Daytrana

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 )
• 2.1 Pretreatment 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 )] .
• 2.2 Recommended 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.
• 2.3 Application 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 transdermal system appears to be damaged.
• Do not cut transdermal systems.
• Only intact transdermal systems should be applied.
• The transdermal system should then be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure that there is good contact of the transdermal system with the skin, especially around the edges.
• Exposure to water during bathing, swimming, or showering can affect transdermal system adherence.
• DAYTRANA should not be applied or re-applied with dressings, tape, or other common adhesives.
• In the event that a transdermal system does not fully adhere to the skin upon application, or becomes partially or fully detached during wear time, the transdermal system should be discarded and a new transdermal system may be applied at a different site.
• The total recommended wear time for that day should remain 9 hours regardless of the number of transdermal systems used.
• All patients should be advised to
• avoid exposing the DAYTRANA application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the transdermal system [see Warnings and Precautions ( 5.10 )] .
• When heat is applied to DAYTRANA after transdermal system application, both the rate and the extent of absorption are significantly increased.
• The temperature-dependent increase in methylphenidate absorption can be greater than 2-fold [see Clinical Pharmacology ( 12.3 )] .
• This increased absorption can be clinically significant and result in overdose of methylphenidate [see Overdosage ( 10 )] .
• DAYTRANA should not be stored in refrigerators or freezers.
• 2.4 Removal of DAYTRANA DAYTRANA should be peeled off slowly.
• If necessary, transdermal system removal may be facilitated by gently applying an oil-based product (i.e., petroleum jelly, olive oil, or mineral oil) to the transdermal system edges, gently working the oil underneath the transdermal system edges.
• If any adhesive remains on the skin following transdermal system removal, an oil-based product may be applied to transdermal system sites in an effort to gently loosen and remove any residual adhesive that remains following transdermal system removal.
• In the unlikely event that a transdermal system remains tightly adhered despite these measures, the patient or caregiver should contact the physician or pharmacist.
• Nonmedical adhesive removers and acetone-based products (i.e., nail polish remover) should not be used to remove DAYTRANA or adhesive.
• 2.5 Dose/Wear Time Reduction and Discontinuation DAYTRANA may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.
• Plasma concentrations of d -methylphenidate generally begin declining when the transdermal system is removed, although absorption may continue for several hours.
• Individualization of wear time may help manage some of the side effects caused by methylphenidate.
• If aggravation of symptoms or other adverse events occur, the dosage or wear time should be reduced, or, if necessary, the drug should be discontinued.
• Residual methylphenidate remains in used transdermal systems when worn as recommended.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

DAYTRANA has not been studied in patients greater than 65 years of age.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 .
• 6.1 Clinical 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 primarily by general inquiry at each visit, and were recorded by the clinical investigators using terminology of their own choosing.
• Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of events into a smaller number of standardized event categories.
• Adverse Reactions in Clinical Studies with Discontinuation of Treatment In a 7-week double-blind, parallel-group, placebo-controlled study in children with ADHD conducted in the outpatient setting, 7.1% (7/98) of patients treated with DAYTRANA discontinued due to adverse events compared with 1.2% (1/85) receiving placebo.
• The most commonly reported (≥ 1% and twice the rate of placebo) adverse reactions leading to discontinuation in the DAYTRANA group were application site reaction (2%), tics (1%), headache (1%), and irritability (1%).
• In a 7-week double-blind, parallel-group, placebo-controlled study in adolescents with ADHD conducted in the outpatient setting, 5.5% (8/145) of patients treated with DAYTRANA discontinued due to adverse reactions compared with 2.8% (2/72) receiving placebo.
• The most commonly reported adverse reactions leading to discontinuation in the DAYTRANA group were application site reaction (2%) and decreased appetite/anorexia (1.4%).
• Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Trials Skin Irritation and Application Site Reactions DAYTRANA is a dermal irritant.
• In addition to the most commonly reported adverse reactions presented in Table 2, the majority of subjects in those studies had minimal to definite skin erythema at the DAYTRANA application site.
• This erythema generally caused no or minimal discomfort and did not usually interfere with therapy or result in discontinuation from treatment.
• Erythema is not by itself a manifestation of contact 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 [ see Warnings and Precautions ( 5.10 ) ].
• Most Commonly Reported Adverse Reactions Table 2 lists treatment-emergent adverse reactions reported in ≥ 1% DAYTRANA-treated children or adolescents with ADHD in two 7 week double-blind, parallel-group, placebo-controlled studies conducted in the outpatient setting.
• Overall, in these studies, 75.5% of children and 78.6% of adolescents experienced at least 1 adverse event. * Six subjects had affect lability, all judged as mild and described as increased emotionally sensitive, emotionality, emotional instability, emotional lability, and intermittent emotional Table 2 Number (%) of Subjects with Commonly Reported Adverse Reactions (≥ 1% in the DAYTRANA Group) in 7-Week Placebo-controlled Studies in Either Children or Adolescents - Safety Population Adolescents Children System Organ Class Preferred term Placebo N = 72 DAYTRANA N = 145 Placebo N = 85 DAYTRANA N = 98 Cardiac Disorders Tachycardia 0 (0) 1 (0.7) 0 (0) 1 (1.0) Gastrointestinal disorders Abdominal pain 0 (0) 7 (4.8) 5 (5.9) 7 (7.1) Nausea 2 (2.8) 14 (9.7) 2 (2.4) 12 (12.2) Vomiting 1 (1.4) 5 (3.4) 4 (4.7) 10 (10.2) Investigations Weight decreased 1 (1.4) 8 (5.5) 0 (0) 9 (9.2) Metabolism and nutrition disorders Anorexia 1 (1.4) 7 (4.8) 1 (1.2) 5 (5.1) Decreased appetite 1 (1.4) 37 (25.5) 4 (4.7) 25 (25.5) Nervous system disorders Dizziness 1 (1.4) 8 (5.5) 1 (1.2) 0 (0) Headache 9 (12.5) 18 (12.4) 10 (11.8) 15 (15.3) Psychiatric disorders Affect lability 1 (1.4) 0 (0) 0 (0) 6 (6.1)* Insomnia 2 (2.8) 9 (6.2) 4 (4.7) 13 (13.3) Irritability 5 (6.9) 16 (11) 4 (4.7) 7 (7.1) Tic 0 (0) 0 (0) 0 (0) 7 (7.1) Adverse Reactions in Studies with the Long-Term Use of DAYTRANA In a long-term open-label study of up to 12 months duration in 326 children wearing DAYTRANA 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite, headache, and weight decreased.
• A total of 30 subjects (9.2%) were withdrawn from the study due to adverse events and 22 additional subjects (6.7%) discontinued treatment as the result of an application site reaction.
• Other than application site reactions, affect lability (5 subjects, 1.5%) was the only additional adverse reaction leading to discontinuation reported with a frequency of greater than 1%.
• In a long-term open-label study of up to 6 months duration in 162 adolescents wearing DAYTRANA 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite and headache.
• A total of 9 subjects (5.5%) were withdrawn from the study due to adverse events and 3 additional subjects (1.9%) discontinued treatment as the result of an application site reaction.
• Other adverse reactions leading to discontinuation that occurred with a frequency of greater than 1% included affect lability and irritability (2 subjects each, 1.2%).
• 6.2 Postmarketing Experience In addition, the following adverse reactions have been identified during the post-approval use of DAYTRANA.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to DAYTRANA exposure.
• Cardiac Disorders: palpitations.
• Eye Disorders:
• visual disturbances, blurred vision, increased intraocular pressure, mydriasis, and accommodation disorder.
• General Disorders and Administration Site Disorders :
• fatigue, application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.
• Immune System Disorders:
• hypersensitivity reactions including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis.
• Investigations: blood pressure increased.
• Nervous System Disorders :
• convulsion, dyskinesia, lethargy, somnolence, serotonin syndrome in combination with serotonergic drugs, and extrapyramidal disorder, motor, and verbal tics.
• Psychiatric Disorders : depression, hallucination, nervousness, and libido changes.
• Skin and Subcutaneous Tissue Disorders : alopecia.
• Adverse Reactions with Oral Methylphenidate Products Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products.
• In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.
• Other reactions include:
• Cardiac Disorders:
• angina, arrhythmia, and pulse increased or decreased.
• Immune System Disorders:
• hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura.
• Metabolism and Nutrition Disorders: anorexia and weight loss during prolonged therapy.
• Nervous System Disorders:
• drowsiness, rare reports of Tourette's syndrome and toxic psychosis.
• Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS.
• In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine.
• It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.
• Vascular Disorders:
• blood pressure increased or decreased and cerebral arteritis and/or occlusion.
• Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:
• Blood and Lymphatic System Disorders:
• leukopenia and/or anemia.
• Hepatobiliary Disorders:
• abnormal liver function, ranging from transaminase elevation to severe hepatic injury.
• Psychiatric Disorders: transient depressed mood.
• Skin and Subcutaneous Tissue Disorders: scalp hair loss.
• Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 patients or caregivers experience difficulty separating the transdermal system from the release liner or observe tearing and/or other damage to the transdermal system during removal from the liner, the transdermal system should be discarded according to the directions provided in this label, and a new transdermal system should be applied [see Dosage and Administration ( 2.3 )] .
• 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.
• DAYTRANA should be applied 2 hours before the desired effect.
• DAYTRANA should be removed approximately 9 hours after it is applied, although the effects from the transdermal system will last for several more hours.
• DAYTRANA may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.
• 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.
• The Medication Guide included at the end of this insert also includes a timetable to calculate when to remove DAYTRANA, based on the 9 hour application time.
• Patients or caregivers should
• avoid touching the adhesive side of the transdermal system during application, in order to
• avoid absorption of methylphenidate.
• If they do touch the adhesive side of the transdermal system, they should immediately wash their hands after application.
• In the event that a DAYTRANA does not fully adhere to the skin upon application, or is partially or fully detached during wear time, the transdermal system should be discarded according to the directions provided in this label, and a new transdermal system should be applied [see Dosage and Administration ( 2.3 )] .
• If a transdermal system is replaced, the total recommended wear time for that day should remain 9 hours, regardless of the number of transdermal systems used.
• DAYTRANA should not be applied or re-applied with dressings, tape, or other common adhesives.
• Exposure to water during bathing, swimming, or showering can affect DAYTRANA adherence.
• Do not cut transdermal systems.
• Only intact transdermal systems should be applied.
• If there is an unacceptable duration of appetite loss or insomnia in the evening, taking the transdermal system off earlier may be attempted before decreasing the transdermal system dose.
• Skin redness or itching is common with DAYTRANA and small bumps on the skin may also occur in some patients.
• If any swelling or blistering occurs the DAYTRANA should not be worn and the patient should be seen by the prescriber.
• Patients or caregivers should not apply hydrocortisone or other solutions, creams, ointments, or emollients immediately prior to DAYTRANA application, since the effect on transdermal system adhesion and methylphenidate absorption has not been established.
• The potential adverse effects of topical corticosteroid use during treatment with DAYTRANA are unknown.
• Recommended Storage Instructions Transdermal systems should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions permitted that
• do not exceed 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) [see How Supplied/Storage and Handling ( 16 )] .
• Patients or caregivers should be advised not to store DAYTRANA in the refrigerator or freezer.
• Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy [ see Use in Specific Populations ( 8.1 )] .
• Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.
• By: Noven Pharmaceuticals, Inc., Miami, FL 33186.
• For more information, call 1-800-455-8070 or visit www.daytrana.com .
• DOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc.
• DAYTRANA ® is a registered trademark of Noven Therapeutics, LLC. 102086-23

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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
• 82.5 Transdermal 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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.

Quoted from the official label, section “How Supplied”.

What is in it

• 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Methylphenidate