DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg Capsule, Extended Release, 100-count
Other active recalls for Dexmethylphenidate 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
- Dexmethylphenidate is essentially the more active half of methylphenidate — think of it as a more refined version. Regular methylphenidate (like Ritalin) is a mix of two mirror-ima...
- What exactly is dexmethylphenidate and how is it different from regular methylphenidate (Ritalin)?
- Either way is fine — dexmethylphenidate can be taken with or without food. If you're taking the extended-release capsule and you can't swallow it whole, you can open it and sprinkl...
- Should I take this with food or on an empty stomach?
Patient education
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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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.556 | $155.58 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.79 | $179.25 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $2.39 | $238.58 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride 10 mg 00093-5551-01 | Teva | 100 capsules | $1.556 | AB | Availability likely | — |
| Dexmethylphenidate hydrochloride 10 mg 00115-9919-01 | Amneal | 100 capsules | $1.556 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride Extended-Release 10 mg 00527-8107-37 | Lannett | 100 capsules | $1.556 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride 10 mg 31722-0230-01 | Camber | 100 capsules | $1.556 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride 10 mg 49884-0049-01 | Par | 100 capsules | $1.556 | AB | Availability likely | — |
| Dexmethylphenidate Hydrochloride 10 mgthis 70010-0005-01 | Granules | 100 capsules | $1.556 | AB | Availability likely | — |
| Focalin XR 10 mg 00078-0431-05 | Novartis | 100 capsules | $4.761 | AB | Discontinued | +206% |
| Focalin XR 10 mg 66758-0236-01 | Sandoz | 100 capsules | $4.762 | AB | Availability likely | +206% |
| Dexmethylphenidate Hydrochloride 10 mg 63629-2171-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| Dexmethylphenidate Hydrochloride 10 mg 72162-1473-01 | Bryant | 100 capsules | — | 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
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70010-0005-01 You're viewing this | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-005-01) | 2020-12-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE AND DEPENDENCE WARNING: ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate hydrochloride extended-release capsules has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing dexmethylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dexmethylphenidate hydrochloride extended-release capsules 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) ] .
WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Dexmethylphenidate hydrochloride extended-release capsules has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, can result in overdose and death ( 5.1 , 9.2 , 10 ).
Before prescribing dexmethylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14 )]. Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) , Use in Specific Populations (8.4) ] .
Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ). Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION N/A • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). • Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release capsules dosage is half (1/2) the current total daily dosage of methylphenidate ( 2.2 ). • Patients currently on dexmethylphenidate hydrochloride immediate-release tablets: Give the same daily dose of dexmethylphenidate hydrochloride extended-release capsules ( 2.2 ). • Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ( 2.2 ). • Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ( 2.2 ). • Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.3 ).
2.1Pretreatment Screening Prior to treating patients with dexmethylphenidate hydrochloride extended-release capsules, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating dexmethylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.10) ] .
2.2Recommended Dosage Patients New to Methylphenidate The recommended starting dosage of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate are: • Pediatric patients: Start with 5 mg orally once daily in the morning with or without food. • Adult patients: Start with 10 mg orally once daily in the morning with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.
Patients currently using dexmethylphenidate hydrochloride immediate-release tablets may be given the same daily dose of dexmethylphenidate hydrochloride extended-release capsules. Titration Schedule The dose may be titrated weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients. The dose should be individualized according to the needs and response of the patient.
Daily doses above 30 mg in pediatrics and 40 mg in adults have not been studied and are not recommended.
2.3Administration Instructions Dexmethylphenidate hydrochloride extended-release capsules are administered orally and may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing.
The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.
2.4Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue dexmethylphenidate hydrochloride extended-release capsules. 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 AND STRENGTHS • The 5 mg capsules are hard gelatin capsules, blue opaque cap printed with "G 5mg" and blue opaque body printed with "004" contains white to off-white pellets. • The 10 mg capsules are hard gelatin capsules, light cream opaque cap printed with "G 10mg" and light cream opaque body printed with "005" contains white to off-white pellets. • The 15 mg capsules are hard gelatin capsules, green opaque cap printed with "G 15mg" and green opaque body printed with "006" contains white to off-white pellets. • The 20 mg capsules are hard gelatin capsules, white opaque cap printed with "G 20mg" and white opaque body printed with "007" contains white to off-white pellets. • The 25 mg capsules are hard gelatin capsules, blue opaque cap printed with "G 25mg" and white opaque body printed with "008" contains white to off-white pellets. • The 30 mg capsules are hard gelatin capsules, light cream opaque cap printed with "G 30mg" and white opaque body printed with "009" contains white to off-white pellets. • The 35 mg capsules are hard gelatin capsules, blue opaque cap printed with "G 35mg" and light cream opaque body printed with "010" contains white to off-white pellets. • The 40 mg capsules are hard gelatin capsules, green opaque cap printed with "G 40mg" and white opaque body printed with "011" contains white to off-white pellets.
Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg of dexmethylphenidate hydrochloride ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. 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 extended-release capsules ( 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 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: Prior to initiating dexmethylphenidate hydrochloride extended-release capsules, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate hydrochloride extended-release capsules ( 5.4 ). • Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ). • Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride extended-release capsules treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ). • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients.
Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted (5.7). • Acute Angle Closure Glaucoma: Dexmethylphenidate hydrochloride extended-release capsules-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 dexmethylphenidate hydrochloride extended-release capsules to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor patients with a history of increased IOP or open angle glaucoma (5.9). • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating dexmethylphenidate hydrochloride extended-release capsules, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate (5.10)
5.1Abuse, Misuse, and Addiction Dexmethylphenidate hydrochloride extended-release capsules has a high potential for abuse and misuse. The use of dexmethylphenidate hydrochloride extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dexmethylphenidate hydrochloride extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ] .
Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dexmethylphenidate hydrochloride extended-release capsules, 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 dexmethylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride extended-release capsules to anyone else. Throughout dexmethylphenidate hydrochloride extended-release capsules 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 disea…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence ( 9.2 , 9.3 )] • Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride extended-release capsules [see Contraindications (4) ] • Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7.1) ] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] • Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] • 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 most common adverse reactions (greater than or equal to 5% and twice the rate of placebo): • Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety ( 6.1 ). • Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3183 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. Adverse Reactions in Studies with Dexmethylphenidate Hydrochloride Extended-Release Capsules in Pediatric Patients with ADHD The safety data in this section is based on data from a 7-week controlled clinical study of dexmethylphenidate hydrochloride extended-release capsules in 100 (103 randomized)pediatric patients with ADHD ages 6 to 17 years (ages 6 to 12, n = 86; ages 13 to 17, n = 17).
This study was a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the time of onset, duration of efficacy, tolerability, safety of dexmethylphenidate hydrochloride extended-release capsules 5 mg to 30 mg/day who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD [ see Clinical Studies (14.1)]. Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): dyspepsia, decreased appetite, headache and anxiety.
Adverse Reactions Leading to Discontinuation : 50 of 684 (7.3%) pediatric patients treated with dexmethylphenidate immediate-release tablets 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 the placebo-controlled, parallel-group study in children and adolescents with ADHD at flexible dexmethylphenidate hydrochloride extended-release capsules doses of 5 to 30 mg/day.
The table includes only those events that occurred in 5% or more of patients treated with dexmethylphenidate hydrochloride extended-release capsules and for which the incidence in patients treated with dexmethylphenidate hydrochloride extended-release capsules was at least twice the incidence in placebo-treated patients. Table 1: Common Adverse Reactions in Pediatric Patients (6 to 17 years of age) With A System organ class Adverse reaction Dexmethylphenidate Hydrochloride Extended-Release Capsules N = 53 Placebo N…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS N/A • Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ).
7.1Clinically Important Drug Interactions With Dexmethylphenidate Hydrochloride Extended-Release Capsules Table 5 presents clinically important drug interactions with dexmethylphenidate hydrochloride extended-release capsules. Table 5: Clinically Important Drug Interactions With Dexmethylphenidate Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, 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 extended-release capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Dexmethylphenidate hydrochloride extended-release capsules may decrease the effectiveness of drugs used to treat hypertension [ see Warnings and Precautions (5.3) ] .
Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical impact Concomitant use of halogenated anesthetics and dexmethylphenidate hydrochloride extended-release capsules may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of dexmethylphenidate hydrochloride extended-release capsules in patients being treated with anesthetics on the day of surgery.
Risperidone Clinical impact Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS) Intervention Monitor for signs of EPS
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS N/A
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhdmedications/. 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 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 (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 extended-release capsules, 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 20 mg/day. Plasma levels in adults were comparatively similar to plasma levels in adolescents. 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-thre o 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 hydr…
🤰 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 extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhdmedications/. 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 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 (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 extended-release capsules, 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 20 mg/day. Plasma levels in adults were comparatively similar to plasma levels in adolescents. 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 extended-release capsules 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.
The safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years in two adequate and well-controlled clinical trials [ see Clinical Studies (14.2) ]. Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride extended-release capsules. 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/day 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 extended-release capsules has not been studied in the geriatric population.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations.
Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of dexmethylphenidate hydrochloride extended-release capsules should be considered when treating patients with overdose.
Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY N/A
12.1Mechanism of Action Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics 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 At the recommended maximum total daily dosage of 40 mg, dexmethylphenidate hydrochloride extended-release capsules does not prolong the QTc interval to any clinically relevant extent.
12.3Pharmacokinetics Absorption Dexmethylphenidate hydrochloride extended-release capsules produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when orally administered to healthy adults. The initial rate of absorption for dexmethylphenidate hydrochloride extended-release capsules are similar to that of dexmethylphenidate hydrochloride tablets as shown by the similar rate parameters between the 2 formulations, i.e., first peak concentration (C max1 ), and time to the first peak (t max1 ), which is reached in 1.5 hours (typical range 1 to 4 hours).
The mean time to the interpeak minimum (t minip ) is slightly shorter, and time to the second peak (t max2 ) is slightly longer for dexmethylphenidate hydrochloride extended-release capsules given once daily (about 6.5 hours; range, 4.5 to 7 hours) compared to dexmethylphenidate hydrochloride tablets given in 2 doses 4 hours apart (see Figure 1), although the ranges observed are greater for dexmethylphenidate hydrochloride extended-release capsules. Dexmethylphenidate hydrochloride extended-release capsules given once daily exhibits a lower second peak concentration (C max2 ), higher interpeak minimum concentrations (C minip ), and fewer peak and trough fluctuations than dexmethylphenidate hydrochloride tablets given in 2 doses given 4 hours apart.
This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1). The ratio of geometric mean of AUC (0-inf) and C max after administration of dexmethylphenidate hydrochloride extended-release capsules given once daily are 1.02 and 0.86 respectively, to the same total dose of dexmethylphenidate hydrochloride tablets given in 2 doses 4 hours apart. The variability in C max , C min , and AUC is similar between dexmethylphenidate hydrochloride extended-release capsules and dexmethylphenidate hydrochloride immediate-release tablets with approximately a 3-fold range in each.
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%. Figure 1.
Mean Dexmethylphenidate Plasma Concentration-Time Profiles After Administration 1 x 20 mg Dexmethylphenidate Hydrochloride Extended-Release (n = 24) Capsules and 2 x 10 mg Dexmethylphenidate Hydrochloride Immediate-Release Tablets (n = 25) After single dose administration, dexmethylphenidate hydrochloride extended-release capsules demonstrated dose proportional pharmacokinetics (PK) in the range of 5 mg to 40 mg. For patients unable to swallow the capsule, the contents may be sprinkled on applesauce and administered [ see Dosage and Administration (2) ] .
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 decline monophasically following oral administration of dexmethylphenidate hydrochloride extended-release capsules. The mean terminal elimination half-life of dexmethylphenidate was about 3 hours in healthy adults. Pediatr…
🧬 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 Dexmethylphenidate hydrochloride extended-release capsules are supplied as: 5 mg: Hard gelatin capsules, blue opaque cap printed with "G 5mg" and blue opaque body printed with "004" contains white to off-white pellets. Bottles of 100 NDC 70010-004-01 10 mg: Hard gelatin capsules, light cream opaque cap printed with "G 10mg" and light cream opaque body printed with "005" contains white to off-white pellets. Bottles of 100 NDC 70010-005-01 15 mg: Hard gelatin capsules, green opaque cap printed with "G 15mg" and green opaque body printed with "006" contains white to off-white pellets.
Bottles of 100 NDC 70010-006-01 20 mg: Hard gelatin capsules, white opaque cap printed with "G 20mg" and white opaque body printed with "007" contains white to off-white pellets. Bottles of 100 NDC 70010-007-01 25 mg: Hard gelatin capsules, blue opaque cap printed with "G 25mg" and white opaque body printed with "008" contains white to off-white pellets. Bottles of 100 NDC 70010-008-01 30 mg: Hard gelatin capsules, light cream opaque cap printed with "G 30mg" and white opaque body printed with "009" contains white to off-white pellets.
Bottles of 100 NDC 70010-009-01 35 mg: Hard gelatin capsules, blue opaque cap printed with "G 35mg" and light cream opaque body printed with "010" contains white to off-white pellets. Bottles of 100 NDC 70010-010-01 40 mg: Hard gelatin capsules, green opaque cap printed with "G 40mg" and white opaque body printed with "011" contains white to off-white pellets. Bottles of 100 NDC 70010-011-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Dispense in tight container (USP).
📋 Description ▾
11 DESCRIPTION Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile.
Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. 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 center 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 : ammonio methacrylate copolymer, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (which contain sucrose and starch), talc, titanium dioxide, and triethyl citrate.
The 5 mg, 25 mg and 35 mg capsule also contains D&C red #28. The 15 mg and 40 mg capsule also contains D&C yellow #10. The 5 mg, 15 mg, 25 mg, 35 mg, and 40 mg capsule also contains FD&C blue #1.
The 10 mg, 30 mg and 35 mg capsule also contains FD&C yellow #6. In addition, capsule imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. dexmethyl-structure-jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients 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 dexmethylphenidate hydrochloride extended-release capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store dexmethylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules 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 Instruct patients that dexmethylphenidate hydrochloride extended-release capsules can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3) ] .
Psychiatric Adverse Reactions Advise patients that dexmethylphenidate hydrochloride extended-release capsules, 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 extended-release capsules 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 extended-release capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6) ] . Long-Term Suppression of Growth in Pediatric Patients Advise patients that dexmethylphenidate hydrochloride extended-release capsules may cause slowing of growth and weight loss [see Warnings and Precautions (5.7) ] .
Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with dexmethylphenidate hydrochloride extended-release capsules [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 treatment with dexmethylphenidate hydrochloride extended-release capsules. 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 Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy [see Use in Specific Populations (8.1) ]. Manufactured By: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Revised: 10/2025
💬 Medication Guide ▾
SPL MEDGUIDE SECTION MEDICATION GUIDE Dexmethylphenidate Hydrochloride Extended-Release Capsules (dex″ meth il fen′ i date hye″ droe klor′ ide) for oral use, CII What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules? Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including: • Abuse, misuse, and addiction. Dexmethylphenidate hydrochloride extended-release capsules has a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of dexmethylphenidate hydrochloride extended-release capsules, 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 dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules and will monitor you or your child during treatment. o Dexmethylphenidate hydrochloride extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give dexmethylphenidate hydrochloride extended-release capsules to anyone else.
See “ What is dexmethylphenidate hydrochloride extended-release capsules? ” for more information. o Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place and properly dispose of any unused medicine. See “ How should I store dexmethylphenidate hydrochloride extended-release capsules? ” 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 dexmethylphenidate hydrochloride extended-release capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking dexmethylphenidate hydrochloride extended-release capsules. • Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules. • Mental (psychiatric) problems: All Patients o new or worse behavior and thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking dexmethylphenidate hydrochloride extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What are dexmethylphenidate hydrochloride extended-release capsules? • Dexmethylphenidate hydrochloride extended-release capsule is a central nervous system stimulant (CNS) prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
Dexmethylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. • Dexmethylphenidate hydrochl…