester: Not well-studied, but continued exposure may lead to risks similar to third trimester.
Third Trimester: Use during the third trimester or near delivery may result in neonatal flaccidity, respiratory depression, feeding difficulties, hypothermia, and withdrawal symptoms (e.g., hypertonia, tremor, hyperreflexia, irritability, crying, vomiting, diarrhea, seizures) in the neonate.
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Lactation

Alprazolam is excreted into breast milk. Due to the potential for sedation, poor feeding, and withdrawal symptoms in the breastfed infant, use during lactation is generally discouraged or requires careful monitoring and consideration of risks vs. benefits.

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

Safety and efficacy have not been established in pediatric patients for most indications. Generally not recommended for use in children and adolescents due to lack of data and potential for adverse effects, including paradoxical reactions.

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Geriatric Use

Elderly patients may be more sensitive to the effects of benzodiazepines and are at increased risk of adverse effects such as sedation, dizziness, ataxia, falls, and cognitive impairment. Lower initial doses (e.g., 0.25 mg BID or TID) are recommended, and dosage should be increased cautiously. Monitor closely for CNS depression.

Clinical Information

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Clinical Pearls

  • Alprazolam ODT offers a convenient dosage form for patients with dysphagia or those who prefer not to take medication with water. It may also have a slightly faster onset of action due to rapid dissolution.
  • Due to its high potential for abuse, misuse, and dependence, alprazolam should be prescribed for the shortest duration possible and at the lowest effective dose.
  • Abrupt discontinuation of alprazolam, especially after prolonged use or high doses, can lead to severe and potentially life-threatening withdrawal symptoms, including seizures. Always taper the dose gradually under medical supervision.
  • Educate patients thoroughly about the risks of concomitant use with opioids and alcohol, emphasizing the potential for severe respiratory depression and death.
  • Monitor for paradoxical reactions (e.g., agitation, aggression, disinhibition), which can occur, particularly in pediatric, geriatric, or psychiatric populations.
  • Consider alternative non-benzodiazepine therapies (e.g., SSRIs, SNRIs) as first-line for chronic anxiety or panic disorder, reserving alprazolam for short-term or acute management.
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Alternative Therapies

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

Average Cost: Varies widely, typically low for generic per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.