Home › NDC Lookup › Ingredients › Dextroamphetamine Saccharate, Amphetamin... › 31722-0186-01
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg Capsule, Extended Release, 100-count — NDC 31722-0186-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg Capsule, Extended Release, 100-count — NDC 31722-186-01 (Billing 31722-0186-01)

by Camber Pharmaceuticals, Inc. · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 capsules of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg Capsule, Extended Release from Camber Pharmaceuticals, Inc., marketed since Sep 2021 and currently FDA-listed; retail pharmacies pay about $0.5395 per capsule (NADAC). It is this product's only package size.

NDC 31722-0186-01
🏷️ FDA NDC (as labeled) 31722-186-01 billing pads the product segment with a zero
Rx only Generic On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 28, 2025 — Failed Impurities/Degradation Specifications: (Granules Pharmaceuticals Inc.) · FDA recall D-0672-2025
Class III · Aug 28, 2025 — Failed Impurities/Degradation Specifications: (Granules Pharmaceuticals Inc.) · FDA recall D-0670-2025
Class III · Aug 28, 2025 — Failed Impurities/Degradation Specifications: (Granules Pharmaceuticals Inc.) · FDA recall D-0669-2025
Class III · Aug 28, 2025 — Failed Impurities/Degradation Specifications: (Granules Pharmaceuticals Inc.) · FDA recall D-0671-2025
Class III · Aug 28, 2025 — Failed Impurities/Degradation Specifications: (Granules Pharmaceuticals Inc.) · FDA recall D-0673-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-186-01
Product NDC 31722-186
11-digit billing NDC 31722018601
NCPDP billing unit EA — each (per item)
RxCUI 861221, 861223, 861225, 861227, 861232, 861237
UNII 6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N
UPC 0331722188012, 0331722186018, 0331722189019, 0331722187015 +2 more
Application # ANDA214959
SPL Set ID 1fc35735-569c-4dcd-b6c6-14443a043de5
Established class (EPC) Central Nervous System Stimulant; Central Nervo
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-29
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
TE code (Orange Book) AB1 · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 61109902107010
GPI class Amphetamine-Dextroamphet ER
GCN Seq No 048701
GCN 14635
HICL code 013449
Ingredient (HICL) Dextroamphetamine/Amphetamine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5B
Therapeutic class — specific (HIC3) Adrenergics, Aromatic, Non-Catecholamine
AHFS code 28:20.04.00
AHFS class Amphetamines
FDB label name DEXTROAMP-AMPHET ER 10 MG CAP
FDB brand name Dextroamphetamine-Amphet Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048701
  • GCN: 14635
  • GPI-14 (Medi-Span): 61109902107010
  • HICL (First Databank): 013449
  • AHFS class code: 28:20.04.00
  • RxCUI (RxNorm): 861221
Why two NDCs? The FDA registers this code as 31722-186-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 31722-0186-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant
Drug family (ATC) Centrally acting sympathomimetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DEXTROAMP-AMPHET ER 10 MG CAP Ingredient Dextroamphetamine/Amphetamine
📗 Our plain-language guide HelloPharmacist
  • It treats ADHD. Some tablet products, including Adderall tablets, are also used for narcolepsy. Which product you have determines the approved ages and uses.
  • Extended-release capsules are usually taken once a day in the morning, because they can last up to 16 hours and may disturb sleep. Take it the same way each day, with or without fo...
  • Loss of appetite, trouble sleeping, stomach pain, nervousness and weight loss are common. Adults may also get dry mouth and headache. Call your doctor if these are bothersome or se...
  • It has a high potential for abuse and misuse, which can lead to addiction and overdose. Take only as prescribed, never share it, store it locked up, and dispose of leftovers safely...
📖 Read our full Amphetamine / Amphetamine Aspartate / Dextroamphetamine / Dextroamphetamine Saccharate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.540 $53.95 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $1.04 $104.48 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $1.09 $109.32 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Mar 2022 Oct 2022 Feb 2026 Sep 2026 $0.626 $0.491
▲ Up 1% over the last 22 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31722-0186-01 You're viewing this Main listing 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2021-09-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 00115-1487-01 Amneal 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 00228-3059-11 Actavis 100 capsules $0.539 AB1 Availability likely —
Mixed Salts of a Single Entity Amphetamine Product XR 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 00406-8952-01 SpecGx 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 00527-0791-37 Lannett 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mgthis 31722-0186-01 Camber 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 35573-0465-02 Burel 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 42858-0610-01 Rhodes 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 43975-0278-10 ANI 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 64850-0511-01 Elite 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 66993-0595-02 Prasco 100 capsules $0.539 AB1 Availability likely —
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 70010-0030-01 Granules 100 capsules $0.539 AB1 Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 00781-2335-01 Sandoz 100 capsules $0.558 AB1 FDA listed +3%
Adderall XR 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 54092-0383-01 Takeda 100 capsules $6.809 AB1 Availability likely +1162%
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 51407-0558-01 Golden 100 capsules — AB1 FDA listed —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 63629-1973-01 Bryant 100 capsules — AB1 FDA listed —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg 72162-1378-01 Bryant 100 capsules — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Blue / white / blue / Orange / orange / yellow
ShapeCapsule
Imprint30mg;T
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.
Application holderASCENT PHARMACEUTICALS INC
FDA applicationANDA214959 (ANDA)
Labeler code31722
First marketedSep 2021
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio603 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules 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. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, can result in overdose and death (5.1, 9.2, 10): Before prescribing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 75 words ▾

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)

1.1Attention 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.

⏱️ Dosage and Administration ~3 min read ▾

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)

2.1Important Information Prior to Initiating Treatment 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 sulfate, amphetamine sulfate extended-release capsules [see Warnings and Precautions (5.9)].

2.2Dosing Considerations for All Patients Individualize the dosage according to the therapeutic needs and response of the patient. Administer dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules at the lowest effective dosage. Based on bioequivalence data, patients taking divided doses of immediate-release dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets, (for example, twice daily), may be switched to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules at the same total daily dose taken once daily.

Titrate at weekly intervals to appropriate efficacy and tolerability as indicated. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules may be taken orally with or without food. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.

2.3Children 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.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules has not been studied in children under 6 years of age.

2.4Adolescents The recommended starting dose for pediatric patients 13 to… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS 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 Capsule Shell Size "1" 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. Extended release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg (3)

⛔ Contraindications 120 words ▾

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)

⚠️ Warnings and Cautions ~2 min read ▾

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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and initiate supportive treatment.

(4, 5.8, 10) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules has a high potential for abuse and misuse. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules in a safe plac… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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 Camber Pharmaceuticals, Inc., at 1-866-495-8330 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules-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 dextroamphetamine saccharate, amphetamin… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 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 doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules initiation or dosage increase.

If serotonin syndrome occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.8)] . CYP2D6 Inhibitors Clinical Impact The concomitant use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and CYP2D6 inhibitors may increase the exposure of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 w… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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,… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules have been established in pediatric patients with ADHD 6 years of age and older. The safety and efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 22 words ▾

8.5Geriatric Use Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules has not been studied in the geriatric population.

🆘 Overdosage 120 words ▾

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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 ~2 min read ▾

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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules have been conducted in healthy adult and pediatric (children aged 6 to 12 yrs) subjects, and adolescent (13 to 17 yrs), and children with ADHD. Both dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (immediate-release) and dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1.

Following administration of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules is about 7 hours, which is about 4 hours longer compared to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules 20 mg (8 am) and Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (immediate-release) 10 mg Twice Daily (8 am and 12 noon) in the Fed State. A single dose of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate 20 mg extended-release capsules provided comparable plasma concentration profiles of both d-amphetamine and l-amphetamine to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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).

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amp… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 23 words ▾

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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are supplied as follows: 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. NDC 31722-185-01 bottles of 100 capsules 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.

NDC 31722-186-01 bottles of 100 capsules 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. NDC 31722-187-01 bottles of 100 capsules 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.

NDC 31722-188-01 bottles of 100 capsules 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. NDC 31722-189-01 bottles of 100 capsules 30 mg extended release capsules: Hard Gelatin Capsule Shell Size "1" 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.

NDC 31722-195-01 bottles of 100 capsules Dispense in a tight, light-resistant container as defined in the USP. Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

📋 Description ~2 min read ▾

11 DESCRIPTION Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains 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. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: Sugar spheres, hydroxy propyl methyl cellulose, talc, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, hard gelatin capsules, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, iron oxide red.

The 5 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin and sodium lauryl sulfate. The 10 mg capsule shell contain Titanium dioxide, FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulfate and D&C Red 28. The 15 mg capsule shell contain Titanium dioxide, FD & C Blue 1, D & C Red 28, gelatin and sodium lauryl sulfate.

The 20 mg capsule shell contain Titanium dioxide, FD & C Red 3, FD & C Yellow 6, FD & C Blue 1, gelatin, sodium lauryl sulfate and FD & C Red 40. The 25 mg capsule shell contain Titanium dioxide, FD & C Red 40, FD & C Yellow 6, gelatin, sodium lauryl sulfate. The 30 mg capsule shell contain Titanium dioxide, FD & C Yellow 6, D & C Yellow 10, sodium lauryl sulfate and gelatin.

The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.

💬 Information for Patients ~2 min read ▾

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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules in a safe place, preferably locked, and instruct patients to not give dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3)]. Psychiatric Adverse Reactions Prior to initiating treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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, dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impa… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~2 min read ▾

MEDICATION GUIDE MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII (dex'' troe am fet' a meen sak" a rate), (am fet' a meen a spar" tate mon" oh hye' drate), (dex'' troe am fet' a meen sul' fate), (am fet' a meen sul' fate) What is the most important information I should know about dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules may cause serious side effects, including: Abuse, misuse, and addiction. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules and will monitor you or your child during treatment.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules to anyone else. See “ What are dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules? ” for more information.

Keep dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules in a safe place and properly dispose of any unused medicine. See “ How should I store dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroam… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pharmacokinetic studies of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules have been conducted in healthy adult and pediatric (children aged 6 to 12 yrs) subjects, and adolescent (13 to 17 yrs), and children with ADHD. Both dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (immediate-release) and dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1.

Following administration of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules is about 7 hours, which is about 4 hours longer compared to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules 20 mg (8 am) and Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (immediate-release) 10 mg Twice Daily (8 am and 12 noon) in the Fed State. A single dose of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate 20 mg extended-release capsules provided comparable plasma concentration profiles of both d-amphetamine and l-amphetamine to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate tablets (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).

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sul… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 25 words ▾

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.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Pediatric Patients A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 6 to 12 (N=584) who met DSM-IV ® criteria for ADHD (either the combined type or the hyperactive-impulsive type). Patients were randomized to fixed-dose treatment groups receiving final doses of 10, 20, or 30 mg of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules or placebo once daily in the morning for three weeks.

Significant improvements in patient behavior, based upon teacher ratings of attention and hyperactivity, were observed for all dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules doses compared to patients who received placebo, for all three weeks, including the first week of treatment, when all dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules subjects were receiving a dose of 10 mg/day.

Patients who received dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules showed behavioral improvements in both morning and afternoon assessments compared to patients on placebo. In a classroom analogue study, patients (N=51) receiving fixed doses of 10, 20, or 30 mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules demonstrated statistically significant improvements in teacher-rated behavior and performance measures, compared to patients treated with placebo.

A double-blind, randomized, multicenter, parallel-group, placebo-controlled study was conducted in adolescents aged 13 to 17 (N=327) who met DSM-IV ® criteria for ADHD. The primary cohort of patients (n=287, weighing ≤75 kg/165 lbs) were randomized to fixed-dose treatment groups and received four weeks of treatment. Patients were randomized to receive final doses of 10, 20, 30, and 40 mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules or placebo once daily in the morning.

Patients randomized to doses greater than 10 mg were titrated to their final doses by 10 mg each week. The secondary cohort consisted of 40 subjects weighing >75 kg/165 lbs who were randomized to fixed-dose treatment groups receiving final doses of 50 and 60 mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules or placebo once daily in the morning for 4 weeks. The primary efficacy variable was the Attention Deficit Hyperactivity Disorder-Rating Scale IV (ADHD-RS-IV) total score for the primary cohort.

The ADHD-RS-IV is an 18-item scale that measures the core symptoms of ADHD. Improvements in the primary cohort were statistically significantly greater in all four primary cohort active treatment groups (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules 10 mg, 20 mg, 30 mg, and 40 mg) compared with the placebo group. There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit.

Adult Patients A double-blind, randomized, placebo-controlled, parallel-group study was conducted in adults (N=255) who met DSM-IV ® criteria for ADHD. Patients were randomized to fixed-dose treatment groups receiving final doses of 20, 40, or 60 mg of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules or placebo once daily in the morning for four weeks. Significant improvements, measured with the Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS), an 18-item scale that measures t… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contains amphetamine, a Schedule II controlled substance.

9.2Abuse Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)] . Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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.

9.3Dependence Physical Dependence Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

🔒 Controlled Substance 21 words ▾

9.1Controlled Substance Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contains amphetamine, a Schedule II controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day given to children, on a mg/m 2 basis. Mutagenesis Amphetamine, in the enantiomer ratio d- to l- ratio of 3:1, was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro . d, l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.

Impairment of Fertility Amphetamine, in the enantiomer ratio d- to l- ratio of 3:1, did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 8 times the maximum recommended human dose of 20 mg/day given to adolescents, on a mg/m 2 basis).

13.2Animal Toxicology and/or Pharmacology Acute administration of high doses of amphetamine (d- or d, l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage in rodents. The significance of these findings to humans is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 217 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day given to children, on a mg/m 2 basis. Mutagenesis Amphetamine, in the enantiomer ratio d- to l- ratio of 3:1, was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro . d, l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.

Impairment of Fertility Amphetamine, in the enantiomer ratio d- to l- ratio of 3:1, did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 8 times the maximum recommended human dose of 20 mg/day given to adolescents, on a mg/m 2 basis).

📄 Recent Major Changes 29 words ▾

Boxed Warning 10/2023 Indications and Usage (1) 10/2023 Dosage and Administration (2.1, 2.2, 2.7) 10/2023 Contraindications (4) 10/2023 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9) 10/2023

📄 Package Label / Principal Display Panel 6 words ▾

5mg 10mg 15mg 20mg 25mg 30mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
65.8K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$2.17M
Avg / prescription
$33.07
Avg / unit
$1.0448
Latest quarter Q1 2026
16.1KRx
Medicaid pays / ea
$1.0448
gross reimbursed
vs
NADAC / ea
$0.5395
acquisition cost
=
Spread
+$0.5053
+94% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 28,593 Rx Managed care · 37,159 Rx
State Medicaid map
Alaska: 14,983 units · 2,044 per 100k residents AK Maine: 7,034 units · 504 per 100k residents ME Washington: 153,384 units · 1,963 per 100k residents WA Idaho: 22,762 units · 1,159 per 100k residents ID Montana: 17,599 units · 1,555 per 100k residents MT North Dakota: 7,824 units · 999 per 100k residents ND Minnesota: 102,982 units · 1,795 per 100k residents MN Wisconsin: 28,929 units · 489 per 100k residents WI Michigan: 22,083 units · 220 per 100k residents MI New York: 187,599 units · 959 per 100k residents NY Vermont: 23,219 units · 3,589 per 100k residents VT New Hampshire: 20,478 units · 1,461 per 100k residents NH Oregon: 179,233 units · 4,234 per 100k residents OR Nevada: 7,657 units · 240 per 100k residents NV Wyoming: 4,587 units · 785 per 100k residents WY South Dakota: 4,517 units · 492 per 100k residents SD Iowa: 40,695 units · 1,269 per 100k residents IA Illinois: 124,449 units · 992 per 100k residents IL Indiana: 22,176 units · 323 per 100k residents IN Ohio: 58,068 units · 493 per 100k residents OH Pennsylvania: 56,947 units · 439 per 100k residents PA New Jersey: 18,271 units · 197 per 100k residents NJ Massachusetts: 2,058 units · 29.4 per 100k residents MA California: 285,727 units · 733 per 100k residents CA Utah: 1,310 units · 38.3 per 100k residents UT Colorado: 56,590 units · 963 per 100k residents CO Nebraska: 33,204 units · 1,679 per 100k residents NE Missouri: 95,338 units · 1,539 per 100k residents MO Kentucky: 24,125 units · 533 per 100k residents KY West Virginia: 16,866 units · 953 per 100k residents WV Virginia: 21,852 units · 251 per 100k residents VA Maryland: 27,611 units · 447 per 100k residents MD Connecticut: 10,852 units · 300 per 100k residents CT Rhode Island: 10,235 units · 935 per 100k residents RI Arizona: 36,604 units · 493 per 100k residents AZ New Mexico: 13,106 units · 620 per 100k residents NM Kansas: 19,069 units · 649 per 100k residents KS Arkansas: 23,845 units · 777 per 100k residents AR Tennessee: 18,902 units · 265 per 100k residents TN North Carolina: 30,794 units · 284 per 100k residents NC South Carolina: 19,411 units · 361 per 100k residents SC Delaware: 2,321 units · 225 per 100k residents DE Oklahoma: 32,482 units · 801 per 100k residents OK Louisiana: 48,055 units · 1,051 per 100k residents LA Mississippi: 19,958 units · 679 per 100k residents MS Alabama: 28,100 units · 550 per 100k residents AL Georgia: 42,244 units · 383 per 100k residents GA D.C.: 1,564 units · 230 per 100k residents DC Hawaii: 2,445 units · 170 per 100k residents HI Texas: 10,509 units · 34.5 per 100k residents TX Florida: 20,207 units · 89.4 per 100k residents FL
Units reimbursed · per 100k residents
29.44,234
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oregon 4,234 /100k
2 Vermont 3,589 /100k
3 Alaska 2,044 /100k
4 Washington 1,963 /100k
5 Minnesota 1,795 /100k
6 Nebraska 1,679 /100k
7 Montana 1,555 /100k
8 Missouri 1,539 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 31722-0185-01 · Camber 31722-0187-01 · Camber →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.