Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Transdermal System 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 0574-2410-65 15 1.6 18.75 41.3 30 0574-2415-65 20 2.2 25 55 30 0574-2420-65 30 3.3 37.5 82.5 30 0574-2430-65 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 Methylphenidate Transdermal System.; Package Label - NDC 0574-2410-65 NDC 0574- 2410 -65 Methylphenidate Transdermal System Delivers 10 mg over 9 hours (1.1 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 19Z65 RC C1 302452-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches 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 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 10mg; Package Label - NDC 0574-2415-65 NDC 0574- 2415 -65 Methylphenidate Transdermal System Delivers 15 mg over 9 hours (1.6 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 40J65 RC C1 302453-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 41.3 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 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 15mg; Package Label - NDC 0574-2420-65 NDC 0574- 2420 -65 Methylphenidate Transdermal System Delivers 20 mg over 9 hours (2.2 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 38U65 RC C1 302454-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 55 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 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 20mg; Package Label - NDC 0574-2430-65 NDC 0574- 2430 -65 Methylphenidate Transdermal System Delivers 30 mg over 9 hours (3.3 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 27Y65 RC C1 302455-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 82.5 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 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 30mg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Transdermal System 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 0574-2410-65 15 1.6 18.75 41.3 30 0574-2415-65 20 2.2 25 55 30 0574-2420-65 30 3.3 37.5 82.5 30 0574-2430-65 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 Methylphenidate Transdermal System.
- Package Label - NDC 0574-2410-65 NDC 0574- 2410 -65 Methylphenidate Transdermal System Delivers 10 mg over 9 hours (1.1 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 19Z65 RC C1 302452-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches 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 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 10mg
- Package Label - NDC 0574-2415-65 NDC 0574- 2415 -65 Methylphenidate Transdermal System Delivers 15 mg over 9 hours (1.6 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 40J65 RC C1 302453-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 41.3 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 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 15mg
- Package Label - NDC 0574-2420-65 NDC 0574- 2420 -65 Methylphenidate Transdermal System Delivers 20 mg over 9 hours (2.2 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 38U65 RC C1 302454-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 55 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 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 20mg
- Package Label - NDC 0574-2430-65 NDC 0574- 2430 -65 Methylphenidate Transdermal System Delivers 30 mg over 9 hours (3.3 mg/hr) Patch should be worn for approximately 9 hours Contains: 30 Patches Rx Only Padagis Once the tray is opened, use contents within 2 months. Manufactured By Noven Pharmaceuticals, Inc. Miami, FL 33186 1-866-634-9120 Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 11-22 27Y65 RC C1 302455-1 Pharmacist: Enclosed Medication Guide to be dispensed to each patient. Contains: 30 Patches Each patch contains 82.5 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 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 30mg
Overview
Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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. Methylphenidate Transdermal System 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. structure patch
Indications & Usage
Methylphenidate Transdermal System (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 Methylphenidate Transdermal System 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 )] . Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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
The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg. ( 2.2 ) Methylphenidate Transdermal System 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. Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, 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 Methylphenidate Transdermal System [see Warnings and Precautions ( 5.15 )] . 2.2 Recommended Dosage It is recommended that Methylphenidate Transdermal System 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. Table 1 Methylphenidate Transdermal System - Recommended Titration Schedule (Patients New to Methylphenidate) *Nominal in vivo delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period. 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 Methylphenidate Transdermal System compared to other products. 2.3 Application The parent or caregiver should be encouraged to use the administration chart included with each carton of Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, based on the 9-hour application time. The adhesive side of Methylphenidate Transdermal System should be placed on a clean, dry area of the hip. The area selected should not be oily, damaged, or irritated. Apply Methylphenidate Transdermal System 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 Methylphenidate Transdermal System. Methylphenidate Transdermal System 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. Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 )] . Methylphenidate Transdermal System should not be stored in refrigerators or freezers. 2.4 Removal of Methylphenidate Transdermal System Methylphenidate Transdermal System 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 Methylphenidate Transdermal System or adhesive. 2.5 Dose/Wear Time Reduction and Discontinuation Methylphenidate Transdermal System 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.
Warnings & 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 Methylphenidate Transdermal System, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Methylphenidate Transdermal System. ( 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 Methylphenidate Transdermal System 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: Methylphenidate Transdermal System 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 Methylphenidate Transdermal System if it occurs. ( 5.9 ) Contact Sensitization: Use of Methylphenidate Transdermal System may lead to contact sensitization. Treatment should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of Methylphenidate Transdermal System 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 Methylphenidate Transdermal System application site to direct external heat sources. When heat is applied to Methylphenidate Transdermal System 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: Methylphenidate Transdermal System -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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, 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 ) 5.1 Abuse, Misuse, and Addiction Methylphenidate Transdermal System has a high potential for abuse and misuse. The use of Methylphenidate Transdermal System exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, 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 Methylphenidate Transdermal System, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their caregivers or families about these risks. Advise patients to store Methylphenidate Transdermal System in a safe place, preferably locked, and instruct patients to not give Methylphenidate Transdermal System to anyone else. Throughout Methylphenidate Transdermal System treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Methylphenidate Transdermal System has special disposal instructions. Instruct patients to find a take back location to dispose of unused or expired Methylphenidate Transdermal System. If a take back program is unavailable, instruct them to: Remove Methylphenidate Transdermal System from its pouch, separate it from its liner, fold it in half with the adhesive sides touching each other, and immediately flush the used transdermal system 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). 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid Methylphenidate Transdermal System use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all Methylphenidate Transdermal System -treated patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating Methylphenidate Transdermal System treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosages, may cause psychotic or manic symptoms, (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing Methylphenidate Transdermal System. 5.5 Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued. 5.6 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on the methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). Methylphenidate Transdermal System -treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. 5.7 Peripheral Vasculopathy, including Raynaud’s phenomenon Stimulant medications, including Methylphenidate Transdermal System, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during Methylphenidate Transdermal System treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Methylphenidate Transdermal System -treated patients who develop signs or symptoms of peripheral vasculopathy. 5.8 Long-Term Suppression of Growth in Pediatric Patients Methylphenidate Transdermal System is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Populations ( 8.4 )] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in Methylphenidate Transdermal System -treated pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. 5.9 Chemical Leukoderma Methylphenidate Transdermal System 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. Chemical leukoderma can mimic the appearance of vitiligo, particularly when the loss of skin pigmentation involves areas distant from the application site. Individuals with a history of vitiligo and/or a family history of vitiligo may be more at risk. Skin depigmentation may persist even after Methylphenidate Transdermal System use is discontinued. Monitor for signs of skin depigmentation, and advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur. Discontinue use of the Methylphenidate Transdermal System in patients with chemical leukoderma. 5.10 Contact Sensitization In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with Methylphenidate Transdermal System using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at Methylphenidate Transdermal System application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate. Use of Methylphenidate Transdermal System may lead to contact sensitization. Methylphenidate Transdermal System should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of Methylphenidate Transdermal System 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. Confirmation of a diagnosis of contact sensitization (allergic contact dermatitis) may require further diagnostic testing. Patients sensitized from use of Methylphenidate Transdermal System, as evidenced by development of an allergic contact dermatitis, may develop systemic sensitization or other systemic reactions if methylphenidate-containing products are taken via other routes, e.g., orally. Manifestations of systemic sensitization may include a flare-up of previous dermatitis or of prior positive patch-test sites, or generalized skin eruptions in previously unaffected skin. Other systemic reactions may include headache, fever, malaise, arthralgia, diarrhea, or vomiting. No cases of systemic sensitization have been observed in clinical trials of Methylphenidate Transdermal System. Patients who develop contact sensitization to Methylphenidate Transdermal System and require oral treatment with methylphenidate should be initiated on oral medication under close medical supervision. It is possible that some patients sensitized to methylphenidate by exposure to Methylphenidate Transdermal System may not be able to take methylphenidate in any form. 5.11 Patients Using External Heat Patients should be advised to avoid exposing the Methylphenidate Transdermal System application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the transdermal system. When heat is applied to Methylphenidate Transdermal System after application, both the rate and 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 can result in overdose of methylphenidate [see Overdosage ( 10 )] . 5.12 Hematologic Monitoring Periodic CBC, differential, and platelet counts are advised during prolonged therapy. 5.13 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, Methylphenidate Transdermal System -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. 5.14 Increased Intraocular Pressure and Glaucoma There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions ( 6.2 )] . Prescribe Methylphenidate Transdermal System to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor Methylphenidate Transdermal System-treated patients with a history of abnormally increased IOP or open angle glaucoma. 5.15 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions ( 6.2 )] . Before initiating Methylphenidate Transdermal System, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor Methylphenidate Transdermal System -treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.
Boxed Warning
ABUSE, MISUSE, AND ADDICTION Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, 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 Methylphenidate Transdermal System, 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing Methylphenidate Transdermal System, 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.
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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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).
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 Padagis at 1-866-634-9120 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 Methylphenidate Transdermal System development program included exposure to Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System discontinued due to adverse reactions compared with 2.8% (2/72) receiving placebo. The most commonly reported adverse reactions leading to discontinuation in the Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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% Methylphenidate Transdermal System -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 Methylphenidate Transdermal System Group) in 7-Week Placebo-controlled Studies in Either Children or Adolescents - Safety Population Adolescents Children System Organ Class Preferred Term Placebo N = 72 Methylphenidate Transdermal System N = 145 Placebo N = 85 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System In a long-term open-label study of up to 12 months duration in 326 children wearing Methylphenidate Transdermal System 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 Methylphenidate Transdermal System 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 Methylphenidate Transdermal System. 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 Methylphenidate Transdermal System 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.
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 Methylphenidate Transdermal System, 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 Methylphenidate Transdermal System with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. 7.2 Antihypertensive Drugs Methylphenidate Transdermal System 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 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. 7.4 Halogenated 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 Methylphenidate Transdermal System in patients being treated with anesthetics on the day of surgery. 7.5 Risperidone 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.
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