Daytrana 30 mg/9h
methylphenidate · PATCH · Noven Therapeutics, LLC
Daytrana is a prescription patch that delivers methylphenidate, a central nervous system stimulant, through your skin over 9 hours to treat attention-deficit/hyperactivity disorder (ADHD). The 30 mg strength patch is applied to your body once daily as prescribed by your doctor.
Key Facts
- Brand Name
- Daytrana
- Generic Name
- methylphenidate
- NDC Code (Product)
68968-5555- Manufacturer
- Noven Therapeutics, LLC
- Strength
- 30 mg/9h
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA021514
- Drug Class
- Central Nervous System Stimulant [EPC]
- Marketing Start
- 04/06/2006
Recall History
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Noven Pharmaceuticals, Inc.
Defective Delivery System: One lot exceeded the mechanical peel specification
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
Noven Pharmaceuticals Inc
Defective Delivery System: customer complaints exceeded respective action limits.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Noven Pharmaceuticals, Inc.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Full Prescribing Information
Indications & 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 & 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 ) 2.1 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 appli…
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate ( 4.1 ) Patients currently using or within 2 weeks of using an MAO inhibitor ( 4.2 ) 4.1 Hypersensitivity 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 )] . 4.2 Monoamine 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).
Drug Interactions
7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.2 ) 7.1 Monoamine 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. 7.2 Antihypertensive 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 )] . 7.3 Coumarin 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 adjus…
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 Intrao…
Frequently Asked Questions
What is Daytrana used for?
Daytrana is a prescription patch that delivers methylphenidate, a central nervous system stimulant, through your skin over 9 hours to treat attention-deficit/hyperactivity disorder (ADHD). The 30 mg strength patch is applied to your body once daily as prescribed by your doctor.
Is Daytrana a controlled substance?
Yes, Daytrana is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Daytrana?
The generic name for Daytrana is methylphenidate. There are 12 other brand versions of methylphenidate.
What is the NDC code for Daytrana 30 mg/9h?
The NDC (National Drug Code) for Daytrana 30 mg/9h is 68968-5555, listed by Noven Therapeutics, LLC.
Other Methylphenidate Brands
See all →- Methylphenidate Hydrochloride5 mg/5mL72162-1992
- Methylphenidate Hydrochloride27 mg/172162-2395
- Methylphenidate Hydrochloride54 mg/10527-3313
- Methylphenidate40 mg/10781-2386
- METHYLPHENIDATE HYDROCHLORIDE5 mg/116729-478
- QuilliChew ER40 mg/124478-076
- Methylphenidate Hydrochloride5 mg/143386-571
- Methylphenidate Hydrochloride5 mg/5mL43386-930
- Methylphenidate Hydrochloride27 mg/150268-546
- Methylphenidate Hydrochloride10 mg/155466-102
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)