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XANAX XR (ZAN-aks XR)
(alprazolam) extended-release tablets, C-IV
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What is the most important information I should know about XANAX XR?
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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:
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- shallow or slowed breathing
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- breathing stops (which may lead to the heart stopping)
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- excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking XANAX XR with opioids affects you.
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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.
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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.
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You can develop an addiction even if you take XANAX XR as prescribed by your healthcare provider.
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Take XANAX XR exactly as your healthcare provider prescribed.
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- Do not share your XANAX XR with other people.
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- Keep XANAX XR in a safe place and away from children.
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Physical dependence and withdrawal reactions. XANAX XR can cause physical dependence and withdrawal reactions.
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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.
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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.
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- 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.
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- Do not take more XANAX XR than prescribed or take XANAX XR for longer than prescribed.
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What is XANAX XR?
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- 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)
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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.
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- It is not known if XANAX XR is safe and effective in children.
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- Elderly patients are especially susceptible to dose related adverse effects when taking XANAX XR.
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- It is not known if XANAX XR is safe and effective in the treatment of panic disorder for use longer than 8 weeks.
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Do not take XANAX XR if:
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- 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.
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- you are taking antifungal medicines including ketoconazole and itraconazole
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Before you take XANAX XR, tell your healthcare provider about all of your medical conditions, including if you:
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- have or have had depression, mood problems, or suicidal thoughts or behavior
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- have liver or kidney problems
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- have lung disease or breathing problems
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- are pregnant or plan to become pregnant.
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- Taking XANAX XR late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
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- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with XANAX XR.
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- There is a pregnancy registry for women who take XANAX XR during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with XANAX XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/.
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- are breastfeeding or plan to breastfeed. XANAX XR passes into your breast milk.
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- Talk to your healthcare provider about the best way to feed your baby if you take XANAX XR.
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- Breastfeeding is not recommended during treatment with 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.
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How should I take XANAX XR?
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- See “What is the most important information I should know about XANAX XR?”
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- 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.
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- If you take too much XANAX XR, call your healthcare provider or go to the nearest hospital emergency room right away.
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- Swallow XANAX XR tablets whole. Do not crush, chew or break XANAX XR.
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What are the possible side effects of XANAX XR?
XANAX XR may cause serious side effects, including:
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- See “What is the most important information I should know about XANAX XR?”
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Seizures. Stopping XANAX XR can cause seizures and seizures that will not stop (status epilepticus).
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Mania. XANAX XR may cause an increase in activity and talking (hypomania and mania) in people who have depression.
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XANAX XR can make you sleepy or dizzy and can slow your thinking and motor skills.
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- Do not drive, operate heavy machinery, or do other dangerous activities until you know how XANAX XR affects you.
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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:
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- sleepiness
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- trouble saying words clearly (dysarthria)
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- problems with memory
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- problems with coordination
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- changes in sex drive (libido)
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- constipation
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- nausea
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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.
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How should I store XANAX XR?
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- Store XANAX XR at room temperature between 68°F to 77°F (20°C to 25°C)
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Keep XANAX XR and all medicines out of the reach of children.
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General information about the safe and effective use of XANAX XR.
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- Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
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- Do not use XANAX XR for a condition for which it was not prescribed.
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- Do not give XANAX XR to other people, even if they have the same symptoms that you have. It may harm them.
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- You can ask your pharmacist or healthcare provider for information about XANAX XR that is written for health professionals.
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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 UPJOHN US 2 LLC, a Viatris Company.
For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).
Distributed by:
Viatris Specialty LLC
Morgantown, WV 26505 U.S.A.
UPJ:MG:XNXXRT:RX2
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