Fentanyl system — 100MCG/HR, Patch, carton of 5 patchs

Fentanyl system — 100MCG/HR, Patch, carton of 5 patchs

Fentanyl system is a patch for transdermal use. Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

• Active ingredient or product type: FENTANYL
• Strength/concentration: 100MCG/HR
• Dosage form and route: Patch, Transdermal
• Exact package presentation: carton of 5 patchs
• NDC/item number: 47781-428-47
• Manufacturer: ALVOGEN INC.
• Storage/handling: Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store fentanyl transdermal system securely and dispose of properly [see Patient Counseling Information ( 17 ) ].
• Status: Rx only

Important safety information: Risk of Increased Fentanyl Absorption with Elevated Body Temperature : Regularly evaluate patients with fever closely for sedation and respiratory depression and reduce the dose if necessary.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.