Alprazolam 0.25mg 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, Antipanic Agent
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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 that belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves to help treat anxiety and panic disorders. It can make you feel relaxed and sleepy.
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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 others cannot easily get to it. Consider using a locked box or area to keep your medication 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 look into local drug take-back programs.

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. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Do not drink alcohol or use illicit drugs while taking alprazolam, as this can increase the risk of serious side effects like extreme 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 alprazolam suddenly, especially if you have been taking it regularly for some time. This can lead to withdrawal symptoms, which can be severe. Your doctor will help you gradually reduce the dose.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, especially opioids or other sedatives.
  • Store alprazolam securely to prevent misuse or diversion, as it is a controlled substance.

Dosing & Administration

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Adult Dosing

Standard Dose: For anxiety: 0.25 mg to 0.5 mg three times daily. For panic disorder: 0.5 mg three times daily.
Dose Range: 0.25 - 10 mg

Condition-Specific Dosing:

anxiety: Initial: 0.25-0.5 mg TID; Max: 4 mg/day
panic_disorder: Initial: 0.5 mg TID; Max: 10 mg/day (average 5-6 mg/day)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established)
Adolescent: Not established (safety and efficacy not established, use generally not recommended)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed, use with caution
Severe: Use with caution, consider lower doses
Dialysis: Not significantly dialyzable; use with caution, monitor for increased effects

Hepatic Impairment:

Mild: Consider lower initial dose (e.g., 0.25 mg BID or TID)
Moderate: Consider lower initial dose (e.g., 0.25 mg BID or TID), titrate slowly
Severe: Significant dose reduction required (e.g., 0.25 mg once daily or every other day), titrate very slowly and monitor closely

Pharmacology

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Mechanism of Action

Alprazolam is a benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron in the central nervous system. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the brain, by increasing the frequency of chloride channel opening, leading to neuronal hyperpolarization and reduced neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1-2 hours
FoodEffect: Food delays Tmax by about 25% but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: Approximately 80% (primarily to serum albumin)
CnssPenetration: Yes

Elimination:

HalfLife: 11.2 hours (range: 6.3-26.9 hours)
Clearance: Approximately 0.9 mL/min/kg
ExcretionRoute: Urine (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours (clinical effects)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND PHYSICAL DEPENDENCE AND WITHDRAWAL REACTIONS.
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 users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing alprazolam, assess each patient’s risk of abuse, misuse, and addiction. After alprazolam has been prescribed, assess and monitor each patient regularly for these behaviors and conditions.
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.
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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 immediately or seek emergency 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
Change in balance
Shortness of breath
Severe dizziness or fainting
Confusion
Memory problems or loss
Difficulty speaking
Trouble urinating
Difficulty controlling 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, contact your doctor if they bother you or do not go away:

Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Changes in appetite
Constipation
Diarrhea
Nausea or vomiting
Upset stomach
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.
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Seek Immediate Medical Attention If You Experience:

  • Excessive drowsiness or sedation that prevents normal activities
  • Difficulty breathing or very slow breathing
  • Severe dizziness or feeling like you might pass out
  • Confusion, disorientation, or memory problems
  • Slurred speech or difficulty speaking
  • Unusual changes in mood or behavior (e.g., 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. Be sure to describe the signs and 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 if it is safe to take this medication with your existing regimen. 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 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 engaging in other activities that require your full attention. Additionally, refrain from consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or any prescription or over-the-counter 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 drug 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 the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or somnolence
  • Confusion
  • Impaired coordination (ataxia)
  • Slurred speech
  • Hypotension (low blood pressure)
  • Bradypnea (slowed breathing)
  • Coma
  • Death

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222). Flumazenil may be used as an antidote in a hospital setting, but it carries risks, especially in patients with benzodiazepine dependence.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, indinavir) due to significant increase in alprazolam plasma concentrations and prolonged effects.
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Major Interactions

  • Opioids (e.g., hydrocodone, oxycodone, morphine): Increased risk of profound sedation, respiratory depression, coma, and death. Concomitant use should be avoided unless benefits outweigh risks, and patients should be monitored closely.
  • Other CNS depressants (e.g., alcohol, barbiturates, sedating antihistamines, other benzodiazepines, tricyclic antidepressants, antipsychotics): Additive CNS depressant effects, leading to increased sedation, respiratory depression, and psychomotor impairment.
  • Moderate CYP3A4 inhibitors (e.g., fluoxetine, fluvoxamine, nefazodone, cimetidine, erythromycin, diltiazem, verapamil): May increase alprazolam plasma concentrations, requiring dose reduction of alprazolam.
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Moderate Interactions

  • Oral contraceptives: May inhibit alprazolam metabolism, leading to increased alprazolam levels.
  • Digoxin: Alprazolam may increase serum digoxin concentrations; monitor digoxin levels.
  • Imipramine, desipramine: Alprazolam may increase steady-state plasma concentrations of these antidepressants.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Mental Status Examination

Rationale: To establish baseline cognitive function, anxiety/panic symptom severity, and identify any pre-existing psychiatric 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 suspected hepatic impairment.

Timing: Prior to initiation, if clinically indicated

Renal Function Tests (RFTs)

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

Timing: Prior to initiation, if clinically indicated

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Routine Monitoring

Efficacy (Anxiety/Panic Symptoms)

Frequency: Regularly, at each visit or as needed

Target: Reduction in symptom severity, improved daily functioning

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

Adverse Effects (Sedation, Dizziness, Cognitive Impairment)

Frequency: Regularly, at each visit or as needed

Target: Minimal to tolerable side effects

Action Threshold: Excessive sedation, impaired coordination, or significant cognitive dysfunction may require dose reduction or discontinuation

Signs of Dependence/Withdrawal

Frequency: Regularly, especially during dose reduction or discontinuation

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

Action Threshold: Emergence of withdrawal symptoms necessitates slower tapering or re-evaluation of treatment plan

Respiratory Status (especially with concomitant opioid use)

Frequency: Closely, especially during initiation or dose titration of either drug

Target: Normal respiratory rate and depth

Action Threshold: Bradypnea, shallow breathing, or hypoxemia requires immediate medical intervention

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Symptom Monitoring

  • Excessive drowsiness or sedation
  • Dizziness or lightheadedness
  • Confusion or disorientation
  • Slurred speech
  • Difficulty breathing or shallow breathing
  • Impaired coordination or ataxia
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations)
  • Signs of withdrawal upon dose reduction or discontinuation (e.g., rebound anxiety, insomnia, irritability, tremors, seizures)

Special Patient Groups

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Pregnancy

Alprazolam is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations, particularly cleft lip and palate, although data are conflicting and the absolute risk is low.
Second Trimester: Potential for fetal exposure and accumulation.
Third Trimester: Risk of neonatal withdrawal syndrome (irritability, hypertonia, tremors, feeding difficulties, respiratory distress) if used late in pregnancy. Risk of 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) if used shortly before or during labor.
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Lactation

Alprazolam and its active metabolites are excreted into breast milk. Use during breastfeeding is generally not recommended, or should be done with extreme caution and close infant monitoring.

Infant Risk: Potential for sedation, lethargy, poor feeding, and weight loss in the breastfed infant. Long-term effects on infant development are unknown. The American Academy of Pediatrics considers benzodiazepines to be drugs for which the effect on the nursing infant is unknown but may be of concern.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to potential for adverse effects and lack of data. If used, it should be under strict specialist supervision for specific indications.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased risk of sedation, dizziness, cognitive impairment, and falls. Lower initial doses (e.g., 0.25 mg BID or TID) are recommended, and titration should be done slowly with close monitoring. The half-life of alprazolam may be prolonged in the elderly.

Clinical Information

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Clinical Pearls

  • Alprazolam has a relatively short half-life among benzodiazepines, which can lead to inter-dose withdrawal symptoms or rebound anxiety, especially with higher doses or less frequent dosing.
  • Due to its rapid onset of action and high potency, alprazolam has a significant potential for abuse, misuse, and physical dependence. It is a Schedule IV controlled substance.
  • Physical dependence can develop even with therapeutic doses and short-term use. Tapering off the medication slowly is crucial to minimize withdrawal symptoms, which can include seizures.
  • Not typically recommended as first-line for long-term generalized anxiety disorder; often used for acute anxiety or panic attacks, or as an adjunct to other therapies (e.g., antidepressants).
  • Patients should be educated about the risks of concomitant use with alcohol and other CNS depressants, including opioids, due to the risk of severe respiratory depression and death.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, clonazepam, diazepam) for anxiety/panic disorders.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) as first-line long-term treatment for anxiety and panic disorders.
  • Buspirone (for generalized anxiety disorder, non-addictive).
  • Hydroxyzine (antihistamine with anxiolytic properties).
  • Beta-blockers (e.g., propranolol) for somatic symptoms of anxiety.
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies.
  • Lifestyle modifications (e.g., exercise, mindfulness, stress management techniques).
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (0.25mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information 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, consult 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.