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Zenzedi is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Zenzedi is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).
Zenzedi may also be used for purposes not listed in this medication guide.
You should not use Zenzedi if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.
Zenzedi may be habit-forming, and this medicine is a drug of abuse. 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 Zenzedi if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Zenzedi 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.
You should not use Zenzedi if you are allergic to any stimulant medicine, or if you have:
moderate to severe high blood pressure;
heart disease or coronary artery disease (hardened arteries);
overactive thyroid;
glaucoma;
severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or
a history of drug or alcohol addiction.
Do not use Zenzedi if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Some medicines can interact with Zenzedi and cause a serious condition called serotonin syndrome. Be sure your doctor knows 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. Ask your doctor before making any changes in how or when you take your medications.
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.
To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:
depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
motor tics (muscle twitches) or Tourette's syndrome;
seizures or epilepsy;
an abnormal brain wave test (EEG); or
blood circulation problems in the hands or feet.
Taking Zenzedi 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.
Dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Zenzedi is not approved for use by anyone younger than 3 years old. This medicine extended-release capsules are not for use in children younger than 6 years old.
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take Zenzedi in larger or smaller amounts or for longer than recommended.
Zenzedi may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Zenzedi is sometimes taken 2 or 3 times per day. Extended-release this medicine is taken only once per day. Follow your doctor's dosing instructions very carefully.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture, heat, and light.
Keep track of your medicine. Zenzedi is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
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 extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Zenzedi can be fatal.
Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, panic, aggressiveness, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.
Zenzedi may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid drinking fruit juices or taking vitamin C at the same time you take Zenzedi. These can make your body absorb less of the medicine.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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); 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.
Zenzedi can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Zenzedi.
Common side effects may include:
dry mouth, upset stomach, loss of appetite, weight loss;
headache, dizziness;
tremors, fast heartbeats; or
sleep problems (insomnia).
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 Zenzedi. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
an antacid;
an antidepressant;
blood pressure medication; or
seizure medicine.
This list is not complete and many other drugs can interact with Zenzedi. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zenzedi (www.drugs.com/mtm/zenzedi.html).
Note: This document contains side effect information about dextroamphetamine. Some of the dosage forms listed on this page may not apply to the brand name Zenzedi.
Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet
Oral route (Capsule, Extended Release)
Amphetamines have a high potential for abuse, and administration for prolonged periods of time may lead to drug dependence and must be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
Along with its needed effects, dextroamphetamine (the active ingredient contained in Zenzedi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dextroamphetamine:
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking dextroamphetamine:
Symptoms of overdose
Some side effects of dextroamphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet
Very common (10% or more): Decreased appetite, reduced weight gain, weight loss
Common (1% to 10%): Anorexia
Frequency not reported: Acidosis
Very common (10% or more): Insomnia, nervousness
Common (1% to 10%): Abnormal behavior, aggression/hostility, excitation, anxiety, depression, irritability
Uncommon (0.1% to 1%): Psychotic episodes/psychosis
Very rare (less than 0.01%): Suicidal behavior (including completed suicide), mania, hallucinations
Frequency not reported: Overstimulation, restlessness, euphoria, dysphoria, confusion, dependence, emotional lability, impaired cognitive test performance, altered libido, night terrors, obsessive-compulsive behavior, panic states, paranoia
Common (1% to 10%): Arrhythmia, palpitations, tachycardia
Rare (less than 0.1%): Angina pectoris
Very rare (less than 0.01%): Cardiac arrest
Frequency not reported: Blood pressure and heart rate changes (usually elevated), cardiomyopathy, myocardial infarction, chest pain, cardiovascular collapse, Raynaud's phenomenon
Common (1% to 10%): Abdominal pain and cramps, nausea, vomiting, dry mouth
Frequency not reported: Ischemic colitis, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances
Common (1% to 10%): Arthralgia
Rare (less than 0.1%): Growth retardation
Very rare (less than 0.01%): Muscle cramps
Frequency not reported: Rhabdomyolysis
Common (1% to 10%): Vertigo, dyskinesia, headache, hyperactivity
Very rare (less than 0.01%): Tourette syndrome, tics, exacerbation of pre-existing motor and phonic tics, convulsions, choreoathetoid movements, intracranial hemorrhage, cerebral vasculitis and/or occlusion, neuroleptic malignant syndrome (NMS)
Frequency not reported: Dizziness, tremor, ataxia, dysgeusia, concentration difficulties, hyperreflexia, stroke
Rare (less than 0.1%): Rash, urticaria
Very rare (less than 0.01%): Erythema multiforme, exfoliative dermatitis, fixed drug eruption
Frequency not reported: Sweating, alopecia
Rare (less than 0.1%): Visual accommodation difficulties, blurred vision, mydriasis
Rare (less than 0.1%): Fatigue
Frequency not reported: Hyperpyrexia, sudden death
Very rare (less than 0.01%): Anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura
Very rare (less than 0.01%): Abnormal liver function ranging from hepatic enzyme elevations to hepatic coma
Frequency not reported: Impotence, libido changes, frequent or prolonged erections
Frequency not reported: Hypersensitivity reactions (e.g., angioedema and anaphylaxis)
Frequency not reported: Renal damage
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zenzedi (www.drugs.com/mtm/zenzedi.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
