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fentora fentanyl 100 mcg tablet

1 INDICATIONS AND USAGE FENTORA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking FENTORA. Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, and dental pain [see Contraindications ( 4 )] . As a part of the TIRF REMS, FENTORA may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions ( 5.7 )] . For inpatient administration of FENTORA, patient and prescriber enrollment are not required. FENTORA is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. ( 1 ) Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking FENTORA. Limitations of Use: Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, or dental pain. As a part of the TIRF REMS, FENTORA may be dispensed by outpatient pharmacies only to patients enrolled in the program ( 5.7 ). For inpatient administration of FENTORA, patient and prescriber enrollment are not required.

cephalon, inc.


2 years ago ROUND WHITE C 1 fentora fentanyl 100 mcg tablet

ROUND WHITE C 1

16 HOW SUPPLIED/STORAGE AND HANDLING FENTORA is supplied in individually sealed, child-resistant blister packages. Each carton contains 7 blister cards with 4 white tablets in each card. The blisters are child-resistant, encased in peelable foil, and provide protection from moisture. Each tablet is debossed on one side with , and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below. In addition, the dosage strength is indicated on the blister package and the carton. See blister package and carton for product information. Dosage Strength Debossing Carton/Blister Package Color NDC Number 100 mcg 1 blue NDC 63459-541-28 200 mcg 2 orange NDC 63459-542-28 400 mcg 4 Sage green NDC 63459-544-28 600 mcg 6 Magenta (pink) NDC 63459-546-28 800 mcg 8 yellow NDC 63459-548-28 Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Storage and Handling Store at 20 to 25°C (68 to 77°F) with excursions permitted between 15° and 30°C (59° to 86°F) until ready to use. (See USP Controlled Room Temperature.) Protect FENTORA from freezing and moisture. Do not use if the blister package has been tampered with. Store FENTORA securely and dispose of properly [see Patient Counseling Information ( 17 )]. Cephalon logo

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