Methylphenidate Hydrochloride 2.5 mg Tablet, Chewable, 100-count
🆔 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...
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Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate Hydrochloride — tap one for details:
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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.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII E89I1637KE
Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
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UNII XJ6S9RV06F
Maltose is a simple sugar made from grain starches. It works as a sweetener and filler in medicines to improve taste and add bulk to tablets and powders.
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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 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
5 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 | $1.283 | $128.29 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.35 | $134.56 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.47 | $147.21 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride 2.5 mg 31722-0926-01 | Camber | 100 tablets | $1.283 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 2.5 mgthis 64980-0221-01 | Rising | 100 tablets | $1.283 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 2.5 mg 43386-0570-01 | Lupin | 100 tablets | $2.026 | — | FDA listed | +58% |
| Methylphenidate Hydrochloride 2.5 mg 63629-1921-01 | Bryant | 100 tablets | — | AB | Discontinued | — |
| Methylphenidate Hydrochloride 2.5 mg 72865-0125-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
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⏳ 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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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64980-0221-01 You're viewing this | 100 TABLET, CHEWABLE in 1 BOTTLE (64980-221-01) | 2018-12-18 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride 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, 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, 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 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 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, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing methylphenidate hydrochloride, 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 Chewable Tablets is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older Narcolepsy Methylphenidate Hydrochloride Chewable Tablets are a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch); titrate the dose in weekly increments of 5 mg to 10 mg. Daily dosages above 60 mg are not recommended. ( 2.2 ) Adults: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.
Maximum recommended daily dosage is 60 mg. ( 2.2 ) Administer with at least 8 ounces (a full glass) of water or other fluid. ( 2.2 )
2.1Pretreatment Screening Prior to treating patients with Methylphenidate Hydrochloride Chewable 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 Chewable Tablets [ see Warnings and Precautions ( 5.10 ) ].
2.2Recommended Dosage and Administration Information Pediatric Patients 6 years and Older The recommended starting dosage is 5 mg orally twice daily before breakfast and lunch (preferably 30 to 45 minutes before meals). Increase the dosage gradually, in increments of 5 mg to 10 mg weekly. Daily dosage above 60 mg is not recommended.
Adults Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. The maximum recommended dosage is 60 mg daily. The average dosage is 20 to 30 mg daily.
For adult patients who are unable to sleep if medication is taken late in the day, administer the last dose before 6 p.m. Administer Methylphenidate Hydrochloride Chewable Tablets with at least 8 ounces (a full glass) of water or other fluid. Do not swallow whole.
Taking this product without enough liquid may cause choking [ see Warnings and Precautions ( 5.11 ) ]
2.3Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue Methylphenidate Hydrochloride Chewable Tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue Methylphenidate Hydrochloride Chewable Tablets.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Chewable tablets: Each Methylphenidate Hydrochloride Chewable Tablet 2.5 mg is available as a white to off-white colored, grape flavored, rounded square shaped tablet with a convex surface, debossed with “τ” above “CHEW” on one side and “2.5” on the other side. Each Methylphenidate Hydrochloride Chewable Tablet 5 mg is available as a white to off-white colored, grape flavored, rounded square shaped tablet with a convex surface, debossed with “τ” above “CHEW” on one side and “5” on the other side.
Each Methylphenidate Hydrochloride Chewable Tablet 10 mg is available as a white to off-white colored, grape flavored, scored rounded square shaped tablet with a convex surface, debossed with “τ” bisect “CHEW” on one side and “10” on the other side. Chewable tablets: 2.5 mg, 5 mg, and 10 mg.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Methylphenidate Hydrochloride Chewable Tablets is contraindicated in patients: with a known hypersensitivity to methylphenidate or other components of Methylphenidate Hydrochloride Chewable Tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] . receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis [see Drug Interactions ( 7.1 )] .
Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride chewable tablets ( 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 Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac 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, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride. ( 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 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-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 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.
( 5.9 ) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating methylphenidate hydrochloride, 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 ) Risk of Choking: Taking this product without enough liquid may cause choking. Discontinue Methylphenidate Hydrochloride Chewable Tablets and seek immediate medical attention if chest pain, vomiting, difficulty in swallowing, or difficulty in breathing occur after administration. ( 5.11 )
5.1Abuse, Misuse, and Addiction Methylphenidate hydrochloride has a high potential for abuse and misuse. The use of methylphenidate hydrochloride exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. methylphenidate hydrochloride can be diverted for non-medical use into illicit channels or distribution [ see Drug Abuse and Dependence ( 9.2 , 9.3 ) ]. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride, 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, 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 chewable tablets in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride to anyone else.
Throughout methylphenidate hydrochloride treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.2Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were taking CNS stimulants at the recommended ADHD dosage. Avoid methylphenidate hydrochloride u…
🤒 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 chewable tablets [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7 )] 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 )] Risk of Choking [see Warnings and Precautions ( 5.11 )] The following adverse reactions associated with the use of methylphenidate containing products were identified in other clinical studies, postmarketing reports, or literature.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and infestations: nasopharyngitis Blood and the lymphatic system disorders: leukopenia, thrombocytopenia, anemia, pancytopenia Immune system disorders: hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas Metabolism and nutrition disorders: decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients Psychiatric disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, affect lability, mania, disorientation, libido changes Nervous system disorders: headache, dizziness, tremor, dyskinesia including choreoathetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine, motor and verbal tics Eye disorders: blurred vision, difficulties in visual accommodation, diplopia, mydriasis, increased intraocular pressure Cardiac disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, thoracic and mediastinal disorders: cough, pharyngolaryngeal pain, dyspnea Gastrointestinal disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea General disorders: fatigue, hyperpyrexia Hepatobiliary disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura, angioneurotic edema, erythema, fixed drug eruption Musculoskeletal and connective tissue disorders: arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching Renal and urinary disorders: hematuria Reproductive system and breast disorders: gynecomastia Urogenital disorders: priapism Vascular disorders: peripheral coldness, Raynaud’s phenomenon Investigations: weight loss Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-746…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.1 )
7.1Clinically Important Drug Interactions Table 1 presents clinically important drug interactions with methylphenidate hydrochloride. Table 1: Drugs Having Clinically Important Interactions with methylphenidate hydrochloride Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride, 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 with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact: Methylphenidate hydrochloride 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 may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention: Avoid use of methylphenidate hydrochloride 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
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. 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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults.
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 7 times the MRHD given to adults (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 65 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults 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 (12 times the MRHD of 60 mg/day given to adults 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 (4 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 (7 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adults 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 e…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. 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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults.
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 7 times the MRHD given to adults (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 65 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults 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 (12 times the MRHD of 60 mg/day given to adults 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 (4 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 (7 times the MRHD of 60 mg/day given to adults on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adults on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride for the treatment of ADHD have been established in pediatric patients six years of age and older. The safety and effectiveness of methylphenidate hydrochloride in pediatric patients under six years of age have not been established. The long-term efficacy of methylphenidate in pediatric patients has not been established.
Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7), Adverse Reactions (6.1)] . Juvenile Animal Toxicity Data 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 (5 mg/kg/day) is less than 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 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. 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 Hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy 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 subjects taking methylphenidate hydrochloride. 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 40 mg dexmethylphenidate hydrochloride extended-release capsule 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 Absorption Following oral administration of Methylphenidate Hydrochloride Chewable Tablets, peak plasma methylphenidate concentrations are achieved at about 1 to 2 hours. The mean C max following a 20 mg dose is approximately 10 ng/mL. No clinically significant difference in methlyphenidate pharmacokinetics was observed between Methylphenidate Hydrochloride Chewable Tablets and immediate-release methylphenidate hydrochloride tablet.
Effect of Food In a study in adult volunteers investigating the effects of a high-fat meal on the bioavailability of Methylphenidate Hydrochloride Chewable Tablets at a dose of 20 mg, the presence of food delayed the peak concentrations by approximately 1 hour (1.5 hours, fasted and 2.4 hours, fed). Overall, a high-fat meal increased the AUC of Methylphenidate Hydrochloride Chewable Tablets by about 20%, on average. Distribution Plasma protein binding is 10% to 33%.
The volume of distribution was 2.65 ±
1.11L/kg for d-methylphenidate and 1.80 ±
0.91L/kg for l-methylphenidate. Elimination The mean terminal half-life (t ½ ) of methylphenidate was 3 hours following administration of 20 mg Methylphenidate Hydrochloride Chewable Tablet. The systemic clearance is 0.40 ±
0.12L/h/kg for d-methylphenidate and 0.73 ±
0.28L/h/kg for l-methylphenidate. Metabolism In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.
Excretion After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose. The pharmacokinetics of the Methylphenidate Hydrochloride Chewable Tablets have been studied in healthy adult volunteers.
The mean terminal half-life (t½) of methylphenidate following administration of 20 mg Methylphenidate Hydrochloride Chewable Tablets is 3 hours. Specific Populations Male and Female Patients, Racial Groups, and Age The effect of gender, race, and age on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride chewable tablets administration have not been studied. Patients with Renal Impairment There is no experience with the use of Methylphenidate Hydrochloride Chewable Tablets in patients with renal insufficiency.
After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioact…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate Hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each Methylphenidate Hydrochloride Chewable Tablet 2.5 mg is available as a white to off-white colored, grape flavored, rounded square shaped tablet with a convex surface, debossed with “τ” above “CHEW” on one side and “2.5” on the other side. Bottles of 100 . . . . . . . . . NDC 64980-221-01 Each Methylphenidate Hydrochloride Chewable Tablet 5 mg is available as a white to off-white colored, grape flavored, rounded square shaped tablet with a convex surface, debossed with “τ” above “CHEW” on one side and “5” on the other side.
Bottles of 100 . . . . . . . . . NDC 64980-222-01 Each Methylphenidate Hydrochloride Chewable Tablet 10 mg is available as a white to off-white colored, grape flavored, scored rounded square shaped tablet with a convex surface, debossed with “τ” bisect “CHEW” on one side and “10” on the other side. Bottles of 100 . . . . . . . . .
NDC 64980-223-01 Protect from moisture. Dispense in tight container with child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. methylphenidate hydrochloride 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.
Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Chewable Tablets also contain the following inactive ingredients: microcrystalline cellulose, grape flavor, guar gum, maltose, stearic acid, and sucralose. methylphenidate-structure
💬 Medication Guide ▾
MEDICATION GUIDE (meth’’ il fen’ i date hye’’ droe klor’ ide) Methylphenidate Hydrochloride Chewable Tablets CII What is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets? Methylphenidate Hydrochloride Chewable Tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate Hydrochloride Chewable Tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of Methylphenidate Hydrochloride Chewable 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 Chewable 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 Chewable Tablets and will monitor you or your child during treatment.
Methylphenidate Hydrochloride Chewable Tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Methylphenidate Hydrochloride Chewable Tablets to anyone else. See “What is Methylphenidate Hydrochloride Chewable Tablets?” for more information.
Keep Methylphenidate Hydrochloride Chewable Tablets in a safe place and properly dispose of any unused medicine. See “How should I store Methylphenidate Hydrochloride Chewable 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 and during treatment with Methylphenidate Hydrochloride Chewable Tablets.
Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away 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 Chewable Tablets. • Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Chewable 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 Chewable Tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What is Methylphenidate Hydrochloride Chewable Tablets? Methylphenidate Hydrochloride Chewable Tablets is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: • Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.
Methylphenidate Hydrochloride Chewable Tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. • a sleep disorder called narcolepsy. It is not known if Methylphenidate Hydrochloride Chewable Tablets is safe and effective in children under 6 years of age. Methylphenidate Hydrochloride Chewable Tablets is a federally controlled substance (CII) b…