Description
Centanafadine is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called serotonin norepinephrine dopamine reuptake inhibitors (SNDRIs) and central nervous system (CNS) stimulants.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of centanafadine in children younger than 6 years of age or weighing less than 20 kilograms (kg). However, children are more likely to have unwanted effects (eg, weight loss). Use in children younger than 6 years of age is not recommended.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of centanafadine in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including bronchial asthma) in patients with this condition.
- Bipolar disorder (mood disorder), or family history of or
- Blood vessel problems (eg, Raynaud disease) or
- Depression, or family history of or
- Drug use disorder, history of or
- Heart disease (eg, cardiomyopathy, coronary artery disease) or
- Hearth rhythm problems (eg, cardiac arrhythmia, ventricular arrhythmia), history of or
- Hypertension (high blood pressure) or
- Liver disease or
- Mental illness (eg, hypomania, mania, psychosis), or family history of or
- Suicide, history of or
- Tourette syndrome, or family history of—Use with caution. May make these conditions worse.
- Liver disease, severe—Use is not recommended in patients with this condition.
- Pheochromocytoma (an adrenal problem), or history of—Should not be used in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food in the morning at the same time each day.
Swallow the extended-release capsule whole. Do not cut, crush, or chew it.
If you are unable to swallow the extended-release capsule whole:
- Open the capsule and sprinkle the entire contents into 15 milliliters (mL) of soft food (eg, applesauce or yogurt) or orange juice. Stir the mixture. Swallow the mixture right away. Drink water right after swallowing the mixture. Do not chew the granules. Do not save the mixture for later use.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ADHD:
- For oral dosage form (extended-release capsule):
- Adults—210 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 280 mg per day.
- Children 13 to 17 years of age weighing 20 kilograms (kg) or more—280 mg once a day.
- Children 6 to 12 years of age—Dose is based on body weight and must be determined by your doctor.
- Weighing more than 50 kilograms (kg)—280 mg once a day.
- Weighing 35 kg to 50 kg—210 mg once a day.
- Weighing 20 kg to less than 35 kg—140 mg once a day.
- Children younger than 6 years of age—Use is not recommended.
- For oral dosage form (extended-release capsule):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is not more than 4 hours of the time it is usually taken, take it as soon as possible, and then go back to your regular schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly. Blood tests and blood pressure tests may be needed to check for unwanted effects. Your doctor may occasionally stop treatment to check symptoms of ADHD.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, fast or uneven heartbeat, trouble breathing, or fainting while using this medicine.
Symptoms of an overdose include: blindness, blurred vision, dizziness, fast, pounding, or irregular heartbeat or pulse, halos around lights, headache, nightmares or unusually vivid dreams, pounding in the ears, seizures, or tunnel vision. Call your doctor right away if you notice these symptoms.
You will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, trouble breathing, or unusual tiredness or weakness after you take this medicine.
This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you or your child have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.
Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Avoid drinking alcohol while using this medicine and for at least 2 hours after taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (eg, St. John's wort) or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.
Side Effects
Along with its needed effects, a medicine 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:
Less common
- Abnormal dreams
- attack, assault, force
- body aches or pain
- chest pain or discomfort
- chills
- cough
- discouragement
- dryness or soreness of the throat
- ear congestion
- fast, pounding, or irregular heartbeat or pulse
- fear, nervousness
- feeling sad or empty
- fever
- headache
- hoarseness
- increased heart rate
- irritability
- lack of appetite
- lost of interest or pleasure
- loss of voice
- muscle aches
- nightmares
- palpitations
- seeing, hearing, or feeling things that are not there
- sleepiness or unusual drowsiness
- sleeplessness
- sneezing
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- thoughts of killing oneself, changes in behavior
- trouble breathing
- trouble concentrating
- trouble swallowing
- trouble sleeping
- unusual tiredness or weakness
- voice changes
Rare
- Diarrhea
- dizziness
- general feeling of discomfort or illness
- joint or muscle pain
- shivering
Incidence not known
- Agitation
- chest tightness
- confusion
- hives, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nosebleeds
- numbness or tingling in the face, arms, or legs
- overactive reflexes
- paleness or cold feeling in the fingertips and toes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- slow growth
- talking or acting with excitement you cannot control
- tingling or pain in the fingers or toes when exposed to cold
- trembling or shaking
- twitching
- weight loss
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- disturbed color perception
- dizziness
- double vision
- halos around lights
- headache
- mental depression or anxiety
- nervousness
- nightmares or unusually vivid dreams
- night blindness
- overbright appearance of lights
- pounding in the ears
- seizures
- slow or fast heartbeat
- tunnel vision
Some side effects 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:
Less common
- Decreased appetite
- nausea
- stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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