Dyanavel XR oral suspension (amphetamine) is a central nervous system stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Dyanavel XR is available as extended-release tablets and extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years and older.

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

Dyanavel XR may be habit-forming. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use Dyanavel XR if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Dyanavel XR may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes.

Before taking this medicine

You should not use Dyanavel XR if you are allergic to amphetamine or any stimulant medicine, or if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

You may not be able to use Dyanavel XR if you have:

• chest pain or breathing problems caused by heart disease;

• hardening of the arteries;

• moderate to severe high blood pressure;

• overactive thyroid;

• a history of drug abuse; or

• if you are agitated.

Tell your doctor if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with amphetamine could cause a serious condition called serotonin syndrome.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Dyanavel XR is not approved for use by anyone younger than 3 years old.

To make sure Dyanavel XR is safe for you, tell your doctor if you or anyone in your family has had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• problems with drug or alcohol abuse;

• motor tics (muscle twitches) or Tourette's syndrome;

• kidney disease;

• a thyroid disorder;

• seizures or epilepsy;

• an abnormal brain wave test (EEG);

• coronary artery disease (clogged arteries); or

• blood circulation problems in the hands or feet.

Taking Dyanavel XR during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Take Dyanavel XR exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Amphetamine may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medicine where others cannot get to it. Selling or giving away Dyanavel XR is against the law.

Take Dyanavel XR with or without food.

Shake Dyanavel XR oral suspension (liquid) well before use. Measure a dose with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Dyanavel XR tablets may be chewed or swallowed whole. The Dyanavel XR 5 mg tablets are scored and can be divided into equal parts at the score line. 

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using Dyanavel XR.

Store at room temperature away from moisture and heat. Keep the oral suspension bottle tightly closed when not in use.

Keep your medicine in a place where no one can use it improperly.

Do not keep leftover Dyanavel XR. Ask your pharmacist where to locate a drug take-back disposal program.

Usual Adult Dose of Dyanavel XR for Attention Deficit Disorder:

-Initial Dose: 2.5 or 5 mg orally once a day in the morning
-Increase in increments of 2.5 to 10 mg per day every 4 to 7 days until optimal response is obtained
-Maximum Dose: 20 mg orally per day.

Usual Pediatric Doseof Dyanavel XR for Attention Deficit Disorder:

-Initial Dose: 2.5 or 5 mg orally once a day in the morning
-Increase in increments of 2.5 to 10 mg/day every 4 to 7 days until optimal response is obtained
-Maximum Dose: 20 mg orally per day

-Use: treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older

Comments:
-Dyanavel XR contains immediate and extended-release components.
-A total treatment program typically includes other remedial measures (e.g., psychological, educational, and social).
-Amphetamines should be administered at the lowest effective dose and dose should be individually adjusted; late evening doses should be avoided because of resulting insomnia.
-Amphetamine products should not be substituted on a mg-per-mg basis because of differing salt compositions and differing pharmacokinetic profiles; see dosage adjustment section for guidance on switching.

You should not use Dyanavel XR if you are allergic to amphetamine or any stimulant medicine, or if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

You may not be able to use Dyanavel XR if you have:

• chest pain or breathing problems caused by heart disease;

• hardening of the arteries;

• moderate to severe high blood pressure;

• overactive thyroid;

• a history of drug abuse; or

• if you are agitated.

Tell your doctor if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with amphetamine could cause a serious condition called serotonin syndrome.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Dyanavel XR is not approved for use by anyone younger than 3 years old.

To make sure Dyanavel XR is safe for you, tell your doctor if you or anyone in your family has had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• problems with drug or alcohol abuse;

• motor tics (muscle twitches) or Tourette's syndrome;

• kidney disease;

• a thyroid disorder;

• seizures or epilepsy;

• an abnormal brain wave test (EEG);

• coronary artery disease (clogged arteries); or

• blood circulation problems in the hands or feet.

Taking Dyanavel XR during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, stomach cramps, vomiting, or diarrhea. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

Avoid drinking alcohol.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make you absorb less amphetamine.

Avoid driving or hazardous activity until you know how Dyanavel XR will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Dyanavel XR: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems - chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

• signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

• a seizure (convulsions);

• muscle twitches (tics);

• pain or burning when you urinate; or

• changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine can affect growth. Tell your doctor if your child is not growing at a normal rate.

Common Dyanavel XR side effects may include:

• increased heart rate;

• mood changes, anxiety, feeling restless or nervous;

• trouble sleeping;

• dry mouth, stomach pain, nausea, vomiting, diarrhea, constipation;

• loss of appetite, weight loss;

• painful urination;

• sexual problems, impotence;

• headache, dizziness;

• fever, weakness; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.