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1 Indications And Usage Abstral ® 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 Around-The-Clock Medicine Consisting Of At Least 60 Mg Of Oral Morphine Per Day, Or At Least 25 Mcg Per Hour Of Transdermal Fentanyl, Or At Least 30 Mg Of Oral Oxycodone Per Day, Or At Least 8 Mg Of Oral Hydromorphone Per Day, Or At Least 25 Mg Oral Oxymorphone Per Day, Or At Least 60 Mg Oral Hydrocodone Per Day Or An Equianalgesic Dose Of Another Opioid Medication Daily For A Week Or Longer. Patients Must Remain On Around-The- Clock Opioids When Taking Abstral ® . 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 Access Program, Abstral May Be Dispensed Only To Outpatients Enrolled In The Program [See Warnings And Precautions ( 5.7 )]. For Inpatient Administration Of Abstral (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required. Abstral ® 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 Oral Hydrocodone Per Day, Or An Equianalgesic Dose Of Another Opioid Daily. Patients Must Remain On Around-The- Clock Opioids While Taking Abstral. Limitations Of Use ( 1 ) 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 ( 4 ). As A Part Of The Tirf Rems Access Program, Abstral May Be Dispensed Only To Outpatients Enrolled In The Program. For Inpatient Administration Of Abstral (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required.
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