INDICATIONS AND USAGE
Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age (1)
DOSAGE AND ADMINISTRATION
- Pediatric patients 6 to 11 years of age: Recommended starting dosage is 100 mg once daily. May titrate in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily (2.2)
- Pediatric patients 12 to 17 years of age: Recommended starting dosage is 200 mg once daily. May titrate after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily (2.2)
- Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce (2.3)
- Severe Renal Impairment: Initial dosage is 100 mg once daily. Titrate in weekly increments of 50 mg to 100 mg to a maximum recommended dosage of 200 mg once daily (2.4, 8.6)
——————— DOSAGE FORMS AND STRENGTHS ——————–
Extended-release capsules: 100 mg, 150 mg and 200 mg (3)
ADVERSE REACTIONS
Most commonly observed adverse reactions (≥5% and at least twice the rate of placebo) were: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Supernus Pharmaceuticals at 18663980833 or FDA at 1800FDA1088 or www.fda.gov/medwatch.
CONTRAINDICATIONS
- Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI (4, 7.1)
- Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (4, 7.1)
WARNINGS AND PRECAUTIONS
- Blood Pressure and Heart Rate Increases: Assess heart rate and blood pressure prior to initiating treatment, following increases in dosage, and periodically while on therapy (5.2)
- Activation of Mania or Hypomania: Screen patients for bipolar disorder (5.3)
- Somnolence and Fatigue: Advise patients to use caution when driving or operating hazardous machinery due to potential somnolence (including sedation and lethargy) and fatigue (5.4)
DRUG INTERACTIONS
Moderate sensitive CYP1A2 substrates: Not recommended for coadministration with Qelbree. Dose reduction may be warranted (7.1)
OVERDOSAGE
Human Experience: The pre-market clinical trials with Qelbree do not provide information regarding symptoms of overdose. Literature reports from post marketing experience with immediate-release viloxazine include cases of overdosage from 1000 mg to 6500 mg (2.5 to 16.25 times the maximum recommended daily dose). The most reported symptom was drowsiness. Impaired consciousness, diminished reflexes, and increased heart rate have also been reported.
Treatment and Management: There is no specific antidote for Qelbree overdose. Administer symptomatic and supportive treatment as appropriate. In case of overdose, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).
- Uses
-
INDICATIONS AND USAGE
Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age (1)
DOSAGE AND ADMINISTRATION
- Pediatric patients 6 to 11 years of age: Recommended starting dosage is 100 mg once daily. May titrate in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily (2.2)
- Pediatric patients 12 to 17 years of age: Recommended starting dosage is 200 mg once daily. May titrate after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily (2.2)
- Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce (2.3)
- Severe Renal Impairment: Initial dosage is 100 mg once daily. Titrate in weekly increments of 50 mg to 100 mg to a maximum recommended dosage of 200 mg once daily (2.4, 8.6)
——————— DOSAGE FORMS AND STRENGTHS ——————–
Extended-release capsules: 100 mg, 150 mg and 200 mg (3)
- Side Effects
-
ADVERSE REACTIONS
Most commonly observed adverse reactions (≥5% and at least twice the rate of placebo) were: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Supernus Pharmaceuticals at 18663980833 or FDA at 1800FDA1088 or www.fda.gov/medwatch.
- Precautions
-
CONTRAINDICATIONS
- Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI (4, 7.1)
- Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (4, 7.1)
WARNINGS AND PRECAUTIONS
- Blood Pressure and Heart Rate Increases: Assess heart rate and blood pressure prior to initiating treatment, following increases in dosage, and periodically while on therapy (5.2)
- Activation of Mania or Hypomania: Screen patients for bipolar disorder (5.3)
- Somnolence and Fatigue: Advise patients to use caution when driving or operating hazardous machinery due to potential somnolence (including sedation and lethargy) and fatigue (5.4)
- Interactions
-
DRUG INTERACTIONS
Moderate sensitive CYP1A2 substrates: Not recommended for coadministration with Qelbree. Dose reduction may be warranted (7.1)
- Overdose
-
OVERDOSAGE
Human Experience: The pre-market clinical trials with Qelbree do not provide information regarding symptoms of overdose. Literature reports from post marketing experience with immediate-release viloxazine include cases of overdosage from 1000 mg to 6500 mg (2.5 to 16.25 times the maximum recommended daily dose). The most reported symptom was drowsiness. Impaired consciousness, diminished reflexes, and increased heart rate have also been reported.
Treatment and Management: There is no specific antidote for Qelbree overdose. Administer symptomatic and supportive treatment as appropriate. In case of overdose, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).