Dexmethylphenidate Hydrochloride
Capsule, Extended Release · Oral
Uses
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
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 Focalin 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 ). 2.1 Pretreatment 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 )]. 2.2 Recommended 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 Focalin 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. 2.3 Administration 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. 2.4 Dosage 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
5 mg extended-release capsules – two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5550” on body. 10 mg extended-release capsules – two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5551” on body. 15 mg extended-release capsules – two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5552” on body. 20 mg extended-release capsules – two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5553” on body. 25 mg extended-release capsules – two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5045” on body. 30 mg extended-release capsules – two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5554” on body. 35 mg extended-release capsules – two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5046” on body. 40 mg extended-release capsules – two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5562” on body. 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
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 precautions
Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions: Prior to initiating 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 ). 5.1 Abuse, Misuse, and Addiction Dexmethylphenidate hydrochloride extended-release capsules have 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. 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid dexmethylphenidate hydrochloride extended-release use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate 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). Some patients may have larger increases. Monitor all dexmethylphenidate hydrochloride extended-release-treated patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing 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 dexmethylphenidate hydrochloride extended-release treatment, screen patients for risk factors for developing 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 the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing dexmethylphenidate hydrochloride extended-release capsules. 5.5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients.
Side effects
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 Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 Focalin 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 ADHD System organ class Adverse reaction Dexmethylphenidate Hydrochloride Extended-Release Capsules N = 53 Placebo N = 47 Gastrointestinal disorders 38% 19% Dyspepsia 8% 4% Metabolism and nutrition disorders 34% 11% Decreased appetite 30% 9% Nervous system disorders 30% 13% Headache 25% 11% Psychiatric disorders 26% 15% Anxiety 6% 0% Abbreviation: ADHD, attention deficit hyperactivity disorder. Table 2 below enumerates the incidence of dose-related adverse reactions that occurred during a fixed-dose, double-blind, placebo-controlled trial in pediatric patients with ADHD taking dexmethylphenidate hydrochloride extended-release capsules up to 30 mg daily versus placebo. The table includes only those reactions that occurred in patients treated with dexmethylphenidate hydrochloride extended-release capsules for which the incidence was at least 5% and greater than the incidence among placebo-treated patients. Table 2: Dose-Related Adverse Reactions in Pediatric Patients (6 to 17 years of age) With ADHD System organ class Adverse reaction Dexmethylphenidate Hydrochloride Extended-Release Capsules Dexmethylphenidate Hydrochloride Extended-Release Capsules Dexmethylphenidate Hydrochloride Extended-Release Capsules 10 mg/day 20 mg/day 30 mg/day Placebo N = 64 N = 60 N = 58 N = 63 Gastrointestinal disorders 22% 23% 29% 24% Vomiting 2% 8% 9% 0% Metabolism and nutritional disorders 16% 17% 22% 5% Anorexia 5% 5% 7% 0% Psychiatric disorders 19% 20% 38% 8% Insomnia 5% 8% 17% 3% Depression 0% 0% 3% 0% Mood swings 0% 0% 3% 2% Other adverse reactions Irritability 0% 2% 5% 0% Nasal congestion 0% 0% 5% 0% Pruritus 0% 0% 3% 0% Abbreviation: ADHD, attention deficit hyperactivity disorder. Adverse Reactions in Studies with Dexmethylphenidate Hydrochloride Extended-Release Capsules in Adult Patients with ADHD The safety data in this section is based on data from a 5-week controlled clinical study of dexmethylphenidate hydrochloride extended-release capsules in 218 adult patients (221 randomized) with ADHD ages 18 to 60 years. In this study, 101 adult patients were treated for at least 6 months.
Drug interactions
Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically 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
8.1 Pregnancy 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/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 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. 8.2 Lactation 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 extended-release capsules and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride extended-release capsules or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 8.4 Pediatric 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.
Pregnancy
8.1 Pregnancy 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/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 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
8.4 Pediatric 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
8.5 Geriatric Use Dexmethylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population.
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.
Description
Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is: C 14 H 19 NO 2
• HCl M.W. 269.77 Note* = asymmetric carbon center Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze, sugar spheres (which contain corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3. 1
Mechanism of action
12.1 Mechanism of Action Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
How supplied
Dexmethylphenidate hydrochloride extended-release capsules are available as follows: 5 mg: Two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5550” on body in bottles of 100 (NDC 0093-5550-01). 10 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5551” on body in bottles of 100 (NDC 0093-5551-01). 15 mg: Two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5552” on body in bottles of 100 (NDC 0093-5552-01). 20 mg: Two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5553” on body in bottles of 100 (NDC 0093-5553-01). 25 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5045” on body in bottles of 100 (NDC 0093-5045-01). 30 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5554” on body in bottles of 100 (NDC 0093-5554-01). 35 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5046” on body in bottles of 100 (NDC 0093-5046-01). 40 mg: Two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5562” on body in bottles of 100 (NDC 0093-5562-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Patient 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 )] . Brands listed are the trademarks of their respective owners. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. P 7/2026
Label text from the FDA structured product label by Teva Pharmaceuticals USA, Inc. (revised Jul 1, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dexmethylphenidate Hydrochloride in 91 products
Dexmethylphenidate Hydrochloride NDC products (91)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0115-9922 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-9921 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-9920 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-9919 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-9918 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1710 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1709 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 67877-657 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Ascend Laboratories, LLC | ANDA · DEA CII |
| 67877-655 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Ascend Laboratories, LLC | ANDA · DEA CII |
| 67877-656 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Ascend Laboratories, LLC | ANDA · DEA CII |
| 63629-2171 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1472 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1286 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1285 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1284 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1488 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2172 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2173 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1473 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1493 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1496 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2174 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2176 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2178 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2427 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2305 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2306 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2307 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1502 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2426 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1507 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1503 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2175 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 31722-232 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-236 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-235 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-234 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-233 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-231 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-230 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-229 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 27808-093 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-092 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-091 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 70010-005 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-006 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-007 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-004 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-008 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-009 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-011 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-010 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 10702-108 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | KVK-TECH, INC | ANDA · DEA CII |
| 10702-107 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | KVK-TECH, INC | ANDA · DEA CII |
| 10702-106 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | KVK-TECH, INC | ANDA · DEA CII |
| 0527-8112 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8106 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8107 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8108 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8109 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8110 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8111 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-8113 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 43386-860 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-861 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-862 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 75834-327 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Nivagen Pharmaceuticals, Inc. | ANDA · DEA CII |
| 75834-328 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Nivagen Pharmaceuticals, Inc. | ANDA · DEA CII |
| 49884-049 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-546 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-430 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-428 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-339 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-333 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-248 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 49884-048 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Par Health USA, LLC | ANDA · DEA CII |
| 57664-378 | Dexmethylphenidate Hydrochloride 5 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 57664-376 | Dexmethylphenidate Hydrochloride 2.5 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 57664-379 | Dexmethylphenidate Hydrochloride 10 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 0093-5046 | Dexmethylphenidate Hydrochloride 35 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5550 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5551 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5552 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5553 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5554 | Dexmethylphenidate Hydrochloride 30 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5562 | Dexmethylphenidate Hydrochloride 40 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0093-5045 | Dexmethylphenidate Hydrochloride 25 mg/1 Capsule, Extended Release | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0781-2727 | Dexmethylphenidate Hydrochloride 5 mg/1 Capsule, Extended Release | Sandoz Inc | NDA AUTHORIZED GENERIC · DEA CII |
| 0781-2728 | Dexmethylphenidate Hydrochloride 10 mg/1 Capsule, Extended Release | Sandoz Inc | NDA AUTHORIZED GENERIC · DEA CII |
| 0781-2729 | Dexmethylphenidate Hydrochloride 15 mg/1 Capsule, Extended Release | Sandoz Inc | NDA AUTHORIZED GENERIC · DEA CII |
| 0781-2730 | Dexmethylphenidate Hydrochloride 20 mg/1 Capsule, Extended Release | Sandoz Inc | NDA AUTHORIZED GENERIC · DEA CII |
Frequently asked questions
What is Dexmethylphenidate Hydrochloride used for?
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…
What are the side effects of Dexmethylphenidate Hydrochloride?
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… See the full label for the complete list.
Who makes Dexmethylphenidate Hydrochloride?
Dexmethylphenidate Hydrochloride is listed by 14 labelers in the FDA NDC directory, including Amneal Pharmaceuticals of New York LLC, Ascend Laboratories, LLC, Bryant Ranch Prepack, Camber Pharmaceuticals, Inc..