MEDICATION GUIDE

Alprazolam (al pra′ zoe lam)

Orally Disintegrating Tablet (ODT), C-IV

• What is the most important information I should know about alprazolam ODT? 
  

Alprazolam ODT 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:

             Do not drive or operate heavy machinery until you know how taking alprazolam ODT with opioids affects you.

•  shallow or slowed breathing
•  breathing stops (which may lead to the heart stopping)
•  excessive sleepiness (sedation)
• Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including alprazolam ODT 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 ODT. 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 ODT exactly as prescribed by your healthcare provider.
  • Take Alprazolam ODT exactly as your healthcare provider prescribed.
  • Do not share your Alprazolam ODT with other people.
  • Keep Alprazolam ODT in a safe place and away from children.

• Physical dependence and withdrawal reactions. Alprazolam ODT can cause physical dependence and withdrawal reactions, especially if you continue to take Alprazolam ODT for several days to several weeks.

• Do not  suddenly stop taking Alprazolam ODT. Stopping Alprazolam ODT 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 Alprazolam ODT than prescribed or take Alprazolam ODT for longer than prescribed.

What is alprazolam ODT?

• Alprazolam ODT is a prescription medicines used to treat:
  • generalized anxiety disorder
  • panic disorder with or without fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)
• Alprazolam ODT is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence.  Keep alprazolam ODT in a safe place to prevent misuse and abuse.  Selling or giving away alprazolam ODT 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 ODT is safe and effective in children.
• It is not known if alprazolam ODT is safe and effective when to treat generalized anxiety disorder for longer than 4 months.
• It is not known if alprazolam ODT is safe and effective when used to treat panic disorder for longer than 10 weeks.

Do not take alprazolam ODT if you:

• take an antifungal medicines including ketoconazole and itraconazole

Before you take alprazolam ODT, tell your healthcare provider about all 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.  You and your healthcare provider should decide if you should take alprazolam ODT while you are pregnant.
  • Taking alprazolam ODT 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 ODT.
  • There is a pregnancy registry for women who take alprazolam ODT 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 ODT, 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 ODT.
  • Breastfeeding is not recommended during treatment with alprazolam ODT.

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

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

How should I take alprazolam ODT?

• Take alprazolam ODT exactly as your healthcare provider tells you to take it.  Your healthcare provider will tell you how much alprazolam ODT to take and when to take it.
• Do not remove alprazolam ODT from the blister until you are ready to take it.  With dry hands, remove the alprazolam ODT, and immediately place on your tongue to dissolve and be swallowed with your saliva.  The tablet may also be taken with water.
• If you take too much alprazolam ODT, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of alprazolam ODT?

Alprazolam ODT may cause serious side effects, including:

• See “What is the most important information I should know about alprazolam ODT?”
•  Seizures.  Stopping alprazolam ODT can cause seizures and seizures that will not stop (status epilepticus).
• Mania.  Alprazolam ODT may cause an increase in activity and talking (hypomania and mania) in people who have depression.
• Alprazolam ODT 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 Alprazolam ODT affects you.
• Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking Alprazolam ODT without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, Alprazolam ODT may make your sleepiness or dizziness much worse.

The most common side effects of alprazolam ODT include:

• sedation
• problems with coordination
• speech problems (dysarthria)
• increased libido
• low blood pressure (hypotension)

These are not all the possible side effects of alprazolam ODT.  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 ODT?

• Store alprazolam ODT at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep alprazolam ODT in a tightly closed container and keep dry.
• Keep alprazolam ODT and all medicines out of the reach of children.

General information about the safe and effective use of alprazolam ODT.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.  Do not use alprazolam ODT for a condition for which it was not prescribed.  Do not give alprazolam ODT 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 ODT that is written for health professionals. For more information call 1-800-828-9393.

What are the ingredients in alprazolam ODT?

Active ingredients: alprazolam

Inactive ingredients: aspartame, crospovidone, basic butylated methacrylate copolymer, magnesium stearate, mannitol, silicon dioxide, sorbitol, talc, xylitol, natural peppermint flavor, artificial vanillin flavor.

Distributed by:

PAR PHARMACEUTICAL

Chestnut Ridge, NY 10977

This Medication Guide has been approved by the U.S. Food and Drug Administration