Abstral
Abstral is a potent, fast-acting synthetic opioid analgesic formulation of fentanyl citrate designed for sublingual administration. It is indicated exclusively for the management of breakthrough pain in cancer patients who are opioid-tolerant. Because of the risk of misuse, abuse, addiction, and overdose, it is only available through a restricted distribution program called the TIRF (Transmucosal Immediate-Release Fentanyl) REMS Access Program.
Dosage by Body Weight
Dosage must be individually titrated to an effective dose. The initial starting dose of Abstral is always 100 mcg. Patients should be monitored closely during the titration phase. If breakthrough pain is not relieved within 30 minutes of the first dose, a second dose of the same strength may be administered. No more than two doses can be used to treat a single breakthrough pain episode, and patients must wait at least 2 hours before treating another episode.
- Body Weight
- Below 5 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals.
- Body Weight
- 5-7 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals.
- Body Weight
- 8-10 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals.
- Body Weight
- 11-15 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals.
- Body Weight
- 16-20 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Contraindicated | Do not use | Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals. |
| 5-7 kg | Contraindicated | Do not use | Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals. |
| 8-10 kg | Contraindicated | Do not use | Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals. |
| 11-15 kg | Contraindicated | Do not use | Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals. |
| 16-20 kg | Contraindicated | Do not use | Abstral is not indicated for pediatric patients and is strictly contraindicated in non-opioid-tolerant individuals. |
Formulation
Purpose
Management of breakthrough cancer pain in adult patients who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Generic Name
Fentanyl citrateScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.