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ABSTRAL- fentanyl tablet


Patient Information

See FDA-approved patient labelling (Medication Guide)

17.1 Patient/Caregiver Instructions

  • Before initiating treatment with Abstral, explain the statements below to patients and/or caregivers. Instruct patients to read the Medication Guide each time Abstral is dispensed because new information may be available.
  • TIRF REMS Access Program
    • Outpatients must be enrolled in the TIRF REMS Access program before they can receive Abstral.
    • Allow patients the opportunity to ask questions and discuss any concerns regarding Abstral or the TIRF REMS Access program.
    • As a component of the TIRF REMS Access program, prescribers must review the contents of the Abstral Medication Guide with every patient before initiating treatment with Abstral.
    • Advise the patient that Abstral is available only from pharmacies that are enrolled in the TIRF REMS Access program, and provide them with the telephone number and website for information on how to obtain the drug.
    • Advise the outpatient that only enrolled health care providers may prescribe Abstral.
    • Patient must sign the Patient-Prescriber Agreement to acknowledge that they understand the risks of Abstral.
    • Advise patients that they may be requested to participate in a survey to evaluate the effectiveness of the TIRF REMS Access program.
  • Instruct patients and their caregivers that ABSTRAL contains medicine in an amount that could be fatal in children, in individuals for whom ABSTRAL is not prescribed, and in those who are not opioid tolerant. Patients and their caregivers must be instructed to keep ABSTRAL, both used and unused dosage units, out of the reach of children. Patients and their caregivers must be instructed to dispose of any unneeded tablets remaining from a prescription as soon as possible [see How Supplied/Storage and Handling (16.2), and Warnings and Precautions (5.2).]
  • Instruct patients and their caregivers to read the Medication Guide each time ABSTRAL is dispensed because new information may be available.
  • Instruct patients not to take Abstral for acute pain, postoperative pain, pain from injuries, headache, migraine, or any other short-term pain, even if they have taken other opioid analgesics for these conditions.
  • Instruct patients on the meaning of opioid tolerance and Abstral is only to be used as a supplemental pain medication for patients with pain requiring regular opioids, who have developed tolerance to the opioid medication and who need additional opioid treatment of breakthrough pain episodes.
  • Instruct that if they are not taking an opioid medication on a regular around-the-clock basis, they must not take Abstral.
  • You must not take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
  • You must wait two hours before treating a new episode of breakthrough pain with ABSTRAL.
  • Instruct patients NOT to share Abstral and that sharing Abstral with anyone else could result in the other individual's death due to overdose.
  • Advise patients that Abstral contains fentanyl, which is a pain medication similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
  • Advise patients that the active ingredient in Abstral, fentanyl, is a drug that some people abuse. Abstral is to be taken only by the patient for whom it was prescribed, and protected from theft or misuse in the work or home environments.
  • Instruct patients to talk to their doctor if breakthrough pain is not alleviated or worsens after taking Abstral.
  • Instruct patients to use Abstral exactly as prescribed by their doctor and not to take Abstral more often than prescribed.
  • Caution patients that Abstral can affect a person's ability to perform activities that require a high level of attention (such as driving or using heavy machinery). Warn patients taking Abstral of these dangers and counsel accordingly.
  • Warn patients not to combine Abstral with alcohol, sleep aids, or tranquilizers except by order of the prescribing physician, because dangerous additive effects may occur resulting in serious injury or death.
  • Inform female patients that if they become pregnant or plan to become pregnant during treatment with Abstral to ask their doctor about the effects that Abstral (or any medicine) may have on them and their unborn child.

17.2 Disposal of Unopened ABSTRAL Blister Packages When No Longer Needed

  • Advise patients and their household members to dispose of any unopened packs remaining from a prescription as soon as they are no longer needed.
  • Instruct patients that, to dispose of any unused ABSTRAL tablets, remove them from the blister cards and flush them down the toilet. Do not dispose of the ABSTRAL blister cards or cartons down the toilet.
  • Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of ABSTRAL are provided in the ABSTRAL Medication Guide. Ensure patients read this information in its entirety and give them an opportunity to have their questions answered.
  • In the event that a caregiver requires additional assistance in disposing of excess units that remain in the home after the drug is no longer needed, instruct them to call the toll-free number for ProStrakan, Inc. 1-888-227-8725 or seek assistance from their local DEA office.



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