Alprazolam XR 3mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a safe location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication by throwing it away. However, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 central nervous system depressants (e.g., opioids, sedatives) while taking this medication, as it can increase drowsiness and dangerous 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 long time, as this can cause withdrawal symptoms (e.g., seizures, severe anxiety). Your doctor will guide you on how to slowly reduce the dose.
- Take exactly as prescribed; do not take more or less than directed.
- Swallow the extended-release tablet whole; do not crush, chew, or break it.
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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 help 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 symptoms that bother you or do not go away, contact your doctor:
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
This is not an exhaustive list of possible side effects. 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)
- Yellowing of the skin or eyes (jaundice)
- Severe skin rash
- Memory problems or confusion
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
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 advise you on other medications that should not be taken in combination 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 if it is safe to take this medication with your other medications and health issues. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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 alertness. 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. 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 potentially 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 these risks with your doctor.
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. Overdose treatment may include supportive care, monitoring vital signs, and in severe cases, administration of flumazenil (a benzodiazepine receptor antagonist), though flumazenil carries risks, including precipitation of acute withdrawal and seizures.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, some macrolide antibiotics like clarithromycin, telithromycin, and protease inhibitors like ritonavir, indinavir, nelfinavir)
Major Interactions
- Opioids (increased risk of respiratory depression, profound sedation, coma, and death)
- Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, antipsychotics, tricyclic antidepressants, muscle relaxants) - additive CNS depressant effects
- Moderate CYP3A4 inhibitors (e.g., fluoxetine, sertraline, diltiazem, verapamil, cimetidine, grapefruit juice) - increased alprazolam concentrations
Moderate Interactions
- Digoxin (may increase digoxin levels)
- Imipramine, desipramine (may increase plasma levels of these antidepressants)
- Oral contraceptives (may inhibit alprazolam metabolism)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline severity of symptoms and guide treatment.
Timing: Prior to initiation of therapy
Rationale: To assess baseline respiratory function, especially if co-prescribing with opioids or other CNS depressants.
Timing: Prior to initiation of therapy
Rationale: Alprazolam is primarily metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Frequency: Regularly during titration and periodically during maintenance (e.g., monthly 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.
Frequency: Regularly during titration and periodically during maintenance
Target: Minimal to tolerable side effects
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Frequency: At every visit
Target: Absence of drug-seeking behavior, escalating doses, or withdrawal symptoms upon dose reduction
Action Threshold: Presence of these signs requires reassessment of treatment plan, potential referral for substance use disorder.
Frequency: Regularly, especially during initiation or dose changes of either drug
Target: Normal respiratory rate and effort, no signs of respiratory depression
Action Threshold: Bradypnea, hypoventilation, or decreased oxygen saturation requires immediate medical attention.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Ataxia (impaired coordination)
- Confusion
- Memory impairment
- Slurred speech
- 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 classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There is 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.
Trimester-Specific Risks:
Lactation
Alprazolam is excreted into breast milk. Due to the potential for sedation, feeding difficulties, and withdrawal symptoms in the infant, use is generally not recommended during breastfeeding. If use is necessary, monitor the infant closely for adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients (under 18 years of age) for the treatment of panic disorder. Use is generally not recommended.
Geriatric Use
Elderly patients may be more sensitive to the effects of benzodiazepines, including increased risk of sedation, dizziness, ataxia, and falls. Initial doses should be lower (e.g., 0.5 mg once daily) and titrated slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Alprazolam XR is specifically formulated for once-daily dosing, which can improve adherence compared to multiple daily doses of immediate-release alprazolam.
- Due to the risk of dependence and withdrawal, alprazolam XR should be tapered slowly when discontinuing, typically over several weeks or months, depending on dose and duration of therapy.
- Patients should be educated on the risks of concomitant use with opioids and alcohol, emphasizing the potential for life-threatening respiratory depression.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in elderly or pediatric patients, or those with personality disorders. Discontinue if these occur.
- While effective for panic disorder, long-term use of benzodiazepines is generally discouraged due to risks of dependence, tolerance, and cognitive impairment. Consider alternative long-term treatments like SSRIs/SNRIs or psychotherapy.
Alternative Therapies
- Other benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for panic disorder, though often with different pharmacokinetic profiles and dosing frequencies.
- Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., sertraline, paroxetine, fluoxetine, escitalopram) - first-line for long-term management of panic disorder.
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine) - also effective for panic disorder.
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, clomipramine) - effective but with more side effects.
- Cognitive Behavioral Therapy (CBT) and other forms of psychotherapy.
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. 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 this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide critical information, including the name of the medication taken, the amount consumed, and the time it happened. This information will enable healthcare professionals to provide you with the most appropriate care and treatment.