Adderall XR

Name: Adderall XR

What is amphetamine and dextroamphetamine, and how does it work (mechanism of action)?

Adderall contains amphetamine salts (amphetamine and dextroamphetamine) and is used for treating attention-deficit hyperactivity disorder (ADHD) and narcolepsy. Amphetamines stimulate the brain by increasing the level of neurotransmitters, dopamine and norepinephrine, in the brain. (Neurotransmitters are chemicals produced by nerves that are released and attach to other nearby nerves as a means of communication among nerves.) The exact mechanism of action in ADHD is unknown. Adderall XR is an extended release form of Adderall. Adderall was approved by the FDA in 1996.

How supplied

Dosage Forms And Strengths

ADDERALL XR 5 mg capsules: Clear/blue (imprinted ADDERALL XR 5 mg)

ADDERALL XR 10 mg capsules: Blue/blue (imprinted ADDERALL XR 10 mg)

ADDERALL XR 15 mg capsules: Blue/white (imprinted ADDERALL XR 15 mg)

ADDERALL XR 20 mg capsules: Orange/orange (imprinted ADDERALL XR 20 mg)

ADDERALL XR 25 mg capsules: Orange/white (imprinted ADDERALL XR 25 mg)

ADDERALL XR 30 mg capsules: Natural/orange (imprinted ADDERALL XR 30 mg)

Storage And Handling

ADDERALL XR 5 mg capsules: Clear/blue (imprinted ADDERALL XR 5 mg), bottles of 100, NDC 54092-381-01

ADDERALL XR 10 mg capsules: Blue/blue (imprinted ADDERALL XR 10 mg), bottles of 100, NDC 54092-383-01

ADDERALL XR 15 mg capsules: Blue/white (imprinted ADDERALL XR 15 mg), bottles of 100, NDC 54092-385-01

ADDERALL XR 20 mg capsules: Orange/orange (imprinted ADDERALL XR 20 mg), bottles of 100, NDC 54092-387-01

ADDERALL XR 25 mg capsules: Orange/white (imprinted ADDERALL XR 25 mg), bottles of 100, NDC 54092-389-01

ADDERALL XR 30 mg capsules: Natural/orange (imprinted ADDERALL XR 30 mg), bottles of 100, NDC 54092-391-01

Dispense in a tight, light-resistant container as defined in the USP.

Store at 25° C (77° F). Excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]

Manufactured for Shire US Inc., Wayne, PA 19087. Revised: Apr 2015

Proper Use of dextroamphetamine and amphetamine

This section provides information on the proper use of a number of products that contain dextroamphetamine and amphetamine. It may not be specific to Adderall XR. Please read with care.

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Talk to your doctor or pharmacist if you have any questions.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose and check with your doctor.

Take the regular tablet in the morning and early afternoon. If you take the tablet in the evening, you may have trouble falling asleep at night.

If you are using the extended-release capsule:

  • Swallow the capsule whole with water or other liquids. Do not crush, break, or chew it.
  • Take the capsule in the morning right after you wake up. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
  • You may take the capsule with or without food, but make sure to take it the same way each time.
  • If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For attention deficit hyperactivity disorder (ADHD):
    • For oral dosage form (Adderall XR® extended-release capsules):
      • Adults—20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children 13 to 17 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed.
      • Children 6 to 12 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (Mydayis™ extended-release capsules):
      • Adults—At first, 12.5 milligrams (mg) once a day in the morning right after you wake up. Your doctor may adjust your dose if needed. However, the dose is usually not more than 50 mg per day.
      • Children 13 to 17 years of age—At first, 12.5 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 25 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (Adderall® tablets):
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) given 1 or 2 times a day. Your doctor may adjust your dose if needed.
      • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
      • Children younger than 3 years of age—Use is not recommended.
  • For narcolepsy:
    • For oral dosage form (Adderall® tablets):
      • Adults and children 12 years of age and older—At first, 10 milligrams (mg) per day, divided and given into 2 doses. Your doctor may adjust your dose if needed.
      • Children 6 to 12 years of age—At first, 5 mg per day. Your doctor may adjust your dose if needed.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Use in specific populations

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Amphetamine, in the enantiomer ratio present in Adderall XR (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 20 mg/day, on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1, the same as in Adderall XR) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 20 mg/day, on a mg/m2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Labor and Delivery

The effects of Adderall XR on labor and delivery in humans is unknown.

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Adderall XR is indicated for use in children 6 years of age and older.

The safety and efficacy of Adderall XR in children under 6 years of age have not been studied. Long-term effects of amphetamines in children have not been well established.

In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in Adderall XR) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to approximately day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 30 mg/day, on a mg/m2 basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.

Geriatric Use

Adderall XR has not been studied in the geriatric population.

Adderall XR - Clinical Pharmacology

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Pharmacokinetic studies of Adderall XR have been conducted in healthy adult and pediatric (children aged 6-12 yrs) subjects, and adolescent (13-17 yrs) and children with ADHD. Both ADDERALL (immediate-release) tablets and Adderall XR capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of ADDERALL (immediate-release), the peak plasma concentrations occurred in about 3 hours for both d-amphetamine and l-amphetamine.

The time to reach maximum plasma concentration (Tmax) for Adderall XR is about 7 hours, which is about 4 hours longer compared to ADDERALL (immediate-release). This is consistent with the extended-release nature of the product.

Figure 1 Mean d-amphetamine and l-amphetamine Plasma Concentrations Following Administration of Adderall XR 20 mg (8 am) and ADDERALL (immediate-release) 10 mg Twice Daily (8 am and 12 noon) in the Fed State.

A single dose of Adderall XR 20 mg capsules provided comparable plasma concentration profiles of both d-amphetamine and l-amphetamine to ADDERALL (immediate-release) 10 mg twice daily administered 4 hours apart.

The mean elimination half-life for d-amphetamine is 10 hours in adults; 11 hours in adolescents aged 13-17 years and weighing less than or equal to 75 kg/165 lbs; and 9 hours in children aged 6 to 12 years. For the l-amphetamine, the mean elimination half-life in adults is 13 hours; 13 to 14 hours in adolescents; and 11 hours in children aged 6 to 12 years. On a mg/kg body weight basis, children have a higher clearance than adolescents or adults (see Special Populations below).

Adderall XR demonstrates linear pharmacokinetics over the dose range of 20 to 60 mg in adults and adolescents weighing greater than 75 kg/165 lbs, over the dose range of 10 to 40 mg in adolescents weighing less than or equal to 75 kg/165 lbs, and 5 to 30 mg in children aged 6 to 12 years. There is no unexpected accumulation at steady state in children.

Food does not affect the extent of absorption of d-amphetamine and l-amphetamine, but prolongs Tmax by 2.5 hours (from 5.2 hrs at fasted state to 7.7 hrs after a high-fat meal) for d-amphetamine and 2.7 hours (from 5.6 hrs at fasted state to 8.3 hrs after a high fat meal) for l-amphetamine after administration of Adderall XR 30 mg. Opening the capsule and sprinkling the contents on applesauce results in comparable absorption to the intact capsule taken in the fasted state. Equal doses of Adderall XR strengths are bioequivalent.

Metabolism and Excretion

Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs, approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30-40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that effect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine's metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased [see DRUG INTERACTIONS (7)].

Special Populations

Comparison of the pharmacokinetics of d- and l-amphetamine after oral administration of Adderall XR in children (6-12 years) and adolescent (13-17 years) ADHD patients and healthy adult volunteers indicates that body weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by area under the curve to infinity (AUC∞) and maximum plasma concentration (Cmax) decreased with increases in body weight, while oral volume of distribution (VZ/F), oral clearance (CL/F), and elimination half-life (t1/2) increased with increases in body weight.

Pediatric Patients

On a mg/kg weight basis, children eliminated amphetamine faster than adults. The elimination half-life (t1/2) is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of Adderall XR, which was attributed to the higher dose administered to children on a mg/kg body weight basis compared to adults. Upon dose normalization on a mg/kg basis, children showed 30% less systemic exposure compared to adults.

Gender

Systemic exposure to amphetamine was 20-30% higher in women (N=20) than in men (N=20) due to the higher dose administered to women on a mg/kg body weight basis. When the exposure parameters (Cmax and AUC) were normalized by dose (mg/kg), these differences diminished. Age and gender had no direct effect on the pharmacokinetics of d- and l-amphetamine.

Race

Formal pharmacokinetic studies for race have not been conducted. However, amphetamine pharmacokinetics appeared to be comparable among Caucasians (N=33), Blacks (N=8) and Hispanics (N=10).

PRINCIPAL DISPLAY PANEL - 5 mg Capsule Bottle Label

NDC 54092-381-01

Adderall XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

5 mg

CII
100 Capsules

Rx only

Shire

015924

LOT
EXP

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label

NDC 54092-389-01

Adderall XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

25 mg

CII
100 Capsules

Rx only

Shire

015928

LOT
EXP

PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label

NDC 54092-391-01

Adderall XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

30 mg

CII
100 Capsules

Rx only

Shire

015929

LOT
EXP

ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-381
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.25 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 1.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FD&C BLUE NO. 2  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code ADDERALL;XR;5;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-381-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 05/22/2002
ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-383
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 2.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FD&C BLUE NO. 2  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code ADDERALL;XR;10;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-383-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 10/11/2001
ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-385
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.75 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.75 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.75 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FD&C BLUE NO. 2  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (blue) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ADDERALL;XR;15;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-385-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 05/22/2002
ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-387
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
Product Characteristics
Color ORANGE (orange) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ADDERALL;XR;20;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-387-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 10/11/2001
ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-389
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 6.25 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 6.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
Product Characteristics
Color ORANGE (orange) , WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 21mm
Flavor Imprint Code ADDERALL;XR;25;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-389-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 05/22/2002
ADDERALL  XR
dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54092-391
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 7.5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 7.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
HYPROMELLOSE, UNSPECIFIED  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
SUCROSE  
TALC  
TRIETHYL CITRATE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
Product Characteristics
Color BROWN (brown) , ORANGE (orange) Score no score
Shape CAPSULE (CAPSULE) Size 21mm
Flavor Imprint Code ADDERALL;XR;30;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:54092-391-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021303 10/11/2001
Labeler - Shire US Manufacturing Inc. (964907406)
Establishment
Name Address ID/FEI Operations
Cambrex Charles City, Inc 782974257 ANALYSIS(54092-389, 54092-391, 54092-381, 54092-383, 54092-385, 54092-387), API MANUFACTURE(54092-381, 54092-385, 54092-387, 54092-389, 54092-391, 54092-383), PACK(54092-389, 54092-391, 54092-381, 54092-383, 54092-385, 54092-387)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 ANALYSIS(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), LABEL(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), MANUFACTURE(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391), PACK(54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391)
Revised: 01/2017   Shire US Manufacturing Inc.

What happens if i miss a dose (adderall, adderall xr)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose, or if it is already evening. Taking this medicine late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

Upsides

  • Used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
  • Once daily dosage. People taking a twice daily dosage of immediate-release Adderall may be switched to Adderall XR at the same total daily dose taken once daily.
  • For ADHD, Adderall may increase attention and decrease hyperactivity and impulsiveness.
  • Usually used in conjunction with other treatment options (such as psychotherapy, education about the disorder, social integration advice).
  • Not recommended in children aged less than six years.

Response and Effectiveness

Peak concentrations are reached within seven hours following a single dose of Adderall XR. This is about four hours longer than the time it takes for immediate-release Adderall to reach its peak. One dose of Adderall XR lasts for approximately 24 hours.

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What should I avoid while taking Adderall XR (amphetamine and dextroamphetamine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine and dextroamphetamine. These can make your body absorb less of the medicine.

What other drugs will affect Adderall XR (amphetamine and dextroamphetamine)?

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs amphetamine and dextroamphetamine, and may increase side effects.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • lithium or other medicine to treat depression or mental illness;

  • blood pressure medicine;

  • a blood thinner such as warfarin, Coumadin, Jantoven;

  • cold or allergy medicine that contains a decongestant;

  • opioid (narcotic) medicine; or

  • seizure medicine.

This list is not complete and many other drugs can interact with amphetamine and dextroamphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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