Alprazolam 1mg 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 works by calming the brain and nerves, helping you feel more relaxed. It's important to take it exactly as prescribed by your doctor, as it can be habit-forming.
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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, but if it causes stomach upset, take it with food to help minimize discomfort.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure 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 properly: do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of 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 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. 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

  • Avoid alcohol and other sedatives while taking alprazolam, as this can increase drowsiness and dangerous side effects.
  • 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 alprazolam suddenly, especially if you have been taking it for a long time or at high doses. Your doctor will guide you on how to slowly reduce the dose to prevent withdrawal symptoms.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially opioids, as dangerous interactions can occur.
  • Store medication safely out of reach of children and pets, and away from heat and moisture.

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 - 10 mg

Condition-Specific Dosing:

anxiety_disorder: Initial: 0.25-0.5 mg three times daily; Max: 4 mg/day in divided doses.
panic_disorder: Initial: 0.5 mg three times daily; Titrate 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 needed, use with caution.
Moderate: No specific adjustment needed, use with caution.
Severe: Use with caution, consider lower doses due to potential for accumulation of active metabolites.
Dialysis: Alprazolam is not significantly removed by dialysis. Use with caution.

Hepatic Impairment:

Mild: Consider lower initial doses (e.g., 0.25 mg 2-3 times daily).
Moderate: Consider lower initial doses (e.g., 0.25 mg 2-3 times daily).
Severe: Contraindicated or use with extreme caution; significantly reduced clearance, increased risk of adverse effects including encephalopathy. Consider 50-75% dose reduction.

Pharmacology

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Mechanism of Action

Alprazolam is a triazolo benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at several sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. It enhances the inhibitory effects of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuron and reduced neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1-2 hours
FoodEffect: Food may delay Tmax but does not significantly affect bioavailability.

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: 80-90%
CnssPenetration: Yes

Elimination:

HalfLife: 11.2 hours (range 6.3-26.9 hours)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours (clinical effects may last longer)

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 are serious and can lead to overdose and 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 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
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 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.
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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 skin or eyes (jaundice)
  • Severe skin rash
  • Signs of an allergic reaction (e.g., swelling of face/lips/tongue, difficulty breathing)
  • Signs of withdrawal if dose is missed or stopped suddenly (e.g., seizures, tremors, severe anxiety, muscle cramps)
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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 allergic reaction you experienced, including any symptoms.
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 other 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 drugs 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 harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become 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:

  • Extreme drowsiness
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Lack of coordination
  • Profound sedation
  • Hypotension
  • Respiratory depression
  • 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 severe cases but carries a risk of precipitating acute withdrawal and seizures.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone)
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Major Interactions

  • Opioids (e.g., hydrocodone, oxycodone, morphine) - increased risk of respiratory depression, profound sedation, coma, and death.
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, sedating antihistamines, tricyclic antidepressants) - additive CNS depression.
  • Protease inhibitors (e.g., ritonavir, indinavir) - significant increase in alprazolam levels.
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin) - increased alprazolam levels.
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Moderate Interactions

  • Moderate CYP3A4 inhibitors (e.g., fluoxetine, fluvoxamine, diltiazem, verapamil, grapefruit juice) - increased alprazolam levels.
  • Oral contraceptives - may increase alprazolam levels.
  • Digoxin - may increase digoxin levels (rare).
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Minor Interactions

  • Caffeine - may reduce anxiolytic effects.
  • Theophylline - may reduce anxiolytic effects.

Monitoring

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Baseline Monitoring

Mental status assessment

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

Timing: Prior to initiation

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess hepatic function, especially in patients with suspected impairment, as alprazolam is primarily metabolized by the liver.

Timing: Prior to initiation (if clinically indicated)

Renal function (BUN, creatinine)

Rationale: To assess renal function, especially in patients with suspected impairment, as metabolites are renally excreted.

Timing: Prior to initiation (if clinically indicated)

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Routine Monitoring

Efficacy (reduction in anxiety/panic symptoms)

Frequency: Regularly during titration and maintenance, typically weekly initially, then monthly/quarterly.

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 (sedation, dizziness, ataxia, cognitive impairment)

Frequency: Regularly during titration and maintenance, typically weekly initially, then monthly/quarterly.

Target: Minimal to tolerable side effects.

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

Signs of abuse, misuse, or dependence

Frequency: At each follow-up visit.

Target: Absence of drug-seeking behavior, escalating doses, or signs of withdrawal.

Action Threshold: Presence of these signs requires intervention, including dose tapering or referral for substance use disorder treatment.

Respiratory rate and oxygen saturation (if co-administered with opioids or other CNS depressants)

Frequency: As clinically indicated, especially during initiation or dose changes of concomitant medications.

Target: Normal respiratory rate (12-20 breaths/min) and SpO2 >92%.

Action Threshold: Bradypnea or desaturation requires immediate intervention.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Ataxia
  • Confusion
  • Slurred speech
  • Memory impairment
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations)
  • Respiratory depression
  • Signs of withdrawal upon dose reduction or discontinuation (e.g., rebound anxiety, insomnia, tremors, seizures, psychosis)

Special Patient Groups

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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:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting.
Second Trimester: Not well-studied, but continued exposure carries risks.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., hypertonia, tremors, irritability, seizures) in the neonate if used late in pregnancy.
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Lactation

Alprazolam is excreted into breast milk. Use is generally not recommended due to potential for sedation, feeding difficulties, and withdrawal symptoms in the breastfed infant.

Infant Risk: L3 (Moderate risk). Potential for sedation, lethargy, poor feeding, and weight gain in the infant. Withdrawal symptoms may occur if maternal dosing is inconsistent or discontinued. Monitor infant for drowsiness, poor feeding, and developmental milestones.
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Pediatric Use

Safety and efficacy 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

Geriatric patients may be more sensitive to the effects of benzodiazepines, including alprazolam. They are at increased risk for sedation, dizziness, ataxia, falls, and cognitive impairment. Lower initial doses (e.g., 0.25 mg 2-3 times daily) and slower titration are recommended. Monitor closely for adverse effects.

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 and a higher potential for dependence.
  • Due to its rapid onset of action and high potency, alprazolam has a significant potential for abuse and physical dependence. Prescribe for the shortest duration possible.
  • Tapering off alprazolam must be done very slowly to minimize withdrawal symptoms, which can include seizures, psychosis, and severe rebound anxiety. A reduction of no more than 0.5 mg every 3 days is often recommended, but slower tapers may be necessary.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric, geriatric, or psychiatric patients. Discontinue if these occur.
  • Avoid concomitant use with opioids due to the black box warning regarding severe respiratory depression and death.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, clonazepam, diazepam) for anxiety/panic disorders (consider differences in half-life and potency).
  • SSRIs (e.g., escitalopram, sertraline, fluoxetine) - first-line for long-term management of anxiety and panic disorders.
  • SNRIs (e.g., venlafaxine, duloxetine) - also effective for anxiety disorders.
  • Buspirone - non-benzodiazepine anxiolytic, slower onset of action.
  • Beta-blockers (e.g., propranolol) - for somatic symptoms of anxiety.
  • Cognitive Behavioral Therapy (CBT) - highly effective non-pharmacological treatment for anxiety and panic disorders.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (1mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your 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 consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.