Alprazolam Con 1mg/ml Solution

Manufacturer ROXANE Active Ingredient Alprazolam Oral Solution(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, Gamma-aminobutyric acid (GABA) A receptor agonist
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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 called a benzodiazepine. It works by calming the brain and nerves, which helps to reduce anxiety and panic attacks. It's important to use it exactly as prescribed because 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. If it causes stomach upset, take it with food to help minimize discomfort.

To measure the correct dose, use the dropper that comes with the medication. You can mix the liquid with water, juice, soda, applesauce, or pudding to make it easier to take. Swallow the mixture immediately after preparing it, and do not store it for later use.

Storing and Disposing of Your Medication

Keep this medication at room temperature, away from light and moisture. Do not store it in a bathroom. After opening, discard any unused medication after 90 days. Store the medication in a secure location where children and pets cannot access it, such as a locked box or cabinet. This will help prevent accidental ingestion or misuse.

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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.

Missing a Dose

If you take this medication regularly and 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 dose. 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 this medication, as it can increase drowsiness and dangerous side effects.
  • Do not drive or operate heavy machinery until you know how this medication affects you.
  • Do not stop taking this medication suddenly, especially if you have been taking it for a long time or at high doses. Your doctor will help you slowly reduce the dose to prevent withdrawal symptoms.
  • Store this medication safely away from children and pets, and out of reach of others who might misuse it.

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. 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 patients under 18 years of age)
Adolescent: Not established (Safety and efficacy not established for patients under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: No specific adjustment recommended, but use with caution. Monitor for increased sedation.
Dialysis: Not significantly dialyzable. Use with caution, monitor for increased effects.

Hepatic Impairment:

Mild: Consider lower starting dose (e.g., 0.25 mg two or three times daily).
Moderate: Consider lower starting dose (e.g., 0.25 mg two or three times daily). Titrate slowly with caution.
Severe: Contraindicated in severe hepatic impairment (e.g., cirrhosis) due to increased risk of encephalopathy and prolonged elimination half-life.

Pharmacology

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Mechanism of Action

Alprazolam, a benzodiazepine, binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA) A receptor complex in the central nervous system (CNS). This binding enhances the inhibitory effects of GABA, leading to increased chloride ion influx into neurons, hyperpolarization, and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
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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: Approximately 80%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 11.2 hours (range: 6.3-26.9 hours)
Clearance: Approximately 0.6-1.0 mL/min/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4-6 hours (clinical effects may last longer depending on dose and individual metabolism)

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 patients 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. Alprazolam is a Schedule IV controlled substance. The continued use of benzodiazepines, including alprazolam, may lead to 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 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
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 that bother you or do not go away, contact your doctor:

Dizziness, drowsiness, tiredness, 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, 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 difficulty waking up
  • Slow or shallow breathing
  • Unusual dizziness or lightheadedness
  • Slurred speech
  • Confusion or memory problems
  • Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Signs of withdrawal if stopping too quickly (e.g., seizures, severe anxiety, tremors, muscle cramps, vomiting)
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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 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 conjunction with this drug.

Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

You should also inform them about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change 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 that 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 operating a vehicle or engaging in activities that require your full attention. Additionally, refrain from consuming alcohol while taking this medication.

Before using marijuana, other forms of cannabis, or prescription or 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.

If you start or stop smoking, inform your doctor, as this may necessitate an adjustment to your medication dosage.

If you are 65 years or older, exercise caution when taking this medication, 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 the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Impaired coordination
  • Slurred speech
  • Slowed reflexes
  • Profound sedation
  • Hypotension
  • Respiratory depression
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone is not effective for benzodiazepine overdose alone, but may be given if opioid co-ingestion is suspected. Flumazenil may be used in severe cases but carries risks (e.g., seizures).

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 anxiolytics, antipsychotics, tricyclic antidepressants) - increased CNS depression
  • Moderate CYP3A4 inhibitors (e.g., fluvoxamine, cimetidine, erythromycin, diltiazem, fluoxetine, propoxyphene, oral contraceptives) - increased alprazolam levels
  • Digoxin (increased digoxin levels)
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Moderate Interactions

  • Imipramine, desipramine (increased plasma levels of these antidepressants)
  • Grapefruit juice (may inhibit CYP3A4, increasing alprazolam levels)
  • St. John's Wort (may induce CYP3A4, decreasing alprazolam levels)
  • Theophylline (may antagonize benzodiazepine effects)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Mental Status Exam (MSE)

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

Timing: Prior to initiation of therapy

Respiratory Rate and Oxygen Saturation

Rationale: Especially if co-prescribing with opioids or other CNS depressants, to assess baseline respiratory function.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with suspected liver impairment, as alprazolam is hepatically metabolized.

Timing: Prior to initiation of therapy (if clinically indicated)

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function, as metabolites are renally excreted.

Timing: Prior to initiation of therapy (if clinically indicated)

Substance Use History

Rationale: To assess risk of abuse, misuse, and dependence.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in anxiety/panic symptoms)

Frequency: Regularly during titration and periodically during maintenance

Target: Patient-specific improvement in symptoms, functional status

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

Adverse Effects (e.g., sedation, dizziness, cognitive impairment, respiratory depression)

Frequency: Regularly, especially during initiation and dose adjustments

Target: Minimization of intolerable side effects

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

Signs of Abuse, Misuse, or Diversion

Frequency: At each visit

Target: Absence of concerning behaviors

Action Threshold: Evidence of abuse/misuse requires re-evaluation of treatment plan, potential referral to addiction specialist.

Signs of Physical Dependence/Withdrawal

Frequency: Especially during dose reduction or discontinuation

Target: Smooth tapering without severe withdrawal symptoms

Action Threshold: Emergence of withdrawal symptoms (e.g., seizures, severe anxiety, insomnia) requires slower taper or temporary dose increase.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Ataxia
  • Confusion
  • Memory impairment
  • Slurred speech
  • Respiratory depression (especially with concomitant opioids)
  • Paradoxical excitation (rare)
  • Signs of withdrawal (e.g., rebound anxiety, insomnia, irritability, tremors, seizures, psychosis) upon discontinuation or dose reduction.

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. 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:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting. Avoid if possible.
Second Trimester: Risk of fetal exposure and potential for withdrawal symptoms in the neonate if used chronically.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors, diarrhea, vomiting) if used late in pregnancy or during labor.
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Lactation

Alprazolam is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on nursing infants is unknown but may be of concern. Use with caution, monitor infant for sedation, poor feeding, and weight gain. Consider alternative agents or temporary discontinuation of breastfeeding.

Infant Risk: L3 (Moderately safe) - Potential for infant sedation, poor feeding, and withdrawal symptoms upon discontinuation of breastfeeding. Monitor closely.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients (under 18 years of age). Use is generally not recommended.

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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, falls, and cognitive impairment. Initial doses should be lower (e.g., 0.25 mg two or three times daily) and titrated slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Alprazolam oral solution (1 mg/ml) allows for flexible and precise dosing, especially for titration or tapering.
  • Due to its relatively short half-life, alprazolam may be associated with more pronounced inter-dose withdrawal symptoms or rebound anxiety compared to longer-acting benzodiazepines.
  • Always emphasize the importance of a slow taper when discontinuing alprazolam to minimize severe withdrawal symptoms, including seizures.
  • Educate patients about the significant risks of concomitant use with opioids and alcohol.
  • Consider the patient's history of substance abuse before prescribing due to the high potential for abuse and dependence.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric or elderly patients, or those with underlying psychiatric conditions.
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Alternative Therapies

  • Other benzodiazepines (e.g., lorazepam, clonazepam, diazepam)
  • SSRIs (e.g., escitalopram, sertraline, fluoxetine) for anxiety and panic disorders (first-line for long-term management)
  • SNRIs (e.g., venlafaxine, duloxetine) for anxiety disorders
  • Buspirone (for generalized anxiety disorder)
  • Hydroxyzine (for short-term anxiety)
  • Beta-blockers (e.g., propranolol) for performance anxiety or physical symptoms of anxiety
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies
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Cost & Coverage

Average Cost: Varies widely by pharmacy and insurance plan per 30 ml (1mg/ml) solution
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 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. 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, we encourage you 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.