Methylphenidate Extended-Release

Methylphenidate Extended-Release is an FDA-registered drug product whose active ingredient is METHYLPHENIDATE EXTENDED-RELEASE. It is labelled by Neos Therapeutics, LP taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 62542-100, application NDA205489, label effective 20260616. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METHYLPHENIDATE EXTENDED-RELEASE are most often described in connection with: methylphenidate extended-release, orally disintegrating, pediatric patients, years age, treatment attention, deficit hyperactivity, disorder adhd, higher plasma. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ] . Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) . Use in Specific Populations (8.4) ]. Methylphenidate extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.7 , 8.4 )

2 DOSAGE AND ADMINISTRATION Recommended starting dose for pediatric patients 6 to 17 years of age is 17.3 mg given orally once daily in the morning. Dosage may be increased weekly in increments of 8.6 mg to 17.3 mg per day. Daily dosage above 51.8 mg is not recommended. ( 2.2 ) Patients are advised to take methylphenidate extended-release orally disintegrating tablets consistently either with food or without food. ( 2.2 ) 2.1 Pretreatment Screening Prior to treating patients with methylphenidate extended-release orally disintegrating tablets, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methylphenidate extended-release orally disintegrating tablets [see Warnings and Precautions (5.9) ]. 2.2 General Administration Information Methylphenidate extended-release orally disintegrating tablets is given orally once daily in the morning. Advise patients to take methylphenidate extended-release orally disintegrating tablets consistently either with food or without food [see Clinical Pharmacology (12.3) ]. The recommended starting dose of methylphenidate extended-release orally disintegrating tablets for patients 6 to 17 years of age is 17.3 mg once daily in the morning. The dose may be titrated weekly in increments of 8.6 mg to 17.3 mg. Daily doses above 51.8 mg have not been studied and are not recommended. The dose should be individualized according to the needs and responses of the patient. 2.3 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue methylphenidate extended-release orally disintegrating tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue methylphenidate extended-release orally disintegrating tablets. 2.4 Methylphenidate Extended-Release Orally Disintegrating Tablets Administration Instruct the patient or caregiver on the following administration instructions: Do not remove the tablet from the bottle until just prior to dosing. Take the tablet immediately after opening the bottle. Do not store the tablet for future use. Use dry hands when removing the tablet from bottle. As soon as the bottle is opened, remove the tablet and place on the patient’s tongue. Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed. No liquid is needed to take the tablet.

4 CONTRAINDICATIONS Methylphenidate extended-release orally disintegrating tablets is contraindicated in patients with: Known hypersensitivity to methylphenidate or other components of methylphenidate extended-release orally disintegrating tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions (6.2) ]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor because of the risk of hypertensive crisis [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 )

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Known hypersensitivity to methylphenidate or other ingredients of methylphenidate extended-release orally disintegrating tablets [see Contraindications (4) ] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , and Drug Abuse and Dependence ( 9.2 , 9.3 )] Risks to patients with serious cardiac disease [see Warnings and Precautions (5.2) ] Increased blood pressure and heart rate [see Warnings and Precautions (5.3) ] Psychiatric adverse reactions [see Warnings and Precautions (5.4) ] 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) ] Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics, Inc. at 1-888-319-1789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Studies with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia. Adverse Reactions in Studies with methylphenidate extended-release orally disintegrating tablets in Children with ADHD There is limited experience with methylphenidate extended-release orally disintegrating tablets in controlled trials. Based on this limited experience, the adverse reaction profile of methylphenidate extended-release orally disintegrating tablets appears similar to other methylphenidate extended release-products. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows: Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole Eye Disorders: Diplopia, Increased intraocular pressure, Mydriasis, Visual impairment General Disorders: Chest pain, Chest discomfort, Hyperpyrexia Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritis NEC, Rashes, Eruptions, and Exanthemas NEC Investigations: Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs, Motor and Verbal Tics Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania Urogenital System: Priapism Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema Vascular Disorders: Raynaud’s phenomenon

What is Methylphenidate Extended-Release used for?
1 INDICATIONS AND USAGE Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ] . Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years …

Who makes Methylphenidate Extended-Release?
Neos Therapeutics, LP is the labeler of record for Methylphenidate Extended-Release.

What form does Methylphenidate Extended-Release come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Methylphenidate Extended-Release prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Methylphenidate Extended-Release been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.