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Alprazolam 0.5mg 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, Sedative-Hypnotic
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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 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 you feel more relaxed.
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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 inquire about drug take-back programs in your area.

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 other drugs that cause drowsiness while taking alprazolam, as this 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.
  • Take exactly as prescribed; do not take more or less than your doctor tells you.
  • Do not stop taking alprazolam suddenly, especially if you have been taking it regularly for a while. This can cause serious withdrawal symptoms. Your doctor will help you slowly reduce your dose over time.
  • Store at room temperature away from moisture and heat.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 0.25-0.5 mg three times daily. Panic Disorder: 0.5 mg three times daily.
Dose Range: 0.25 - 4 mg

Condition-Specific Dosing:

anxiety: Initial: 0.25-0.5 mg three times daily. Max: 4 mg/day in divided doses.
panicDisorder: Initial: 0.5 mg three times daily. May increase by no more than 1 mg/day every 3-4 days. Max: 10 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established for <18 years)
Adolescent: Not established (safety and efficacy not established for <18 years)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: Use with caution, consider lower doses and monitor for adverse effects.
Dialysis: Not significantly dialyzable. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 0.25 mg two or three times daily).
Moderate: Consider lower initial doses (e.g., 0.25 mg two or three times daily) and titrate slowly.
Severe: Contraindicated or use with extreme caution; significantly reduced clearance, increased risk of adverse effects. Consider alternative therapies.

Pharmacology

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Mechanism of Action

Alprazolam is a triazolo analog of the 1,4 benzodiazepine class. It 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), a major inhibitory neurotransmitter, by increasing chloride ion conductance through the GABA-gated chloride channel, leading to neuronal hyperpolarization and reduced neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90%
Tmax: 1-2 hours
FoodEffect: Food delays Tmax by about 25% but does not significantly affect bioavailability.

Distribution:

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

Elimination:

HalfLife: 11.2 hours (range: 6.3-26.9 hours)
Clearance: Approximately 0.9 mL/min/kg
ExcretionRoute: Renal (urine)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours

Safety & Warnings

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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 with benzodiazepines, including alprazolam, can lead to overdose or death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions. Continued use of benzodiazepines, including alprazolam, may lead to clinically significant physical dependence. The risks of withdrawal reactions, including seizures, may 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 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. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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. If you have questions or concerns about side effects, contact 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:

  • Severe drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Extreme dizziness or lightheadedness
  • Confusion or unusual thoughts/behavior
  • Slurred speech
  • Loss of coordination or balance
  • Yellowing of the skin or eyes (jaundice)
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty 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, 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 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 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.
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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 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 other activities that require your full attention. 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 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. Discuss this with your doctor.

If you regularly consume grapefruit juice or eat grapefruit, inform your doctor, as this may interact with your medication. Similarly, if you start or stop smoking, consult with your doctor, as your dosage may need to be adjusted.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

This medication may pose risks to 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 potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Impaired coordination
  • Slurred speech
  • Slowed reflexes
  • Coma
  • Respiratory depression

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Overdose treatment may include supportive care, maintaining airway, and potentially flumazenil (a benzodiazepine antagonist), though flumazenil carries risks, especially in patients with chronic benzodiazepine use or co-ingestion of proconvulsant drugs.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone)
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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) - additive CNS depression
  • Moderate CYP3A4 inhibitors (e.g., fluvoxamine, cimetidine, erythromycin, clarithromycin, diltiazem, verapamil, fluoxetine, sertraline) - increased alprazolam plasma concentrations
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Moderate Interactions

  • Oral contraceptives (may increase alprazolam levels)
  • Digoxin (may increase digoxin levels, monitor)
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Minor Interactions

  • Not many specific minor interactions; general caution with other sedatives.

Monitoring

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Baseline Monitoring

Mental status examination

Rationale: To assess baseline anxiety/panic symptoms and cognitive function.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Alprazolam is primarily metabolized by the liver; assess for pre-existing hepatic impairment.

Timing: Prior to initiation, especially in patients with suspected hepatic dysfunction

Renal function (BUN, creatinine)

Rationale: To assess baseline renal function, though renal impairment has less impact than hepatic.

Timing: Prior to initiation, especially in patients with suspected renal dysfunction

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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-specific improvement in symptom scores (e.g., GAD-7, Panic Disorder Severity Scale)

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

Adverse effects (e.g., sedation, dizziness, cognitive impairment, ataxia)

Frequency: At every visit, especially during dose titration

Target: Minimal to tolerable side effects

Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.

Signs of tolerance, dependence, or withdrawal

Frequency: At every visit, particularly with long-term use

Target: Absence of escalating dose requirements or withdrawal symptoms upon dose reduction

Action Threshold: Evidence of dependence or withdrawal symptoms necessitates slow, gradual tapering.

Respiratory status (especially with concomitant opioid use)

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

Target: Normal respiratory rate and depth

Action Threshold: Bradypnea, hypoventilation, or respiratory depression requires immediate intervention.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Ataxia (loss of coordination)
  • Confusion
  • Memory impairment
  • Slurred speech
  • Difficulty breathing or shallow breathing
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations)
  • Signs of withdrawal upon discontinuation or dose reduction (e.g., seizures, rebound anxiety, insomnia, tremors, muscle cramps, vomiting, sweating)

Special Patient Groups

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Pregnancy

Category D. Alprazolam can cause fetal harm when administered to a pregnant woman. There is an increased risk of congenital malformations (e.g., cleft lip/palate) and withdrawal symptoms in the neonate if used during 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: Risk of neonatal withdrawal syndrome if continued into later pregnancy.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., hypertonia, tremor, hyperreflexia, irritability, crying, vomiting, diarrhea, seizures) if used near term or during labor.
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Lactation

Alprazolam and its active metabolites are excreted into breast milk. Use is generally not recommended due to potential for infant sedation, poor feeding, and withdrawal symptoms upon discontinuation of breastfeeding. Monitor infants for drowsiness, feeding difficulties, and weight gain.

Infant Risk: L3 (Moderate risk) - Potential for sedation, lethargy, poor feeding, and withdrawal symptoms in the infant. Consider alternative agents or monitor infant closely.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients (<18 years of age). Use is generally not recommended due to lack of data and potential for adverse effects.

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Geriatric Use

Elderly patients may be more sensitive to the effects of benzodiazepines, including alprazolam. They are at increased risk for sedation, dizziness, ataxia, and falls. Lower initial doses (e.g., 0.25 mg two or three times daily) and slower titration are recommended. Monitor closely for cognitive impairment and falls.

Clinical Information

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Clinical Pearls

  • Alprazolam has a relatively short half-life compared to other benzodiazepines, which can lead to more pronounced inter-dose withdrawal symptoms or rebound anxiety.
  • Due to its rapid onset and short duration, it has a higher potential for abuse and dependence compared to longer-acting benzodiazepines.
  • Always emphasize the importance of gradual tapering when discontinuing alprazolam to prevent severe withdrawal symptoms, including seizures.
  • Educate patients about the black box warning regarding concomitant opioid use and the risks of abuse, misuse, and dependence.
  • Consider non-pharmacological treatments (e.g., psychotherapy, CBT) as first-line or adjunctive therapy for anxiety and panic disorders, especially for long-term management.
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Alternative Therapies

  • Other Benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam)
  • Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., Sertraline, Paroxetine, Escitalopram) - often first-line for long-term anxiety/panic management
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., Venlafaxine, Duloxetine)
  • Buspirone (for generalized anxiety disorder)
  • Hydroxyzine (for acute anxiety)
  • Beta-blockers (e.g., Propranolol) (for performance anxiety or physical symptoms of anxiety)
  • Cognitive Behavioral Therapy (CBT)
  • Psychotherapy
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (0.5mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 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.