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ALPRAZOLAM XR Extended Release Tablets, C-IV (GREENSTONE LLC)

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ALPRAZOLAM XR Extended Release Tablets, C-IV (GREENSTONE LLC) Quick Finder

What is Alprazolam XR?

  • Alprazolam XR is a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • Alprazolam XR is a federal...

What is Alprazolam XR?

  • Alprazolam XR is a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • Alprazolam XR is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep Alprazolam XR in a safe place to prevent misuse and abuse. Selling or giving away Alprazolam XR may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if Alprazolam XR is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking Alprazolam XR.
  • It is not known if Alprazolam XR is safe and effective in the treatment of panic disorder for use longer than 8 weeks.
Do not take Alprazolam XR if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in Alprazolam XR. See the end of this Medication Guide for a complete list of ingredients in Alprazolam XR.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take Alprazolam XR, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver or kidney problems
  • have lung disease or breathing problems
  • are pregnant or plan to become pregnant. Alprazolam XR may harm your unborn baby. You and your healthcare provider should decide if you should take Alprazolam XR while you are pregnant.
  • are breastfeeding or plan to breastfeed. Alprazolam XR passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Alprazolam XR. You should not breastfeed while taking Alprazolam XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Alprazolam XR with certain other medicines can cause side effects or affect how well Alprazolam XR or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Did you find an answer to your question? Yes No

How should I take Alprazolam XR?

How should I take Alprazolam XR?

  • See "What is the most important information I should know about Alprazolam XR?"
  • Take Alprazolam XR exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Alprazolam XR to take and when to take it.
  • If you take too much Alprazolam XR, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Swallow Alprazolam XR tablets whole. Do not crush, chew or break Alprazolam XR.
Did you find an answer to your question? Yes No

What are the possible side effects of Alprazolam XR?

Alprazolam XR may cause serious side effects, including:

What are the possible side effects of Alprazolam XR?

Alprazolam XR may cause serious side effects, including:

  • See "What is the most important information I should know about Alprazolam XR?"
  • Seizures. Stopping Alprazolam XR can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. Alprazolam XR may cause an increase in activity and talking (hypomania and mania) in people who have depression.
  • Alprazolam XR can make you sleepy or dizzy and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Alprazolam XR affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Alprazolam XR without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Alprazolam XR may make your sleepiness or dizziness much worse.
The most common side effects of Alprazolam XR include:
  • sleepiness
  • trouble saying words clearly (dysarthria)
  • problems with memory
  • problems with coordination
  • changes in sex drive (libido)
  • constipation
  • nausea
These are not all the possible side effects of Alprazolam XR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store Alprazolam XR?

  • Store Alprazolam XR at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep Alprazolam XR and all medicines out of the reach of children.

How should I store Alprazolam XR?

  • Store Alprazolam XR at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep Alprazolam XR and all medicines out of the reach of children.
Did you find an answer to your question? Yes No

General information about the safe and effective use of Alprazolam XR.

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Alprazolam XR for a condition for which it was not prescribed.
  • Do not give Alprazolam XR to...
  • General information about the safe and effective use of Alprazolam XR.

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Alprazolam XR for a condition for which it was not prescribed.
  • Do not give Alprazolam XR to other people, even if they have the same symptoms that you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about Alprazolam XR that is written for health professionals.
  • Did you find an answer to your question? Yes No

    What are the ingredients in Alprazolam XR?

    Active ingredient: alprazolam

    Inactive ingredients: lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C...

    What are the ingredients in Alprazolam XR?

    Active ingredient: alprazolam

    Inactive ingredients: lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.

    This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

    Logo

    LAB-0823-3.0


    Did you find an answer to your question? Yes No

    17 PATIENT COUNSELING INFORMATION

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Risks from Concomitant Use with Opioids

    Advise both...

    17 PATIENT COUNSELING INFORMATION

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Risks from Concomitant Use with Opioids

    Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when Alprazolam XR is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see

    Abuse, Misuse, and Addiction

    Inform patients that the use of Alprazolam XR, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see

    Withdrawal Reactions

    Inform patients that the continued use of Alprazolam XR may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Alprazolam XR may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of Alprazolam XR may require a slow taper [see

    Effects on Driving and Operating Machinery

    Advise patients not to drive a motor vehicle or operate heavy machinery while taking Alprazolam XR due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking Alprazolam XR [see

    Patients with Depression

    Advise patients, their families and caregivers to look for signs of suicidality or worsening depression, and to inform the patient's healthcare provider immediately [see

    Concomitant Medications

    Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see

    Pregnancy

    Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using Alprazolam XR to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with Alprazolam XR [see

    Lactation

    Advise women not to breastfeed during treatment with Alprazolam XR [see Use in Specific Populations (8.2)].

    Did you find an answer to your question? Yes No

    Full Patient Information

    ...

    Full Patient Information

    MEDICATION GUIDE
    Alprazolam XR
    extended-release tablets, C-IV
    This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised 3/2021
    What is the most important information I should know about Alprazolam XR?
    • Alprazolam XR is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens:
      • shallow or slowed breathing
      • breathing stops (which may lead to the heart stopping)
      • excessive sleepiness (sedation)
      Do not drive or operate heavy machinery until you know how taking Alprazolam XR with opioids affects you.
    • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including Alprazolam XR which can lead to overdose and serious side effects including coma and death.
      • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Alprazolam XR. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
      • You can develop an addiction even if you take Alprazolam XR as prescribed by your healthcare provider.
      • Take Alprazolam XR exactly as your healthcare provider prescribed.
      • Do not share your Alprazolam XR with other people.
      • Keep Alprazolam XR in a safe place and away from children.
    • Physical dependence and withdrawal reactions. Alprazolam XR can cause physical dependence and withdrawal reactions.
      • Do not suddenly stop taking Alprazolam XR. Stopping Alprazolam XR suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of the following symptoms.
      • Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
      • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
      • Do not take more Alprazolam XR than prescribed or take Alprazolam XR for longer than prescribed.
    What is Alprazolam XR?
    • Alprazolam XR is a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
    • Alprazolam XR is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep Alprazolam XR in a safe place to prevent misuse and abuse. Selling or giving away Alprazolam XR may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
    • It is not known if Alprazolam XR is safe and effective in children.
    • Elderly patients are especially susceptible to dose related adverse effects when taking Alprazolam XR.
    • It is not known if Alprazolam XR is safe and effective in the treatment of panic disorder for use longer than 8 weeks.
    Do not take Alprazolam XR if:
    • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in Alprazolam XR. See the end of this Medication Guide for a complete list of ingredients in Alprazolam XR.
    • you are taking antifungal medicines including ketoconazole and itraconazole
    Before you take Alprazolam XR, tell your healthcare provider about all of your medical conditions, including if you:
    • have or have had depression, mood problems, or suicidal thoughts or behavior
    • have liver or kidney problems
    • have lung disease or breathing problems
    • are pregnant or plan to become pregnant. Alprazolam XR may harm your unborn baby. You and your healthcare provider should decide if you should take Alprazolam XR while you are pregnant.
    • are breastfeeding or plan to breastfeed. Alprazolam XR passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Alprazolam XR. You should not breastfeed while taking Alprazolam XR.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Taking Alprazolam XR with certain other medicines can cause side effects or affect how well Alprazolam XR or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

    How should I take Alprazolam XR?
    • See " What are the possible side effects of Alprazolam XR?

      Alprazolam XR may cause serious side effects, including:

      • See " How should I store Alprazolam XR?
        • Store Alprazolam XR at room temperature between 68°F to 77°F (20°C to 25°C)
        • Keep Alprazolam XR and all medicines out of the reach of children.
    • General information about the safe and effective use of Alprazolam XR.
    • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
    • Do not use Alprazolam XR for a condition for which it was not prescribed.
    • Do not give Alprazolam XR to other people, even if they have the same symptoms that you have. It may harm them.
    • You can ask your pharmacist or healthcare provider for information about Alprazolam XR that is written for health professionals.

    What are the ingredients in Alprazolam XR?

    Active ingredient: alprazolam

    Inactive ingredients: lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.

    This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

    Logo

    LAB-0823-3.0


    17 PATIENT COUNSELING INFORMATION

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Risks from Concomitant Use with Opioids

    Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when Alprazolam XR is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see

    Abuse, Misuse, and Addiction

    Inform patients that the use of Alprazolam XR, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see

    Withdrawal Reactions

    Inform patients that the continued use of Alprazolam XR may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Alprazolam XR may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of Alprazolam XR may require a slow taper [see

    Effects on Driving and Operating Machinery

    Advise patients not to drive a motor vehicle or operate heavy machinery while taking Alprazolam XR due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking Alprazolam XR [see

    Patients with Depression

    Advise patients, their families and caregivers to look for signs of suicidality or worsening depression, and to inform the patient's healthcare provider immediately [see

    Concomitant Medications

    Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see

    Pregnancy

    Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using Alprazolam XR to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with Alprazolam XR [see

    Lactation

    Advise women not to breastfeed during treatment with Alprazolam XR [see Use in Specific Populations (8.2)].

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