IMPORTANT SAFETY INFORMATION
DESOXYN® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DESOXYN® in a safe place to prevent misuse and abuse. Selling or giving away DESOXYN® may harm others, and is against the law. Tell your or your child’s doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
What is DESOXYN®?
- DESOXYN® is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). DESOXYN® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
- DESOXYN® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Who should not take DESOXYN®?
DESOXYN® should not be taken if you or your child: have heart disease or hardening of the arteries, have moderate to severe high blood pressure, have hyperthyroidism, have an eye problem called glaucoma, are agitated, have a history of drug abuse, are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI, are sensitive to, allergic to or had a reaction to other stimulant medicines
DESOXYN® is not recommended for use in children less than 6 years old in the treatment of ADHD.
DESOXYN® may not be right for you or your child. Before starting DESOXYN® tell your or your child’s doctor about all health conditions (or a family history of) including: heart problems, heart defects, high blood pressure, mental problems including psychosis, mania, bipolar illness or depression, tics or Tourette’s syndrome, thyroid problems, diabetes, seizures or have had an abnormal brain wave test (EEG), or circulation problems in fingers and toes.
Tell your or your child’s doctor if you or your child is pregnant, planning to become pregnant or breastfeeding.
What is the most important information I should know about DESOXYN®?
The following have been reported with use of methamphetamine hydrochloride and other stimulant medicines.
- Heart-related problems:Sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, increased blood pressure and heart rate. Tell your or your child’s doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your or your child’s doctor should check you or your child carefully for heart problems before starting DESOXYN®. Your or your child’s doctor should check you or your child’s blood pressure and heart rate regularly during treatment with DESOXYN®. Call your or your child’s doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DESOXYN®.
- Mental (Psychiatric) problems:
All Patients: new or worse behavior and thought problems, new or worse bipolar illness, new or worse aggressive behavior or hostility.
Children and Teenagers: new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.
Tell your or your child’s doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your or your child’s doctor right away if you or your child have any new or worsening mental symptoms or problems while taking DESOXYN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful and fingers or toes may change color from pale, to blue, to red.
Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call you your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DESOXYN®.
What are possible side effects of DESOXYN®?
- See “What is the most important information I should know about DESOXYN®?”Medication Guide. for information on reported heart and mental problems.
- Other serious side effects include: slowing of growth (height and weight) in children, seizures, mainly in patients with a history of seizures, and eyesight changes or blurred vision.
- Common side effects include: fast heart beat, decreased appetite, tremors, headache, trouble sleeping, dizziness, stomach upset, weight loss and dry mouth.
- DESOXYN® may affect your or your child’s ability to drive or do other dangerous activities. Talk to your or your child’s doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your or your child’s doctor or pharmacist for more information. Call your or your child’s doctor for medical advice about side effects.
You may report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information including Boxed WARNING and Medication Guide.