Methylphenidate Hydrochloride 40 mg Capsule, Extended Release, 100-count — NDC 70010-015-01 (Billing 70010-0015-01)
This is a package of 100 capsules of Methylphenidate Hydrochloride 40 mg Capsule, Extended Release from Granules Pharmaceuticals Inc., marketed since Sep 2019 and currently FDA-listed; retail pharmacies pay about $1.85 per capsule (NADAC). It is this product's only package size.
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 053061
- GCN: 20391
- GPI-14 (Medi-Span): 61400020107040
- HICL (First Databank): 001682
- AHFS class code: 28:20.32.00
- RxCUI (RxNorm): 1806177
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.854 | $185.37 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $2.59 | $258.89 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $3.97 | $396.51 / 100 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70010-0015-01 You're viewing this Main listing | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 2019-09-10 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride Extended-Release 40 mg 00406-1840-01 | SpecGx | 100 capsules | $1.441 | AB2 | Availability likely | save 22% |
| Methylphenidate Hydrochloride 40 mg 00115-1739-01 | Amneal | 100 capsules | $1.441 | AB2 | Availability likely | save 22% |
| methylphenidate hydrochloride CD 40 mg 00527-4582-37 | Lannett | 100 capsules | $1.441 | AB2 | Availability likely | save 22% |
| Methylphenidate Hydrochloride (LA) 40 mg 00093-5348-01 | Teva | 100 capsules | $1.854 | — | Discontinued | — |
| Methylphenidate 40 mg 00781-2364-01 | Sandoz | 100 capsules | $1.854 | AB1 | Availability likely | — |
| Methylphenidate 40 mg 00781-2386-01 | Sandoz | 100 capsules | $1.854 | AB1 | Availability likely | — |
| Methylphenidate Hydrochloride 40 mgthis 70010-0015-01 | Granules | 100 capsules | $1.854 | AB1 | Availability likely | — |
| Methylphenidate Hydrochloride (LA) 40 mg 75907-0052-01 | Dr. | 100 capsules | $1.854 | AB1 | Availability likely | — |
| Methylphenidate Hydrochloride (LA) 40 mg 51862-0612-01 | Mayne | 100 capsules | $2.078 | AB1 | Discontinued | +12% |
| Ritalin LA 40 mg 00078-0372-05 | Novartis | 100 capsules | $12.726 | AB1 | Availability likely | +586% |
| Metadate Cd 40 mg 69654-0582-30 | Aytu | 30 capsules | — | AB2 | FDA listed | — |
| Methylphenidate Hydrochloride 40 mg 42858-0079-45 | Rhodes | 90 capsules | — | AB3 | FDA listed | — |
| methylphenidate hydrochloride 40 mg 00591-3891-19 | Actavis | 90 capsules | — | AB3 | FDA listed | — |
| Metadate Cd 40 mg 00527-6582-30 | Lannett | 30 capsules | — | AB2 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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UNII 0ZBX0N59RZ
A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII BEI30UXK2N
Cellulose butyrate is a chemically modified plant fiber used as a coating and binder in medicines. It helps control how fast the drug dissolves and protects the tablet or capsule contents.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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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.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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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.
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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.
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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.
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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.
15 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Methylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can result in overdose and death ( 5.1 , 9.2 , 10 ). Before prescribing methylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.
Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14) ] . Limitations of Use The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) , Use in Specific Populations (8.4) ] .
Methylphenidate hydrochloride extended-release capsule is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age ( 1 ). Limitations of Use The use of methylphenidate hydrochloride extended-release capsules are 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 ( 5.7 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION N/A Administer orally once daily in the morning (2.2) . Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce (2.2) . Should not be crushed, chewed, or divided ( 2.2 ).
Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended (2.3) . For patients currently using methylphenidate hydrochloride tablets: Dosage is based on current dose regimen (2.4) .
If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules (2.4) .
2.1Pretreatment Screening Prior to treating patients with methylphenidate hydrochloride extended-release capsules, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.10) ] .
2.2General Dosing Information The recommended starting dose for methylphenidate hydrochloride extended-release capsule is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended.
When a lower initial dose is appropriate, patients may begin treatment with 10 mg. Administer methylphenidate hydrochloride extended-release capsules orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce ( see specific instructions below ).
Methylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided. The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation.
The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
2.3Patients Currently Using Methylphenidate Hydrochloride Tablets The recommended dose of methylphenidate hydrochloride extended-release capsules for patients currently taking methylphenidate hydrochloride tablets twice daily is provided below in Table 1. Table 1: Recommended Dose Conversion from Methylphenidate Hydrochloride Tablets Previous Methylphenidate Hydrochloride Tablets dose Recommended Methylphenidate Hydrochloride Extended-Release Capsules dose 5 mg methylphenidate hydrochloride tablets twice daily 10 mg once daily 10 mg methylphenidate hydrochloride tablets twice daily 20 mg once daily 15 mg methylphenidate hydrochloride tablets twice daily 30 mg once daily 20 mg methylphenidate hydrochloride tablets twice daily 40 mg once daily 30 mg methylphenidate hydrochloride tablets twice daily 60 mg once daily
2.4Switching from Other Methylphenidate Products If switching from other methylphenidate products, discontinue that treatment, and titrate with methylphenidate hydrochloride extended-release capsules using the titration schedule. Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11) , Clinical Pharmacology (12.3) ] . Clinical judgment should be used when selecting the starting dose.
Daily dosage above 60 mg is not recommended.
2.5Dosage Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release capsules. If improvement is not observed after appropriate dosage adjustment o… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 10 mg Hard gelatin capsules, yellow opaque cap printed with “G 10mg” and white opaque body printed with “012” contains white to off-white pellets. 20 mg Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with “013” contains white to off-white pellets. 30 mg Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with “014” contains white to off-white pellets.
40 mg Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with “015” contains white to off-white pellets. 60 mg Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with “016” contains white to off-white pellets. Extended-release capsules: 10 mg, 20 mg, 30 mg, 40 mg and 60 mg ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [ see Drug Interactions (7.1)].
Known hypersensitivity to methylphenidate or product components (4) . Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS N/A Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac rhythm arrhythmias, 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 methylphenidate hydrochloride extended-release capsules, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release capsules ( 5.4 ). Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ). Peripheral Vasculopathy, including Raynaud’s Phenomenon : Careful observation for digital changes is necessary during methylphenidate hydrochloride extended-release capsules treatment.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ). 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 ( 5.7 ).
Acute Angle Closure Glaucoma : Methylphenidate hydrochloride extended-release capsules-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist ( 5.8 ). Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe methylphenidate hydrochloride extended-release capsules 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 abnormally increased IOP or open angle glaucoma ( 5.9 ).
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome : Before initiating methylphenidate hydrochloride extended-release capsules, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate ( 5.10 ).
5.1Abuse, Misuse, and Addiction Methylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate hydrochloride extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ] .
Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store methylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release capsules to anyone else. Throughout methylphenidate hydrochloride extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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 are treated with… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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) , Drug Abuse and Dependence (9.2 , 9.3) ] Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride extended-release capsules [see Contraindications (4) ] Hypertensive crisis when used concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) , 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) ] Priapism [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions (5.6) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10) ] Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain, decreased appetite, and anorexia (6) .
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical program for methylphenidate hydrochloride extended-release capsules consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers.
These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received methylphenidate hydrochloride extended-release capsules in doses of 10 to 40 mg per day. Safety of methylphenidate hydrochloride extended-release capsules was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight.
A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules in children with ADHD aged 6 to 12 years. All subjects received methylphenidate hydrochloride extended-release capsules for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind treatment phase of this study, patients received either placebo or methylphenidate hydrochloride extended-release capsules at their individually-titrated dose (range, 10 mg to 40 mg).
Adverse reactions with an incidence greater than 5% during the initial 4-week single-blind methylphenidate hydrochloride extended-release capsules titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia. Adverse reactions with an incidence greater than 2% among methylphenidate hydrochloride extended-release capsules-treated subjects, during the 2-week double-blind phase of the clinical study, are shown in Table 2. Table 2: Adverse Reactions in Greater Than 2% Methylphenidate Hydrochloride Extended-Release Capsules-Treated Subjects in the 2-Week Double-Blind Phase Preferred Term Methylphenidate Hydrochloride Extended-Release Capsules N = 65 N (%) Placebo N = 71 N (%) Anorexia 2 (3.1) 0 (0) Insomnia 2 (3.1) 0 (0) Adverse Reactions Associated with Discontinuation of Treatment In the 2-week double-blind treatment phase of a placebo-controlled parallel-g… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antihypertensive Drugs : Monitor blood pressure and heart. Adjust dosage of antihypertensive drug as needed (7.1) .
7.1Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Capsules Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules Table 3: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical impact Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can cause hypertensive crisis.
Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4) ] . Intervention Concomitant use of methylphenidate hydrochloride extended-release capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Methylphenidate hydrochloride extended-release capsules may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3) ] .
Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical impact Concomitant use of halogenated anesthetics and methylphenidate hydrochloride extended-release capsules may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of methylphenidate hydrochloride extended-release capsules in patients being treated with anesthetics on the day of surgery.
Risperidone Clinical impact 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) Intervention Monitor for signs of EPS
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS N/A
8.1Pregnancy Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy ( see Clinical Considerations ). No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth-weight-infants have been reported in amphetamine-dependent mothers. Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and post-natal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m 2 basis).
8.2Lactation Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-releas… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy ( see Clinical Considerations ). No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth-weight-infants have been reported in amphetamine-dependent mothers. Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and post-natal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release capsules 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.
The safety and effectiveness of methylphenidate hydrochloride extended-release capsules for the treatment of ADHD have been established in pediatric patients aged 6 to 12 years. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7) ] .
Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis.
In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use Methylphenidate hydrochloride extended-release capsules has not been studied in the geriatric population.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.
Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release capsules 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 ▾
12 CLINICAL PHARMACOLOGY N/A
12.1Mechanism of Action Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
Cardiac Electrophysiology A formal QT study has not been conducted in patients taking methylphenidate hydrochloride extended-release capsules. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose.
Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.
12.3Pharmacokinetics Methylphenidate hydrochloride extended-release capsules produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when administered orally to children diagnosed with ADHD and healthy adults. No accumulation of methylphenidate is expected following multiple once daily oral dosing with methylphenidate hydrochloride extended-release capsules, however, there is a slight upward trend in the methylphenidate area under the curve and peak plasma concentrations (C max1 and C max2 ) after oral administration of methylphenidate hydrochloride extended-release capsules 20 mg and 40 mg capsules to adults.
Absorption The absolute oral bioavailability of methylphenidate in children was 22% ± 8% for d-methylphenidate and 5% ± 3% for l-methylphenidate. The relative bioavailability of methylphenidate hydrochloride extended-release capsules given once daily is comparable to the same total dose of methylphenidate hydrochloride tablets given in 2 doses 4 hours apart in both children and adults. The initial rate of absorption for methylphenidate hydrochloride extended-release capsules is similar to that of methylphenidate hydrochloride tablets as shown by the similar rate parameters between the 2 formulations, i.e., initial lag time (T lag ), first peak concentration (C max1 ), and time to the first peak (T max1 ), which is reached in 1 to 3 hours.
The mean time to the interpeak minimum (T minip ), and time to the second peak (T max2 ) are also similar for methylphenidate hydrochloride extended-release capsules given once daily and methylphenidate hydrochloride tablets given in 2 doses 4 hours apart (see Figure 1 and Table 1), although the ranges observed are greater for methylphenidate hydrochloride extended-release capsules. Methylphenidate hydrochloride extended-release capsules given once daily exhibits a lower second peak concentration (C max2 ), higher interpeak minimum concentrations (C minip ), and less peak and trough fluctuations than methylphenidate hydrochloride tablets given in 2 doses given 4 hours apart.
This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1 and Table 4). Figure 1: Mean Plasma Concentration Time-profile of Methylphenidate After a Single Dose of Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg and Methylphenidate Hydrochloride Tablets, 20 mg Given in Two Doses 4 Hours Apart Table 4: Mean ± SD and Range of Pharmacokinetic Parameters of Methylphenidate… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate hydrochloride extended-release capsules are supplied as: 10 mg: Hard gelatin capsules, yellow opaque cap printed with “G 10mg” and white opaque body printed with “012” contains white to off-white pellets. Bottles of 100 NDC 70010-012-01 20 mg: Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with “013” contains white to off-white pellets. Bottles of 100 NDC 70010-013-01 30 mg: Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with “014” contains white to off-white pellets.
Bottles of 100 NDC 70010-014-01 40 mg: Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with “015” contains white to off-white pellets. Bottles of 100 NDC 70010-015-01 60 mg: Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with “016” contains white to off-white pellets. Bottles of 30 NDC 70010-016-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP with a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.
The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white, odorless, fine 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 g/mol. Inactive ingredients: Acetyltributyl citrate, cellaburate, corn starch, gelatin, hypromellose acetate succinate, polyethylene glycol, sucrose, talc, and titanium dioxide. The 10 mg, 30 mg, 40 mg, and 60 mg capsules contain FD & C Yellow #6.
The 10 mg, 30 mg, and 60 mg capsules also contain FD&C Yellow #5. The 40 mg and 60 mg capsules contain D&C Yellow #10. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. methylphenidate-struct.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride extended-release capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store methylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release capsules to anyone else.
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride extended-release capsules use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Instruct patients that methylphenidate hydrochloride extended-release capsules can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3) ] .
Psychiatric Adverse Reactions Advise patients that methylphenidate hydrochloride extended-release capsules, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ]. Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5) ] .
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients beginning treatment with methylphenidate hydrochloride extended-release capsules 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 hydrochloride extended-release capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6) ] . Long Term Suppression of Growth in Pediatric Patients Advise patients that methylphenidate hydrochloride extended-release capsules may cause slowing of growth and weight loss [see Warnings and Precautions (5.7) ].
Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with methylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.9) ] . 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 hydrochloride extended-release capsules. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10) ] .
Alcohol Effect Advise patients to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules. Consumption of alcohol while taking methylphenidate hydrochloride extended-release capsules may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3) ]. Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Revised: 10/2025
💬 Medication Guide ▾
SPL MEDGUIDE SECTION MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Capsules for oral use, CII (METH-il-FEN-i-date HYE-droe-KLOR-ide) What is the most important information I should know about methylphenidate hydrochloride extended-release capsules? Methylphenidate hydrochloride extended-release capsules may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of methylphenidate hydrochloride extended-release capsules, 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 hydrochloride extended-release capsules or when it is used in ways that are not approved, such as snorting or injection. • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release capsules and will monitor you or your child during treatment. • Methylphenidate hydrochloride extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give methylphenidate hydrochloride extended-release capsules to anyone else.
See “What are methylphenidate hydrochloride extended-release capsules?” for more information. • Keep methylphenidate hydrochloride extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride extended-release capsules?” for more information. • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease.
Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting methylphenidate hydrochloride extended-release capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride extended-release capsules. Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules.
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 methylphenidate hydrochloride extended-release capsules , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious .
What are methylphenidate hydrochloride extended-release capsules ? Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Methylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methylphenidate hydrochloride extended-release capsules should be used as a part of a total treatment progr… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Methylphenidate hydrochloride extended-release capsules produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when administered orally to children diagnosed with ADHD and healthy adults. No accumulation of methylphenidate is expected following multiple once daily oral dosing with methylphenidate hydrochloride extended-release capsules, however, there is a slight upward trend in the methylphenidate area under the curve and peak plasma concentrations (C max1 and C max2 ) after oral administration of methylphenidate hydrochloride extended-release capsules 20 mg and 40 mg capsules to adults.
Absorption The absolute oral bioavailability of methylphenidate in children was 22% ± 8% for d-methylphenidate and 5% ± 3% for l-methylphenidate. The relative bioavailability of methylphenidate hydrochloride extended-release capsules given once daily is comparable to the same total dose of methylphenidate hydrochloride tablets given in 2 doses 4 hours apart in both children and adults. The initial rate of absorption for methylphenidate hydrochloride extended-release capsules is similar to that of methylphenidate hydrochloride tablets as shown by the similar rate parameters between the 2 formulations, i.e., initial lag time (T lag ), first peak concentration (C max1 ), and time to the first peak (T max1 ), which is reached in 1 to 3 hours.
The mean time to the interpeak minimum (T minip ), and time to the second peak (T max2 ) are also similar for methylphenidate hydrochloride extended-release capsules given once daily and methylphenidate hydrochloride tablets given in 2 doses 4 hours apart (see Figure 1 and Table 1), although the ranges observed are greater for methylphenidate hydrochloride extended-release capsules. Methylphenidate hydrochloride extended-release capsules given once daily exhibits a lower second peak concentration (C max2 ), higher interpeak minimum concentrations (C minip ), and less peak and trough fluctuations than methylphenidate hydrochloride tablets given in 2 doses given 4 hours apart.
This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1 and Table 4). Figure 1: Mean Plasma Concentration Time-profile of Methylphenidate After a Single Dose of Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg and Methylphenidate Hydrochloride Tablets, 20 mg Given in Two Doses 4 Hours Apart Table 4: Mean ± SD and Range of Pharmacokinetic Parameters of Methylphenidate After a Single Dose of Methylphenidate Hydrochloride Extended-Release Capsules and Methylphenidate Hydrochloride Tablets Given in Two Doses 4 Hours Apart a N = 15.
Population Children Adult Males Formulation D ose N Methylphenidate Hydrochloride Tablets 10 mg & 10 mg 21 Methylphenidate Hydrochloride Extended-Release Capsules 20 mg 18 Methylphenidate Hydrochloride Tablets 10 mg & 10 mg 9 Methylphenidate Hydrochloride Extended-Release Capsules 20 mg 8 T lag (h) 0.24 ± 0.44 0 to 1 0.28 ± 0.46 0 to 1 1 ± 0.5 0.7 to 1.3 0.7 ± 0.2 0.3 to 1 T max1 (h) 1.8 ± 0.6 1 to 3 2 ± 0.8 1 to 3 1.9 ± 0.4 1.3 to 2.7 2 ± 0.9 1.3 to 4 C max1 (ng/mL) 10.2 ± 4.2 4.2 to 20.2 10.3 ± 5.1 5.5 to 26.6 4.3 ± 2.3 1.8 to 7.5 5.3 ± 0.9 3.8 to
6.9T minip (h) 4 ± 0.2 4 to 5 4.5 ± 1.2 2 to 6 3.8 ± 0.4 3.3 to 4.3 3.6 ± 0.6 2.7 to
4.3C minip (ng/mL) 5.8 ± 2.7 3.1 to 14.4 6.1 ± 4.1 2.9 to 21 1.2 ± 1.4 0 to 3.7 3 ± 0.8 1.7 to 4 T max2 (h) 5.6 ± 0.7 5 to 8 6.6 ± 1.5 5 to 11 5.9 ± 0.5 5 to 6.5 5.5 ± 0.8 4.3 to
6.5C max2 (ng/mL) 15.3 ± 7 6.2 to 32.8 10.2 ± 5.9 4.5 to 31.1 5.3 ± 1.4 3.6 to 7.2 6.2 ± 1.6 3.9 to
8.3AUC (0-∞) (ng/mL x h-1) 102.4 ± 54.6 40.5 to 261.6 86.6 ± 64 a 43.3 to 301.44 37.8 ± 21.9 14.3 to 85.3 45.8 ± 10 34 to 61.6 t 1/2 (h) 2.5 ± 0.8 1.8 to 5.3 2.4 ± 0.7 a 1.5 to 4 3.5 ± 1.9 1.3 to 7.7 3.3 ± 0.4 3 to
4.2Effect of Food Administration times relative to meals and meal composition may need to be individually titrated. When methylphenidate hydrochloride extende… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
Cardiac Electrophysiology A formal QT study has not been conducted in patients taking methylphenidate hydrochloride extended-release capsules. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose.
Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES N/A
14.1Children and Adolescents Methylphenidate hydrochloride extended-release capsules was evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12 years, with DSM-IV diagnoses of ADHD received a single morning dose of methylphenidate hydrochloride extended-release capsules in the range of 10 to 40 mg/day, or placebo, for up to 2 weeks. The doses used were the optimal doses established in a previous individual dose titration phase. In that titration phase, 53 of 164 patients (32%) started on a daily dose of 10 mg and 111 of 164 patients (68%) started on a daily dose of 20 mg or higher.
The patient’s regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter.
Patients treated with methylphenidate hydrochloride extended-release capsules showed a statistically significant improvement in symptom scores from baseline [Mean (final score - baseline) = -10.7 points] over patients who received placebo [Mean (final score - baseline) = +2.8 points]. The lower the final score on the CADS-T scale from baseline, the less severe the disease is. This demonstrates that a single morning dose of methylphenidate hydrochloride extended-release capsules exerts a treatment effect in ADHD.
Figure 2: CADS-T Total Subscale - Mean Change from Baseline* methylphenidate-fig-2.jpg
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE
9.1Controlled Substance Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, a Schedule II controlled substance.
9.2Abuse Methylphenidate hydrochloride extended-release capsules 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 hydrochloride extended-release capsules can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect.
Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a 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 hydrochloride 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 hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
9.3Dependence Physical Dependence Methylphenidate hydrochloride extended-release capsules may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance Methylphenidate hydrochloride extended-release capsules may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
🔒 Controlled Substance ▾
9.1Controlled Substance Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, a Schedule II controlled substance.
🧪 Nonclinical Toxicology ▾
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 2 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. 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 increase 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 4 times the MRHD (children) on a mg/m 2 basis.
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, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes.
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 10 times the maximum recommended dose of 60 mg/day given to adolescents on a mg/m 2 basis.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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 2 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. 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 increase 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 4 times the MRHD (children) on a mg/m 2 basis.
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, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes.
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 10 times the maximum recommended dose of 60 mg/day given to adolescents on a mg/m 2 basis.
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.7 ) 09/2025
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL methylphenidate-10mg-label.jpg methylphenidate-20mg-label.jpg methylphenidate-30mg-label.jpg methylphenidate-40mg-label.jpg methylphenidate-60mg-label.jpg