Dexmethylphenidate Hydrochloride 5 mg Tablet, 100-count — NDC 67877-656-01 (Billing 67877-0656-01)
This is a package of 100 tablets of Dexmethylphenidate Hydrochloride 5 mg Tablet from Ascend Laboratories, LLC, marketed since Jul 2019 and currently FDA-listed; retail pharmacies pay about $0.2698 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Other active recalls for Dexmethylphenidate Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048983
- GCN: 14974
- GPI-14 (Medi-Span): 61400016100330
- HICL (First Databank): 022987
- AHFS class code: 28:20.32.00
- RxCUI (RxNorm): 899518
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Dexmethylphenidate treats ADHD. It's a stimulant that comes as tablets or extended-release capsules. The label says exactly how it helps ADHD isn't known, but it does affect the br...
- Tablets are taken twice a day, at least 4 hours apart. Extended-release capsules are taken once in the morning. You can open the capsule and sprinkle the beads on applesauce, but e...
- Headache, lower appetite, indigestion and anxiety are common. Adults may also get dry mouth, a sore throat or feel jittery. Call your doctor for hallucinations, painful long erecti...
- Never take it with an MAOI or within 14 days of stopping one, since that can cause a dangerous blood pressure spike. It can also weaken blood pressure medicines and interact with r...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.270 | $26.98 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4967 | $49.67 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2385 | $23.85 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 67877-0656-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | $0.2698 / ea | $26.98 | 2019-07-21 | — | Active |
| 67877-0656-05 67877-656-05 | 500 TABLET in 1 BOTTLE | — | — | 2019-07-21 | — | Active |
| 67877-0656-30 67877-656-30 | 30 TABLET in 1 BOTTLE | — | — | 2019-07-21 | — | Active |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 67877-0656-30?
What NDC number is used to bill for this package of Dexmethylphenidate Hydrochloride 5 mg Tablet?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride 5 mg 43386-0860-01 | Lupin | 100 tablets | $0.188 | AB | FDA listed | save 30% |
| Dexmethylphenidate Hydrochloride 5 mg 10702-0107-01 | KVK-TECH, | 100 tablets | $0.270 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride 5 mg 27808-0092-01 | Cranbury | 100 tablets | $0.270 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride 5 mgthis 67877-0656-01 | Ascend | 100 tablets | $0.270 | AB | Availability likely | — |
| Dexmethylphenidate hydrochloride 5 mg 75834-0327-01 | Nivagen | 100 tablets | $0.270 | AB | Availability likely | — |
| Focalin 5 mg 00078-0381-05 | Novartis | 100 tablets | $0.921 | AB | Discontinued | +241% |
| Focalin 5 mg 66758-0251-01 | Sandoz | 100 tablets | $0.923 | AB | Availability likely | +242% |
| Dexmethylphenidate Hydrochloride 5 mg 55466-0122-12 | Neolpharma, | 100 tablets | — | AB | Discontinued | — |
| Dexmethylphenidate hydrochloride 5 mg 57664-0378-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| Dexmethylphenidate Hydrochloride 5 mg 63629-2306-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Dexmethylphenidate Hydrochloride 5 mg 72162-1285-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Dexmethylphenidate hydrochloride 5 mg 72162-2426-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE AND DEPENDENCE WARNING: ABUSE AND DEPENDENCE CNS stimulants, including Dexmethylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] . See full prescribing information for complete boxed warning.
CNS stimulants, including Dexmethylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence ( 5.1 , 9.2 , 9.3 ). Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy ( 5.1 , 9.2 ).
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Administer orally twice daily, 4 hours apart with or without food ( 2 ). For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily) ( 2.2 ). For patients currently taking methylphenidate: Initiate dexmethylphenidate hydrochloride therapy with half (1/2) the current total daily dose of methylphenidate ( 2.
2). Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) ( 2.2 ).
2.1Pretreatment Screening Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including dexmethylphenidate hydrochloride, 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 )]. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for dexmethylphenidate hydrochloride tablet use [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence (9.2, 9.3 )].
2.2Pediatric Patients With Attention Deficit Hyperactivity Disorder Patients New to Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride for pediatric patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg daily (2.5 mg twice daily) with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride for pediatric patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.
Titration Schedule The dose may be titrated weekly in increments of 2.5 to 5 mg to a maximum of 20 mg daily (10 mg twice daily). The dose should be individualized according to the needs and response of the patient. Maintenance/Extended Treatment Pharmacological treatment of ADHD may be needed for extended periods.
Periodically reevaluate the long-term use of dexmethylphenidate hydrochloride tablet and adjust dosage as needed.
2.3Administration Instructions Dexmethylphenidate hydrochloride tablet is administered orally twice daily, at least 4 hours apart.
2.4Dose Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue dexmethylphenidate hydrochloride tablet. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Dexmethylphenidate hydrochloride tablets are round uncoated tablet, debossed with “DM” on one side and dosage strength on other side in the following colors: 2.5 mg tablets – light blue to blue 5 mg tablets – light yellow to yellow 10 mg tablets – white to off white 2.5 mg and 5 mg tablets may have mottled appearance. Tablets: 2.5 mg, 5 mg, and 10 mg (3).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablet. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )].
Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablet (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 Serious Cardiovascular Events : Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, arrhythmias, or coronary artery disease ( 5.2 ).
Blood Pressure and Heart Rate Increases : Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic ( 5.3 ). Psychotic Adverse Reactions : Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness.
Evaluate for preexisting psychotic or bipolar disorder prior to dexmethylphenidate hydrochloride use ( 5.4 ). Priapism : Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed ( 5.5 ).
Peripheral Vasculopathy, Including Raynaud’s Phenomenon : Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants ( 5.6 ). Long-Term Suppression of Growth : Monitor height and weight at appropriate intervals in the pediatric population ( 5.7 ).
5.1Potential for Abuse and Dependence CNS stimulants, including dexmethylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence ( 9.2 , 9.3 )].
5.2Serious Cardiovascular Reactions Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.
Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during dexmethylphenidate hydrochloride treatment.
5.3Blood Pressure and Heart Rate Increases CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
5.4Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Induction of a Manic Episode in Patients With Bipolar Disorder CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing dexmethylphenidate hydrochloride tablet. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic, or manic symptoms occurred in appr… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride tablet [see Contraindications ( 4 )] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] Serious Cardiovascular Reactions [see Warnings and Precautions ( 5.2 )] Blood Pressure and Heart Rate Increases [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 [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASCRX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience With dexmethylphenidate hydrochloride in Pediatric Patients With ADHD The safety data in this section is based on data related to dexmethylphenidate hydrochloride exposure during the premarketing development program in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects).
These participants received dexmethylphenidate hydrochloride tablets 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 open-label long-term safety studies. Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): abdominal pain, fever, anorexia, and nausea Adverse Reactions Leading to Discontinuation : Overall, 50 of 684 (7.3%) pediatric patients treated with dexmethylphenidate hydrochloride tablet experienced an adverse reaction that resulted in discontinuation.
The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each). Table 1 enumerates adverse reactions for two, placebo-controlled, parallel group studies in pediatric patients with ADHD taking dexmethylphenidate hydrochloride tablet doses of 5, 10, and 20 mg/day. The table includes only those reactions that occurred in patients treated with Dexmethylphenidate hydrochloride for which the incidence was at least 5% and twice the incidence among placebo-treated patients.
Table 1: Common Adverse Reactions in Pediatric Patients (6 to 17 years of age) With ADHD System Organ Class Adverse Reactions Dexmethylphenidate hydrochloride (N = 79) Placebo (N = 82) Body as a Whole Abdominal pain 15% 6% Fever 5% 1% Digestive System Anorexia 6% 1% Nausea 9% 1% Abbreviation: ADHD, attention deficit hyperactivity disorder.
6.2Postmarketing Experience The following additional adverse reactions have been identified during post approval use of dexmethylphenidate. Because these reactions are 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. Musculoskeletal: rhabdomyolysis Immune System Disorders : hypersensitivity reactions, such as angioedema, anaphylactic reactions Adverse Reactions Reported With All Ritalin and dexmethylphenidate hydrochloride Formulations The following adverse… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). Halogenated Anesthetics: Avoid use of dexmethylphenidate hydrochloride tablet on the day of surgery if halogenated anesthetics will be used ( 7.1 ).
7.1Clinically Important Drug Interactions With dexmethylphenidate hydrochloride Table 2 presents clinically important drug interactions with dexmethylphenidate hydrochloride. Table 2: Clinically Important Drug Interactions With dexmethylphenidate hydrochloride Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including dexmethylphenidate 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 dexmethylphenidate hydrochloride with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Dexmethylphenidate hydrochloride may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3)] . Intervention Adjust the dosage of the antihypertensive drug as needed.
Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and dexmethylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Monitor blood pressure and avoid use of dexmethylphenidate hydrochloride in patients being treated with anesthetics on the day of surgery.
Examples halothane, isoflurane, enflurane, desflurane, sevoflurane 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 dexmethylphenidate hydrochloride 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 Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate.
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). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels.
A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels. Plasma levels in adults were comparatively similar to plasma levels in adolescents (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as dexmethylphenidate 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, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats.
When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the MRHD of 20 mg/day. Racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.
8.2Lactation Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production.
Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride tablets and any potential ad… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate hydrochloride 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 Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate.
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). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels.
A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels. Plasma levels in adults were comparatively similar to plasma levels in adolescents (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as dexmethylphenidate 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, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats.
When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the MRHD of 20 mg/day. Racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dexmethylphenidate hydrochloride tablets have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see Clinical Studies (14)]. The safety and effectiveness of dexmethylphenidate hydrochloride tablets in pediatric patients less than 6 years have not been established. The long-term efficacy of dexmethylphenidate hydrochloride tablets in pediatric patients has not been established.
Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride tablets. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)]. Juvenile Animal Toxicity Data Rats treated with racemic 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 6 times the MRHD of 60 mg/day given to children on a mg/m 2 basis. In a study conducted in young rats, racemic 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 of racemic methylphenidate 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 Dexmethylphenidate hydrochloride tablets has not been studied in the geriatric population.
🆘 Overdosage ▾
10 OVERDOSAGE Human Experience Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes, and rhabdomyolysis.
Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for latest recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics Pharmacodynamics Dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Cardiac Electrophysiology A formal QT study has not been conducted in patients taking dexmethylphenidate hydrochloride tablet; however, a large QT effect is not expected.
At the recommended maximum total daily dosage of 40 mg, dexmethylphenidate hydrochloride extended-release capsule does not prolong the QTc interval to any clinically relevant extent.
12.3Pharmacokinetics Absorption Dexmethylphenidate hydrochloride is readily absorbed following oral administration of dexmethylphenidate hydrochloride. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1.5 hours postdose. No differences in the pharmacokinetics of dexmethylphenidate hydrochloride tablets were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.
After single dose administration of dexmethylphenidate hydrochloride to pediatric patients, dexmethylphenidate exposure (C max and AUC 0-inf ) showed dose-proportional increase in the range of 2.5 mg to 10 mg. Comparable plasma dexmethylphenidate levels were achieved following single dl-threo- methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to dexmethylphenidate hydrochloride). Approximately 90% of the dose is absorbed after oral administration of radiolabeled racemic methylphenidate.
However, due to first pass metabolism the mean absolute bioavailability of dexmethylphenidate when administered in various formulations was 22% to 25%. Effect of Food High fat breakfast did not significantly affect C max or AUC 0-inf of dexmethylphenidate when two 10 mg dexmethylphenidate hydrochloride tablets were administered, but delayed T max from 1.5 hours post dose to 2.9 hours post dose. Distribution The plasma protein binding of dexmethylphenidate is not known; racemic methylphenidate is bound to plasma proteins by 12% to 15%, independent of concentration.
Dexmethylphenidate shows a volume of distribution of 2.65 ±
1.11L/kg. Elimination Plasma dexmethylphenidate concentrations declined exponentially following oral administration of dexmethylphenidate hydrochloride. Intravenous dexmethylphenidate was eliminated with a mean clearance of 0.40 ±
0.12L/hr/kg. The mean terminal elimination half-life of dexmethylphenidate was approximately 2.2 hours. Metabolism In humans, dexmethylphenidate is metabolized primarily via de-esterification to d-α-phenyl-piperidine acetic acid (also known as d -ritalinic acid).
This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l-threo -enantiomer. Excretion After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine.
The main urinary metabolite of racemic dl- methylphenidate was dl- ritalinic acid, accountable for approximately 80% of the dose. Urinary excretion of parent compound accounted for 0.5% of an intravenous dose. Studies in Special Populations Male and Female Patients Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).
In a single dose study conducted in adults, the mean dexmethylphenidate AUC 0-inf values (adjusted for body weight) following single two 10 mg doses of dexmethylphenidate hydrochloride tablet were 25% to 35% higher in adult female volunteers (n = 6) compared to male volunteers (n = 9). Both T max and t 1/2 were comparable for males and females. Racial or Ethnic Groups There is… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets: Round, light blue to blue uncoated tablet, debossed with “DM” on one side and “2.5” on other side, may have mottled appearance. Bottle of 30………………………………………………….NDC 67877-655-30 Bottle of 100………………………………………………...NDC 67877-655-01 Bottle of 500………………………………………………...NDC 67877-655-05 5 mg Tablets: Round, light yellow to yellow uncoated tablet, debossed with “DM” on one side and “5” on other side, may have mottled appearance. Bottle of 30………………………………………………….NDC 67877-656-30 Bottle of 100………………………………………………...NDC 67877-656-01 Bottle of 500………………………………………………...NDC 67877-656-05 10 mg Tablets: Round, white to off white uncoated tablet, debossed with “DM” on one side and “10” on other side.
Bottle of 30………………………………………………….NDC 67877-657-30 Bottle of 100………………………………………………...NDC 67877-657-01 Bottle of 500………………………………………………...NDC 67877-657-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants.
Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride tablet by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix dexmethylphenidate hydrochloride tablet with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard dexmethylphenidate hydrochloride tablet in the household trash.
📋 Description ▾
11 DESCRIPTION Dexmethylphenidate hydrochloride tablet contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration.
Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note: * = asymmetric carbon centers Dexmethylphenidate hydrochloride is a white to off-white powder.
Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.
Inactive ingredients: anhydrous lactose, citric acid anhydrous, colloidal silicon dioxide, D & C Yellow # 10 (5 mg tablets), Lake Pigment HT 5516 FD&C Blue # 1 (2.5 mg tablets), magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate; the 10 mg tablet contains no dye. dexmethyl-fig1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence Advise patients that dexmethylphenidate hydrochloride is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give dexmethylphenidate hydrochloride tablet to anyone else.
Advise patients to store dexmethylphenidate hydrochloride tablet in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired dexmethylphenidate hydrochloride tablet by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.1 , 9.2 , 9.3 ), How Supplied/Storage and Handling ( 16 )] .
Serious Cardiovascular Risks Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with dexmethylphenidate hydrochloride tablet 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 )]. Blood Pressure and Heart Rate Increases Instruct patients that dexmethylphenidate hydrochloride tablet can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions ( 5.3 )] .
Psychiatric Risks Advise patients that dexmethylphenidate hydrochloride tablet, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )]. Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.5 )] .
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients beginning treatment with dexmethylphenidate hydrochloride tablet about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking dexmethylphenidate hydrochloride tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] . Suppression of Growth Advise patients that dexmethylphenidate hydrochloride tablets may cause slowing of growth and weight loss [see Warnings and Precautions ( 5.7 )].
Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including dexmethylphenidate hydrochloride tablets, during pregnancy [see Use in Specific Populations ( 8.1 )]. Manufactured by: Alkem Laboratories 1733 Gilsinn Lane, Fenton, MO 63026 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: September, 2021
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production.
Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride tablets and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride tablets or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Dexmethylphenidate hydrochloride is readily absorbed following oral administration of dexmethylphenidate hydrochloride. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1.5 hours postdose. No differences in the pharmacokinetics of dexmethylphenidate hydrochloride tablets were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.
After single dose administration of dexmethylphenidate hydrochloride to pediatric patients, dexmethylphenidate exposure (C max and AUC 0-inf ) showed dose-proportional increase in the range of 2.5 mg to 10 mg. Comparable plasma dexmethylphenidate levels were achieved following single dl-threo- methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to dexmethylphenidate hydrochloride). Approximately 90% of the dose is absorbed after oral administration of radiolabeled racemic methylphenidate.
However, due to first pass metabolism the mean absolute bioavailability of dexmethylphenidate when administered in various formulations was 22% to 25%. Effect of Food High fat breakfast did not significantly affect C max or AUC 0-inf of dexmethylphenidate when two 10 mg dexmethylphenidate hydrochloride tablets were administered, but delayed T max from 1.5 hours post dose to 2.9 hours post dose. Distribution The plasma protein binding of dexmethylphenidate is not known; racemic methylphenidate is bound to plasma proteins by 12% to 15%, independent of concentration.
Dexmethylphenidate shows a volume of distribution of 2.65 ±
1.11L/kg. Elimination Plasma dexmethylphenidate concentrations declined exponentially following oral administration of dexmethylphenidate hydrochloride. Intravenous dexmethylphenidate was eliminated with a mean clearance of 0.40 ±
0.12L/hr/kg. The mean terminal elimination half-life of dexmethylphenidate was approximately 2.2 hours. Metabolism In humans, dexmethylphenidate is metabolized primarily via de-esterification to d-α-phenyl-piperidine acetic acid (also known as d -ritalinic acid).
This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l-threo -enantiomer. Excretion After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine.
The main urinary metabolite of racemic dl- methylphenidate was dl- ritalinic acid, accountable for approximately 80% of the dose. Urinary excretion of parent compound accounted for 0.5% of an intravenous dose. Studies in Special Populations Male and Female Patients Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).
In a single dose study conducted in adults, the mean dexmethylphenidate AUC 0-inf values (adjusted for body weight) following single two 10 mg doses of dexmethylphenidate hydrochloride tablet were 25% to 35% higher in adult female volunteers (n = 6) compared to male volunteers (n = 9). Both T max and t 1/2 were comparable for males and females. Racial or Ethnic Groups There is insufficient experience with the use of dexmethylphenidate hydrochloride to detect ethnic variations in pharmacokinetics.
Pediatric Patients The pharmacokinetics of dexmethylphenidate after dexmethylphenidate hydrochloride tablet administration have not been studied in children less than 6 years of age. When single doses of dexmethylphenidate hydrochloride tablet were given to children between the ages of 6 to 12 years and healthy adult volunteers, C max of dexmethylphenidate was similar, however, pediatric patients showed somewhat lower AUCs compared to the adults. Patients with Renal Impairment There is no experience with the use of dexmethylphenidate hydrochloride tablet in patients with renal impairment.
Since renal clearance is not an important route of methylphenidate clearance, renal impairment is… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pharmacodynamics Dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Cardiac Electrophysiology A formal QT study has not been conducted in patients taking dexmethylphenidate hydrochloride tablet; however, a large QT effect is not expected.
At the recommended maximum total daily dosage of 40 mg, dexmethylphenidate hydrochloride extended-release capsule does not prolong the QTc interval to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of dexmethylphenidate hydrochloride tablet for the treatment of ADHD was established in two double-blind, parallel-group, placebocontrolled trials in untreated or previously treated patients (ages 6 to 17 years old) who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. The sample was predominantly younger (ages 6 to 12 years); thus, the findings are most pertinent to this age group.
In Study 1, patients were randomized to receive either dexmethylphenidate hydrochloride tablet (5, 10, or 20 mg/day total dose), racemic methylphenidate HCl (10, 20, or 40 mg/day total dose), or placebo in a multicenter, 4-week, parallel group study in 132 pediatric patients. Patients received study medication twice daily separated by a 3.5 to 5.5 hours interval. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose.
The primary outcome was change from baseline to week 4 of the average score (an average of 2 ratings during the week) of the teacher’s version of the Swanson, Nolan and Pelham (SNAP)-ADHD Rating Scale. This 18 item scale measures ADHD symptoms of inattention and hyperactivity/impulsivity, rated on a scale of 0 (Not at All) to 3 (Very Much). Patients treated with dexmethylphenidate hydrochloride tablet showed a statistically significant improvement in symptom scores from baseline over patients who received placebo (Table 3).
Table 3: Summary of Efficacy Results from ADHD Acute-Phase Study in Pediatric Patients (6 – 17 years) (Study 1) Study Number Treatment Group Primary Efficacy Measure: Teacher SNAP-ADHD Total Score a Mean Baseline Score (SD) Mean Change from Baseline Week 4 Score (SD) Study 1 Dexmethylphenidate hydrochloride 5-20 mg/day b (n = 44) 1.4 (0.7) (n = 42) - 0.7 (0.7) (n = 42) Placebo (n = 42) 1.6 (0.7) (n = 41) - 0.2 (0.7) (n = 39) Abbreviations: ADHD, attention deficit hyperactivity disorder; SD, standard deviation; SNAP; swanson, Nolan and Pelham; n, number of patients available at the assessment time point. a Average of two ratings. b Statistically significantly different from placebo.
Study 2 was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in 75 children (ages 6 to 12 years) who were responders during a 6-week, open-label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression - Improvement (CGI-I).
Patients continued on dexmethylphenidate hydrochloride tablet showed a statistically significant lower rate of failure over patients who received placebo (Table 4). Table 4: Summary of Efficacy Results from ADHD Randomized Withdrawal Study in Pediatric Patients (6 – 17 years) (Study 2) Study Number Treatment Group Primary Efficacy Measure: Proportion of Treatment Failure a Number of Treatment Failures /Number of Randomized Patients Percentage Study 2 Dexmethylphenidate hydrochloride 5-20 mg/day b 6/35 17.1% Placebo 25/40 62.5% Abbreviation: ADHD, attention deficit hyperactivity disorder. a One patient did not have the value at Visit 10 and hence not included in this analysis. b Statistically significantly different from placebo.
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE
9.1Controlled Substance Dexmethylphenidate hydrochloride tablet contains dexmethylphenidate hydrochloride, a Schedule II controlled substance.
9.2Abuse CNS stimulants, including dexmethylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving. Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain.
Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see Overdosage ( 10 )] . To reduce the abuse of CNS stimulants, including dexmethylphenidate hydrochloride, assess the risk of abuse prior to prescribing.
After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants [see How Supplied/Storage and Handling ( 16 )] , monitor for signs of abuse while on therapy, and reevaluate the need for dexmethylphenidate hydrochloride use.
9.3Dependence Tolerance Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including dexmethylphenidate hydrochloride. Dependence Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) can occur in patients treated with CNS stimulants, including dexmethylphenidate hydrochloride.
Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
🔒 Controlled Substance ▾
9.1Controlled Substance Dexmethylphenidate hydrochloride tablet contains dexmethylphenidate hydrochloride, a Schedule II controlled substance.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/day of racemic methylphenidate given to children on a mg/m 2 basis.
Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown.
Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) of 60 mg/day of racemic methylphenidate on a mg/m 2 basis. In a 24-week carcinogenicity study with racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60-74 mg/kg/day of racemic methylphenidate.
Mutagenesis Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vivo mouse bone marrow micronucleus test. In an in vitro assay using cultured Chinese Hamster Ovary cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available.
Fertility studies have not been conducted with dexmethylphenidate. Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day of racemic methylphenidate given adolescents on a mg/m 2 basis.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/day of racemic methylphenidate given to children on a mg/m 2 basis.
Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown.
Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) of 60 mg/day of racemic methylphenidate on a mg/m 2 basis. In a 24-week carcinogenicity study with racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60-74 mg/kg/day of racemic methylphenidate.
Mutagenesis Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vivo mouse bone marrow micronucleus test. In an in vitro assay using cultured Chinese Hamster Ovary cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available.
Fertility studies have not been conducted with dexmethylphenidate. Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day of racemic methylphenidate given adolescents on a mg/m 2 basis.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC 67877-655-01 Dexmethylphenidate Hydrochloride Tablets 2.5 mg 100 Tablets Dispense medication Guide attached or provided separately. Rx Only NDC 67877-656-01 Dexmethylphenidate Hydrochloride Tablets 5 mg 100 Tablets Dispense medication Guide attached or provided separately. Rx Only NDC 67877-657-01 Dexmethylphenidate Hydrochloride Tablets 10 mg 100 Tablets Dispense medication Guide attached or provided separately. dexmethyl-2pt5mg-1 dexmethyl-5mg-1 dexmethyl-10mg-1