METHYLPHENIDATE HYDROCHLORIDE 20 mg Tablet, Extended Release, 100-count
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 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
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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.
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UNII Z78RG6M2N2
Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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 | $0.512 | $51.19 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.7913 | $79.13 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.04 | $104.08 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride 20 mg 00406-1473-01 | SpecGx | 100 tablets | $0.512 | AB | Discontinued | — |
| Methylphenidate Hydrochloride Extended Release 20 mg 10702-0076-01 | KVK-Tech, | 100 tablets | $0.512 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 20 mgthis 70010-0043-01 | Granules | 100 tablets | $0.512 | AB | Availability likely | — |
| Methylphenidate Hydrochloride 20 mg 51407-0528-01 | Golden | 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
💊 Medicaid utilization by pack size
🔬 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70010-0043-01 You're viewing this | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01) | $0.5119 / ea | $51.19 | 2018-12-17 | Active |
| 70010-0043-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-03) | — | — | 2022-10-31 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 70010-0043-01?
What is the difference between NDC 70010-0043-01 and NDC 70010-0043-03?
What NDC number is used to bill for this package of METHYLPHENIDATE HYDROCHLORIDE 20 mg Tablet, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage 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 methylphenidate hydrochloride extended-release tablets, 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) , Drug Abuse and Dependence ( 9.2 , 9.3 )] . WARNING: ABUSE, MISUSE AND ADDICTION See full prescribing information for complete boxed warning.
Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate 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 methylphenidate hydrochloride extended-release tablets, 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 in adults and pediatric patients 6 years and older are indicated for the treatment of: Attention deficit hyperactivity disorder (ADHD) Narcolepsy Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ] .
Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of adults and pediatric patients 6 years and older ( 1 ): • Attention deficit hyperactivity disorder (ADHD) and • Narcolepsy. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION N/A • Prior to initiating methylphenidate hydrochloride extended-release tablets treatment, assess each patient’s risk for ( 2.1 ): o Abuse, misuse, and addiction ( 5.1 ) o Presence of cardiac disease ( 5.2 ) o Developing a manic episode ( 5.4 ) o A family history of tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette syndrome • See the recommended dosage and administration in the Full Prescribing Information ( 2 ) • Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets.
2.1Pretreatment Screening Prior to treating patients with Methylphenidate hydrochloride extended-release tablets, assess: • The risk for abuse, misuse, and addiction [see Warnings and Precautions (5.1) ] . • 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 risk for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) [see Warnings and Precautions (5.4) ] . • For a family history for tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions (5.10) ]
2.2Recommended Dosage In pediatric patients 6 years of age and older, start with an immediate-release methylphenidate product 5 mg orally twice daily. Subsequently, switch to methylphenidate hydrochloride extended-release tablets 10 mg once daily. May gradually increase the methylphenidate hydrochloride extended-release tablets dosage.
The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in pediatric patients 6 years of age and older is 60 mg per day. In adult patients, the recommended oral dosage of methylphenidate hydrochloride extended-release tablets is 20 mg or 30 mg daily. The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in adults is 60 mg per day.
Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets.
2.3Dosage Reduction and Discontinuation If paradoxical aggravation of ADHD or narcolepsy symptoms or methylphenidate hydrochloride extended-release tablets-associated adverse reactions occur, reduce the methylphenidate hydrochloride extended-release tablets dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release tablets. If improvement is not observed after appropriate dosage modification over a one-month period, discontinue methylphenidate hydrochloride extended-release tablets.
2.4Starting Methylphenidate Hydrochloride Extended-Release Tablets After Use of a Monoamine Oxidase Inhibitor Must wait at least 14 days after stopping a monoamine oxidase (MAO) inhibitor before starting methylphenidate hydrochloride extended-release tablets [see Contraindications (4) and Drug Interactions (7) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 10 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and plain on other side. 20 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and plain on other side. Extended-release tablets: 10 mg and 20 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Methylphenidate Hydrochloride Extended-Release Tablets are contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ see Adverse Reactions (6) ]. Receiving concomitant monoamine oxidase inhibitors (MAOIs), or those that discontinued treatment with an MAOI in the last 14 days, because of the risk of hypertensive crises [ see Drug Interactions (7) ].
Patients with pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received an amphetamine product. Methylphenidate hydrochloride extended-release tablets are contraindicated in patients ( 4 ): With known hypersensitivity to methylphenidate or other product components of Methylphenidate hydrochloride extended-release tablets.
(4) Receiving concomitant monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4) . Patients with pheochromocytoma or a history of pheochromocytoma ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS N/A • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac 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: If new psychotic or manic symptoms occur, consider discontinuing Methylphenidate hydrochloride extended-release Tablets. ( 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: Carefully assess for digital changes 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 ( 5.6 ) • 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 Methylphenidate hydrochloride extended-release tablets treatment interrupted. ( 5.7 ) • 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.
( 5.8 ) • Increased Intraocular Pressure (IOP) 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. ( 5.9 ) • Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Regularly monitor patients for the emergence or Methylphenidate hydrochloride extended-release tablets worsening of tics or Tourette's syndrome.
Discontinue Methylphenidate hydrochloride extended-release tablets treatment if clinically appropriate. ( 5.10 )
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 [see Drug Abuse and Dependence ( 9.1 , 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 dosage 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 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 treated with CNS stimulants at the recommended ADHD dosage. Prior to treating patients with methylphenidate hydrochloride extended-release tablets, assess for the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Avoid methylph…
🤒 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 ) ] Hypersensitivity Reactions [ see Contraindications (4) ] Hypertensive crisis with Concomitant Use of 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) ] The following adverse reactions associated with the use of methylphenidate were identified in clinical trials, spontaneous reports, and literature.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported with Methylphenidate Hydrochloride Extended-Release Tablets • Infections and Infestations: nasopharyngitis • Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia, anemia • Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis • 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 • Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs • Eye Disorders: blurred vision, difficulties in visual accommodation • Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris • Respiratory, Thoracic and Mediastinal Disorders: cough • Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia • 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 • Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis • Investigations: weight loss (adult ADHD patients) Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions reported with other methylphenidate-containing products. • Blood and Lymphatic Disorders: pancytopenia • Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas • Psychiatric Disorders: affect lability, mania, disorientation and libido changes • Nervous System Disorders: migraine • Eye Disorders: diplopia, mydriasis • Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole • Vascular Disorders: peripheral coldness, Raynaud's phenomenon • Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea • Gastrointestinal Disorders: diarrhea, constipation • Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption • Muscul…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1 presents clinically significant drug interactions with methylphenidate hydrochloride extended-release tablets. Table 1: Clinically Significant Drug Interactions with Methylphenidate Hydrochloride Extended-Release Tablets Monoamine Oxidase Inhibitors (MAOI) Prevention or Management Concomitant use of methylphenidate hydrochloride extended-release tablets with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [see Contraindications (4) ] . Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can cause hypertensive crisis.
Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) Methylphenidate hydrochloride extended-release tablets may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ] .
Halogenated Anesthetics Prevention or Management Avoid use of methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of methylphenidate hydrochloride extended-release tablets and halogenated anesthetics may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms.
Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant methylphenidate hydrochloride extended-release tablets when there is a change in the methylphenidate hydrochloride extended-release tablets or risperidone dosage. Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7) See additional clinically significant drug interactions, in the DRUG INTERACTIONS section ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS N/A
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants use during pregnancy [see Clinical Considerations] . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.
A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The background risk of major birth defects and miscarriage in those with ADHD or narcolepsy 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 extended-release tablets, 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 In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis).
There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis).
8.2Lactation Risk Summary Limited published literature, based on milk sampling from a small number of methylphenidate-treated lactating women, 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.…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants use during pregnancy [see Clinical Considerations] . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.
A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The background risk of major birth defects and miscarriage in those with ADHD or narcolepsy 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 extended-release tablets, 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 In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2 basis).
There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of ADHD and narcolepsy have been established in pediatric patients 6 years of age and older. The safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage.
Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored during treatment with CNS stimulants, including Methylphenidate hydrochloride extended-release tablets.
Pediatric patients who are not growing or gaining weight as expected may need to have their methylphenidate hydrochloride extended-release tablets treatment interrupted [ see Warnings and Precautions (5.7) ] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only.
The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use Methylphenidate hydrochloride tablet has not been studied in the geriatric population.
🆘 Overdosage ▾
10 OVERDOSAGE Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.
Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI).
Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.
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. • Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI).
10.2Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release tablets should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful.
If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY N/A
12.1Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
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. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of methylphenidate hydrochloride extended-release tablets have not been fully characterized.
Cardiac Electrophysiology A formal QT study has not been conducted in patients who received Methylphenidate hydrochloride extended-release tablets. The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Methylphenidate hydrochloride tablets on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) 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 (CI) 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 Methylphenidate hydrochloride in methylphenidate hydrochloride extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the Methylphenidate hydrochloride tablet measured by the urinary excretion of Methylphenidate hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Methylphenidate hydrochloride tablets and 4.7 hours (1.3 to 8.2 hours) for the Methylphenidate hydrochloride extended-release tablets.
An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults. Effect of Food: After a high-fat meal, both area under the curve (AUC) (by 25%) and C max (by 27%) are higher. Time to C max (T max ) is faster after a high-fat meal (median T max : 2.5 hours) as compared to without food (median T max : 3 hours).
Distribution Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ±
1.11L/kg for d-methylphenidate and 1.8 ±
0.91L/kg for l-methylphenidate. Elimination The systemic clearance is 0.4 ±
0.12L/h/kg for d-methylphenidate and 0.73 ±
0.28L/h/kg for l-methylphenidate. Metabolism: Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Excretion: After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.
Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for Methylphenidate hydrochloride extended-release tablets. Studies in Specific Populations Male and Female Patients: In a clinical study involving adult subjects who received Methylphenidate hydrochloride extended-release tablets plasma concentrations of Methylphenidate hydrochloride's major metabolite appeared to be greater in females than in males.
No gender differences were…
🧬 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. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases 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 as follows: 10 mg: White to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and plain on other side. Bottles of 30 tablets NDC 70010-042-03 Bottles of 100 tablets NDC 70010-042-01 20 mg: White to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and plain on other side. Bottles of 30 tablets NDC 70010-043-03 Bottles of 100 tablets NDC 70010-043-01 NOTE : Methylphenidate hydrochloride extended-release tablets, USP are color-additive free.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength 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. Its molecular weight is 269.77 g/mol.
Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str
💬 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 ( 9.1 , 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 and their caregivers 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 and their caregivers 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 methylphenidate hydrochloride extended-release tablets-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [ see Warnings and Precautions (5.5) ] .
Peripheral Vasculopathy, including Raynaud’s Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms; to report to their health care provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their health care provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release tablets [ see Warnings and Precautions (5.6) ] .
Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that Methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss in pediatric patients [ see Warnings and Precautions (5.7) ]. Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during methylphenidate hydrochloride extended-release tablets treatment [see Warnings and Precautions (5.9) ] . Motor and Verbal Tics, and Worsening of Tourette's Syndrome Advise patients that motor and verbal tics and worsening of Tourette's Syndrome may occur during methylphenidate hydrochloride extended-release tablets treatment.
Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Warnings and Precautions (5.10) ] . Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Methylphenidate hydrochloride extended-release tablets during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Advise methylphenidate hydrochloride extended-release tablets-treated breastfeeding women to monitor their infants for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2) ] .
The Medication Guide may also be obtained by calling 1-877-770-3183. Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 R…
💬 Medication Guide ▾
MEDICATION GUIDE MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Tablets (meth" il fen' i date hye" droe klor' ide), for oral use, CII 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 have a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of methylphenidate hydrochloride extended-release 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. o 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. o Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give methylphenidate hydrochloride extended-release tablets to anyone else because it may cause death or harm them.
See " What are Methylphenidate hydrochloride extended-release tablets? " for more information. o 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. o 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 or go to the nearest hospital emergency room right away if you or your child develop 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 problems (psychiatric reactions), including: o worsening behavior or thought problems in people with thought or psychotic disorders o maniac episodes in people with bipolar disorder o new psychotic or manic symptoms in people without bipolar or psychotic disorders Tell your healthcare provider right away if any mental symptoms or problems develop or worsen during treatment with methylphenidate hydrochloride extended-release tablets, including: o greatly increased energy o severe trouble sleeping o racing thoughts o reckless behavior o unusually grand ideas o excessive happiness or irritability o talking more or faster than usual o seeing or hearing things that are not real (hallucinations).
See " What are the possible side effects of methylphenidate hydrochloride extended-release tablets? " for more information about side effects. What are Methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release 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 extended-release tablets may help increase attention and decrease impulsiveness…