Description
Viloxazine is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called selective norepinephrine reuptake inhibitors (SNRIs).
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 viloxazine in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of viloxazine have not been performed in the geriatric population.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alosetron
- Caffeine
- Duloxetine
- Fezolinetant
- Furazolidone
- Iproniazid
- Isocarboxazid
- Linezolid
- Melatonin
- Methylene Blue
- Mexiletine
- Moclobemide
- Nialamide
- Ozanimod
- Phenelzine
- Pomalidomide
- Procarbazine
- Ramelteon
- Rasagiline
- Safinamide
- Selegiline
- Tacrine
- Tasimelteon
- Theophylline
- Tizanidine
- Tranylcypromine
- Warfarin
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clozapine
- Istradefylline
- Lidocaine
- Olanzapine
- Pirfenidone
- Roflumilast
- Ropivacaine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Carbamazepine
- Fosphenytoin
- Phenytoin
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:
- Bipolar disorder, history of or
- Depression, history of or
- Heart disease or
- Heart rhythm problems, or a family history of or
- Hypertension (high blood pressure) or
- Mental illness, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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 these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
This medicine may be taken with or without food.
Do not cut, crush, or chew the capsule. You may swallow the capsule whole, or open it and sprinkle the contents over a teaspoonful of applesauce or pudding. Swallow the mixture right away, within 2 hours of mixing for applesauce, or within 15 minutes of mixing for pudding. Do not chew the mixture or store it for future 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 oral dosage form (extended-release capsules):
- For attention deficit hyperactivity disorder (ADHD):
- Adults—At first, 200 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 600 mg once a day.
- Children 12 to 17 years of age—At first, 200 mg once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg once a day.
- Children 6 to 11 years of age—At first, 100 mg once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg once a day.
- Children younger than 6 years of age—Use and dose must be determined by the doctor.
- For attention deficit hyperactivity disorder (ADHD):
Missed Dose
Call your doctor or pharmacist for instructions.
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 this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Do not take viloxazine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop extremely high blood pressure.
Do not use this medicine if you are using alosetron (Lotronex®), duloxetine (Cymbalta®), ramelteon (Rozerem®), tasimelteon (Hetlioz®), theophylline (Theo-24®), or tizanidine (Zanaflex®).
Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.
You will also need to have your or your child's blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your or your child's blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
This medicine may make you drowsy, sleepy, or tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, 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:
More common
- Sleepiness or unusual drowsiness
Less common
- Body aches or pain
- chills
- cough
- ear congestion
- fast, pounding, or irregular heartbeat or pulse
- fever
- headache
- hoarseness
- loss of voice
- muscle aches
- pain or tenderness around the eyes and cheekbones
- relaxed and calm
- sneezing
- sore throat
- stuffy or runny nose
- tender, swollen glands in the neck
- tightness of the chest
- trouble breathing or swallowing
- unusual dullness or feeling of sluggishness
- unusual tiredness or weakness
- voice changes
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
- irritability
- nausea
- stomach pain
- trouble sleeping
- vomiting
Incidence not known
- Weight changes
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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