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Outline
What is the generic name?
FENTANYL
What is the Trade Name for FENTANYL?
LAZANDA
What are the Indications for FENTANYL?
- INDICATIONS AND USAGE LAZANDA 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, 25 mcg of transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking LAZANDA. 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, dental pain, or in the emergency department [see Contraindications ( 4 )]. As a part of the TIRF REMS, LAZANDA may be dispensed by outpatient pharmacies only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7 )] . For inpatient administration of LAZANDA, patient and prescriber enrollment are not required.
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References: https://open.fda.gov/
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