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ALPRAZOLAM Tablets, C-IV (GREENSTONE LLC)

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

What is Alprazolam?

  • Alprazolam is a prescription medicine used:
    • to treat anxiety disorders
    • for the short-term relief of the symptoms of anxiety
    • to treat panic disorder with or without a fear of places and situations that might...

What is Alprazolam?

  • Alprazolam is a prescription medicine used:
    • to treat anxiety disorders
    • for the short-term relief of the symptoms of anxiety
    • to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • Alprazolam is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep Alprazolam in a safe place to prevent misuse and abuse. Selling or giving away Alprazolam 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 is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking Alprazolam.
  • It is not known if Alprazolam is safe and effective when used to treat anxiety disorder for longer than 4 months.
  • It is not known if Alprazolam is safe and effective when used to treat panic disorder for longer than 10 weeks.
Do not take Alprazolam if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in Alprazolam. See the end of this Medication Guide for a complete list of ingredients in Alprazolam.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take Alprazolam, 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 may harm your unborn baby. You and your healthcare provider should decide if you should take Alprazolam while you are pregnant.
  • are breastfeeding or plan to breastfeed. Alprazolam 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. You should not breastfeed while taking Alprazolam.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking Alprazolam with certain other medicines can cause side effects or affect how well Alprazolam 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?

How should I take Alprazolam?

  • See "What is the most important information I should know about Alprazolam?"
  • Take Alprazolam exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Alprazolam to take and when to take it.
  • If you take too much Alprazolam, call your healthcare provider or go to the nearest hospital emergency room right away.
Did you find an answer to your question? Yes No

What are the possible side effects of Alprazolam?


What are the possible side effects of Alprazolam?


  • See "What is the most important information I should know about Alprazolam?"
  • Seizures. Stopping Alprazolam can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. Alprazolam may cause an increase in activity and talking (hypomania and mania) in people who have depression.
    • Alprazolam 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 affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Alprazolam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Alprazolam may make your sleepiness or dizziness much worse.
The most common side effects of Alprazolam include:
  • problems with coordination
  • hypotension
  • trouble saying words clearly (dysarthria)
  • changes in sex drive (libido)
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How should I store Alprazolam?

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

How should I store Alprazolam?

  • Store Alprazolam at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep Alprazolam 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.

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Alprazolam for a condition for which it was not prescribed.
  • Do not give...

General information about the safe and effective use of Alprazolam.

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Alprazolam for a condition for which it was not prescribed.
  • Do not give Alprazolam 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 that is written for health professionals.
Did you find an answer to your question? Yes No

What are the ingredients in Alprazolam?


Inactive ingredients:

Logo

What are the ingredients in Alprazolam?


Inactive ingredients:

Logo

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 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, 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 may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of alprazolam 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 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 due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking alprazolam [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 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 [see

Lactation

Advise women not to breastfeed during treatment with alprazolam [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 tablets, C-IV
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: February 2021
What is the most important information I should know about Alprazolam?
  • Alprazolam 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 with opioids affects you.
  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Alprazolam, 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. 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 as prescribed by your healthcare provider.
    • Take Alprazolam exactly as your healthcare provider prescribed.
    • Do not share your Alprazolam with other people.
    • Keep Alprazolam in a safe place and away from children.
  • Physical dependence and withdrawal reactions. Alprazolam can cause physical dependence and withdrawal reactions.
    • Do not suddenly stop taking Alprazolam. Stopping Alprazolam 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 these 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 than prescribed or take Alprazolam for longer than prescribed.
What is Alprazolam?
  • Alprazolam is a prescription medicine used:
    • to treat anxiety disorders
    • for the short-term relief of the symptoms of anxiety
    • to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
  • Alprazolam is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep Alprazolam in a safe place to prevent misuse and abuse. Selling or giving away Alprazolam 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 is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking Alprazolam.
  • It is not known if Alprazolam is safe and effective when used to treat anxiety disorder for longer than 4 months.
  • It is not known if Alprazolam is safe and effective when used to treat panic disorder for longer than 10 weeks.
Do not take Alprazolam if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in Alprazolam. See the end of this Medication Guide for a complete list of ingredients in Alprazolam.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take Alprazolam, 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 may harm your unborn baby. You and your healthcare provider should decide if you should take Alprazolam while you are pregnant.
  • are breastfeeding or plan to breastfeed. Alprazolam 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. You should not breastfeed while taking Alprazolam.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking Alprazolam with certain other medicines can cause side effects or affect how well Alprazolam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take Alprazolam?
  • See " What are the possible side effects of Alprazolam?
    Alprazolam may cause serious side effects, including:
    • See " How should I store Alprazolam?
      • Store Alprazolam at room temperature between 68°F to 77°F (20°C to 25°C)
      • Keep Alprazolam and all medicines out of the reach of children.
General information about the safe and effective use of Alprazolam.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Alprazolam for a condition for which it was not prescribed.
  • Do not give Alprazolam 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 that is written for health professionals.
What are the ingredients in Alprazolam?
Active ingredient:
alprazolam
Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

Logo

LAB-0822-3.0
Revised February 2021

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 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, 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 may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of alprazolam 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 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 due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking alprazolam [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 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 [see

Lactation

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

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