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Alprazolam 2mg Tablets

Manufacturer SANDOZ Active Ingredient Alprazolam 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 1981
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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 disorders and panic disorder. It belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves, helping you feel more 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, taking it with food may help.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. It's essential to store it in a secure location where children and pets cannot access it, and it's out of reach of others. Consider using a locked box or area to keep it safe. 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, consult your pharmacist for guidance on the best disposal method or inquire 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 resume your regular schedule. Avoid taking two doses at the same time or taking extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid alcohol and other central nervous system depressants (e.g., opioids, sedatives) while taking alprazolam, as this can lead to dangerous side effects like severe drowsiness, breathing problems, coma, and death.
  • Do not drive or operate heavy machinery until you know how alprazolam affects you, as it can cause drowsiness and dizziness.
  • Do not stop taking alprazolam suddenly, especially if you have been taking it regularly for a long time. This can cause serious withdrawal symptoms. Your doctor will help you gradually reduce the dose.
  • Store alprazolam securely to prevent misuse or accidental ingestion by others, especially children.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 0.25-0.5 mg three times daily; Panic Disorder: 0.5 mg three times daily
Dose Range: 0.25 - 10 mg

Condition-Specific Dosing:

anxiety: Initial: 0.25-0.5 mg three times daily; Max: 4 mg/day in divided doses
panic_disorder: Initial: 0.5 mg three times daily; Titrate 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 <18 years)
Adolescent: Not established (Safety and efficacy not established for <18 years)
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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: Use with caution, consider lower doses
Dialysis: Not significantly dialyzable; use with caution, consider lower doses

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 0.25 mg 2-3 times daily)
Moderate: Consider lower initial doses (e.g., 0.25 mg 2-3 times daily)
Severe: Contraindicated or use with extreme caution; significant dose reduction required (e.g., 0.25 mg once daily or every other day)

Pharmacology

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Mechanism of Action

Alprazolam is a triazolo analog of the 1,4 benzodiazepine class. It binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at various sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by increasing chloride ion conductance through the GABA-gated chloride channel, leading to hyperpolarization and stabilization of the neuronal membrane.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1-2 hours
FoodEffect: Food may delay Tmax but does not significantly affect bioavailability.

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: Renal (urine)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours

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 are serious and 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. Physical dependence and withdrawal reactions can occur upon discontinuation or dose reduction of benzodiazepines. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam 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 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 coordination or 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. Although 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, 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 that prevents normal activity
  • Difficulty breathing or shallow breathing
  • Extreme confusion or disorientation
  • Unusual changes in mood or behavior (e.g., increased agitation, aggression, hallucinations)
  • Yellowing of the skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
 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.
 If you are breastfeeding. It is recommended that you do not breastfeed 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 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 that 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 alertness. Additionally, refrain from consuming alcohol while taking this medication.

Before using marijuana, other forms of cannabis, or prescription or 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. Similarly, if you start or stop smoking, inform your doctor, as your dosage may need to be adjusted.

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

This medication can harm an unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, contact 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 the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Impaired coordination (ataxia)
  • Slurred speech
  • Slowed reflexes
  • 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 may be used in severe cases, but it can precipitate acute withdrawal in dependent patients.

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, other benzodiazepines, general anesthetics, tricyclic antidepressants, antipsychotics) - additive CNS depression
  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice) - increased alprazolam levels
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Moderate Interactions

  • CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort) - decreased alprazolam levels
  • Oral contraceptives - may increase alprazolam levels
  • Digoxin - may increase digoxin levels (monitor digoxin levels)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Mental status and psychiatric symptoms

Rationale: To establish baseline severity of anxiety/panic disorder and assess for co-morbid conditions.

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 pre-existing hepatic impairment.

Timing: Prior to initiation of therapy, if clinically indicated

Renal function tests (e.g., BUN, creatinine)

Rationale: Although primarily hepatic metabolism, metabolites are renally excreted; baseline assessment is important in patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy, if clinically indicated

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Routine Monitoring

Efficacy (reduction in anxiety/panic symptoms)

Frequency: Regularly, at each visit

Target: Patient-reported improvement in symptoms, reduction in panic attack frequency/severity

Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.

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

Frequency: Regularly, at each visit

Target: Minimal to tolerable side effects

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

Signs of tolerance, dependence, or withdrawal symptoms (upon dose reduction or discontinuation)

Frequency: Regularly, at each visit, and especially during tapering

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

Action Threshold: Presence of withdrawal symptoms indicates need for slower taper or re-evaluation of treatment plan.

Respiratory status (especially with concomitant opioid use)

Frequency: As clinically indicated, particularly at initiation or dose escalation with opioids

Target: Normal respiratory rate and effort

Action Threshold: Bradypnea, hypoventilation, or respiratory depression requires immediate intervention.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Confusion
  • Memory impairment
  • Ataxia (loss of coordination)
  • Slurred speech
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations)
  • Signs of respiratory depression (slow, shallow breathing)
  • Symptoms of withdrawal (e.g., rebound anxiety, insomnia, irritability, tremors, seizures, muscle cramps, vomiting, sweating) upon discontinuation or dose reduction

Special Patient Groups

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Pregnancy

Alprazolam is classified as Pregnancy Category D, meaning there is 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) if used during the first trimester, though data are conflicting.
Second Trimester: Less data available, but continued use may lead to fetal exposure.
Third Trimester: Use during the third trimester or near term can lead to 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) and withdrawal symptoms (e.g., irritability, hypertonia, tremors, feeding difficulties) in the neonate.
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Lactation

Alprazolam is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. It is generally not recommended during breastfeeding due to potential for sedation, poor feeding, and weight loss in the infant.

Infant Risk: Moderate risk (L3). Potential for sedation, lethargy, poor feeding, and withdrawal symptoms in the infant. Monitor infant for drowsiness, feeding difficulties, and developmental milestones.
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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 may be more sensitive to the effects of benzodiazepines, including increased risk of sedation, dizziness, falls, and cognitive impairment. Lower initial doses (e.g., 0.25 mg 2-3 times daily) are recommended, and dosage should be increased cautiously to minimize adverse effects.

Clinical Information

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Clinical Pearls

  • Alprazolam has a relatively short half-life compared to other benzodiazepines, which can lead to more pronounced inter-dose withdrawal symptoms and a higher potential for dependence if not dosed appropriately or tapered slowly.
  • Due to its rapid onset of action and high potency, alprazolam has a higher abuse potential compared to some other benzodiazepines.
  • Always emphasize the importance of a slow, gradual taper when discontinuing alprazolam to minimize severe withdrawal symptoms, including seizures.
  • Educate patients about the risks of concomitant use with opioids and alcohol, which can be life-threatening.
  • Consider non-pharmacological interventions (e.g., CBT, psychotherapy) as first-line or adjunctive therapy for anxiety and panic disorders, especially for long-term management.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, clonazepam, diazepam)
  • SSRIs (Selective Serotonin Reuptake Inhibitors) for anxiety and panic disorder (e.g., escitalopram, sertraline, fluoxetine)
  • SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) for anxiety (e.g., venlafaxine, duloxetine)
  • Buspirone (for generalized anxiety disorder)
  • Hydroxyzine (for short-term anxiety)
  • Beta-blockers (e.g., propranolol for performance anxiety or physical symptoms of anxiety)
  • Cognitive Behavioral Therapy (CBT)
  • Psychotherapy
  • Mindfulness and relaxation techniques
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (2mg)
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 is a valuable resource 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, we encourage you 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.