Uses
What is Qelbree used for?
Qelbree (viloxazine) is commonly used to treat attention deficit hyperactivity disorder (ADHD).
Qelbree may also be used for other conditions as determined by your healthcare provider.
How does Qelbree work (mechanism of action)?
Qelbree may affect certain substances in your brain called neurotransmitters.
How is Qelbree supplied (dosage forms)?
Qelbree is available in the following dosage forms that are taken by mouth.
- 100 mg extended-release oral capsules
- 150 mg extended-release oral capsules
- 200 mg extended-release oral capsules
How should I store Qelbree?
Qelbree should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Qelbree?
The most common side effects of Qelbree are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Tiredness and sleepiness (see below)
- Decreased appetite
- Nausea and vomiting
- Trouble sleeping
- Irritability (children)
- Headache (adults)
- Dry mouth (adults)
- Constipation (adults)
There may be other side effects of Qelbree that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Qelbree?
While less common, the most serious side effects of Qelbree are described below, along with what to do if they happen.
Severe Allergic Reactions. Qelbree may cause allergic reactions, which can be serious. Stop taking Qelbree and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Suicidal Thoughts and Actions. Qelbree may cause suicidal thoughts or actions in a small number of people, especially in the first few months of taking the medicine or when the dose is changed. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
Increased Blood Pressure and Heart Rate. Qelbree may increase your blood pressure and heart rate. Keep all appointments with your healthcare provider to check your heart rate and blood pressure before starting Qelbree and during treatment.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ear
- Nosebleed
- Feeling of skipped heartbeats
If you measure your heart rate and it is more than 100 beats per minute for more than a few minutes while you are resting and not moving around, get medical attention right away. While you may feel no symptoms at all, watch for any of the following symptoms of a very fast heart beat.
- Feeling dizzy, lightheaded, or fainting
- Shortness of breath
- Chest pain
- Heart palpitations, or feeling of skipped or extra heartbeats
- Racing heart
Extremely Elevated Mood (Mania). People with bipolar disorder can have severe high and low moods. The first symptom of bipolar disorder may be depression. People with bipolar disorder who take Qelbree may have a higher risk of having mania or a manic episode. Call your healthcare provider right away if you have any of the following symptoms of a manic episode.
- Very increased energy
- Significant trouble sleeping
- Racing, fast-paced thoughts
- Reckless behavior
- Unusually grand ideas
- Excessive happiness or irritability
- Talking more or faster than usual
Tiredness and Sleepiness. Qelbree can make you tired or sleepy. Do not drive or do other activities that require alertness or coordination until you know how Qelbree affects you.
Warnings & Precautions
Who should not use Qelbree?
Allergies to Ingredients. People who are allergic to any of the following should not take Qelbree.
- Qelbree
- Viloxazine
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Qelbree.
Drug Interactions. Qelbree should not be taken while you are using certain other medicines. Before taking Qelbree, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
What should I know about Qelbree before using it?
Do not take Qelbree unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Qelbree with other people, even if they have the same condition as you. It may harm them.
Keep Qelbree out of the reach of children.
Take Qelbree by mouth with or without food. Swallow the capsules whole. Do not cut, crush, or chew the capsules.
If you have difficulty swallowing Qelbree, open the capsules and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce. Consume the entire food mixture right away without chewing, or within 15 minutes for pudding or 2 hours for applesauce. Do not store the food mixture for future use.
Qelbree can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Qelbree affects you.
You should check your heart rate and blood pressure before starting Qelbree and regularly during treatment, including when your dosage is changed. Be sure to talk with your healthcare provider about your readings.
You should check your weight before starting Qelbree and regularly during treatment. Qelbree may affect your weight. Be sure to talk with your healthcare provider about any weight changes you have.
What should I tell my healthcare provider before using Qelbree?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Qelbree is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- High blood pressure
- Heart rate problems
- Kidney problems
- Personal or family history of depression, suicidal thoughts or behaviors, mania or hypomania, or bipolar disorder
Pregnancy. Qelbree may cause harm to the mother if it is taken during pregnancy. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider may recommend stopping Qelbree during your pregnancy. If you become pregnant while taking Qelbree, you can register for the National Pregnancy Registry for Psychiatric Medications by calling 866-961-2388 or at www.womensmentalhealth.org/preg. This registry collects safety information about the use of psychiatric medicines during pregnancy.
Breastfeeding. It is not known if Qelbree passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Qelbree while breastfeeding.
How can I get more information about Qelbree?
For more information about Qelbree, you can visit the manufacturer’s website at www.qelbree.com or call them at 866-398-0833.
Interactions
Does Qelbree interact with foods or drinks?
There are no known interactions between Qelbree and foods or drinks.
It is unknown if drinking alcohol will affect Qelbree.
Does Qelbree interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Qelbree.
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- Alosetron (Lotronex), which is a medicine commonly used for irritable bowel syndrome with diarrhea
- Duloxetine (Cymbalta and others), which is a medicine commonly used for anxiety and depression
- Ramelteon (Rozerem), which is a medicine commonly used for insomnia
- Tasimelteon (Hetlioz), which is a medicine commonly used for sleep disorders
- Tizanidine (Zanaflex), which is a medicine commonly used for muscle spasms
- Theophylline (Theo-24 and others), which is a medicine commonly used for lung conditions
Qelbree may alter the blood levels of many other medicines. Tell your healthcare provider about all medicines that you take or have recently taken
This may not be a complete list of medicines that can interact with Qelbree. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Qelbree?
If you or someone else has used too much Qelbree, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Qelbree?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Are you currently using Qelbree (viloxazine)?
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