XANAX^®, CIV (alprazolam)

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• problems with coordination
• hypotension
• trouble saying words clearly (dysarthria)
• changes in sex drive (libido)

• 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.

• 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.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).