Vyvanse Chewable Tablets Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Vyvanse Chewable Tablets Indications
Indications
Vyvanse Chewable Tablets Dosage and Administration
Adults and Children
Renal Impairment
-
Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.
-
Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.
Administration
-
Take by mouth in the morning with or without food. Avoid afternoon doses due to the potential for insomnia.
-
Information for Vyvanse capsules:
-
Swallow whole, or
-
Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. May break apart any compacted powder with a spoon. Mix contents until completely dispersed, then consume immediately. Do not store mixed content.
-
Information for Vyvanse chewable tablets:
-
Must chew thoroughly before swallowing.
-
May substitute Vyvanse capsules with Vyvanse chewable tablets on a unit per unit/mg per mg basis.
-
A single dose should not be divided.
Vyvanse Chewable Tablets Contraindications
Contraindications
Vyvanse Chewable Tablets Boxed Warnings
Boxed Warning
Vyvanse Chewable Tablets Warnings/Precautions
Warnings/Precautions
Vyvanse Chewable Tablets Pharmacokinetics
Absorption
-
After a single dose administration of 60 mg Vyvanse chewable tablet in healthy subjects under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 4.4 hours post dose, respectively. The exposure (Cmax and AUCinf) of dextroamphetamine is similar between Vyvanse chewable tablet and Vyvanse capsule.
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Administration of 60 mg Vyvanse chewable tablet with food (a high-fat meal) decreases the exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax by approximately 1 hour (from 3.9 hours at fasted state to 4.9 hours).
Elimination
-
Renal (96%), fecal (0.3%).
-
Half-life: <1 hour (lisdexamfetamine).
-
Plasma elimination half-life of dextroamphetamine: 8.6–9.5 hours for pediatric patients 6 to 12 years of age, and 10–11.3 hours in healthy adults.
Vyvanse Chewable Tablets Interactions
Interactions
Vyvanse Chewable Tablets Adverse Reactions
Adverse Reactions
Vyvanse Chewable Tablets Clinical Trials
Vyvanse Chewable Tablets Note
Not Applicable
Vyvanse Chewable Tablets Patient Counseling
Cost Savings Program
Vyvanse Chewable Tablets Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Vyvanse Chewable Tablets Indications
Indications
Limitations of Use
Vyvanse Chewable Tablets Dosage and Administration
Adult
Children
Renal Impairment
-
Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.
-
Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.
Administration
-
Take by mouth in the morning with or without food. Avoid afternoon doses due to the potential for insomnia.
-
Information for Vyvanse capsules:
-
Swallow whole, or
-
Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. May break apart any compacted powder with a spoon. Mix contents until completely dispersed, then consume immediately. Do not store mixed content.
-
Information for Vyvanse chewable tablets:
-
Must chew thoroughly before swallowing.
-
May substitute Vyvanse capsules with Vyvanse chewable tablets on a unit per unit/mg per mg basis.
-
A single dose should not be divided.
Vyvanse Chewable Tablets Contraindications
Contraindications
Vyvanse Chewable Tablets Boxed Warnings
Boxed Warning
Vyvanse Chewable Tablets Warnings/Precautions
Warnings/Precautions
Vyvanse Chewable Tablets Pharmacokinetics
Absorption
-
After single-dose oral administration of Vyvanse capsule (30 mg, 50 mg, or 70 mg) in patients 6 to 12 years of age with ADHD under fasting conditions, the time to peak drug concentration (Tmax) of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 3.5 hours post dose, respectively.
-
After single-dose oral administration of Vyvanse 70 mg capsule, food prolonged Tmax by approximately 1 hour (from 3.8 hours at fasted state to 4.7 hours after a high fat meal or to 4.2 hours with yogurt). Food or orange juice did not affect the observed AUC and Cmax.
Elimination
-
Renal (96%), fecal (0.3%).
-
Half-life: <1 hour (lisdexamfetamine).
-
Plasma elimination half-life of dextroamphetamine: 8.6–9.5 hours for pediatric patients 6 to 12 years of age, and 10–11.3 hours in healthy adults.
Vyvanse Chewable Tablets Interactions
Interactions
Vyvanse Chewable Tablets Adverse Reactions
Adverse Reactions
Vyvanse Chewable Tablets Clinical Trials
Vyvanse Chewable Tablets Note
Not Applicable