MEDICATION GUIDE

Dextroamphetamine Sulfate Oral Solution, CII 5 mg/5 mL

(DEX-troe-am-FET-a-meen SUL-fate)

Rx Only

What is the most important information I should know about Dextroamphetamine Sulfate Oral Solution? Dextroamphetamine Sulfate Oral Solution may cause serious side effects, including: Abuse, misuse, and addiction. Dextroamphetamine Sulfate Oral Solution has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Dextroamphetamine Sulfate Oral Solution, 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 Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution and will monitor you or your child during treatment. Dextroamphetamine Sulfate Oral Solution may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Dextroamphetamine Sulfate Oral Solution to anyone else. See “What is Dextroamphetamine Sulfate Oral Solution?” for more information. Keep Dextroamphetamine Sulfate Oral Solution in a safe place and properly dispose of any unused medicine. See “How should I store Dextroamphetamine Sulfate Oral Solution?” 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 treatment with Dextroamphetamine Sulfate Oral Solution. 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 Dextroamphetamine Sulfate Oral Solution. 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 Dextroamphetamine Sulfate Oral Solution. 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 Dextroamphetamine Sulfate Oral Solution, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is Dextroamphetamine Sulfate Oral Solution?

Dextroamphetamine Sulfate Oral Solution 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.
• Dextroamphetamine Sulfate Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dextroamphetamine Sulfate Oral Solution is safe and effective in children under 6 years of age.

Dextroamphetamine Sulfate Oral Solution is a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs.  Keep Dextroamphetamine Sulfate Oral Solution in a safe place to protect it from theft. Never give your Dextroamphetamine Sulfate Oral Solution to anyone else because it may cause death or harm them. Selling or giving away Dextroamphetamine Sulfate Oral Solution may harm others, and is against the law.

 Do not take Dextroamphetamine Sulfate Oral Solution if you or your child:

• are allergic to amphetamine products or any of the ingredients in Dextroamphetamine Sulfate Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Dextroamphetamine Sulfate Oral Solution.
• 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 Dextroamphetamine Sulfate Oral Solution, 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 Dextroamphetamine Sulfate Oral Solution will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Dextroamphetamine Sulfate Oral Solution.
• are breastfeeding or plan to breastfeed. Dextroamphetamine Sulfate Oral Solution passes into breast milk. You or your child should not breastfeed during treatment with Dextroamphetamine Sulfate Oral Solution. Talk to your healthcare provider about the best way to feed the baby during treatment with Dextroamphetamine Sulfate Oral Solution.

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.

Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution. Your healthcare provider will decide if Dextroamphetamine Sulfate Oral Solution can be taken with other medicines.

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

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

Do not start any new medicine during treatment with Dextroamphetamine Sulfate Oral Solution without talking to your healthcare provider first.

How should Dextroamphetamine Sulfate Oral Solution be taken?

•  Take Dextroamphetamine Sulfate Oral Solution exactly as prescribed by your or your child’s healthcare provider.
• Your healthcare provider may change the dose if needed.
•  Dextroamphetamine Sulfate Oral Solution is usually taken two to three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.

If you or your child take too much Dextroamphetamine Sulfate Oral Solution, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking Dextroamphetamine Sulfate Oral Solution?

Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Dextroamphetamine Sulfate Oral Solution affects you.

What are possible side effects of Dextroamphetamine Sulfate Oral Solution?

Dextroamphetamine Sulfate Oral Solution may cause serious side effects, including:

See “What is the most important information I should know about Dextroamphetamine Sulfate Oral Solution?”

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Dextroamphetamine Sulfate Oral Solution. Your healthcare provider may stop your child’s Dextroamphetamine Sulfate Oral Solution treatment if they are not growing or gaining weight as expected.

• Seizures. Your healthcare provider may stop treatment with Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution.

•  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 Dextroamphetamine Sulfate Oral Solution.
•  Serotonin syndrome. This problem may happen when Dextroamphetamine Sulfate Oral Solution is taken with certain other medicines and may be life-threatening. Stop taking Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution. 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 Dextroamphetamine Sulfate Oral Solution?

• Store Dextroamphetamine Sulfate Oral Solution at room temperature between 68° to 77°F (20° to 25°C). 
• Store Dextroamphetamine Sulfate Oral Solution in a safe place, like a locked cabinet. Protect from light.
• Dispose of remaining, unused, or expired Dextroamphetamine Sulfate Oral Solution by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no takeback program or DEA authorized collector is available, mix Dextroamphetamine Sulfate Oral Solution 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 Dextroamphetamine Sulfate Oral Solution in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep Dextroamphetamine Sulfate Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Dextroamphetamine Sulfate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Oral Solution for a condition for which it was not prescribed. Do not give Dextroamphetamine Sulfate Oral Solution to other people, even if they have the same symptoms that you or your child have. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Dextroamphetamine Sulfate Oral Solution that is written for health professionals.

What are the ingredients in Dextroamphetamine Sulfate Oral Solution?

Active ingredient: dextroamphetamine sulfate

Inactive ingredients: anhydrous citric acid, benzoic acid, bubble gum flavor, purified water, sodium citrate anhydrous, sodium saccharin, and sorbitol solution.

Manufactured by:

Tris Pharma, Inc.

Monmouth Junction, NJ 08852

For more information about Dextroamphetamine Sulfate Oral Solution, please contact Tris Pharma, Inc. at 1-732-940-0358 or go to www.trispharma.com.

LB8256

Rev. 06

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

Revised: 09/2023