Alprazolam 0.5mg ODT 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, take it with food to help minimize this side effect.
When taking the tablets, do not push them out of the foil blister pack. Instead, use dry hands to remove the tablet from the foil. Place the tablet on your tongue and let it dissolve completely. You do not need to drink water with it. It's essential to let the tablet dissolve and not swallow it whole, chew, break, or crush it.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe and secure location where children cannot see or reach it, and other people cannot access it. Consider using a locked box or area to store your medication. Keep all medications away from 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, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Avoid alcohol and other CNS depressants (e.g., opioids, sedating antihistamines) as they can increase drowsiness and breathing problems.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly for a long time. This can lead to serious withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort or grapefruit juice, as they can interact with alprazolam.
- Store medication safely to prevent misuse or abuse by 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
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
Concomitant use of benzodiazepines, including alprazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
The use of benzodiazepines, including alprazolam, exposes patients to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing alprazolam and throughout treatment, assess each patientβs risk of abuse, misuse, and addiction.
The continued use of benzodiazepines, including alprazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage.
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 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 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:
- Severe drowsiness or sedation
- Difficulty breathing or shallow breathing
- Extreme dizziness or lightheadedness
- Confusion or disorientation
- Slurred speech
- Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
- Yellowing of skin or eyes (jaundice)
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Symptoms of withdrawal if stopped abruptly (e.g., seizures, tremors, severe anxiety, insomnia, muscle cramps, vomiting, sweating)
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 provide guidance on other medications that should not be taken concurrently with this drug.
Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication 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
If you have been using this drug 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 other activities that require alertness. Additionally, refrain from consuming alcohol while taking this drug.
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. Individuals with phenylketonuria (PKU) should also consult their doctor, as some products contain phenylalanine.
If you start or stop smoking, inform your doctor, as this may require an adjustment to your medication dosage.
Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects.
This medication can pose risks to an 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 these potential risks with your doctor.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Impaired coordination
- Slurred speech
- Slowed reflexes
- 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. Flumazenil may be used as an antidote in severe cases, but it carries risks (e.g., precipitating withdrawal seizures).
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, fluoxetine)
Major Interactions
- Opioids (increased risk of respiratory depression, profound sedation, coma, death)
- Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, antipsychotics, tricyclic antidepressants, muscle relaxants) - additive CNS depression
- Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil, grapefruit juice) - increased alprazolam levels
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
Rationale: Alprazolam is primarily metabolized by the liver; assess baseline hepatic function, especially in patients with pre-existing liver disease.
Timing: Prior to initiation, if clinically indicated.
Rationale: Metabolites are renally excreted; assess baseline renal function, especially in patients with pre-existing kidney disease.
Timing: Prior to initiation, if clinically indicated.
Rationale: Assess baseline anxiety/panic symptoms, history of substance abuse, and risk for suicidal ideation.
Timing: Prior to initiation.
Routine Monitoring
Frequency: Regularly during titration and maintenance, typically at follow-up visits (e.g., weekly initially, then monthly).
Target: Symptom reduction to a tolerable or absent level.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Frequency: Regularly, especially during initiation and dose changes.
Target: Minimal to no intolerable side effects.
Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.
Frequency: At each follow-up visit, particularly with long-term use.
Target: Absence of signs of tolerance (requiring higher doses for same effect), dependence, or withdrawal symptoms upon dose reduction.
Action Threshold: Presence of these signs necessitates careful re-evaluation of treatment plan, including slow tapering if discontinuation is desired.
Frequency: Closely monitor during co-administration, particularly at initiation or dose changes.
Target: Normal respiratory rate and depth.
Action Threshold: Bradypnea, hypoventilation, or signs of respiratory depression require immediate medical attention.
Symptom Monitoring
- Drowsiness
- Dizziness
- Lightheadedness
- Confusion
- Memory impairment
- Slurred speech
- Lack of coordination
- Difficulty concentrating
- Paradoxical excitement or agitation
- Depressed mood or suicidal thoughts
- Signs of withdrawal (e.g., seizures, tremors, muscle cramps, vomiting, sweating, anxiety, insomnia) upon abrupt discontinuation.
Special Patient Groups
Pregnancy
Alprazolam is classified as Pregnancy Category D. It should not be used during pregnancy due to evidence of fetal risk. Use only if the potential benefit justifies the potential risk to the fetus.
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). Use is generally not recommended due to potential for adverse effects and lack of data.
Geriatric Use
Elderly patients may be more sensitive to the effects of benzodiazepines, including alprazolam, and may experience increased risk of sedation, dizziness, ataxia, and falls. Lower starting doses (e.g., 0.25 mg two or three times daily) and careful titration are recommended. Monitor closely for cognitive impairment and falls.
Clinical Information
Clinical Pearls
- Alprazolam ODT offers convenience for patients who have difficulty swallowing pills or prefer not to use water. It dissolves rapidly on the tongue.
- Due to its relatively short half-life and high potency, alprazolam has a significant potential for physical dependence and withdrawal symptoms, even with therapeutic doses. Tapering is crucial.
- The Black Box Warning regarding concomitant opioid use and risks of abuse/dependence/withdrawal is critical for prescribers and patients.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric, elderly, or psychiatric patients.
- Patients should be advised to avoid grapefruit juice as it can inhibit CYP3A4 and increase alprazolam levels, leading to enhanced effects and toxicity.
Alternative Therapies
- Other benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam, Oxazepam)
- SSRIs (Selective Serotonin Reuptake Inhibitors) for anxiety/panic disorders (e.g., Sertraline, Paroxetine, Escitalopram)
- SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., Venlafaxine, Duloxetine)
- Buspirone (for generalized anxiety disorder)
- Hydroxyzine (for anxiety)
- Beta-blockers (e.g., Propranolol for performance anxiety or somatic symptoms)
- Cognitive Behavioral Therapy (CBT) and other psychotherapies.
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.