MEDICATION GUIDE

What is the most important information I should know about DEXEDRINE?

DEXEDRINE may cause serious side effects, including:

• Abuse misuse, and addiction. DEXEDRINE has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DEXEDRINE, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DEXEDRINE or when it is used in ways that are not approved, such as snorting or injection.
  • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with DEXEDRINE and will monitor you or your child during treatment.
  • DEXEDRINE may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
  • Do not give DEXEDRINE to anyone else. See “What is DEXEDRINE?” for more information.
  • Keep DEXEDRINE in a safe place and properly dispose of any unused medicine. See “How should I store DEXEDRINE?” for more information.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

   

• Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease.

  Your healthcare provider should check you or your child carefully for heart problems before starting DEXEDRINE. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

  Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DEXEDRINE.

• Increased blood pressure and heart rate.
  Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with DEXEDRINE.
• Mental (psychiatric) problems, including:

• new or worse behavior or thought problems
• new or worse bipolar illness

• new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with DEXEDRINE, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is DEXEDRINE?

DEXEDRINE is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:

• a sleep disorder called narcolepsy.
• Attention-Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age.
• DEXEDRINE may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if DEXEDRINE is safe and effective in children under 6 years of age.

Do not take DEXEDRINE if you or your child:

• are allergic to amphetamine products or any of the ingredients in DEXEDRINE. See the end of this Medication Guide for a complete list of ingredients in DEXEDRINE.
• are taking or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or the intravenous medicine methylene blue.

Before taking DEXEDRINE, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have heart problems, heart disease, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers and toes
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• are pregnant or plan to become pregnant. It is not known if DEXEDRINE will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with DEXEDRINE.
• are breastfeeding or plan to breastfeed. DEXEDRINE passes into breast milk. You or your child should not breastfeed during treatment with DEXEDRINE. Talk to your healthcare provider about the est way to feed the baby during treatment with DEXEDRINE.

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

DEXEDRINE and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with DEXEDRINE. Your healthcare provider will decide if DEXEDRINE can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• medicines used to treat migraine headaches called triptans
• tricyclic antidepressants
• lithium
• fentanyl
• tramadol
• tryptophan
• buspirone
• St. John’s Wort

Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

How should DEXEDRINE be taken?

• Take DEXEDRINE exactly as prescribed by your or your child’s healthcare provider.
• Your healthcare provider may change the dose if needed.
• DEXEDRINE DEXEDRINE is an extended-release capsule. It releases medicine into your body throughout the day.

What are possible side effects of DEXEDRINE?

DEXEDRINE may cause serious side effects, including:

• See “What is the most important information I should know about DEXEDRINE?”
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with DEXEDRINE. Your healthcare provider may stop your child’s DEXEDRINE treatment if they are not growing or gaining weight as expected.
• Seizures. Your healthcare provider may stop treatment with DEXEDRINE if you or your child have a seizure.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
• fingers or toes may feel numb, cool, painful
• fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with DEXEDRINE.

• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with DEXEDRINE.
• Serotonin syndrome. This problem may happen when DEXEDRINE is taken with certain other medicines and may be life-threatening. Stop taking DEXEDRINE and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:

• agitation,
• fast heartbeat
• flushing
• seizures
• coma
• sweating
• loss of coordination
• confusion
• dizziness
• tremors, stiff muscles, or muscle twitching
• seeing or hearing things that are not real (hallucination)
• changes in blood pressure
• high body temperature (hypothermia)
• nausea, vomiting, diarrhea

The most common side effects of DEXEDRINE include:

• fast heartbeat
• decreased appetite
• tremors
• headache
• trouble sleeping
• dizziness
• stomach upset
• weight loss
• dry mouth

These are not all of the possible side effects of DEXEDRINE. 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 DEXEDRINE?

• Store DEXEDRINE at room temperature between 68° to 77°F (20° to 25°C).
• Store DEXEDRINE in a safe place, like a locked cabinet. Protect from light.
• Dispose of remaining, unused, or expired DEXEDRINE by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix DEXEDRINE with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away DEXEDRINE in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep DEXEDRINE and all medicines out of the reach of children.

General information about the safe and effective use of DEXEDRINE.

What are the ingredients in DEXEDRINE?

Active ingredient: dextroamphetamine sulfate

Inactive ingredients: cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.

Manufactured by:

Catalent Pharma Solutions

Winchester, KY 40391

Distributed by:

Amneal Specialty, a division of

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

For more information about DEXEDRINE, visit www.amneal.com or call 1-877-835-5472.