MEDICATION GUIDE

What is the most important information I should know about alprazolam extended-release tablets?

• Alprazolam extended-release tablets are 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 alprazolam extended-release tablets with opioids affect you.

• Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including alprazolam extended-release tablets 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 alprazolam extended-release tablets. 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 alprazolam extended-release tablets as prescribed by your healthcare provider.
  • Take alprazolam extended-release tablets exactly as your healthcare provider prescribed.
  • Do not share your alprazolam extended-release tablets with other people.
  • Keep alprazolam extended-release tablets in a safe place and away from children.
• Physical dependence and withdrawal reactions. Alprazolam extended-release tablets can cause physical dependence and withdrawal reactions.
  • Do not suddenly stop taking alprazolam extended-release tablets. Stopping alprazolam extended-release tablets 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 alprazolam extended-release tablets than prescribed or take alprazolam extended-release tablets for longer than prescribed.

What are alprazolam extended-release tablets?

• Alprazolam extended-release tablets are 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)
• Alprazolam extended-release tablets are a federal controlled substance (C-IV) because they contain alprazolam that can be abused or lead to dependence. Keep alprazolam extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam extended-release tablets 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 alprazolam extended-release tablets are safe and effective in children.
• Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam extended-release tablets.
• It is not known if alprazolam extended-release tablets are safe and effective in the treatment of panic disorder for use longer than 8 weeks.

Do not take alprazolam extended-release tablets if:

• you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in alprazolam extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in alprazolam extended-release tablets.
• you are taking antifungal medicines including ketoconazole and itraconazole

Before you take alprazolam extended-release tablets, 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.
  
  • Taking alprazolam extended-release tablets 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).
    
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with alprazolam extended-release tablets.
  • There is a pregnancy registry for women who take alprazolam extended-release tablets 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 alprazolam extended-release tablets, 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/.
• are breastfeeding or plan to breastfeed. Alprazolam passes into your breast milk.
  • Talk to your healthcare provider about the best way to feed your baby if you take alprazolam extended-release tablets.
  • Breastfeeding is not recommended during treatment with alprazolam extended-release tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking alprazolam extended-release tablets with certain other medicines can cause side effects or affect how well alprazolam extended-release tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take alprazolam extended-release tablets?

• See “What is the most important information I should know about alprazolam extended-release tablets?”
• Take alprazolam extended-release tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how many alprazolam extended-release tablets to take and when to take it.
• If you take too many alprazolam extended-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
• Swallow alprazolam extended-release tablets whole. Do not crush, chew or break alprazolam extended-release tablets.

These are not all the possible side effects of alprazolam extended-release tablets. 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 alprazolam extended-release tablets?

• Store alprazolam extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep alprazolam extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of alprazolam extended-release tablets.

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use alprazolam extended-release tablets for a condition for which it was not prescribed.
• Do not give alprazolam extended-release tablets 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 alprazolam extended-release tablets that is written for health professionals.