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Amphetamine Extended-Release 3.1 mg Tablet, Orally Disintegrating — NDC 62542-0005-30 package photo

Amphetamine Extended-Release 3.1 mg Tablet, Orally Disintegrating

by Neos Therapeutics, LP · 30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
NDC 62542-0005-30
🏷️ FDA NDC (as labeled) 62542-005-30 billing pads the product segment with a zero
Rx only Brand On market CII
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 62542-005-30
Product NDC 62542-005
11-digit billing NDC 62542000530
NCPDP billing unit EA — each (per item)
RxCUI 1739803, 1739813, 1739819, 1739825, 1739831, 1739837
UNII CK833KGX7E
UPC 0362542030304, 0362542005302, 0362542010306, 0362542015301 +2 more
Application # NDA204326
SPL Set ID 48d0f55c-f847-4d26-b2ed-94b5a2770228
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-01
Route ORAL
Dosage form TABLET, ORALLY DISINTEGRATING
Substance AMPHETAMINE
GPI-14 6110001000H410
GCN Seq No 075544
GCN 40647
HICL code 043652
Ingredient (HICL) 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 AMPHETAMINE ER 3.1 MG ODT
FDB brand name Amphetamine Er Odt
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62542-005-30 — 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 → 62542-0005-30. 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.

🏭 Manufacturer & labeler

LabelerNeos Therapeutics, LP
Application holderNEOS THERAPEUTICS
FDA applicationNDA204326 (NDA AUTHORIZED GENERIC)
Labeler code62542
First marketedSep 2025
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio10 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.

🩺 Clinical

Label name AMPHETAMINE ER 3.1 MG ODT Ingredient Amphetamine
📖 What it is MedlinePlus · NLM

Amphetamine (Adzenys® ER, Adzenys® XR, Dyanavel® XR, Evekeo®, Evekeo® ODT, others) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Amphetamine (Evekeo®, others) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Amphetamine (Evekeo®, others) is also used for a limited period of time (a few weeks) along with a reduced calorie...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the specific product. Most amphetamine products — including Adzenys XR-ODT, Dyanavel XR, and the extended-release orally disintegrating tablets — are approved to trea...
  • What conditions is amphetamine actually approved to treat?
  • You can take most amphetamine products with or without food — it won't meaningfully change how much you absorb. That said, eating (especially a high-fat meal) can delay when it kic...
  • Is it okay to take this with food, or does it have to be on an empty stomach?
📖 Read our full Amphetamine 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.

💊 What it looks like

Color orange
ShapeRound
ImprintA6
Size6 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 $15.842 $2,851.49 / 180 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $12.15 $2,186.14 / 180 tablets
NADAC price history (per ea) — tap or hover for the price & month
Mar 2026 May 2026 Jul 2026 Sep 2026 $16.306 $15.842
▼ Down 3% over the last 7 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amphetamine 3.1 mg 00480-3315-65 Teva 6 tablets $15.842 AB Availability likely —
Amphetamine Extended-Release 3.1 mgthis 62542-0005-30 Neos 6 tablets $15.842 AB Availability likely —
Adzenys XR-ODT 3.1 mg 70165-0005-30 Neos 6 tablets $19.205 AB Availability likely +21%
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2016
First FDA approval
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 27, 2016 AB TE-rated RLD RS ⏳ ~5.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8709491 — drug product
US 8709491 — drug product
US 9017731 — drug product
US 8840924 — drug product
US 8840924 — drug product
US 9017731 — drug product
US 8709491 — drug product
US 8709491 — drug product
US 9839619 — drug product
US 9265737 — drug product
US 9839619 — drug product
US 9265737 — drug product
US 8840924 — drug product
US 9017731 — drug product
US 8840924 — drug product
US 8840924 — drug product
US 9017731 — drug product
US 9265737 — drug product
US 9839619 — drug product
US 9265737 — drug product
US 9017731 — drug product
US 9839619 — drug product
US 9839619 — drug product
US 9265737 — drug product
US 8840924 — drug product
US 9017731 — drug product
US 9265737 — drug product
US 9839619 — drug product
US 8709491 — drug product
US 8709491 — drug product
2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (30)
PatentTypeUse codeExpires
US 8709491 ↗ Drug product — Jun 28, 2032
US 8709491 ↗ Drug product — Jun 28, 2032
US 9017731 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Apr 9, 2026
US 8840924 ↗ Drug product — Apr 9, 2026
US 9017731 ↗ Drug product — Jun 28, 2032
US 8709491 ↗ Drug product — Jun 28, 2032
US 8709491 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Apr 9, 2026
US 9017731 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Apr 9, 2026
US 8840924 ↗ Drug product — Apr 9, 2026
US 9017731 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 9017731 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 8840924 ↗ Drug product — Apr 9, 2026
US 9017731 ↗ Drug product — Jun 28, 2032
US 9265737 ↗ Drug product — Jun 28, 2032
US 9839619 ↗ Drug product — Jun 28, 2032
US 8709491 ↗ Drug product — Jun 28, 2032
US 8709491 ↗ Drug product — Jun 28, 2032
Common questions
Is there a generic version of AMPHETAMINE ER 3.1 MG ODT?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for AMPHETAMINE ER 3.1 MG ODT. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62542-0005-30 You're viewing this 30 BLISTER PACK in 1 CARTON (62542-005-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2025-09-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets 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 amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets 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.

Amphetamine extended-release orally disintegrating tablets 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 amphetamine extended-release orally disintegrating tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing amphetamine extended-release orally disintegrating tablets, 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 180 words ▾

1 INDICATIONS AND USAGE Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )]. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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 [see Warnings and Precautions (5.5).

Use in Specific Populations (8.4) ]. Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. ( 1 ) Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION May be taken with or without food. Allow tablet to disintegrate in saliva then swallow. ( 2.2 ) Pediatric patients (ages 6 to 17 years): Starting dose is 6.3 mg once daily in the morning.

Maximum dose is 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years. ( 2.3 ) Adults: 12.5 mg once daily in the morning. ( 2.4 ) To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

( 2.5 , 5.7 )

2.1Pre-treatment Screening Prior to treating patients with amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets [see Warnings and Precautions ( 5.9 )] .

2.2General Administration Information Amphetamine extended-release orally disintegrating tablets may be taken orally with or without food. Individualize the dosage according to the therapeutic needs and response of the patient. Amphetamine extended-release orally disintegrating tablets should be taken as follows: The tablet should remain in the blister pack until the patient is ready to take it.

The patient or caregiver should use dry hands to open the blister. Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.

As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue. The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed.

2.3Dosage Recommendations in Pediatric Patients The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years [see Use in Specific Populations ( 8.3 ), Clinical Studies ( 14 )] .

2.4Dosage Recommendations in Adults The recommended dose is amphetamine extended-release orally disintegrating tablets 12.5 mg daily.

2.5Switching from Other Amphetamine Products Patients taking ADDERALL XR may be switched to amphetamine extended-release orally disintegrating tablets at the equivalent dose taken once daily [see Clinical Pharmacology ( 12 .3 ) ]. Refer to Table 1 for equivalent doses of amphetamine extended-release orally disintegrating tablets and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of Amphetamine extended-release orally disintegrating tablets and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules Amphetamine extended-release orally disintegrating tablets 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.7 mg 18.8 mg ADDERALL XR Mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER) 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg If switching from any other amphetamine products, discontinue that treatment, and titrate with amphetamine extended-release orally disintegrating tablets using the titration schedule [see Dosage and Administration ( 2.3 ) , ( 2.4 ) ].

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing…

💊 Dosage Forms and Strengths 132 words ▾

3 DOSAGE FORMS AND STRENGTHS Amphetamine extended-release orally disintegrating tablets 3.1 mg: round, orange to light orange mottled (debossed A1 on one side) Amphetamine extended-release orally disintegrating tablets 6.3 mg: round, orange to light orange mottled (debossed A2 on one side) Amphetamine extended-release orally disintegrating tablets 9.4 mg: round, orange to light orange mottled (debossed A3 on one side) Amphetamine extended-release orally disintegrating tablets 12.5 mg: round, orange to light orange mottled (debossed A4 on one side) Amphetamine extended-release orally disintegrating tablets 15.7 mg: round, orange to light orange mottled (debossed A5 on one side) Amphetamine extended-release orally disintegrating tablets 18.8 mg: round, orange to light orange mottled (debossed A6 on one side) Extended-release orally disintegrating tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg ( 3 )

⛔ Contraindications 128 words ▾

4 CONTRAINDICATIONS Amphetamine extended-release orally disintegrating tablets is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ( 6.2 )] . Patients 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 ( 5.7 ), Drug Interactions 7.1 ] .

Known hypersensitivity to amphetamine products or other ingredients in amphetamine extended-release orally disintegrating tablets. ( 4 ) Use of monoamine oxidase inhibitor (MAOI) or within 14 days of the last MAOI dose. ( 4 )

⚠️ 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 heart arrhythmia, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse.

( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating amphetamine extended-release orally disintegrating tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing amphetamine extended-release orally disintegrating tablets. ( 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 ) Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during amphetamine extended-release orally disintegrating tablets treatment. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.

( 5.6 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g. SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue amphetamine extended-release orally disintegrating tablets and initiate supportive treatment.

( 5.7 , 17 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating amphetamine extended-release orally disintegrating tablets, 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.

( 5.8 )

5.1Abuse, Misuse, and Addiction Amphetamine extended-release orally disintegrating tablets has a high potential for abuse and misuse. The use of amphetamine extended-release orally disintegrating tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. amphetamine extended-release orally disintegrating tablets 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 amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets in a safe place, preferably locked, and instruct patients to not give amphetamine extended-release orally disintegrating tablets to anyone else.

Throughout amphetamine extended-release orally disintegrating tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid amphetamine extended-release orally disintegrating tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

5.3Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean incre…

🤒 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 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets [see Contraindications ( 4 )] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] 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 )] Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.8 )] Pediatric patients ages 6 to 12 years: 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 years: 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 Neos Therapeutics, Inc. at 1-888-319-1789 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 clinical practice. The safety of amphetamine extended-release orally disintegrating tablets has been established from adequate and well-controlled studies of single-entity amphetamine product extended-release (MAS ER) capsules [see Clinical Studies ( 14 ) ].

The adverse reactions of MAS ER capsules in these adequate and well-controlled studies are described below. The premarketing development program for MAS ER 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 years) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40).

Adverse Reactions Leading to Discontinuation of Treatment The most frequent adverse reactions leading to discontinuation of MAS ER in controlled and uncontrolled, multiple-dose clinical trials of pediatric patients ages 6 to 12 years (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). In a separate placebo-controlled 4-week study in pediatric patients ages 13 to 17 years with ADHD, five patients (2.1%) discontinued treatment due to adverse events among MAS ER-treated patients (N=233) compared to 0% who received placebo (N=54).

The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of MAS ER-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatm…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. Adjust amphetamine extended-release orally disintegrating tablets dosage accordingly. ( 7.1 )

7.1Drugs Having Clinically Important Interactions with Amphetamines Table 5: Drugs having clinically important interactions with amphetamines. MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Intervention Do not administer amphetamine extended-release orally disintegrating tablets during or within 14 days following the administration of MAOI [see Contraindications ( 4 )]. Serotonergic Drugs Clinical Impact The concomitant use of amphetamine extended-release orally disintegrating tablets 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 amphetamine extended-release orally disintegrating tablets initiation or dosage increase.

If serotonin syndrome occurs, discontinue amphetamine extended-release orally disintegrating tablets and the concomitant serotonergic drug(s) [see Warnings and Precautions ( 5.7 )] . Alkalinizing Agents Clinical Impact Increase blood levels and potentiate the action of amphetamine. Intervention Co-administration of amphetamine extended-release orally disintegrating tablets and gastrointestinal 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.

7.2Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

👥 Use in Specific Populations ~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 outcomes in women exposed to ADHD medications, including amphetamine extended-release orally disintegrating tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by contacting the National Pregnancy Registry for ADHD Medication at 1-866-961-2388 or online at www.womensmentalhealth.org/pregnancyregistry. Risk Summary Available data from epidemiologic studies and postmarketing reports on the use of amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage.

Neonates exposed to amphetamine in utero are at risk for withdrawal symptoms following delivery. 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.

However, in a pre- and post-natal 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 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 adverseoutcomes. 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 amphetamine extended-release orally disintegrating tablets, 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, in the enantiomer ratio present in amphetamine extended-release orally disintegrating tablets, (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively.

These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 12.5 mg/day (as base), on a mg/m 2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/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, the same as in amphetamine extended-release orally disintegrating tablets) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2,…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women exposed to ADHD medications, including amphetamine extended-release orally disintegrating tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by contacting the National Pregnancy Registry for ADHD Medication at 1-866-961-2388 or online at www.womensmentalhealth.org/pregnancyregistry. Risk Summary Available data from epidemiologic studies and postmarketing reports on the use of amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage.

Neonates exposed to amphetamine in utero are at risk for withdrawal symptoms following delivery. 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.

However, in a pre- and post-natal 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 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 adverseoutcomes. 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 amphetamine extended-release orally disintegrating tablets, 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, in the enantiomer ratio present in amphetamine extended-release orally disintegrating tablets, (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively.

These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 12.5 mg/day (as base), on a mg/m 2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/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, the same as in amphetamine extended-release orally disintegrating tablets) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 12.5 mg/day (as base), on a mg/m 2 basis. All doses caused hyperactivity and decre…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12 ), Clinical Studies ( 14 )] . The safety and effectiveness of amphetamine extended-release orally disintegrating tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage.

Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. Long-Term Growth Suppression Growth should be monitored during treatment with stimulants, including amphetamine extended-release orally disintegrating tablets, in 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 Data In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in amphetamine extended-release orally disintegrating tablets) 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 twice daily for total daily doses of 4, 12, or 40 mg/kg.

The latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 18.8 mg/day (as base), on a mg/m 2 basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period.

A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.

🧓 Geriatric Use 16 words ▾

8.5Geriatric Use Amphetamine extended-release orally disintegrating tablets has not been studied in the geriatric population.

🆘 Overdosage 114 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 hallucination. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104ºF) and rhabdomyolysis may develop.

Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of amphetamine extended-release orally disintegrating tablets 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 ~3 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. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

12.3Pharmacokinetics Absorption Following a single, 18.8 mg oral dose of amphetamine extended-release orally disintegrating tablets in 40 healthy adult subjects in a crossover study under fasting conditions, d-amphetamine mean ( + SD) peak plasma concentrations of 44.9 ( + 8.9) ng/mL occurred at a median time of 5.0 hours after dosing, and l-amphetamine mean ( + SD) peak plasma concentrations of 14.5 (+ 3.0 ng/mL occurred at a median time of 5.25 hours after dosing (Figure 1). The single dose pharmacokinetics of d-amphetamine under fed conditions are summarized (Table 6) from studies in healthy adults following an oral dose of 18.8 mg amphetamine extended-release orally disintegrating tablets.

Table 6: d-Amphetamine PK Parameters (mean + SD) after amphetamine extended-release orally disintegrating tablets 18.8 mg PK parameter Adults Fasted Adults Fed a T max (hr) b 5.00 (3.00-12.00) 7.00 (3.00-16.00) T 1/2 (hr) 11.25 + 2.0 11.33 +

2.0C max (ng/ml) 44.9 + 8.9 36.3 +

6.9AUC inf (hr*ng/mL) 876.9 + 182.4 856.3 + 166.1 a A high-fat meal was consumed 30 minutes prior to drug administration b Data presented as median (range) A single dose of amphetamine extended-release orally disintegrating tablets 18.8 mg provided comparable plasma concentration profiles of both d-amphetamine and l-amphetamine to mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER) 30 mg. The mean elimination half-life for d-amphetamine is 11 hours in adults and 9-10 hours in pediatric patients aged 6 to 12 years.

For l-amphetamine, the mean elimination half-life in adults is 14 hours and 10-11 hours in pediatric patients aged 6 to 12 years. Mean weight-normalized clearance values for d-amphetamine and l-amphetamine decreased slightly with an increase in age. Food Effect Food does not affect the extent of absorption of d-amphetamine and l-amphetamine but caused a 19% reduction in C max .

Food also prolonged the median t max by approximately 2.0 hours for d-amphetamine and by 2.5 hours for l-amphetamine after administration of amphetamine extended-release orally disintegrating tablets. These changes are not considered clinically significant. Alcohol Effect In an in vitro alcohol-induced dose dumping study, a substantial increase in amphetamine release occurred in the presence of 40% alcohol but not with 5%, 10% and 20% alcohol.

Elimination Metabolism and Excretion Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid.

Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated.

In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of…

🧬 Mechanism of Action 49 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. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED How Supplied Amphetamine extended-release orally disintegrating tablets 3.1 mg: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-005-30 Amphetamine extended-release orally disintegrating tablets 6.3 mg: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-010-30 Amphetamine extended-release orally disintegrating tablets 9.4 mg: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-015-30 Amphetamine extended-release orally disintegrating tablets 12.5 mg: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-020-30 Amphetamine extended-release orally disintegrating tablets 15.7 mg: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-025-30 Amphetamine extended-release orally disintegrating tablets 18.8 mg: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 62542-030-30 Storage Store at 20°C to 25º C (68°F to 77º F).

Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature] Store amphetamine extended-release orally disintegrating tabletsblister packagesin the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-888-236-6816.

📋 Description 139 words ▾

11 DESCRIPTION Amphetamine extended-release orally disintegrating tablets contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.

Structural Formula: Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.

Chemical Structure

💬 Information for Patients ~3 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 amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets in a safe place, preferably locked, and instruct patients to not give amphetamine extended-release orally disintegrating tablets to anyone else.

Dosage and Administration Instructions Provide the following instructions on administration to the patient: The tablet should remain in the blister pack until the patient is ready to take it. The patient or caregiver should use dry hands to open the blister. Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet.

The tablet should not be pushed through the foil. As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue. The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.

The tablet will disintegrate in saliva so that it can be swallowed. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with amphetamine extended-release orally disintegrating tablets 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 Instruct patients that amphetamine extended-release orally disintegrating tablets can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions ( 5.3 )] . Psychiatric Adverse Reactions Advise patients that amphetamine extended-release orally disintegrating tablets, at recommended doses, may cause psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )] . Long-Term Suppression of Growth Advise patients that amphetamine extended-release orally disintegrating tablets may cause slowing of growth and weight loss [see Warnings and Precautions ( 5.5 )] .

Circulation problems in Fingers and Toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with amphetamine extended-release orally disintegrating tablets about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and 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 amphetamine extended-release orally disintegrating tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of amphetamine extended-release orally disintegrating tablets and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St.

John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.1 )] . Advise patients to contact their healthcare provider or…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE AMPHETAMINE EXTENDED-RELEASE ORALLY DISINTEGRATING TABLETS (am-fet’-a-meen), CII What is the most important information I should know about amphetamine extended-release orally disintegrating tablets? Amphetamine extended-release orally disintegrating tablets may cause serious side effects, including: Abuse, misuse, and addiction. Amphetamine extended-release orally disintegrating tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of amphetamine extended-release orally disintegrating tablets, 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 amphetamine extended-release orally disintegrating tablets 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 amphetamine extended-release orally disintegrating tablets and will monitor you or your child during treatment.

Amphetamine extended-release orally disintegrating tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give amphetamine extended-release orally disintegrating tablets to anyone else. See “ What is amphetamine extended-release orally disintegrating tablets? ” for more information.

Keep amphetamine extended-release orally disintegrating tablets in a safe place and properly dispose of any unused medicine. See “ How should I store amphetamine extended-release orally disintegrating tablets? ” 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 amphetamine extended-release orally disintegrating tablets.

Tell your healthcare provider if you or your child has 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 has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking amphetamine extended-release orally disintegrating tablets. 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 amphetamine extended-release orally disintegrating tablets. Mental (Psychiatric) problems: All Patients ·new or worse behavior and thought problems ·new or worse bipolar illness new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking amphetamine extended-release orally disintegrating tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What is amphetamine extended-release orally disintegrating tablets? Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant prescription medicine.

It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) . Amphetamine extended-release orally disintegrating tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Amphetamine extended-release orally disintegrating tablets is not recommended for use in children under 6 years of ag…

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