Alprazolam ER 2mg Tablets
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 panic attacks.
Drug Class
Anxiolytic, Sedative-Hypnotic
Pharmacologic Class
Benzodiazepine, GABA-A Receptor Agonist
Pregnancy Category
D
FDA Approved
Aug 2003
DEA Schedule
Schedule IV
Overview
What is this medicine?
Alprazolam ER is an extended-release medication used to treat anxiety and panic disorders. It belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves, helping to reduce feelings of anxiety and panic. Because it's extended-release, it releases the medicine slowly over time, so you usually take it only once a day.
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. It's essential to swallow the medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. 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 proper disposal or explore local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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. It's essential to swallow the medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. 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 proper disposal or explore local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Do not drink alcohol or use other drugs that cause drowsiness while taking this medication, as it can increase the risk of serious side effects like severe drowsiness or breathing problems.
- Avoid driving or operating 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 for a long time or at high doses. This can lead to withdrawal symptoms, including seizures. Your doctor will help you slowly reduce the dose over time.
- Store medication safely away from children and pets, and do not share it with others.
Available Forms & Alternatives
Available Strengths:
- Alprazolam 0.25mg Tablets
- Alprazolam 0.5mg Tablets
- Alprazolam 1mg Tablets
- Alprazolam 2mg Tablets
- Alprazolam Con 1mg/ml Solution
- Alprazolam 2mg ODT Tablets
- Alprazolam 1mg ODT Tablets
- Alprazolam 0.5mg ODT Tablets
- Alprazolam 0.25mg ODT Tablets
- Alprazolam ER 1mg Tablets
- Alprazolam ER 2mg Tablets
- Alprazolam XR 3mg Tablets
- Alprazolam ER 0.5mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mg to 1 mg once daily, usually in the morning
Dose Range:
0.5 - 4 mg
Condition-Specific Dosing:
panicDisorder:
Initial: 0.5 mg to 1 mg once daily. Titrate by no more than 1 mg/day every 3-4 days. Max: 10 mg/day.
generalizedAnxietyDisorder:
Initial: 0.5 mg once daily. Titrate by no more than 0.5 mg every 3 days. Max: 4 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in patients < 18 years old)
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 sedation.
Dialysis:
Not significantly dialyzable. Use with caution, monitor for increased sedation.
Hepatic Impairment:
Mild:
Consider lower starting dose (e.g., 0.5 mg once daily) and titrate slowly.
Moderate:
Consider lower starting dose (e.g., 0.5 mg once daily) and titrate slowly. Monitor closely for adverse effects.
Severe:
Contraindicated or use with extreme caution at significantly reduced doses (e.g., 0.5 mg once daily or less) due to risk of encephalopathy and prolonged elimination.
Pharmacology
Mechanism of Action
Alprazolam, a benzodiazepine, binds to specific benzodiazepine receptors on the GABA-A receptor complex in the central nervous system. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), leading to increased chloride ion influx, hyperpolarization of the neuronal membrane, and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (for immediate-release, ER is similar but slower absorption)
Tmax:
5-11 hours (for extended-release)
FoodEffect:
Food delays absorption and decreases Cmax, but does not significantly affect AUC.
Distribution:
Vd:
0.9-1.2 L/kg
ProteinBinding:
Approximately 80% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
10.6-20.3 hours (for extended-release)
Clearance:
Approximately 0.9 mL/min/kg
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
< 1% (in urine)
Pharmacodynamics
OnsetOfAction:
1-2 hours (for extended-release)
PeakEffect:
5-11 hours (for extended-release)
DurationOfAction:
Approximately 24 hours (due to extended-release formulation)
Safety & Warnings
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.
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 medical attention immediately:
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.
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 immediately:
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.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or sedation
- Difficulty breathing or shallow breathing
- Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
- Severe dizziness or loss of coordination
- 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)
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 any 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 in conjunction 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 with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting 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 any 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 in conjunction 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 with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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 taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may require higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not exceed the prescribed dose.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while taking this drug.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may 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 may pose a risk to the 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 the potential risks with your doctor.
If you have been taking this drug for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may require higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not exceed the prescribed dose.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while taking this drug.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may 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 may pose a risk to the 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 the potential risks with your doctor.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness or confusion
- Slurred speech
- Slowed reflexes
- Loss of coordination
- Profound sedation
- 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.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, ritonavir, nelfinavir, indinavir)
- Opioids (concomitant use with benzodiazepines carries a Black Box Warning due to risk of profound sedation, respiratory depression, coma, and death)
Major Interactions
- Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, antipsychotics, tricyclic antidepressants, muscle relaxants) - increased risk of additive CNS depression.
- Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice) - increased alprazolam levels.
- Digoxin - increased digoxin levels (rare but reported).
Moderate Interactions
- Oral contraceptives - may decrease alprazolam clearance.
- Cimetidine - inhibits alprazolam metabolism.
- Fluoxetine - increases alprazolam Cmax and half-life.
- Propoxyphene - inhibits alprazolam metabolism.
Minor Interactions
- Theophylline - may antagonize benzodiazepine effects.
- Caffeine - may reduce sedative effects.
Monitoring
Baseline Monitoring
Mental status examination
Rationale: To assess baseline anxiety/panic symptoms, cognitive function, and identify any pre-existing psychiatric conditions.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: Alprazolam is primarily metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation, if clinically indicated
Renal function (BUN, creatinine)
Rationale: Although primarily hepatic, severe renal impairment may affect elimination; baseline assessment is prudent.
Timing: Prior to initiation, if clinically indicated
Routine Monitoring
Efficacy (reduction in anxiety/panic symptoms)
Frequency: Regularly, at each follow-up visit (e.g., monthly initially, then every 3-6 months)
Target: Patient-reported improvement in symptom severity and functional status
Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or re-evaluation of diagnosis/treatment plan.
Adverse effects (e.g., sedation, dizziness, cognitive impairment, ataxia)
Frequency: Regularly, at each follow-up visit
Target: Minimal to tolerable side effects
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Signs of tolerance, dependence, or withdrawal symptoms
Frequency: Regularly, at each follow-up visit, especially with long-term use
Target: Absence of signs of dependence or withdrawal
Action Threshold: Development of tolerance or withdrawal symptoms upon dose reduction/discontinuation indicates dependence and requires careful tapering.
Concomitant opioid use
Frequency: At each visit
Target: Avoid concomitant use if possible; if unavoidable, use lowest doses and shortest duration, and monitor closely.
Action Threshold: If co-prescribed, ensure patient education on risks and monitor for respiratory depression and profound sedation.
Symptom Monitoring
- Excessive sedation or drowsiness
- Dizziness or lightheadedness
- Impaired coordination or ataxia
- Memory problems or confusion
- Paradoxical reactions (e.g., agitation, aggression, hallucinations)
- Signs of withdrawal upon discontinuation or dose reduction (e.g., rebound anxiety, insomnia, seizures, tremors, muscle cramps, vomiting, sweating)
Special Patient Groups
Pregnancy
Alprazolam is 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) has been suggested in some studies, though data are conflicting.
Second Trimester:
Not well-studied, but continued exposure may lead to fetal dependence.
Third Trimester:
Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., hypertonia, tremor, irritability, seizures) in the newborn if used late in pregnancy.
Lactation
Alprazolam and its metabolites are excreted into breast milk. Use is generally not recommended during breastfeeding due to potential for sedation, poor feeding, and withdrawal symptoms in the infant.
Infant Risk:
L3 (Moderate risk) - Potential for sedation, lethargy, poor feeding, and withdrawal symptoms in the infant. Monitor infant closely if use is unavoidable. Consider alternative agents or temporary cessation of breastfeeding.
Pediatric Use
Safety and efficacy have not been established in pediatric patients (under 18 years of age). Use is generally not recommended.
Geriatric Use
Elderly patients may be more sensitive to the effects of benzodiazepines, including increased risk of sedation, dizziness, falls, and cognitive impairment. Lower starting doses (e.g., 0.5 mg once daily) and slower titration are recommended. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Alprazolam ER is designed for once-daily dosing and should not be crushed, chewed, or broken, as this will destroy the extended-release properties and lead to rapid absorption and potential for overdose.
- Due to the risk of dependence and withdrawal, alprazolam should be tapered slowly when discontinuing, especially after prolonged use. Abrupt discontinuation can lead to severe withdrawal symptoms, including seizures.
- Patients should be advised about the potential for additive CNS depression when combining alprazolam with alcohol or other CNS depressants.
- The Black Box Warning regarding concomitant opioid use is critical; prescribers must carefully weigh risks and benefits and educate patients thoroughly.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in pediatric, geriatric, or psychiatric patients. Discontinue if these occur.
- Consider non-pharmacological treatments (e.g., psychotherapy, CBT) as first-line or adjunctive therapy for anxiety and panic disorders.
Alternative Therapies
- Other benzodiazepines (e.g., clonazepam, lorazepam, diazepam)
- SSRIs (Selective Serotonin Reuptake Inhibitors) for anxiety/panic disorder (e.g., sertraline, paroxetine, escitalopram)
- SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) for anxiety/panic disorder (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
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.