|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?|
|What is XANAX XR?|
|Do not take XANAX XR if:|
|Before you take XANAX XR, tell your healthcare provider about all of your medical conditions, including if you:|
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?|
|What are the possible side effects of XANAX XR? |
XANAX XR may cause serious side effects, including:
|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?|
|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.
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 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)].
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)].
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)].
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)].
Advise women not to breastfeed during treatment with XANAX XR [see Use in Specific Populations (8.2)].