Alprazolam ER 0.5mg 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, Antipanic Agent
Pharmacologic Class
Benzodiazepine
Pregnancy Category
Category D
FDA Approved
Sep 2003
DEA Schedule
Schedule IV
Overview
What is this medicine?
Alprazolam ER is an extended-release medication used to treat panic disorder. It belongs to a class of drugs called benzodiazepines, which work by calming the brain and nerves. The 'ER' means 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. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store it in a secure location where children and others cannot access it. Consider using a locked box or area to protect your medication. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to 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 a 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. Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store it in a secure location where children and others cannot access it. Consider using a locked box or area to protect your medication. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to 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 a missed one.
Lifestyle & Tips
- Avoid alcohol and other sedating medications while taking this drug, as it can increase drowsiness and dangerous side effects.
- Do not drive or operate heavy machinery until you know how this medication affects you.
- Do not stop taking this medication suddenly, especially if you have been taking it for a long time or at high doses. Your doctor will help you slowly reduce the dose to prevent withdrawal symptoms.
- Store medication safely away from children and pets, and out of reach of others who might misuse it.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially opioids, as serious interactions can occur.
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, preferably in the morning
Dose Range:
0.5 - 10 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. Target dose: 3-6 mg/day. Max: 10 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
No specific dose adjustment generally required, but use with caution.
Severe:
Use with caution; consider lower initial doses and slower titration.
Dialysis:
Not significantly dialyzable; use with caution.
Hepatic Impairment:
Mild:
Consider lower initial doses (e.g., 0.5 mg once daily) and slower titration.
Moderate:
Consider lower initial doses (e.g., 0.5 mg once daily) and slower titration.
Severe:
Contraindicated in severe hepatic impairment due to increased risk of encephalopathy.
Confidence:
Medium
Pharmacology
Mechanism of Action
Alprazolam, a benzodiazepine, 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), the primary inhibitory neurotransmitter in the brain, by increasing chloride ion conductance through the GABA-gated chloride channel, leading to hyperpolarization and stabilization of the neuronal membrane.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80%
Tmax:
5-11 hours (extended-release)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.9-1.2 L/kg
ProteinBinding:
Approximately 80%
CnssPenetration:
Yes
Elimination:
HalfLife:
10.6-20.3 hours (extended-release)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 1% (in urine)
Pharmacodynamics
OnsetOfAction:
Not immediately apparent due to extended-release formulation; typically within hours for initial effect.
PeakEffect:
5-11 hours
DurationOfAction:
Approximately 24 hours
Confidence:
Medium
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. The risks of abuse, misuse, and addiction to benzodiazepines can lead to overdose or death. Physical dependence can occur with benzodiazepine use. The risk of dependence and withdrawal increases with longer treatment duration and higher doses. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Alprazolam ER.
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 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 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 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 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 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 dizziness or lightheadedness
- Confusion or memory problems
- Slurred speech
- Loss of coordination or balance
- Yellowing of skin or eyes (jaundice)
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Worsening anxiety or panic attacks
- New or worsening depression or suicidal thoughts
- Unusual changes in behavior or mood (e.g., agitation, aggression, hallucinations)
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 combination 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.
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 combination 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.
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 operating a vehicle or 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 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 pose a risk to the 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.
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 operating a vehicle or 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 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 pose a risk to the 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.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Impaired coordination
- Diminished reflexes
- Slurred speech
- 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. Naloxone may reverse opioid-induced respiratory depression but will not reverse benzodiazepine-induced respiratory depression. Flumazenil may be used in a hospital setting to reverse benzodiazepine effects but carries a risk of precipitating acute withdrawal, including seizures.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole)
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)
- Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice)
- Nefazodone, fluvoxamine, cimetidine (significantly increase alprazolam concentrations)
Moderate Interactions
- Oral contraceptives (may decrease alprazolam clearance)
- Digoxin (may increase digoxin levels)
- Imipramine, desipramine (may increase plasma levels of these antidepressants)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Mental status and psychiatric symptoms (e.g., anxiety, panic attacks)
Rationale: To establish baseline severity and assess treatment efficacy.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: Alprazolam is primarily metabolized by the liver; to identify pre-existing impairment.
Timing: Prior to initiation, especially in patients with suspected hepatic impairment
Renal function (BUN, creatinine)
Rationale: To assess kidney function, though renal excretion of unchanged drug is minimal.
Timing: Prior to initiation, especially in patients with suspected renal impairment
Routine Monitoring
Efficacy (reduction in anxiety/panic symptoms)
Frequency: Regularly during titration and maintenance, typically at follow-up visits (e.g., every 2-4 weeks initially, then every 3-6 months)
Target: Patient-reported improvement in symptoms, reduction in panic attack frequency/severity
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (e.g., sedation, dizziness, ataxia, cognitive impairment)
Frequency: Regularly, especially during dose titration and initial weeks of therapy
Target: Minimization of intolerable side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs of tolerance, dependence, or withdrawal symptoms (if dose reduced or discontinued)
Frequency: At each follow-up visit, particularly if long-term use or dose changes are planned
Target: Absence of signs of dependence or withdrawal
Action Threshold: Development of tolerance or withdrawal symptoms indicates need for careful dose management or slow tapering.
Concomitant opioid use and risk of respiratory depression
Frequency: Continuously if co-prescribed
Target: Patient education and monitoring for signs of respiratory depression
Action Threshold: Signs of respiratory depression require immediate medical attention.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Ataxia
- Confusion
- Slurred speech
- Difficulty breathing (especially with opioids)
- Paradoxical reactions (e.g., agitation, aggression, hallucinations)
- Signs of withdrawal upon discontinuation (e.g., seizures, rebound anxiety, insomnia, tremors, muscle cramps, vomiting, sweating)
Special Patient Groups
Pregnancy
Alprazolam is classified as Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Use during pregnancy, especially in the first trimester, has been associated with an increased risk of congenital malformations. Neonatal withdrawal syndrome (e.g., hypotonia, lethargy, feeding difficulties, respiratory depression, hypothermia) has been reported in infants born to mothers who took benzodiazepines during late pregnancy.
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:
Potential for fetal exposure and accumulation.
Third Trimester:
Risk of neonatal withdrawal syndrome, 'floppy infant' syndrome (hypotonia, lethargy, feeding difficulties, respiratory depression) if used close to delivery.
Lactation
Alprazolam and its active metabolites are excreted into breast milk. The American Academy of Pediatrics considers alprazolam to be a drug for which the effect on the nursing infant is unknown but may be of concern. Due to the potential for sedation, feeding difficulties, and withdrawal symptoms in the infant, use is generally not recommended. If use is necessary, monitor the infant closely for sedation, poor feeding, and weight gain.
Infant Risk:
L3 (Moderate risk) - Potential for sedation, poor feeding, and withdrawal symptoms in the infant. Consider alternative agents or close infant monitoring.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended due to lack of data and potential for adverse effects.
Geriatric Use
Elderly patients may be more sensitive to the effects of benzodiazepines, including increased risk of sedation, dizziness, ataxia, and falls. Lower initial doses (e.g., 0.5 mg once daily) and slower titration are recommended. Monitor closely for cognitive impairment and falls.
Clinical Information
Clinical Pearls
- Alprazolam ER is specifically formulated for once-daily dosing, which can improve adherence and provide more consistent symptom control compared to immediate-release formulations.
- Due to its extended-release nature, it is not suitable for acute, 'as-needed' anxiety relief.
- Always emphasize the importance of not crushing, chewing, or breaking the extended-release tablets, as this will lead to rapid release and potential overdose.
- Educate patients on the significant risks of concomitant use with opioids and the importance of avoiding alcohol and other CNS depressants.
- Physical dependence and withdrawal can occur even with therapeutic doses. Tapering off the medication slowly is crucial to minimize withdrawal symptoms.
- Consider the potential for abuse and misuse, especially in patients with a history of substance use disorder.
- Regularly reassess the need for continued treatment, as long-term benzodiazepine use is generally discouraged.
Alternative Therapies
- Other benzodiazepines (e.g., clonazepam, lorazepam, diazepam - for panic disorder or anxiety)
- SSRIs (Selective Serotonin Reuptake Inhibitors) (e.g., sertraline, paroxetine, escitalopram - first-line for panic disorder and long-term anxiety management)
- SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., venlafaxine - for panic disorder and anxiety)
- Buspirone (for generalized anxiety disorder, less effective for panic disorder)
- Beta-blockers (e.g., propranolol - for situational anxiety symptoms like palpitations, tremor)
- Cognitive Behavioral Therapy (CBT) and other psychotherapies (often recommended as first-line or adjunctive treatment for anxiety and panic disorders)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult 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 quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult 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 quantity, and the time it occurred.