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Xanax XR alprazolam

Get an overview of XANAX XR (alprazolam tablet, extended release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Xanax XR can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Xanax XR.

Drug Basics

Brand Name: Xanax XR

Generic Name: ALPRAZOLAM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, EXTENDED RELEASE

Packager: Pharmacia & Upjohn Company LLC

Data Current As Of: 2021-03-29

Boxed Warning 2/2021
Dosage and Administration (2.2) 2/2021
Warnings and Precautions (5.2, 5.3) 2/2021

Indications & Usage

XANAX XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.

XANAX XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. (1)

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

Abuse, Misuse, and Addiction

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

Withdrawal Reactions

Inform patients that the continued use of XANAX XR may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX 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 XANAX XR 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 XR due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking XANAX XR [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 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 XANAX XR [see Warnings and Precautions (5.4)]. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX XR during pregnancy [see Use in Specific Populations (8.1)].

Lactation

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

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

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LAB-0006-10.0

MEDICATION GUIDE
XANAX XR (ZAN-aks XR)
(alprazolam) 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 XANAX XR?
  • XANAX 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 XANAX XR with opioids affects you.

  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including XANAX 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 XANAX 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 XANAX XR as prescribed by your healthcare provider.
    • Take XANAX XR exactly as your healthcare provider prescribed.
    • Do not share your XANAX XR with other people.
    • Keep XANAX XR in a safe place and away from children.
  • Physical dependence and withdrawal reactions. XANAX XR can cause physical dependence and withdrawal reactions.
    • Do not suddenly stop taking XANAX XR. Stopping XANAX 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 XANAX XR than prescribed or take XANAX XR for longer than prescribed.
What is XANAX XR?
  • XANAX 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)
  • XANAX XR is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence. Keep XANAX XR in a safe place to prevent misuse and abuse. Selling or giving away XANAX 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 XANAX XR is safe and effective in children.
  • Elderly patients are especially susceptible to dose related adverse effects when taking XANAX XR.
  • It is not known if XANAX XR is safe and effective in the treatment of panic disorder for use longer than 8 weeks.
Do not take XANAX XR if:
  • you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in XANAX XR. See the end of this Medication Guide for a complete list of ingredients in XANAX XR.
  • you are taking antifungal medicines including ketoconazole and itraconazole
Before you take XANAX 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. XANAX XR may harm your unborn baby. You and your healthcare provider should decide if you should take XANAX XR while you are pregnant.
  • are breastfeeding or plan to breastfeed. XANAX 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 XANAX XR. You should not breastfeed while taking XANAX XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking XANAX XR with certain other medicines can cause side effects or affect how well XANAX XR or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take XANAX XR?
  • See "What is the most important information I should know about XANAX XR?"
  • Take XANAX XR exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much XANAX XR to take and when to take it.
  • If you take too much XANAX XR, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Swallow XANAX XR tablets whole. Do not crush, chew or break XANAX XR.
What are the possible side effects of XANAX XR?
XANAX XR may cause serious side effects, including:
  • See "What is the most important information I should know about XANAX XR?"
  • Seizures. Stopping XANAX XR can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. XANAX XR may cause an increase in activity and talking (hypomania and mania) in people who have depression.
  • XANAX 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 XANAX XR affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX XR without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, XANAX XR may make your sleepiness or dizziness much worse.

The most common side effects of XANAX 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 XANAX XR. 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 XR?
  • Store XANAX XR at room temperature between 68°F to 77°F (20°C to 25°C)
  • Keep XANAX XR and all medicines out of the reach of children.
  • General information about the safe and effective use of XANAX XR.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use XANAX XR for a condition for which it was not prescribed.
  • Do not give XANAX 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 XANAX XR that is written for health professionals.
What are the ingredients in XANAX 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.
XANAX® XR 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-0824-3.0

also known as
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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