Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Prescribing Information
| Boxed Warning | 7/2019 |
| Dosage and Administration (2.1) | 7/2019 |
| Warnings and Precautions (5.1) | 7/2019 |
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1)
- Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14)
- Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14)
- Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14)
- Pediatric patients (ages 6-17): 10 mg once daily in the morning. Maximum dose for children 6-12 years of age is 30 mg once daily. (2.2, 2.3, 2.4)
- Adults: 20 mg once daily in the morning. (2.5)
- Pediatric patients (ages 6-17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6- 12 years of age with severe renal impairment is 20 mg once daily. (2.6, 8.6)
- Adults with severe renal impairment: 15 mg once daily in the morning. (2.6, 8.6)
- Patients with ESRD: not recommended. (2.6, 8.6)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are available as:
5 mg extended release capsules: Hard Gelatin Capsule Shell Size “3” Blue Opaque Cap and Clear transparent body, imprinted with “5 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets.
10 mg extended release capsules: Hard Gelatin Capsule Shell Size “3” Blue Opaque Cap and Blue transparent body, imprinted with “10 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets.
15 mg extended release capsules: Hard Gelatin Capsule Shell Size “2” White Opaque Cap and Blue transparent body, imprinted with “15 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets.
20 mg extended release capsules: Hard Gelatin Capsule Shell Size “2” Orange Opaque Cap and Orange transparent body, imprinted with “20 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets.
25 mg extended release capsules: Hard Gelatin Capsule Shell Size “1” White Opaque Cap and Orange transparent body, imprinted with “25 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets.
30 mg extended release capsules: Hard Gelatin Size " 1" Capsule with Yellow Opaque Cap imprinted with “30 mg” and White Opaque body imprinted with “T” in black ink filled with light to dark beige colored spherical pellets.
- Pregnancy: May cause fetal harm. (8.1)
- Lactation: Breastfeeding not recommended. (8.2)