Daytrana methylphenidate 15 mg/9h Patch — NDC 68968-5553-3 (Billing 68968-5553-03)
This is a package of Daytrana methylphenidate 15 mg/9h Patch from Noven Therapeutics, LLC, marketed since Apr 2006 and currently FDA-listed; retail pharmacies pay about $5.74 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 68968-5553-3 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68968 labeler · 5553 product · 3 package
- Package marketed since
- Apr 6, 2006
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6896855533 9
- Medicaid fills, this package
- 150 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 060616
- GCN: 26802
- GPI-14 (Medi-Span): 61400020005915
- HICL (First Databank): 033556
- AHFS class code: 28:20.32.00
- RxCUI (RxNorm): 753436
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It mainly treats ADHD, and some products are also used for narcolepsy. The exact approval depends on the product and the age group. Your prescriber chooses the right one for you.
- It depends on your product. Many extended-release forms are taken once daily in the morning, while Jornay PM is taken in the evening. Swallow extended-release tablets whole, and fo...
- The most common ones are decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety and dizziness. Children and teens may get upper stomach pain. Call your doctor i...
- Call for chest pain, fainting, a racing heartbeat, hallucinations, seizures, painful erections that won’t go away, or color changes in your fingers or toes. Also call if you notice...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylphenidate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $5.744 | $172.32 / 30 patch |
| Medicaid paysCMS SDUD · 12 mo | $5.92 | $177.59 / 30 patch |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of May 20, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68968-5553-03 You're viewing this Main listing | 30 PATCH in 1 CARTON / 9 h in 1 PATCH | 2006-04-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Daytrana 15 mg/9hthis 68968-5553-03 | Noven | 30 patches | $5.744 | AB | Availability likely | — |
| Methylphenidate 1.6 mg/h 00378-8261-93 | Mylan | 30 patches | $6.633 | AB | Availability likely | +15% |
| Methylphenidate Transdermal System 41.3 mg/mg 00574-2415-65 | PADAGIS | 30 patches | $6.633 | AB | Availability likely | +15% |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of May 20, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Noven Therapeutics, LLC labeler code 68968
- Estradiol .1 mg/d Film, Extended Release NDC 68968-3410-8
- Estradiol .025 mg/d Film, Extended Release NDC 68968-3425-8
- Estradiol .0375 mg/d Film, Extended Release NDC 68968-3437-8
- Estradiol .05 mg/d Film, Extended Release NDC 68968-3450-8
- Estradiol .075 mg/d Film, Extended Release NDC 68968-3475-8
- Daytrana methylphenidate 10 mg/9h Patch NDC 68968-5552-3
- Daytrana methylphenidate 20 mg/9h Patch NDC 68968-5554-3
- Daytrana methylphenidate 30 mg/9h Patch NDC 68968-5555-3
- Minivelle estradiol .1 mg/d Film, Extended Release NDC 68968-6610-8
- Minivelle estradiol .025 mg/d Film, Extended Release NDC 68968-6625-8
- Minivelle estradiol .0375 mg/d Film, Extended Release NDC 68968-6637-8
- Minivelle estradiol .05 mg/d Film, Extended Release NDC 68968-6650-8
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION DAYTRANA has a high potential for abuse and misuse, which can lead to the development of substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DAYTRANA, 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 DAYTRANA, 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 DAYTRANA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning DAYTRANA has 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 DAYTRANA, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing DAYTRANA, 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 DAYTRANA (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use The use of DAYTRANA 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 ( 5.8 ), Use in Specific Populations ( 8.4 )] .
DAYTRANA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of DAYTRANA 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 ( 5.8 , 8.4 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg. ( 2.2 ) DAYTRANA should be applied to the hip area (using alternating sites) 2 hours before an effect is needed and should be removed 9 hours after application. DAYTRANA may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.
( 2.2 , 2.3 ) Dosage should be titrated to effect. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. ( 2.2 )
2.1Pretreatment Screening Prior to treating patients with DAYTRANA, 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 DAYTRANA [see Warnings and Precautions ( 5.15 )] .
2.2Recommended Dosage It is recommended that DAYTRANA be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. Dosage should be titrated to effect. The recommended dose titration schedule is shown in the table below.
Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. *Nominal in vivo delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period. Table 1 DAYTRANA - Recommended Titration Schedule (Patients New to Methylphenidate) Upward Titration, if Response is Not Maximized Week 1 Week 2 Week 3 Week 4 Transdermal System Size 12.5 cm 2 18.75 cm 2 25 cm 2 37.5 cm 2 Nominal Delivered Dose* (mg/9 hours) 10 mg 15 mg 20 mg 30 mg Delivery Rate* (1.1 mg/hr)* (1.6 mg/hr)* (2.2 mg/hr)* (3.3 mg/hr)* Patients converting from another formulation of methylphenidate should follow the above titration schedule due to differences in bioavailability of DAYTRANA compared to other products.
2.3Application The parent or caregiver should be encouraged to use the administration chart included with each carton of DAYTRANA to monitor application and removal time, and method of disposal. It is recommended that parents or caregivers apply and remove the transdermal system for children; responsible adolescents may apply or remove the transdermal system themselves if appropriate. If a transdermal system was removed without the parent or caregiver's knowledge, or if a transdermal system is missing from the tray, the parent or caregiver should be encouraged to ask the child when and how the transdermal system was removed.
The Medication Guide includes a timetable to calculate when to remove DAYTRANA, based on the 9-hour application time. The adhesive side of DAYTRANA should be placed on a clean, dry area of the hip. The area selected should not be oily, damaged, or irritated.
Apply DAYTRANA to the hip area avoiding the waistline, since clothing may cause the transdermal system to rub off. When applying the transdermal system the next morning, place on the opposite hip at a new site if possible. If patients or caregivers experience difficulty separating the transdermal system from the release liner or observe transfer of adhesive to the liner, tearing and/or other damage to the transdermal system during removal from the liner, the transdermal system should be discarded and a new transdermal system should be applied.
Patients or caregivers should inspect the release liner to ensure that no adhesive containing medication has transferred to the liner. If adhesive transfer has occurred, the transdermal system should be discarded. Refer to the Instructions for Use for recommendations for discarding used DAYTRANA.
DAYTRANA should be applied immediately after opening the individual pouch and removing the protective liner. Do not use if the individual pouch seal is broken or if the trans… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORM AND STRENGTHS Four dosage strengths are available: *Nominal in vivo delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period. Nominal Dose Delivered (mg) Over 9 Hours* Dosage Rate* (mg/hr) Transdermal System Size (cm 2 ) Methylphenidate Content per Transdermal System (mg) 10 1.1 12.5 27.5 15 1.6 18.75 41.3 20 2.2 25 55 30 3.3 37.5
82.5Transdermal system: 10mg/9 hours (1.1 mg/hr), 15mg/9 hours (1.6 mg/hr), 20mg/9 hours (2.2 mg/hr), 30mg/9 hours (3.3 mg/hr) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate ( 4.1 ) Patients currently using or within 2 weeks of using an MAO inhibitor ( 4.2 )
4.1Hypersensitivity to Methylphenidate DAYTRANA is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (polyester/ethylene vinyl acetate laminate film backing, acrylic adhesive, silicone adhesive, and fluoropolymer-coated polyester) [see Description ( 11 )] .
4.2Monoamine Oxidase Inhibitors DAYTRANA is contraindicated during treatment with monoamine oxidase inhibitors, and within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating DAYTRANA, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing DAYTRANA. ( 5.4 ) Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures.
( 5.5 ) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. ( 5.6 ) Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during DAYTRANA treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
( 5.7 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.8 ) Chemical Leukoderma: DAYTRANA use may result in a persistent loss of skin pigmentation at and around the application site.
Loss of pigmentation, in some cases, has been reported at other sites distant from the application site. Monitor for signs of skin depigmentation. Discontinue DAYTRANA if it occurs.
( 5.9 ) Contact Sensitization: Use of DAYTRANA may lead to contact sensitization. Treatment should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of DAYTRANA and is not by itself an indication of sensitization.
However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site. ( 5.10 ) External Heat: Patients should be advised to avoid exposing the DAYTRANA application site to direct external heat sources. When heat is applied to DAYTRANA after application, both the rate and extent of absorption are significantly increased.
( 5.11 ) Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. ( 5.12 ) Acute Angle Closure Glaucoma: DAYTRANA-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.13 ) Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe DAYTRANA 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. ( 5.14 ) Motor and Verbal Tics and Worsening of Tourette’s Syndrome: Before initiating DAYTRANA, 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. ( 5.15 )
5.1Abuse, Misuse, and Addiction DAYTRANA has a high potential for abuse and misuse. The use of DAYTRANA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. DAYTRANA 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 DAYTRANA, 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 DAYTRANA, assess each patient’s risk for abuse, mi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Detailed information on serious and adverse reactions of particular importance is provided in the Boxed Warning and Warnings and Precautions ( 5 ) sections: Abuse, Misuse, and Addiction [see Boxed Warning ] Hypersensitivity to Methylphenidate [ see Contraindications ( 4.1 ) ] Monoamine Oxidase Inhibitors [ see Contraindications ( 4.2 ) and 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 )] Seizures [see Warnings and Precautions ( 5.5 )] Priapism [see Warnings and Precautions ( 5.6 )] Peripheral Vasculopathy [see Warnings and Precautions ( 5.7 )] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.8 )] Chemical Leukoderma [see Warnings and Precautions ( 5.9 )] Contact Sensitization [see Warnings and Precautions ( 5.10 )] External Heat [see Warnings and Precautions ( 5.11 )] Hematologic Monitoring [see Warnings and Precautions ( 5.12 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.13 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.14 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.15 )] Pediatric patients (ages 6 to 12 years): The most commonly (≥5% and twice the rate of placebo) reported adverse reactions in pediatric patients ages 6 to 12 years included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia.
( 6.1 ) Pediatric patients (ages 13 to 17 years): The most commonly (≥5% and twice the rate of placebo) reported adverse reactions in pediatric patients ages 13 to 17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of subjects in these trials had erythema at the application site. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Noven Therapeutics, LLC at 1-800-455-8070 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 reactions 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 practice. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia.
The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia [see Adverse Reactions ( 6.1 )] . The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Adverse Reactions ( 6.1 )] . The overall DAYTRANA development program included exposure to DAYTRANA in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults.
The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using DAYTRANA with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents were exposed for ≥ 6 months. Most patients studied were exposed to DAYTRANA transdermal system sizes of 12.5 cm 2 , 18.75 cm 2 , 25 cm 2 or 37.5 cm 2 , with a wear time of 9 hours.
In the data presented below, the adverse reactions reported during exposure were obtained pr… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.2 )
7.1Monoamine Oxidase Inhibitors (MAOI) Concomitant use of MAOIs and CNS stimulants, including DAYTRANA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4.2 )] . Concomitant use of DAYTRANA with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
7.2Antihypertensive Drugs DAYTRANA may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see Warnings and Precautions ( 5.2 )] .
7.3Coumarin Anticoagulants, Antidepressants, and Selective Serotonin Reuptake Inhibitors Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some tricyclic drugs (e.g., imipramine, clomipramine, desipramine) and selective serotonin reuptake inhibitors. Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.
7.4Halogenated Anesthetics Concomitant use of halogenated anesthetics and methylphenidate may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of DAYTRANA in patients being treated with anesthetics on the day of surgery.
7.5Risperidone Combined use of methylphenidate with risperidone when there is a change in dosage, whether an increase or decrease, of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants during pregnancy ( see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. However, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day.
When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (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 clinical recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as DAYTRANA, 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 Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. No evidence of morphological development effects was found in either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose.
In a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses. In a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity.
8.2Lactation Risk Summary Limited published literature, based on breast milk sampling from five 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 DAYTRANA and any potential adverse effects on the breastfed infant from DAYTRANA or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitatio… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There are risks to the fetus associated with the use of CNS stimulants during pregnancy ( see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. However, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day.
When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (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 clinical recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions CNS stimulants, such as DAYTRANA, 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 Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. No evidence of morphological development effects was found in either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose.
In a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses. In a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of DAYTRANA 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 DAYTRANA for the treatment of ADHD have been established in pediatric patients 6 to 17 years. Long Term Suppression of Growth Growth should be monitored during treatment with stimulants, including DAYTRANA. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions ( 5.8 )] .
Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. Studies with transdermal methylphenidate have not been performed in juvenile animals.
In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose.
The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day. The clinical significance of the long-term behavioral effects observed in rats is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use DAYTRANA has not been studied in patients greater than 65 years of age.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.
Overdose Management Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Remove all transdermal systems immediately and cleanse the area(s) to remove any remaining adhesive.
The continuing absorption of methylphenidate from the skin, even after removal of the transdermal system, should be considered when treating patients with overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Methylphenidate is a CNS stimulant. Its mode of therapeutic action in ADHD is not known.
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l- enantiomers. The d- enantiomer is more pharmacologically active than the l- enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
12.3Pharmacokinetics The pharmacokinetics of DAYTRANA when applied to the hip for 9 hours have been studied in ADHD patients 6 to 17 years old. Absorption The amount of methylphenidate absorbed systemically is a function of both wear time and transdermal system size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat transdermal system applications (12.5cm 2 to 37.5cm 2 ) when worn up to 9 hours.
On single dosing of children or adolescents with DAYTRANA, there was a delay of, on average, 2 hours before d -methylphenidate was detectable in the circulation. On repeat dosing, low concentrations (1.2-3.0 ng/mL in children and 0.5-1.7ng/mL in adolescents, on average across the dose range) were observed earlier in the profile, due to carry-over effect. Following the application of DAYTRANA once daily with a 9-hour wear time, the mean pharmacokinetic parameters of d -methylphenidate in children and adolescents with ADHD after 4 weeks of therapy are summarized in Table 3.
1 Dose maintained fixed for 28 days; 2 Dose escalated at 7 day intervals from 12.5 cm 2 through 18.75 cm 2 and 25 cm 2 to 37.5 cm 2 ; 3 Dose escalated at 7 day intervals from 18 mg through 27 mg and 36 mg to 54 mg; 4 Median (minimum - maximum); t lag = Last Sampling Time Prior to Time of First Quantifiable Plasma Concentration Table 3 Mean Plasma d-Methylphenidate Pharmacokinetic Parameters After Repeated 9-Hour Applications of DAYTRANA or Oral ER-MPH for up to 28 days to Pediatric ADHD Patients (Aged 6 - 17 years) Children Parameter DAYTRANA 1 12.5cm 2 (N=12) DAYTRANA 2 37.5cm 2 (N=10) Oral ER-MPH 3 18mg Oral ER-MPH 3 54mg C ssmax (ng/mL) 15.7 ± 9.39 42.9 ± 22.4 8.37 ± 4.14 26.1 ±
11.2C ssmin (ng/mL) 1.04 ± 1.17 1.96 ± 1.73 0.708 ± 1.08 1.19 ±
1.54AUC ss (ng·hr/mL) 163 ± 101 447 ± 230 97.7 ± 67.0 317 ± 160 t lag (h) 4 0 (0 - 2.0) 0 (0 - 1.0) 0 0 Adolescents C ssmax (ng/mL) 8.32 ± 4.60 16.5 ± 6.94 5.23 ± 1.72 18.0 ±
6.97C ssmin (ng/mL) 0.544 ± 0.383 1.02 ± 0.629 0.360 ± 0.478 1.50 ± 0.937 AUC ss (ng·hr/mL) 85.7 ± 50.0 167 ± 66.0 59.7 ± 19.1 216 ± 80.8 t lag (h) 4 0 (0 - 2.0) 0 (0 - 2.0) 0 0 Following administration of DAYTRANA 12.5cm 2 to pediatric and adolescent ADHD patients daily for 7 days, there were 13% and 14% increases, respectively, in steady state area under the plasma concentration-time curve (AUC ss ) relative to that anticipated on the basis of single dose pharmacokinetics (AUC0 -∞ ); after 28 days administration, these increments increased to 64% and 76%, respectively.
C max increased by nearly 69% and 100% within 4 weeks of daily administration of the starting dose in children and adolescents, respectively. The observed exposures with DAYTRANA could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender.
This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with DAYTRANA; on average, steady-state is likely to have been achieved by approximately 14 days of dosing. In the single- and multiple dose study described above, exposure to l- methylphenidate was 46% of the exposure to d- methylphenidate in children and 40% in adolescents. l -methylphenidate is less pharmacologically active than d -methylphenidate [… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Methylphenidate is a CNS stimulant. Its mode of therapeutic action in ADHD is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING DAYTRANA is supplied in a sealed tray containing 30 individually pouched transdermal systems. See the chart below for information regarding available strengths. *Nominal in vivo delivery rate per hour in children and adolescents when applied to the hip, based on a 9-hour wear period. **Methylphenidate content in each transdermal system. Nominal Dose Delivered (mg) Over 9 Hours Dosage Rate* (mg/hr) Transdermal System Size (cm 2 ) Methylphenidate Content per Transdermal System** (mg) Transdermal Systems Per Carton NDC Number 10 1.1 12.5 27.5 30 68968-5552-3 15 1.6 18.75 41.3 30 68968-5553-3 20 2.2 25 55 30 68968-5554-3 30 3.3 37.5 82.5 30 68968-5555-3 Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].
Do not store transdermal systems unpouched. Do not store transdermal systems in refrigerators or freezers. Once the sealed tray is opened, use contents within 2 months.
Apply the transdermal system immediately upon removal from the individual protective pouch. For transdermal use only. See the Patient Counseling Information ( 17 ) for specific disposal instructions for unused or expired DAYTRANA.
📋 Description ▾
11 DESCRIPTION DAYTRANA is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether.
Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C 14 H 19 NO 2 .
The structural formula of methylphenidate is: Transdermal System Components DAYTRANA contains methylphenidate in a multipolymeric adhesive. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time.
DAYTRANA consists of three layers, as seen in the figure below (cross-section of the transdermal system). Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing, (2) a proprietary adhesive formulation incorporating Noven Pharmaceuticals, Inc.'s DOT Matrix™ transdermal technology consisting of an acrylic adhesive, a silicone adhesive, and methylphenidate, and (3) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used.
The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive. daytrana-structure daytrana-figure-section
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of DAYTRANA, 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 DAYTRANA in a safe place, preferably locked, and instruct patients to not give DAYTRANA to anyone else.
Special Disposal Instructions Advise patients that there are special disposal instructions for unused or expired DAYTRANA [see Warnings and Precautions ( 5.1 )] . Instruct patients to find a take back location to dispose of unused or expired DAYTRANA. If a take back program is unavailable, instruct them to: Remove DAYTRANA from its pouch, separate it from its liner, fold it in half with the adhesive sides touching each other, and immediately flush it down the toilet, and Place the pouch and liner in a container, close the container, and throw out the container in the trash (advise patients not to flush the pouch and liner down the toilet).
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with DAYTRANA 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 )] . Priapism Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism).
Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.6 )]. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] [see Warnings and Precautions ( 5.7 )] Instruct patients beginning treatment with DAYTRANA about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and in 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 using DAYTRANA. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Long-Term Suppression of Growth in Pediatric Patients Advise patients that DAYTRANA may cause slowing of growth including weight loss [see Warnings and ( 5.8 )] . Chemical Leukoderma Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [see Warnings and Precautions ( 5.9 )] .
Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with DAYTRANA [see Warnings and Precautions ( 5.14 )] . 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 DAYTRANA. 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 ( 5.15 )] .
Important Preparation and Administration Instructions [see Dosage and Administration ( 2.3 )] Parents and patients should be informed to apply DAYTRANA to a clean, dry site on the hip, which is not oily, damaged, or irritated. The site of application must be alternated daily. DAYTRANA should not be applied to the waistline, or where tight clothing may rub it.
If pat… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 09/2025 MEDICATION GUIDE DAYTRANA ® (day-TRON-ah) (methylphenidate transdermal system) CII Important: DAYTRANA is for use on the skin only.
What is the most important information I should know about DAYTRANA? DAYTRANA may cause serious side effects, including: Abuse, misuse, and addiction. DAYTRANA has a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of DAYTRANA, 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 DAYTRANA or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check your child's risk for abuse, misuse, and addiction before starting treatment with DAYTRANA and will monitor your child during treatment.
DAYTRANA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give DAYTRANA to anyone else. See " What is DAYTRANA? " for more information.
Keep DAYTRANA in a safe place and properly dispose of any unused medicine. See " How should I store DAYTRANA? " for more information. Tell your healthcare provider if your child has 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 child's healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using DAYTRANA.
Tell your child's healthcare provider if your child has any heart problems, heart disease or heart defects. Remove the DAYTRANA transdermal system (patch) and call your child's healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DAYTRANA. Increased blood pressure and heart rate.
Your child's healthcare provider should check your child's blood pressure and heart rate regularly during treatment with DAYTRANA. Mental (psychiatric) problems, including: new or worse behavior or thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms Tell your child's healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression. Call your child's healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with DAYTRANA, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.
What is DAYTRANA? DAYTRANA is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. DAYTRANA may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD.
DAYTRANA is not recommended for use in children under 6 years of age with ADHD. DAYTRANA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep DAYTRANA in a safe place to protect it from theft.
Never give your DAYTRANA to anyone else because it may cause death or harm them. Selling or giving away DAYTRANA may harm others and is against the law. Do not use DAYTRANA if your child: is allergic to methylphenidate or any of the ingredients in DAYTRANA.
See the end of this Medication Guide for a complete list of ingredients in DAYTRANA. is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of DAYTRANA when applied to the hip for 9 hours have been studied in ADHD patients 6 to 17 years old. Absorption The amount of methylphenidate absorbed systemically is a function of both wear time and transdermal system size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat transdermal system applications (12.5cm 2 to 37.5cm 2 ) when worn up to 9 hours.
On single dosing of children or adolescents with DAYTRANA, there was a delay of, on average, 2 hours before d -methylphenidate was detectable in the circulation. On repeat dosing, low concentrations (1.2-3.0 ng/mL in children and 0.5-1.7ng/mL in adolescents, on average across the dose range) were observed earlier in the profile, due to carry-over effect. Following the application of DAYTRANA once daily with a 9-hour wear time, the mean pharmacokinetic parameters of d -methylphenidate in children and adolescents with ADHD after 4 weeks of therapy are summarized in Table 3.
1 Dose maintained fixed for 28 days; 2 Dose escalated at 7 day intervals from 12.5 cm 2 through 18.75 cm 2 and 25 cm 2 to 37.5 cm 2 ; 3 Dose escalated at 7 day intervals from 18 mg through 27 mg and 36 mg to 54 mg; 4 Median (minimum - maximum); t lag = Last Sampling Time Prior to Time of First Quantifiable Plasma Concentration Table 3 Mean Plasma d-Methylphenidate Pharmacokinetic Parameters After Repeated 9-Hour Applications of DAYTRANA or Oral ER-MPH for up to 28 days to Pediatric ADHD Patients (Aged 6 - 17 years) Children Parameter DAYTRANA 1 12.5cm 2 (N=12) DAYTRANA 2 37.5cm 2 (N=10) Oral ER-MPH 3 18mg Oral ER-MPH 3 54mg C ssmax (ng/mL) 15.7 ± 9.39 42.9 ± 22.4 8.37 ± 4.14 26.1 ±
11.2C ssmin (ng/mL) 1.04 ± 1.17 1.96 ± 1.73 0.708 ± 1.08 1.19 ±
1.54AUC ss (ng·hr/mL) 163 ± 101 447 ± 230 97.7 ± 67.0 317 ± 160 t lag (h) 4 0 (0 - 2.0) 0 (0 - 1.0) 0 0 Adolescents C ssmax (ng/mL) 8.32 ± 4.60 16.5 ± 6.94 5.23 ± 1.72 18.0 ±
6.97C ssmin (ng/mL) 0.544 ± 0.383 1.02 ± 0.629 0.360 ± 0.478 1.50 ± 0.937 AUC ss (ng·hr/mL) 85.7 ± 50.0 167 ± 66.0 59.7 ± 19.1 216 ± 80.8 t lag (h) 4 0 (0 - 2.0) 0 (0 - 2.0) 0 0 Following administration of DAYTRANA 12.5cm 2 to pediatric and adolescent ADHD patients daily for 7 days, there were 13% and 14% increases, respectively, in steady state area under the plasma concentration-time curve (AUC ss ) relative to that anticipated on the basis of single dose pharmacokinetics (AUC0 -∞ ); after 28 days administration, these increments increased to 64% and 76%, respectively.
C max increased by nearly 69% and 100% within 4 weeks of daily administration of the starting dose in children and adolescents, respectively. The observed exposures with DAYTRANA could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender.
This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with DAYTRANA; on average, steady-state is likely to have been achieved by approximately 14 days of dosing. In the single- and multiple dose study described above, exposure to l- methylphenidate was 46% of the exposure to d- methylphenidate in children and 40% in adolescents. l -methylphenidate is less pharmacologically active than d -methylphenidate [see Pharmacodynamics ( 12.2 )] . In a phase 2 PK/PD study in children aged 6-12 years, 2/3 of patients had 2-hour d- MPH concentrations < 5 ng/mL on chronic dosing, and at 3 hours 40% of patients had d- MPH concentrations < 5 ng/mL [see Clinical Studies ( 14 )] .
When DAYTRANA is applied to inflamed skin both the rate and extent of absorption are increased as compared with intact skin. When applied to inflamed skin, lag time is no greater than 1 hour, T max is 4 hours, and both C… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Methylphenidate is a racemic mixture comprised of the d- and l- enantiomers. The d- enantiomer is more pharmacologically active than the l- enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES DAYTRANA was demonstrated to be effective in the treatment of ADHD in two (2) randomized double-blind, placebo-controlled studies in children aged 6 to 12 years and one (1) randomized, double-blind, placebo-controlled study in adolescents aged 13 to 17 years who met Diagnostic and Statistical Manual (DSM-IV-TR ® ) criteria for ADHD. DAYTRANA wear time was 9 hours in all three (3) studies. In Study 1, conducted in a classroom setting, symptoms of ADHD were evaluated by school teachers and observers using the Deportment Subscale from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale which assesses behavior symptoms in the classroom setting.
DAYTRANA was applied for 9 hours before removal. There was a 5-week open-label DAYTRANA dose optimization phase using dosages of 10, 15, 20, and 30 mg / 9 hours, followed by a 2-week randomized, double-blind, placebo-controlled crossover treatment phase using the optimal transdermal system dose for each patient or placebo. The mean differences between DAYTRANA and placebo in change from baseline in SKAMP Deportment Scores were statistically significant in favor of DAYTRANA beginning at 2 hours and remained statistically significant at all subsequent measured time points through 12 hours after application of the DAYTRANA.
In Study 2, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours to achieve an optimal regimen over 5 weeks, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated by the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline for the ADHD-RS-IV total score.
Although this study was not designed specifically to evaluate dose response, in general there did not appear to be any additional effectiveness accomplished by increasing the transdermal system dose from 20 mg / 9 hours to 30 mg / 9 hours. In Study 3, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours during a 5-week dose-optimization phase, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient.
Symptoms of ADHD were evaluated using the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline in the ADHD-RS-IV total score.
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE
9.1Controlled Substance DAYTRANA contains methylphenidate, a Schedule II controlled substance.
9.2Abuse DAYTRANA has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions ( 5.1 )] . DAYTRANA can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect.
Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including DAYTRANA, 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.
9.3Dependence Physical Dependence DAYTRANA may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including DAYTRANA include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance DAYTRANA may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
🔒 Controlled Substance ▾
9.1Controlled Substance DAYTRANA contains methylphenidate, a Schedule II controlled substance.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis/Mutagenesis and Impairment of Fertility Carcinogenesis Carcinogenicity studies of transdermal methylphenidate have not been performed. In a lifetime carcinogenicity study of oral methylphenidate carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type.
There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Orally administered methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.
In a 24-week oral carcinogenicity study in the transgenic mouse strain p53 +/- , which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. In this study, male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay.
Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study.
The study was conducted at doses up to 160 mg/kg/day.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis/Mutagenesis and Impairment of Fertility Carcinogenesis Carcinogenicity studies of transdermal methylphenidate have not been performed. In a lifetime carcinogenicity study of oral methylphenidate carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type.
There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown. Orally administered methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.
In a 24-week oral carcinogenicity study in the transgenic mouse strain p53 +/- , which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. In this study, male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate. Mutagenesis Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay.
Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Impairment of Fertility Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study.
The study was conducted at doses up to 160 mg/kg/day.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE DAYTRANA ® (day-TRON-ah) (methylphenidate transdermal system) CII 1. DAYTRANA Dosing Chart Each carton of DAYTRANA contains a DAYTRANA Dosing Chart to help you keep track of your DAYTRANA transdermal system (patch) including: when you apply patch to the skin on your hip each morning when you remove the patch how and where you threw DAYTRANA away To use the DAYTRANA Dosing Chart, follow these instructions: Each day, when a new patch is applied to your hip, write down the date and time that you applied the patch.
Use the DAYTRANA schedule below so you can decide when to remove the patch. For example, if the patch is applied to the skin at 6:00 a.m., remove the patch at 3:00 p.m. on the same day. After you remove and throw away the patch, write down the time you removed the patch and how and where you threw it away.
If the patch you placed on your child is missing, ask your child: when the patch came off how the patch came off where the patch is DAYTRANA Schedule for 9 Hour Dosing If you put the patch on at: On the same day, remove the patch at: 5:00 a.m. 2:00 p.m. 6:00 a.m.
3:00 p.m. 7:00 a.m. 4:00 p.m.
8:00 a.m. 5:00 p.m. 9:00 a.m.
6:00 p.m. 10:00 a.m. 7:00 p.m.
11:00 a.m. 8:00 p.m. 12:00 p.m.
9:00 p.m. 2. Where to apply DAYTRANA Apply patch to your hip area.
Do not put the patch near your waist. Clothing and movement may make your patch rub off (See Figure A). Use your other hip when you apply a new patch the next morning.
Make sure there is no redness, small bumps or itching at the site where the patch is going to be applied. Figure A 3. Before you apply DAYTRANA Make sure your skin: Is clean (freshly washed), dry, and cool Does not have any powder, oil, or lotion Does not have any cuts and irritation (rashes, inflammation, redness, or other skin problems).
4 . How to apply DAYTRANA Open the sealed tray and throw away the small packet (drying agent). Each patch is sealed in its own protective pouch.
Carefully cut the protective pouch open with scissors, being careful not to cut the patch. Do not use patches that have been cut or damaged in any way (See Figure B). Figure B Remove the patch from the protective pouch.
Look at the patch to make sure it is not damaged. The patch should separate easily from the protective liner. Throw away the patch if the protective liner is hard to remove.
DAYTRANA has 3 layers. The 3 layers are pictured below. The pictures show both sides of the patch: Figure C Figure D Layers: Protective liner: The protective liner is the layer that you remove before you put the patch on (See Figure C).
Adhesive with medicine: The adhesive with medicine is the layer that sticks to your skin (See Figure C). Outside backing: The outside backing is the layer that you see after you put the patch on your skin. The word "Daytrana" is printed on this layer (See Figure D).
Apply the patch right away after you remove the patch from protective pouch . Hold the patch with the hard protective liner facing you. The word DAYTRANA will appear backwards.
Gently bend the patch along the faint line and slowly peel half the liner, which covers the sticky surface of the patch (See Figure E). Figure E Avoid touching the sticky side of the patch with your fingers. If you accidentally touch the sticky side of the patch, apply the patch, then wash your hands right away so that the medicine does not go into the skin on your hands.
Using the other half of the protective liner as a handle, apply the sticky side of the patch to the selected area of the child's hip (See Figure F). Figure F Press the sticky side of the patch firmly into place and smooth it down. While you are still holding the sticky side down, gently fold back the other half of the patch.
Hold an edge of the remaining protective liner and slowly peel it off (See Figure G). Figure G After the protective liner is removed, there should not be any adhesive (glue) sticking to the liner. Figure H Press the entire patch firmly into place with the palm of your… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.8 ) 09/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - NDC 68968-5552-3 - 10 mg 30 Count Carton NDC 68968-5552-3 Daytrana ® (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches CII Rx only Noven Therapeutics, LLC Once the tray is opened, use contents within 2 months. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc. ©2007, 2010 Noven Pharmaceuticals, Inc. 1-877-567-7857 Pharmacists: Enclosed Medication Guide to be dispensed to each patient.
302188-8 Rev. 9/2016 Each patch contains 27.5 mg of methylphenidate. Active ingredient release is limited; please see recommended dosing in patient instructions.
Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive. For transdermal use only (applied only to skin). Keep all patches within provided containers and dispense one patch daily.
Apply immediately upon removal from pouch. Do not store unpouched. Do not store patches in refrigerators or freezers.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature] Important: Keep out of the reach of children. It is important that this product be disposed of properly. See patient instructions for disposal information.
Dosage and Administration: See package insert. Date of Patch Application MM/DD/YYYY Time Applied Time Removed Application Side Disposal Method Date of Patch Application MM/DD/YYYY Time Applied Time Removed Application Side Disposal Method _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash _AM _PM _AM _PM _Right _Left _Fold & flush _ Fold & trash daytrana-10mg-30ct-carton
PRINCIPAL DISPLAY PANEL - NDC 68968-5553-3 - 15 mg 30 Count Carton NDC 68968-5553-3 Daytrana ® (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches CII Rx only Noven Therapeutics, LLC Once the tray is opened, use contents within 2 months. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc. ©2007, 2010 Noven Pharmaceuticals, Inc. 1-877-567-7857 Pharmacists: Enclosed Medication Guide to be dispensed to each patient.
302189-8 Rev. 9/2016 Each patch contains 41.3 mg of methylphenidate. Active ingredient release is limited; please see recommende… [Excerpted — this section continues on DailyMed.]