DYANAVEL XR 10

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DYANAVEL XR 10 (DYANAVEL XR 10).

How it works

Dyanavel XR is a central nervous system stimulant that increases extracellular levels of dopamine and norepinephrine by inhibiting their reuptake and enhancing their release from presynaptic neurons.

What the body does with it

Metabolism	Metabolized primarily via deamination and oxidation to 4-hydroxyamphetamine and norephedrine. CYP2D6 involved in minor hydroxylation pathways.
Excretion	Renal (80-90% as unchanged drug); fecal (minor, 1-5%)
Half-life	12 hours (amphetamine); clinical context: extended-release profile allows once-daily dosing
Protein binding	20-25% (amphetamine); albumin, alpha1-acid glycoprotein
Volume of Distribution	3.5-4.6 L/kg; indicates extensive tissue distribution
Bioavailability	90-100% for extended-release oral formulation
Onset of Action	30-60 minutes (extended-release oral); peak concentration at 5-6 hours
Duration of Action	12 hours (clinical effect); designed for daytime dosing with once-daily administration

Classification & Brands

Dosing & administration

Recommended starting dose for adults is 10 mg orally once daily in the morning. May increase in increments of 5-10 mg at weekly intervals based on tolerability and response. Maximum recommended dose is 60 mg/day.

Dosage form	TABLET, EXTENDED RELEASE
Renal impairment	For GFR 15-30 mL/min: reduce dose by 50%. For GFR <15 mL/min: not recommended. Hemodialysis: supplemental dose not required; administer after dialysis if needed.
Liver impairment	Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: not recommended.
Pediatric use	For patients aged 6-12 years: starting dose 5-10 mg orally once daily in the morning; may increase by 5 mg weekly. For patients aged 13-17 years: starting dose 10 mg orally once daily; may increase by 5-10 mg weekly. Maximum 60 mg/day.
Geriatric use	Elderly patients may be more sensitive to the effects; start at the low end of the dosing range (5 mg once daily) and titrate cautiously due to increased risk of adverse effects such as increased blood pressure, insomnia, and cardiovascular events.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DYANAVEL XR 10 (DYANAVEL XR 10).

Breastfeeding	Amphetamines are excreted in breast milk; M/P ratio not established for Dyanavel XR. Potential for infant stimulation, insomnia, and growth suppression. Not recommended during breastfeeding.
Teratogenic Risk	First trimester: Limited human data; animal studies show increased risk of cardiovascular and neural tube defects at high doses. Second/third trimester: Increased risk of preterm delivery, low birth weight, and neonatal withdrawal syndrome. Avoid in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

DYANAVEL XR has a high potential for abuse and misuse, which can lead to tolerance, physical dependence, and substance use disorder. Misuse may cause sudden death or serious cardiovascular events.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to amphetamine or other components","Concurrent use or within 14 days of MAO inhibitors","Advanced arteriosclerosis","Symptomatic cardiovascular disease","Moderate to severe hypertension","Hyperthyroidism","Glaucoma","Agitated states","History of drug abuse"]

Clinical Precautions

Precautions

["Serious cardiovascular events including sudden death in patients with structural cardiac abnormalities or other serious heart problems.","Blood pressure and heart rate increases; monitor regularly.","Psychiatric adverse events including exacerbation of pre-existing psychosis, manic episodes, and new psychotic or manic symptoms.","Long-term suppression of growth in pediatric patients.","Peripheral vasculopathy including Raynaud's phenomenon.","Serotonin syndrome risk when co-administered with serotonergic drugs."]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

DYANAVEL XR 10

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DYANAVEL XR 10 (DYANAVEL XR 10).

How it works

Dyanavel XR is a central nervous system stimulant that increases extracellular levels of dopamine and norepinephrine by inhibiting their reuptake and enhancing their release from presynaptic neurons.

What the body does with it

Metabolism	Metabolized primarily via deamination and oxidation to 4-hydroxyamphetamine and norephedrine. CYP2D6 involved in minor hydroxylation pathways.
Excretion	Renal (80-90% as unchanged drug); fecal (minor, 1-5%)
Half-life	12 hours (amphetamine); clinical context: extended-release profile allows once-daily dosing
Protein binding	20-25% (amphetamine); albumin, alpha1-acid glycoprotein
Volume of Distribution	3.5-4.6 L/kg; indicates extensive tissue distribution
Bioavailability	90-100% for extended-release oral formulation
Onset of Action	30-60 minutes (extended-release oral); peak concentration at 5-6 hours
Duration of Action	12 hours (clinical effect); designed for daytime dosing with once-daily administration

Classification & Brands

Dosing & administration

Dosage form	TABLET, EXTENDED RELEASE
Renal impairment	For GFR 15-30 mL/min: reduce dose by 50%. For GFR <15 mL/min: not recommended. Hemodialysis: supplemental dose not required; administer after dialysis if needed.
Liver impairment	Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: not recommended.
Pediatric use	For patients aged 6-12 years: starting dose 5-10 mg orally once daily in the morning; may increase by 5 mg weekly. For patients aged 13-17 years: starting dose 10 mg orally once daily; may increase by 5-10 mg weekly. Maximum 60 mg/day.
Geriatric use	Elderly patients may be more sensitive to the effects; start at the low end of the dosing range (5 mg once daily) and titrate cautiously due to increased risk of adverse effects such as increased blood pressure, insomnia, and cardiovascular events.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DYANAVEL XR 10 (DYANAVEL XR 10).

Breastfeeding	Amphetamines are excreted in breast milk; M/P ratio not established for Dyanavel XR. Potential for infant stimulation, insomnia, and growth suppression. Not recommended during breastfeeding.
Teratogenic Risk	First trimester: Limited human data; animal studies show increased risk of cardiovascular and neural tube defects at high doses. Second/third trimester: Increased risk of preterm delivery, low birth weight, and neonatal withdrawal syndrome. Avoid in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

DYANAVEL XR has a high potential for abuse and misuse, which can lead to tolerance, physical dependence, and substance use disorder. Misuse may cause sudden death or serious cardiovascular events.