Mixed Salts of a Single-Entity Amphetamine Product 9.375 mg/1
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE · CAPSULE, EXTENDED RELEASE · SpecGx LLC
Mixed Salts of a Single-Entity Amphetamine Product is a capsule, extended release containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate at 9.375 mg/1, taken oral. Manufactured by SpecGx LLC.
Key Facts
- Brand Name
- Mixed Salts of a Single-Entity Amphetamine Product
- Generic Name
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
- NDC Code (Product)
0406-0807- Manufacturer
- SpecGx LLC
- Strength
- 9.375 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA211546
- Marketing Start
- 11/01/2023
Recall History
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
ANI Pharmaceuticals, Inc.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Amerisource Health Services
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.5 , 8.4 ) 1.1 Attention Deficit Hyperactivity Disorder Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-rel…
Dosage & 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 end stage renal disease (ESRD): Not recommended. ( 2.6 , 8.6 ) 2.1 Pretreatment Screening Prior to treating patients with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfa…
Contraindications
4 CONTRAINDICATIONS Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules administration is contraindicated in patients: known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 )
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 ) 7.1 Clinically 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules concomitantly or within 14 days after discontinuing MAOI [see CONTRAINDICATIONS ( 4 )]. Serotonergic Drugs Clinical Impact The concomitant use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower dose…
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 …
Frequently Asked Questions
What is Mixed Salts of a Single-Entity Amphetamine Product used for?
Mixed Salts of a Single-Entity Amphetamine Product contains DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Mixed Salts of a Single-Entity Amphetamine Product a controlled substance?
Yes, Mixed Salts of a Single-Entity Amphetamine Product is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Mixed Salts of a Single-Entity Amphetamine Product?
The generic name for Mixed Salts of a Single-Entity Amphetamine Product is DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE. There are 9 other brand versions of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE.
What is the NDC code for Mixed Salts of a Single-Entity Amphetamine Product 9.375 mg/1?
The NDC (National Drug Code) for Mixed Salts of a Single-Entity Amphetamine Product 9.375 mg/1 is 0406-0807, listed by SpecGx LLC.
Other Mixed Salts of a Single-Entity Amphetamine Product Dosages
Other Dextroamphetamine Brands
See all →- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate3.125 mg/157664-950
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate6.25 mg/157664-951
- Mixed Salts of a Single Entity Amphetamine Product XR5 mg/10406-8954
- Mixed Salts of a Single Entity Amphetamine Product XR7.5 mg/10406-8956
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate9.375 mg/157664-952
- Mixed Salts of a Single Entity Amphetamine Product XR3.75 mg/10406-8953
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate12.5 mg/157664-953
- Mixed Salts of a Single Entity Amphetamine Product XR2.5 mg/10406-8952
- Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate7.5 mg/10228-3061
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)