Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg Capsule, Extended Release, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🩺 Clinical
- It helps your brain maintain higher levels of two key signaling chemicals — dopamine and norepinephrine. In people with ADHD, those chemical signals can be inconsistent, making it...
- What exactly is this medication supposed to do for ADHD?
- The most common ones, especially at first, are reduced appetite, trouble falling asleep, and sometimes a stomachache or headache. These often improve after your body adjusts to the...
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.594 | $59.43 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.02 | $101.97 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.09 | $109.32 / 100 capsules |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00781-2343-01 You're viewing this | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2343-01) | 2009-04-02 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION MAS-ER Capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including MAS-ER Capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing MAS-ER Capsules, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout MAS-ER Capsule treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.
MAS-ER Capsules has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including MAS-ER Capsules, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing MAS-ER Capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.
Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE extended-release capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 )
1.1Attention Deficit Hyperactivity Disorder MAS-ER Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 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 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 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 )
2.1Pretreatment Screening Prior to treating patients with MAS-ER Capsules, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating MAS-ER Capsules [see Warnings and Precautions (5.9) ] .
2.2General Administration Information Individualize the dosage according to the therapeutic needs and response of the patient. Administer MAS-ER Capsules at the lowest effective dosage. Based on bioequivalence data, patients taking divided doses of immediate-release Adderall, (for example, twice daily), may be switched to MAS-ER Capsules at the same total daily dose taken once daily.
Titrate at weekly intervals to appropriate efficacy and tolerability as indicated. MAS-ER Capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored.
Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.
MAS-ER Capsules may be taken orally with or without food. MAS-ER Capsules should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.
2.3Recommended Dosage in Pediatric Patients 6 to 12 Years In pediatric patients 6 to 12 years of age with ADHD and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children 6 to 12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children.
MAS-ER Capsules has not been studied in children under 6 years of age.
2.4Recommended Dosage in Pediatric Patients 13 to 17 Years The recommended starting dose for pediatric patients 13 to 17 years of age with ADHD and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.
2.5Recommended Dosage in Adults In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.
2.6Dosage in Patients with Renal Impairment In adult patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m 2 ), the recommended dose is 15 mg once daily in the morning. In pediatric patients (6 to 17 years of age) with severe renal impairment, the recommended dose is 5 mg once daily. The maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily.
MAS-ER Capsules are not recommended in patients with end stage renal disease (ESRD) (GFR <15 mL/min/1.73 m 2 ) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .
2.7 Dosage Modi…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 5 mg extended-release capsules: Clear/blue (imprinted M. Amphet Salts 5 mg) 10 mg extended-release capsules: Blue/blue (imprinted M. Amphet Salts 10 mg) 15 mg extended-release capsules: Blue/white (imprinted M.
Amphet Salts 15 mg) 20 mg extended-release capsules: Orange/orange (imprinted M. Amphet Salts 20 mg) 25 mg extended-release capsules: Orange/white (imprinted M. Amphet Salts 25 mg) 30 mg extended-release capsules: Natural/orange (imprinted M.
Amphet Salts 30 mg) Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS MAS-ER Capsules administration is contraindicated in patients: known to be hypersensitive to amphetamine, or other components of MAS-ER Capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2) ]. taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.8) , Drug Interactions (7.1) ] Known hypersensitivity or idiosyncrasy to amphetamine ( 4 ) During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) ( 4 , 7.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse at appropriate intervals. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating MAS-ER Capsules, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing MAS-ER Capsules. ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
( 5.5 ) Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures. ( 5.6 ) Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during MAS-ER Capsule treatment.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.7 ) Serotonin Syndrome: Increased risk when coadministered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue MAS-ER Capsules and initiate supportive treatment.
( 4 , 5.8 , 10 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating MAS-ER Capsules, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate.
( 5.9 )
5.1Abuse, Misuse, and Addiction MAS-ER Capsules have a high potential for abuse and misuse. The use of MAS-ER Capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. MAS-ER Capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ] .
Misuse and abuse of CNS stimulants, including MAS-ER Capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing MAS-ER Capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store MAS-ER Capsules in a safe place, preferably locked, and instruct patients to not give MAS-ER Capsules to anyone else. Throughout MAS-ER Capsule treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.2Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid MAS-ER Capsule use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
5.3Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Monitor all MAS-ER Capsule-treated patients for hypertension and tachycardia.
5.4Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in patients. Prior to initia…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2 , 9.3) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Seizures [see Warnings and Precautions (5.6) ] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7) ] Serotonin Syndrome [see Warnings and Precautions (5.8) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.9) ] Pediatric patients ages 6 to 12: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
( 6.1 ) Pediatric patients ages 13 to 17: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. ( 6.1 ) Adults: Most common adverse reactions ≥5% and with a higher incidence than on placebo were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The premarketing development program for MAS-ER Capsules included exposures in a total of 1,315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects).
Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N=40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. Adverse Reactions Leading to Discontinuation of Treatment In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of MAS-ER Capsule-treated patients discontinued due to adverse reactions (including three patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo.
The most frequent adverse reactions leading to discontinuation of MAS-ER Capsules in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to MAS-…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. ( 2.7 , 7.1 ) Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine. ( 7.1 )
7.1Clinically Important Interactions with Amphetamines Table 4: Drugs Having Clinically Important Interactions with Amphetamines Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Intervention Do not administer MAS-ER Capsules concomitantly or within 14 days after discontinuing MAOI [see Contraindications (4) ] .
Serotonergic Drugs Clinical Impact The concomitant use of MAS-ER Capsules and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during MAS-ER Capsules initiation or dosage increase. If serotonin syndrome occurs, discontinue MAS-ER Capsules and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.8) ] .
CYP2D6 Inhibitors Clinical Impact The concomitant use of MAS-ER Capsules and CYP2D6 inhibitors may increase the exposure of MAS-ER Capsules compared to the use of the drug alone and increase the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during MAS-ER Capsules initiation and after a dosage increase. If serotonin syndrome occurs, discontinue MAS-ER Capsules and the CYP2D6 inhibitor [see Warnings and Precautions (5.8) , Overdosage (10) ] .
Alkalinizing Agents Clinical Impact Increase blood levels and potentiate the action of amphetamine. Intervention Coadministration of MAS-ER Capsules and gastrointestinal or urinary alkalinizing agents should be avoided. Acidifying Agents Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose based on clinical response. Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.
Proton Pump Inhibitors Clinical Impact Time to maximum concentration (T max ) of amphetamine is decreased compared to when administered alone. Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response.
7.2Drug-Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
🔄 Drug / Laboratory Test Interactions ▾
7.2Drug-Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MAS-ER Capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . Risk Summary Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see Data ).
Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations ) . No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. However, in a pre- and postnatal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine.
In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as MAS-ER Capsules, cause vasoconstriction and thereby may decrease placental perfusion.
In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.
Data Animal Data Amphetamine (d- to l- enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when administered orally 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) of 20 mg/day given to adolescents, on a mg/m 2 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 given to adolescents on a mg/m 2 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) 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 of 20 mg/day given to adolescents, on a mg/m 2 basis.
All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MAS-ER Capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . Risk Summary Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage (see Data ).
Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations ) . No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. However, in a pre- and postnatal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine.
In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as MAS-ER Capsules, cause vasoconstriction and thereby may decrease placental perfusion.
In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.
Data Animal Data Amphetamine (d- to l- enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when administered orally 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) of 20 mg/day given to adolescents, on a mg/m 2 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 given to adolescents on a mg/m 2 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) 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 of 20 mg/day given to adolescents, on a mg/m 2 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 body weight was seen at 6 and 10 mg/kg which correlated with delays in developme…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of MAS-ER Capsules have been established in pediatric patients with ADHD 6 years of age and older. The safety and efficacy of MAS-ER Capsules in pediatric patients less than 6 years of age have not been established. Long-term effects of amphetamines in pediatric patients has not been well established.
Long-Term Growth Suppression Growth should be monitored during treatment with stimulants, including MAS-ER Capsules, and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.5) ] . Juvenile Animal Toxicity Data Juvenile rats treated with mixed amphetamine salts early in the postnatal period through sexual maturation demonstrated transient changes in motor activity. Learning and memory was impaired at approximately 6 times the maximum recommended human dose (MRHD) given to children on a mg/m 2 basis.
No recovery was seen following a drug-free period. A delay in sexual maturation was observed at a dose approximately 6 times the MRHD given to children on a mg/m 2 basis, although there was no effect on fertility. In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1) of 2, 6, or 20 mg/kg on Days 7 to 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 MRHD of 30 mg/day, given to children on a mg/m 2 basis. Postdosing 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 ▾
8.5Geriatric Use MAS-ER Capsules have not been studied in the geriatric population.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.
Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of MAS-ER Capsules should be considered when treating patients with overdose. D-amphetamine is not dialyzable.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
12.3Pharmacokinetics Pharmacokinetic studies of MAS-ER Capsules have been conducted in healthy adult and pediatric (children aged 6 to 12 yrs) subjects, adolescent (13 to 17 yrs), and children with ADHD. Both Adderall (immediate-release) tablets and MAS-ER 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 (T max ) for MAS-ER Capsules 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 MAS-ER Capsules 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 MAS-ER 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 to 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) . MAS-ER Capsules 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 T max 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 MAS-ER Capsules 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 MAS-ER Capsules 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 i…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg extended-release capsules: Clear/blue (imprinted M. Amphet Salts 5 mg), bottles of 100, NDC 0781-2329-01 10 mg extended-release capsules: Blue/blue (imprinted M. Amphet Salts 10 mg), bottles of 100, NDC 0781-2335-01 15 mg extended-release capsules: Blue/white (imprinted M.
Amphet Salts 15 mg), bottles of 100, NDC 0781-2343-01 20 mg extended-release capsules: Orange/orange (imprinted M. Amphet Salts 20 mg), bottles of 100, NDC 0781-2352-01 25 mg extended-release capsules: Orange/white (imprinted M. Amphet Salts 25 mg), bottles of 100, NDC 0781-2368-01 30 mg extended-release capsules: Natural/orange (imprinted M.
Amphet Salts 30 mg), bottles of 100, NDC 0781-2371-01 Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86° F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at room temperature, 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86° F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION MAS-ER Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. MAS-ER Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent.
The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. MAS-ER Capsules contain two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Adderall (immediate-release) tablet formulation. Each capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d -amphetamine base equivalence 2.4 mg 4.7 mg 7.1 mg 9.5 mg 11.9 mg 14.2 mg l -amphetamine base equivalence 0.75 mg 1.5 mg 2.3 mg 3.0 mg 3.8 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in MAS-ER Capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate.
Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5, 10, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of MAS-ER Capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store MAS-ER Capsules in a safe place, preferably locked, and instruct patients to not give MAS-ER Capsules to anyone else.
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with MAS-ER Capsule use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Advise patients that MAS-ER Capsules can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ] .
Psychiatric Adverse Reactions Prior to initiating treatment with MAS-ER Capsules, adequately screen patients with comorbid depressive symptoms to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Additionally, MAS-ER Capsule therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ] .
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud's Phenomenon] Instruct patients beginning treatment with MAS-ER Capsules about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking MAS-ER Capsules.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.7) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of MAS-ER Capsules and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid) [see Contraindications (4) , Warnings and Precautions (5.8) , Drug Interactions (7.1) ] .
Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Concomitant Medications Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1) ] . Growth Monitor growth in children during treatment with MAS-ER Capsules, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.5) ] .
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s syndrome may occur during treatment with MAS-ER Capsules. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.9) ] . Pregnancy Registry Advise patients tha…
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2023 MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate mon-uh-HYED-rate, DEX-troe-am-FET-uh-meen SULL-fate, am-FET-uh-meen SULL-fate) Extended-Release Capsules (MAS-ER Capsules CII) What is the most important information I should know about MAS-ER Capsules?
MAS-ER Capsules may cause serious side effects, including: Abuse, misuse, and addiction. MAS-ER Capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of MAS-ER Capsules, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death.
The risk of overdose and death is increased with higher doses of MAS-ER Capsules or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with MAS-ER Capsules and will monitor you or your child during treatment. MAS-ER Capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
Do not give MAS-ER Capsules to anyone else. See “ What is MAS-ER Capsules? ” for more information. Keep MAS-ER Capsules in a safe place and properly dispose of any unused medicine.
See “ How should I store MAS-ER Capsules? ” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease.
Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with MAS-ER Capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with MAS-ER Capsules. Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with MAS-ER Capsules.
Mental (psychiatric) problems, including: new or worse behavior or thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with MAS-ER Capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
What are MAS-ER Capsules? MAS-ER Capsules is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. MAS-ER Capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if MAS-ER Capsules are safe and effective in children under 6 years of age. MAS-ER Capsules are a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep MAS-ER Capsules in a safe place to protect it from theft.
Never give your MAS-ER Capsules to anyone else because it may cause death or harm them. Selling or giving away MAS-ER Capsules may harm others, and is against the law. Do not take MAS-ER C…