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Methylphenidate Hydrochloride 27 mg Tablet, Extended Release, 100-count — NDC 72162-2395-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Methylphenidate Hydrochloride 27 mg Tablet, Extended Release, 100-count — NDC 72162-2395-1 (Billing 72162-2395-01)

by Bryant Ranch Prepack · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Methylphenidate Hydrochloride 27 mg Tablet, Extended Release from Bryant Ranch Prepack, marketed since Jul 2013 and currently FDA-listed. It is this product's only package size.

NDC 72162-2395-01
🏷️ FDA NDC (as labeled) 72162-2395-1 billing pads the package segment with a zero
Rx only Generic On market CII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 7, 2022 — Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. (RISING PHARMACEUTICALS) · FDA recall D-0573-2022
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) 72162-2395-1
Product NDC 72162-2395
11-digit billing NDC 72162239501
RxCUI 2001565
UNII 4B3SC438HI
Application # ANDA091695
SPL Set ID 5a29687b-5294-4b27-a556-514b092a877d
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-10
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METHYLPHENIDATE HYDROCHLORIDE
TE code (Orange Book) BX · RLD · RS
Quick answers
  • RxCUI (RxNorm): 2001565
Why two NDCs? The FDA registers this code as 72162-2395-1 — a 5-4-1 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 package segment → 72162-2395-01. 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

📖 What it is MedlinePlus · NLM

Methylphenidate is used to control symptoms of attention deficit hyperactivity disorder (ADHD; condition that makes it hard to pay attention, control your behavior, and remain still or quiet) and to treat narcolepsy (condition that causes people to be very sleepy during the day and to fall asleep suddenly). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It mainly treats ADHD, and some products are also used for narcolepsy. The exact approval depends on the product and the age group. Your prescriber chooses the right one for you.
  • It depends on your product. Many extended-release forms are taken once daily in the morning, while Jornay PM is taken in the evening. Swallow extended-release tablets whole, and fo...
  • The most common ones are decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety and dizziness. Children and teens may get upper stomach pain. Call your doctor i...
  • Call for chest pain, fainting, a racing heartbeat, hallucinations, seizures, painful erections that won’t go away, or color changes in your fingers or toes. Also call if you notice...
📖 Read our full Methylphenidate guide →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $2.25 $225.15 / 100 tablets
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
72162-2395-01 You're viewing this Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 2026-03-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methylphenidate Hydrochloride 27 mg 50268-0546-12 AvPAK 1 tablet $0.645 AB Discontinued —
Methylphenidate Hydrochloride Extended-Release 27 mg 00406-0127-01 SpecGx 100 tablets $0.677 — Availability likely —
Methylphenidate Hydrochloride 27 mg 62175-0311-37 Lannett 100 tablets $0.677 BX Availability likely —
Methylphenidate Hydrochloride 27 mg 31722-0953-01 Camber 100 tablets $0.677 AB Availability likely —
Methylphenidate Hydrochloride 27 mg 13811-0707-10 Trigen 100 tablets $0.677 AB Availability likely —
Methylphenidate Hydrochloride 27 mg 60687-0543-21 American 1 tablet $0.677 AB Availability likely —
Methylphenidate Hydrochloride 27 mg 62037-0734-01 Actavis 100 tablets $0.677 AB Availability likely —
Methylphenidate Hydrochloride 27 mg 57664-0607-88 Sun 100 tablets $0.760 — Discontinued —
Methylphenidate Hydrochloride 27 mg 00527-3311-37 Lannett 100 tablets $0.760 AB FDA listed —
Relexxii 27 mg 68025-0096-10 Vertical 100 tablets $11.325 — Availability likely —
Concerta 27 mg 50458-0588-01 Janssen 100 tablets $12.654 AB Availability likely —
Methylphenidate Hydrochloride 27 mgthis 72162-2395-01 Bryant 100 tablets — BX FDA listed —
Methylphenidate Hydrochloride 27 mg 72865-0134-01 XLCare 100 tablets — AB FDA listed —
Methylphenidate Hydrochloride 27 mg 51407-0925-01 Golden 100 tablets — AB 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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 yellow
ShapeOval
Imprint27
Size11 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 FC40A8XAJ3
    A plant-based thickener made from cellulose, a natural fiber. It acts as a binder to hold ingredients together and increases viscosity to give the medicine proper texture and consistency.
  • UNII 3DYK7UYZ62
    Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 6N003M473W
    Hypromellose acetate succinate is a modified cellulose polymer that dissolves in the small intestine. It's used as a coating material to protect the medicine from stomach acid and control where and when the drug is released in the digestive tract.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

15 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.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderLANNETT CO INC
FDA applicationANDA091695 (ANDA)
Labeler code72162
First marketedJul 2013
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio4,436 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 🍼 Nursing Mothers 🧬 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 Methylphenidate HCl Extended-Release Tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release 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) and Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): • Before prescribing Methylphenidate HCl Extended-Release 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 193 words ▾

1 INDICATIONS AND USAGE Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14) ] . Limitations of Use The use of Methylphenidate HCl Extended-Release 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 (5.8) , Use in Specific Populations (8.4) ].

Methylphenidate HCl Extended-Release Tablets is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. ( 1 ) Limitations of Use The use of Methylphenidate HCl Extended-Release 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 ( 5.8 , 8.4 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Methylphenidate HCl Extended-Release Tablets should be taken once daily in the morning and swallowed whole with the aid of liquids. Methylphenidate HCl Extended-Release Tablets should not be chewed or crushed. Methylphenidate HCl Extended-Release Tablets may be taken with or without food.

( 2.2 ) For children and adolescents new to methylphenidate, the recommended starting dosage is 18 mg once daily. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 54 mg/day in children and 72 mg/day in adolescents. ( 2.3 ) For adult patients new to methylphenidate, the recommended starting dose is 18 or 36 mg/day.

Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 72 mg/day for adults. ( 2.3 ) For patients currently using methylphenidate, dosing is based on current dose regimen and clinical judgment. ( 2.4 )

2.1Pretreatment Screening Prior to treating patients with Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets [see Warnings and Precautions (5.13) ] .

2.2Recommended Dosage Methylphenidate HCl Extended-Release Tablets should be administered orally once daily in the morning with or without food. Methylphenidate HCl Extended-Release Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17) ] .

2.3Patients New to Methylphenidate The recommended starting dose of Methylphenidate HCl Extended-Release Tablets for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1 ). Table 1 . Methylphenidate HCl Extended-Release Tablets Recommended Starting Doses and Dose Ranges Patient Age Recommended Starting Dose Dose Range Children 6-12 years of age 18 mg/day 18 mg - 54 mg/day Adolescents 13-17 years of age 18 mg/day 18 mg - 72 mg/day not to exceed 2 mg/kg/day Adults 18-65 years of age 18 or 36 mg/day 18 mg - 72 mg/day

2.4Patients Currently Using Methylphenidate The recommended dose of Methylphenidate HCl Extended-Release Tablets for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.

Table 2 . Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate HCl Extended-Release Tablets Previous Methylphenidate Daily Dose Recommended Methylphenidate HCl Extended-Release Tablets Starting Dose 5 mg Methylphenidate twice daily or three times daily 18 mg every morning 10 mg Methylphenidate twice daily or three times daily 36 mg every morning 15 mg Methylphenidate twice daily or three times daily 54 mg every morning 20 mg Methylphenidate twice daily or three times daily 72 mg every morning Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.

2.5Dose Titration Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended. A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.

2.6Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue Methylphenidate HCl E… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Methylphenidate HCl Extended-Release Tablets, USP are available in the following dosage strengths: 18 mg tablets are pink and imprinted with “18”, 27 mg tablets are yellow and imprinted with “27”, 36 mg tablets are pink and imprinted with “36”, and 54 mg tablets are pink and imprinted with “54”. Tablets: 18, 27, 36, and 54 mg ( 3 )

⛔ Contraindications 124 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to the product ( 4.1 ) Do not use Methylphenidate HCl Extended-Release Tablets in patients currently using or within 2 weeks of using an MAO inhibitor ( 4.2 )

4.1Hypersensitivity to Methylphenidate Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with Methylphenidate HCl Extended-Release Tablets. Therefore, Methylphenidate HCl Extended-Release Tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see Adverse Reactions (6.5) ] .

4.2Monoamine Oxidase Inhibitors Methylphenidate HCl Extended-Release Tablets are contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO inhibitor (hypertensive crises may result) [see Drug Interactions (7.1) ] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increase in Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating Methylphenidate HCl Extended-Release Tablets, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing Methylphenidate HCl Extended-Release Tablets. ( 5.4 ) Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures.

( 5.5 ) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. ( 5.6 ) Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during Methylphenidate HCl Extended-Release Tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.

( 5.7 ) 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. ( 5.8 ) Gastrointestinal obstruction with preexisting GI narrowing.

( 5.9 ) Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. ( 5.10 ) Acute Angle Closure Glaucoma: Methylphenidate HCl Extended-Release Tablets -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.11 ) Increased Intraocular Pressure and Glaucoma: Prescribe Methylphenidate HCl Extended-Release Tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.

Closely monitor patients with a history of increased IOP or open angle glaucoma. ( 5.12 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating Methylphenidate HCl Extended-Release 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. ( 5.13 )

5.1Abuse, Misuse, and Addiction Methylphenidate HCl Extended-Release Tablets have a high potential for abuse and misuse. The use of Methylphenidate HCl Extended-Release Tablets expose individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets in a safe place, preferably locked, and instruct patients to not give Methylphenidate HCl Extended-Release Tablets to anyone else. Throughout Methylphenidate HCl Extended-Release 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 i… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) ] Hypersensitivity to Methylphenidate [see Contraindications (4.1) ] Monoamine Oxidase Inhibitors [see Contraindications (4.2) 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) ] Seizures [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.6) ] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.8) ] Potential for Gastrointestinal Obstruction [see Warnings and Precautions (5.9) ] Hematologic Monitoring [see Warnings and Precautions (5.10) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.11) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.12) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.13) ] The most common adverse reaction in double-blind clinical trials (>5%) in pediatric patients (children and adolescents) was abdominal pain upper.

The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis [see Adverse Reactions (6.1) ] . The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased [see Adverse Reactions (6.3) ] . The development program for Methylphenidate HCl Extended-Release Tablets included exposures in a total of 3906 participants in clinical trials.

Children, adolescents, and adults with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies (see Table 3 ). Safety was assessed by collecting adverse events, vital signs, weights, ECGs, and by performing physical examinations and laboratory analyses. Table 3.

Methylphenidate HCl Extended-Release Tablets Exposure in Double-Blind and Open-Label Clinical Studies Patient Population N Dose Range Children 2216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults 1188 18 to 108 mg once daily Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Throughout this section, adverse reactions are reported.

Adverse reactions are adverse events that were considered to be reasonably associated with the use of Methylphenidate HCl Extended-Release Tablets based on the comprehensive assessment of the available adverse event information. A causal association for Methylphenidate HCl Extended-Release Tablets often cannot be reliably established in individual cases. Further, 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 clinical trials of another drug and may not reflect the rates observed in clinical practice.

The majority of adverse reactions were mild to moderate in severity. The most common adverse reaction in double-blind clinica… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Methylphenidate HCl Extended-Release Tablets may increase blood pressure; use cautiously with vasopressors ( 7.2 ) Inhibition of metabolism of coumarin anticoagulants, anticonvulsants, and some antidepressants ( 7.3 )

7.1MAO Inhibitors Methylphenidate HCl Extended-Release Tablets should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO inhibitors [see Contraindications (4.2) ] .

7.2Vasopressor Agents Because of possible increases in blood pressure, Methylphenidate HCl Extended-Release Tablets should be used cautiously with vasopressor agents [see Warnings and Precautions (5.3) ] .

7.3Coumarin Anticoagulants, Antidepressants, and Selective Serotonin Reuptake Inhibitors Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

7.4Halogenated Anesthetics Concomitant use of halogenated anesthetics and Methylphenidate HCl Extended-Release Tablets may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of Methylphenidate HCl Extended-Release Tablets in patients being treated with anesthetics on the day of surgery.

7.5Risperidone Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Caution should be exercised if administered to nursing mothers ( 8.3 ) Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age ( 8.4 and 8.5 )

8.1Pregnancy Pregnancy Category C Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2 basis, respectively. A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1-2 times that seen in trials in volunteers and patients with the maximum recommended dose of Methylphenidate HCl Extended-Release Tablets based on the AUC. The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women.

Methylphenidate HCl Extended-Release Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2Labor and Delivery The effect of Methylphenidate HCl Extended-Release Tablets on labor and delivery in humans is unknown.

8.3Nursing Mothers It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Methylphenidate HCl Extended-Release Tablets are administered to a nursing woman. In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma.

8.4Pediatric Use The safety and effectiveness of Methylphenidate HCl Extended-Release Tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate 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.

8.5Geriatric Use Methylphenidate HCl Extended-Release Tablets have not been studied in patients greater than 65 years of age.

🤰 Pregnancy 168 words ▾

8.1Pregnancy Pregnancy Category C Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2 basis, respectively. A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1-2 times that seen in trials in volunteers and patients with the maximum recommended dose of Methylphenidate HCl Extended-Release Tablets based on the AUC. The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women.

Methylphenidate HCl Extended-Release Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 73 words ▾

8.4Pediatric Use The safety and effectiveness of Methylphenidate HCl Extended-Release Tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate 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.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use Methylphenidate HCl Extended-Release Tablets have not been studied in patients greater than 65 years of age.

🆘 Overdosage 127 words ▾

10 OVERDOSAGE

10.1Clinical 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.

10.2Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of Methylphenidate HCl Extended-Release Tablets should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. 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 Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer.

12.3Pharmacokinetics Absorption Methylphenidate is readily absorbed. Following oral administration of Methylphenidate HCl Extended-Release Tablets, plasma methylphenidate concentrations increase rapidly, reaching an initial maximum at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours, after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of Methylphenidate HCl Extended-Release Tablets occurred between 6 and 10 hours.

Methylphenidate HCl Extended-Release Tablets once daily minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate three times daily (see Figure 1 ). The relative bioavailability of Methylphenidate HCl Extended-Release Tablets once daily and methylphenidate three times daily in adults is comparable. Figure 1.

Mean methylphenidate plasma concentrations in 36 adults, following a single dose of Methylphenidate HCl Extended-Release Tablets 18 mg once daily and immediate-release methylphenidate 5 mg three times daily administered every 4 hours. The mean single-dose pharmacokinetic parameters in 36 healthy adults following the administration of Methylphenidate HCl Extended-Release Tablets 18 mg once daily and methylphenidate 5 mg three times daily are summarized in Table 6. Table 6.

Pharmacokinetic Parameters (Mean ± SD) After Single Dose in Healthy Adults Parameters Methylphenidate HCl Extended-Release Tablets (18 mg once daily) (n=36) Methylphenidate (5 mg three times daily) (n=35) C max (ng/mL) 3.7 ± 1.0 4.2 ±

1.0T max (h) 6.8 ± 1.8 6.5 ±

1.8AUC inf (ng∙h/mL) 41.8 ± 13.9 38.0 ± 11.0 t 1/2 (h) 3.5 ± 0.4 3.0 ±

0.5The pharmacokinetics of Methylphenidate HCl Extended-Release Tablets were evaluated in healthy adults following single- and multiple-dose administration (steady state) of doses up to 144 mg/day. The mean half-life was about 3.6 hours. No differences in the pharmacokinetics of Methylphenidate HCl Extended-Release Tablets were noted following single and repeated once-daily dosing, indicating no significant drug accumulation.

The AUC and t 1/2 following repeated once-daily dosing are similar to those following the first dose of Methylphenidate HCl Extended-Release Tablets in a dose range of 18 to 144 mg. Dose Proportionality Following administration of Methylphenidate HCl Extended-Release Tablets in single doses of 18, 36, and 54 mg/day to healthy adults, C max and AUC (0-inf) of d-methylphenidate were proportional to dose, whereas l-methylphenidate C max and AUC (0-inf) increased disproportionately with respect to dose. Following administration of Methylphenidate HCl Extended-Release Tablets, plasma concentrations of the l-isomer were approximately 1/40th the plasma concentrations of the d-isomer.

In healthy adults, single and multiple dosing of once-daily Methylphenidate HCl Extended-Release Tablets doses from 54 to 144 mg/day resulted in linear and dose-proportional increases in C max and AUC inf for total methylphenidate (MPH) and its major metabolite, α-phenyl-piperidine acetic acid (PPAA). There was no time dependency in the pharmacokinetics of methylphenidate. The ratio of metabolite (PPAA) to parent drug (MPH) was constant across doses from 54 to 144 mg/day, both after single dose and upon multiple dosing.

In a multiple-dose study in adolescent ADHD patients aged 13 to 16 administered their prescribed dose (18 to 72 mg/… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is 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 61 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate HCl Extended-Release Tablets, USP is available in 27 mg dosage strength. 27 mg tablets are yellow and imprinted with “27”. NDC: 72162-2395-1: 100 Tablets in a Bottle Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from humidity. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description ~1 min read ▾

11 DESCRIPTION Methylphenidate HCl Extended-Release Tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate HCl Extended-Release Tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect.

Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder.

Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.

Methylphenidate HCl Extended-Release Tablets, USP also contains the following inert ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, ethocel, hydroxypropyl cellulose, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, talc, titanium dioxide and triethyl citrate. The 18, 36, and 54 mg tablets also contain synthetic red iron oxide. The 27 mg tablets also contain yellow iron oxide.

Methylphenidate HCl Extended-Release Tablets meet USP Dissolution Test 3.

11.1System Components and Performance Methylphenidate HCl Extended-Release Tablets uses extended-release bead technology to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, is comprised of a tablet core containing the extended-release beads and the core is covered with an immediate-release drug overcoat. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate.

The tablet disintegrates and then polymer coatings on the beads control the release of methylphenidate HCl over the 12 hour dosing period.

💬 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 Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets in a safe place, preferably locked, and instruct patients to not give Methylphenidate HCl Extended-Release Tablets 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 Methylphenidate HCl Extended-Release 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 Advise patients that Methylphenidate HCl Extended-Release Tablets can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ] .

Psychiatric Risks Advise patients that Methylphenidate HCl Extended-Release Tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ] . Priapism Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.6) ] .

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud’s Phenomenon] Instruct patients beginning treatment with Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets . Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. Suppression of Growth Advise patients, caregivers, and family members that Methylphenidate HCl Extended-Release Tablets may cause slowing of growth and weight loss [see Warnings and Precautions (5.8) ] .

Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with Methylphenidate HCl Extended-Release Tablets [see Warnings and Precautions (5.12) ] . Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with Methylphenidate HCl Extended-Release Tablets. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.13) ] .

Administration Instructions Patients should be informed that Methylphenidate HCl Extended-Release Tablets should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. For more information call 1-844-834-0530.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Methylphenidate (meth” il fen’ i date ) HCl Extended-Release Tablets, USP CII What is the most important information I should know about Methylphenidate HCl Extended-Release Tablets? Methylphenidate HCl Extended-Release Tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate HCl Extended-Release Tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of Methylphenidate HCl Extended-Release Tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Methylphenidate HCl Extended-Release 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 Methylphenidate HCl Extended-Release Tablets and will monitor you or your child during treatment.

Methylphenidate HCl Extended-Release Tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Methylphenidate HCl Extended-Release Tablets to anyone else. See “ What is Methylphenidate HCl Extended-Release Tablets? ” for more information.

Keep Methylphenidate HCl Extended-Release Tablets in a safe place and properly dispose of any unused medicine. See “ How should I store Methylphenidate HCl Extended-Release 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 treatment with Methylphenidate HCl Extended-Release Tablets.

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 Methylphenidate HCl Extended-Release Tablets. Increased blood pressure and heart rate.

Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate HCl Extended-Release Tablets. Mental (psychiatric) problems, including: new or worse behavior or thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Methylphenidate HCl Extended-Release Tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What is Methylphenidate HCl Extended-Release Tablets ? Methylphenidate HCl Extended-Release Tablets are a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD) in children 6 years of age and older and adults up to 65 years of age.

Methylphenidate HCl Extended-Release Tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. Methylphenidate HCl Extended-Release Tablets are not recommended for use in children under 6 years of age with ADHD. Methylphenidate HCl Extended-Release Tablets have not been studied in adults older than 65 years of age.

Methylphenidate HCl Extended-Release Tablets are a federally controlle… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 71 words ▾

8.3Nursing Mothers It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Methylphenidate HCl Extended-Release Tablets are administered to a nursing woman. In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Methylphenidate is readily absorbed. Following oral administration of Methylphenidate HCl Extended-Release Tablets, plasma methylphenidate concentrations increase rapidly, reaching an initial maximum at about 1 hour, followed by gradual ascending concentrations over the next 5 to 9 hours, after which a gradual decrease begins. Mean times to reach peak plasma concentrations across all doses of Methylphenidate HCl Extended-Release Tablets occurred between 6 and 10 hours.

Methylphenidate HCl Extended-Release Tablets once daily minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate three times daily (see Figure 1 ). The relative bioavailability of Methylphenidate HCl Extended-Release Tablets once daily and methylphenidate three times daily in adults is comparable. Figure 1.

Mean methylphenidate plasma concentrations in 36 adults, following a single dose of Methylphenidate HCl Extended-Release Tablets 18 mg once daily and immediate-release methylphenidate 5 mg three times daily administered every 4 hours. The mean single-dose pharmacokinetic parameters in 36 healthy adults following the administration of Methylphenidate HCl Extended-Release Tablets 18 mg once daily and methylphenidate 5 mg three times daily are summarized in Table 6. Table 6.

Pharmacokinetic Parameters (Mean ± SD) After Single Dose in Healthy Adults Parameters Methylphenidate HCl Extended-Release Tablets (18 mg once daily) (n=36) Methylphenidate (5 mg three times daily) (n=35) C max (ng/mL) 3.7 ± 1.0 4.2 ±

1.0T max (h) 6.8 ± 1.8 6.5 ±

1.8AUC inf (ng∙h/mL) 41.8 ± 13.9 38.0 ± 11.0 t 1/2 (h) 3.5 ± 0.4 3.0 ±

0.5The pharmacokinetics of Methylphenidate HCl Extended-Release Tablets were evaluated in healthy adults following single- and multiple-dose administration (steady state) of doses up to 144 mg/day. The mean half-life was about 3.6 hours. No differences in the pharmacokinetics of Methylphenidate HCl Extended-Release Tablets were noted following single and repeated once-daily dosing, indicating no significant drug accumulation.

The AUC and t 1/2 following repeated once-daily dosing are similar to those following the first dose of Methylphenidate HCl Extended-Release Tablets in a dose range of 18 to 144 mg. Dose Proportionality Following administration of Methylphenidate HCl Extended-Release Tablets in single doses of 18, 36, and 54 mg/day to healthy adults, C max and AUC (0-inf) of d-methylphenidate were proportional to dose, whereas l-methylphenidate C max and AUC (0-inf) increased disproportionately with respect to dose. Following administration of Methylphenidate HCl Extended-Release Tablets, plasma concentrations of the l-isomer were approximately 1/40th the plasma concentrations of the d-isomer.

In healthy adults, single and multiple dosing of once-daily Methylphenidate HCl Extended-Release Tablets doses from 54 to 144 mg/day resulted in linear and dose-proportional increases in C max and AUC inf for total methylphenidate (MPH) and its major metabolite, α-phenyl-piperidine acetic acid (PPAA). There was no time dependency in the pharmacokinetics of methylphenidate. The ratio of metabolite (PPAA) to parent drug (MPH) was constant across doses from 54 to 144 mg/day, both after single dose and upon multiple dosing.

In a multiple-dose study in adolescent ADHD patients aged 13 to 16 administered their prescribed dose (18 to 72 mg/day) of Methylphenidate HCl Extended-Release Tablets, mean C max and AUC TAU of d- and total methylphenidate increased proportionally with respect to dose. Distribution Plasma methylphenidate concentrations in adults and adolescents decline biexponentially following oral administration. The half-life of methylphenidate in adults and adolescents following oral administration of Methylphenidate HCl Extended-Release Tablets was approximately 3.5 hours.

Metabolism and Excretion In humans, methylphenidate is metabolized primarily by de-esterification t… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 22 words ▾

12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Methylphenidate HCl Extended-Release Tablets were demonstrated to be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 4 randomized, double-blind, placebo-controlled studies in children and adolescents and 2 double-blind placebo-controlled studies in adults who met the Diagnostic and Statistical Manual 4 th edition (DSM-IV) criteria for ADHD.

14.1Children Three double-blind, active- and placebo-controlled studies were conducted in 416 children aged 6 to 12 years. The controlled studies compared Methylphenidate HCl Extended-Release Tablets given once daily (18, 36, or 54 mg), methylphenidate given three times daily over 12 hours (15, 30, or 45 mg total daily dose), and placebo in two single-center, 3-week crossover studies (Studies 1 and 2) and in a multicenter, 4-week, parallel-group comparison (Study 3). The primary comparison of interest in all three trials was Methylphenidate HCl Extended-Release Tablets versus placebo.

Symptoms of ADHD were evaluated by community schoolteachers using the Inattention/Overactivity with Aggression (IOWA) Conners scale. Statistically significant reduction in the Inattention/Overactivity subscale versus placebo was shown consistently across all three controlled studies for Methylphenidate HCl Extended-Release Tablets. The scores for Methylphenidate HCl Extended-Release Tablets and placebo for the three studies are presented in Figure 2.

Figure 2. Mean Community School Teacher IOWA Conners Inattention/Overactivity Scores with Methylphenidate HCl Extended-Release Tablets once daily (18, 36, or 54 mg) and placebo. Studies 1 and 2 involved a 3-way crossover of 1 week per treatment arm.

Study 3 involved 4 weeks of parallel-group treatments with a Last Observation Carried Forward analysis at week 4. Error bars represent the mean plus standard error of the mean. In Studies 1 and 2, symptoms of ADHD were evaluated by laboratory schoolteachers using the SKAMP 1 laboratory school rating scale.

The combined results from these two studies demonstrated statistically significant improvements in attention and behavior in patients treated with Methylphenidate HCl Extended-Release Tablets versus placebo that were maintained through 12 hours after dosing. Figure 3 presents the laboratory schoolteacher SKAMP ratings for Methylphenidate HCl Extended-Release Tablets and placebo. 1 Swanson, Kotkin, Agler, M-Fynn, and Pelham Figure 3.

Laboratory School Teacher SKAMP Ratings: Mean (SEM) of Combined Attention (Studies 1 and 2)

14.2Adolescents In a randomized, double-blind, multicenter, placebo-controlled trial (Study 4) involving 177 patients, Methylphenidate HCl Extended-Release Tablets was demonstrated to be effective in the treatment of ADHD in adolescents aged 13 to 18 years at doses up to 72 mg/day (1.4 mg/kg/day). Of 220 patients who entered an open 4-week titration phase, 177 were titrated to an individualized dose (maximum of 72 mg/day) based on meeting specific improvement criteria on the ADHD Rating Scale and the Global Assessment of Effectiveness with acceptable tolerability.

Patients who met these criteria were then randomized to receive either their individualized dose of Methylphenidate HCl Extended-Release Tablets (18 – 72 mg/day, n=87) or placebo (n=90) during a two-week double-blind phase. At the end of this phase, mean scores for the investigator rating on the ADHD Rating Scale demonstrated that Methylphenidate HCl Extended-Release Tablets was statistically significantly superior to placebo.

14.3Adults Two double-blind, placebo-controlled studies were conducted in 627 adults aged 18 to 65 years. The controlled studies compared Methylphenidate HCl Extended-Release Tablets administered once daily and placebo in a multicenter, parallel-group, 7-week dose-titration study (Study 5) (36 to 108 mg/day) and in a multicenter, parallel-group, 5-week, fixed-dose study (Study 6) (18, 36, and 72 mg/day). Study 5 demonstrated the effectiveness of Methylphenidate… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~3 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Methylphenidate HCl Extended-Release Tablets contain methylphenidate, a Schedule II controlled substance.

9.2Abuse Methylphenidate HCl Extended-Release Tablets have 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) ] . Methylphenidate HCl Extended-Release Tablets 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 health care 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 methylphenidate 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 Methylphenidate HCl Extended-Release 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.

In two placebo-controlled human abuse potential studies, single oral doses of Methylphenidate HCl Extended-Release Tablets were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. For the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. In one study (n=40), both Methylphenidate HCl Extended-Release Tablets (108 mg) and 60 mg IR MPH compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential.

In comparisons between the two active treatments, however, Methylphenidate HCl Extended-Release Tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (Abuse Potential, Drug Liking, Amphetamine, and Morphine Benzedrine Group [Euphoria]) or statistically less than (Stimulation-Euphoria) responses produced by 60 mg IR MPH. In another study (n=49), both doses of Methylphenidate HCl Extended-Release Tablets (54 mg and 108 mg) and both doses of IR MPH (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (Drug Liking, Euphoria).

When doses of Methylphenidate HCl Extended-Release Tablets (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, Methylphenidate HCl Extended-Release Tablets produced statistically significantly lower subjective responses on these two scales than IR MPH. Methylphenidate HCl Extended-Release Tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by IR MPH (50 mg). Differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in Methylphenidate HCl Extended-Release Tablets is available for immediate release from the drug overcoat [ see System Components and Performance (11.1) ] .… [Excerpted — this section continues on DailyMed.]

🔒 Controlled Substance 14 words ▾

9.1Controlled Substance Methylphenidate HCl Extended-Release Tablets contain methylphenidate, a Schedule II controlled substance.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 4 times the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 5 times the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay.

Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study.

The study was conducted at doses up to 160 mg/kg/day, approximately 80-fold and 8-fold the highest recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 4 times the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type.

There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 5 times the maximum recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay.

Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study.

The study was conducted at doses up to 160 mg/kg/day, approximately 80-fold and 8-fold the highest recommended human dose of Methylphenidate HCl Extended-Release Tablets on a mg/kg and mg/m 2 basis, respectively.

📄 Recent Major Changes 80 words ▾

Boxed Warning 10/2023 Indications and Usage ( 1 ) 10/2023 Dosage and Administration ( 2.1 , 2.6 ) 10/2023 Dosage and Administration, Maintenance/Extended Treatment ( 2.5 ) Removed 10/2023 Contraindications ( 4 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2, 5.3 , 5.4 , 5.6 , 5.7 , 5.8 , 5.11 , 5.12 , 5.13 ) 10/2023 Warnings and Precautions ( 5.7 ) Removed 10/2023 Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.8 ) 09/2025

📄 Package Label / Principal Display Panel 7 words ▾

Methylphenidate HCl 27mg (CII) Tablet #100 Label

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

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