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XANAX®, CIV Medication Guide (alprazolam)

MEDICATION GUIDE
XANAX (ZAN-aks)
(alprazolam) 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 XANAX?

  • XANAX 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 XANAX with opioids affects you.
  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including XANAX, 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 XANAX. 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 XANAX as prescribed by your healthcare provider.
    • Take XANAX exactly as your healthcare provider prescribed.
    • Do not share your XANAX with other people.
    • Keep XANAX in a safe place and away from children.
  • Physical dependence and withdrawal reactions. XANAX can cause physical dependence and withdrawal reactions.
    • Do not suddenly stop taking XANAX. Stopping XANAX 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 XANAX than prescribed or take XANAX for longer than prescribed.
What is XANAX?
  • XANAX 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)
  • XANAX is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep XANAX in a safe place to prevent misuse and abuse. Selling or giving away XANAX 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 XANAX is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking XANAX.
  • It is not known if XANAX is safe and effective when used to treat anxiety disorder for longer than 4 months.
  • It is not known if XANAX is safe and effective when used to treat panic disorder for longer than 10 weeks.
Do not take XANAX if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in XANAX. See the end of this Medication Guide for a complete list of ingredients in XANAX.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take XANAX, 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. XANAX may harm your unborn baby. You and your healthcare provider should decide if you should take XANAX while you are pregnant.
  • are breastfeeding or plan to breastfeed. XANAX 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 XANAX. You should not breastfeed while taking XANAX.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking XANAX with certain other medicines can cause side effects or affect how well XANAX or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take XANAX?
  • See "What is the most important information I should know about XANAX?"
  • Take XANAX exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much XANAX to take and when to take it.
  • If you take too much XANAX, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of XANAX?
XANAX may cause serious side effects, including:
  • See "What is the most important information I should know about XANAX?"
  • Seizures. Stopping XANAX can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. XANAX may cause an increase in activity and talking (hypomania and mania) in people who have depression.
    • XANAX 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 XANAX affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, XANAX may make your sleepiness or dizziness much worse.
The most common side effects of XANAX include:
  • problems with coordination
  • hypotension
  • trouble saying words clearly (dysarthria)
  • changes in sex drive (libido)
These are not all the possible side effects of XANAX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store XANAX?
  • Store XANAX at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep XANAX and all medicines out of the reach of children.
General information about the safe and effective use of XANAX.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use XANAX for a condition for which it was not prescribed.
  • Do not give XANAX 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 XANAX that is written for health professionals.
What are the ingredients in XANAX?
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.
XANAX® is a registered trademark of Pharmacia & Upjohn Company LLC.
For more information, go to www.pfizer.com or call 1-800-438-1985.

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LAB 0825-3.0

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 XANAX 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 Warnings and Precautions (5.1), Drug Interactions (7.1)].

Abuse, Misuse, and Addiction

Inform patients that the use of XANAX, 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 Warnings and Precautions (5.2), Drug Abuse and Dependence (9.2)].

Withdrawal Reactions

Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX 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 XANAX may require a slow taper [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].

Effects on Driving and Operating Machinery

Advise patients not to drive a motor vehicle or operate heavy machinery while taking XANAX due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking XANAX [see Warnings and Precautions (5.3)].

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 Warnings and Precautions (5.6)].

Concomitant Medications

Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7)].

Pregnancy

Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using XANAX 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 XANAX [see Warnings and Precautions (5.4). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX during pregnancy [see Use in Specific Populations (8.1)].

Lactation

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

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