Methylphenidate Hydrochloride 18 mg Tablet, Extended Release
Other active recalls for Methylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🏭 Manufacturer & labeler
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🩺 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 ↗- Methylphenidate helps boost two brain chemicals — dopamine and norepinephrine — that play a big role in attention, focus, and impulse control. When those chemicals are more availab...
- What exactly is methylphenidate supposed to do for my ADHD?
- Methylphenidate is a controlled substance, and it does have a real potential for abuse and dependence — that's something the FDA takes seriously enough to put a boxed warning on th...
- The most common ones — decreased appetite, some trouble sleeping, headache, and a slightly faster heartbeat — are annoying but usually manageable and tend to improve over time. For...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:
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💊 What it looks like
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🧪 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 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
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A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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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.
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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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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.
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Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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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Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII AB6MNQ6J6L
Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
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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.
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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
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💲 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 | $0.576 | $17.27 / 30 tablet |
| 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 | $2.92 | $87.74 / 30 tablet |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride 18 mg 13811-0706-10 | Trigen | 100 tablets | $0.576 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 31722-0952-01 | Camber | 100 tablets | $0.576 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 50268-0545-12 | AvPAK | 1 tablet | $0.576 | AB | Discontinued | — |
| Methylphenidate Hydrochloride 18 mgthis 60687-0532-21 | American | 1 tablet | $0.576 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 62037-0725-01 | Actavis | 100 tablets | $0.576 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 62175-0310-37 | Lannett | 100 tablets | $0.576 | BX | Availability likely | — |
| Methylphenidate Hydrochloride 18 mg 00527-3310-37 | Lannett | 100 tablets | $0.736 | AB | FDA listed | +28% |
| Methylphenidate Hydrochloride 18 mg 57664-0606-88 | Sun | 100 tablets | $0.736 | — | Discontinued | +28% |
| Concerta 18 mg 50458-0585-01 | Janssen | 100 tablets | $12.329 | AB | Availability likely | +2041% |
| Methylphenidate Hydrochloride 18 mg 51407-0924-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Relexxii 18 mg 68025-0095-10 | Vertical | 100 tablets | — | — | FDA listed | — |
| Methylphenidate Hydrochloride 18 mg 72865-0133-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60687-0532-21 You're viewing this | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-532-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-532-11) | 2020-06-25 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets, can result in overdose and death (5.1 , 9.2 , 10) : Before prescribing methylphenidate hydrochloride 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 ▾
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets is 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) ]. Methylphenidate hydrochloride 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)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Methylphenidate hydrochloride extended-release tablets should be taken once daily in the morning and swallowed whole with the aid of liquids. Methylphenidate hydrochloride extended-release tablets should not be chewed or crushed. Methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets [see Warnings and Precautions (5.13) ] .
2.2Recommended Dosage Methylphenidate hydrochloride extended-release tablets should be administered orally once daily in the morning with or without food. Methylphenidate hydrochloride 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 hydrochloride 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 Hydrochloride 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 hydrochloride 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 Hydrochloride Extended-Release Tablets Previous Methylphenidate Daily Dose Recommended Methylphenidate hydrochloride 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.
2.6 Dose Reduction and Discontinuation If paradoxical aggravation of s…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in 18 mg, 27 mg, 36 mg and 54 mg of methylphenidate hydrochloride, USP. The 18 mg tablets are light yellow to yellow film coated round cylindrical biconvex tablets printed with “212” in black ink. The 27 mg tablets are light pink to pink film coated round cylindrical biconvex tablets printed with “213” in black ink.
The 36 mg tablets are white to off white film coated round cylindrical biconvex tablets printed with “214” in black ink. The 54 mg tablets are light to dark brown film coated round cylindrical biconvex tablets printed with “215” in black ink. Tablets: 18, 27, 36, and 54 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Known hypersensitivity to the product (4.1) Do not use methylphenidate hydrochloride 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 hydrochloride extended-release tablets. Therefore, methylphenidate hydrochloride 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 hydrochloride 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 ▾
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 hydrochloride extended-release tablets, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets has a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release tablets 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 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release tablets to anyone else. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abu…
🤒 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) ] 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 hydrochloride extended-release tablets included exposures in a total of 3,906 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, and ECGs, and by performing physical examinations and laboratory analyses. Table 3.
Methylphenidate hydrochloride extended-release tablets Exposure in Double-Blind and Open-Label Clinical Studies Patient Population N Dose Range Children 2,216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults 1,188 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 hydrochloride extended-release tablets based on the comprehensive assessment of the available adverse event information. A causal association for methylphenidate hydrochloride 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 com…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 ▾
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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets is 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 Methylphenidate hydrochloride extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established.
8.5Geriatric Use Methylphenidate hydrochloride extended-release tablets has not been studied in patients greater than 65 years of age.
🤰 Pregnancy ▾
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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Methylphenidate hydrochloride extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established.
🧓 Geriatric Use ▾
8.5Geriatric Use Methylphenidate hydrochloride extended-release tablets has not been studied in patients greater than 65 years of age.
🆘 Overdosage ▾
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 hydrochloride extendedrelease 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 ▾
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 hydrochloride 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 hydrochloride extended-release tablets occurred between 6 and 10 hours.
Methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 ½ (h) 3.5 ± 0.4 3.0 ±
0.5The pharmacokinetics of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets in a dose range of 18 to 144 mg. Dose Proportionality Following administration of methylphenidate hydrochloride 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 hydrochloride extended-release tablets, plasma concentrations of the l-isomer were approximately 1/40 the plasma concentrations of the d-isomer. In healthy adults, single and multiple dosing of once-daily methylphenidate hydrochloride 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 multipl…
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. The 18 mg tablets are light yellow to yellow film coated round cylindrical biconvex tablets printed with “212” in black ink. Unit dose packages of 30 (3 x 10) NDC 60687-532-21 The 27 mg tablets are light pink to pink film coated round cylindrical biconvex tablets printed with “213” in black ink.
Unit dose packages of 30 (3 x 10) NDC 60687-543-21 The 36 mg tablets are White to off white film coated round cylindrical biconvex tablets printed with “214” in black ink. Unit dose packages of 30 (3 x 10) NDC 60687-554-21 The 54 mg tablets are light to dark brown film coated round cylindrical biconvex tablets printed with “215” in black ink. Unit dose packages of 30 (3 x 10) NDC 60687-565-21 Storage and Handling Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Protect from humidity. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
📋 Description ▾
11 DESCRIPTION Methylphenidate hydrochloride extended-release tablets, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets 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 to off-white 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 hydrochloride extended-release tablets, USP also contains the following inert ingredients and are common to all strengths: butylated hydroxytoluene, cellulose acetate, hypromellose, phosphoric acid, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, ferric oxide yellow, FD&C Red No 40 and titanium dioxide. The 18 mg tablet strength also contains iron oxide yellow and Polysorbate 80. The 27 mg tablet strength also contains iron oxide red.
The 36 mg tablet strength also contains talc. The 54 mg tablet strength also contains iron oxide yellow, iron oxide red and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink.
USP Dissolution Test Pending. Structural Formula
11.1System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components.
There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core.
As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets.
The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
💬 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 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 hydrochloride extended-release tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ] .
Psychiatric Risks Advise patients that methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate.
The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in the…
💬 Medication Guide ▾
MEDICATION GUIDE 8453221/1125F Methylphenidate hydrochloride Extended-release Tablets, USP CII (meth' il fen' i date hye" droe klor' ide) What is the most important information I should know about methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets and will monitor you or your child during treatment.
Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give methylphenidate hydrochloride extended-release tablets to anyone else. See “What are methylphenidate hydrochloride extended-release tablets?” for more information.
Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride 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 hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if methylphenidate hydrochloride extended-release tablets…