What is Abstral?Abstral is a strong opioid pain medicine that contains fentanyl. Abstral is used to treat breakthrough pain (pain that comes on suddenly for short periods of time and is not relieved with the normal pain medications). It is used in adults with cancer who regularly use opioid pain medicines (such as morphine) around-the-clock for cancer pain. Abstral is started only after you have been taking another opioid pain medicine and your body is used to it (opioid-tolerant). Do not use Abstral if you are not opioid tolerant.
Abstral is a federally controlled substance because it has abuse potential.
What is the most important information I should know about Abstral?Abstral can cause life-threatening breathing problems which can lead to death if you are not opioid tolerant, if you do not use Abstral exactly as prescribed by your doctor, or if a child takes Abstral by accident.
Keep Abstral in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. Get emergency help immediately if a child takes Abstral by accident. If possible, try to remove Abstral from the child's mouth.
Abstral is available only through a restricted distribution program called the Abstral Risk Evaluation and Mitigation Strategy (REMS) program.
Abstral is only available at pharmacies that are part of the Abstral REMS program. Your doctor will let you know the pharmacy closest to your home where you can have your Abstral prescription filled.
Call your doctor or get emergency medical help immediately if you have breathing problems, drowsiness, faintness, dizziness, confusion, or any other unusual symptoms. These can be symptoms of an overdose. Your dose of Abstral may be too high for you. These symptoms may lead to serious problems or death if not treated right away. Do not take another dose of Abstral.
Who should not take Abstral?Do not use Abstral if you are not already taking another opioid pain medicine around-the-clock for your constant pain.
Do not use Abstral if you only have pain for a short period of time that you would expect to go away in a few days, such as pain from surgery, headache, migraine, or dental pain.
Do not use Abstral if you are allergic to it or any of its ingredients.
What should I tell my doctor before I take the first dose of Abstral?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Abstral. Also, talk to your doctor about your complete medical history, especially if you have brain problems or head injury; breathing problems (asthma, wheezing, shortness of breath); heart problems, slow heart rate, or low blood pressure; history of or a present drinking problem (alcoholism), drug abuse, or addiction; kidney or liver problems; mental health problems or seizures; or if you are pregnant or breastfeeding.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults ≥18 years: The starting dose is 100 micrograms (mcg). Your doctor will increase your dose as needed, until the desired effect is achieved.
How should I take Abstral?Take Abstral exactly as prescribed by your doctor. Do not use Abstral more often than prescribed.
Do not use more than 2 doses of Abstral for each episode of breakthrough cancer pain. Take 1 dose for an episode of breakthrough cancer pain. If your breakthrough pain does not get better within 30 minutes after taking the first dose of Abstral, you can take 1 more dose of Abstral as instructed by your doctor. If your breakthrough pain does not get better after the second dose of Abstral, call your doctor for instructions. Do not take another dose of Abstral at this time.
Wait at least 2 hours before treating a new episode of breakthrough cancer pain with Abstral. If you only need to take 1 dose of Abstral for an episode of breakthrough pain, you must wait 2 hours from the time of that dose to take another dose of Abstral for a new episode of breakthrough pain.
If you need to take 2 doses of Abstral for an episode of breakthrough pain, you must wait 2 hours after the second dose to take another dose of Abstral for a new episode of breakthrough pain.
Place Abstral tablets on the floor of the mouth directly under the tongue immediately after you remove it from the blister unit. Do not chew, suck, or swallow Abstral tablets. Allow Abstral tablets to completely dissolve under the tongue. Do not eat or drink anything until the tablet is completely dissolved. If you have a dry mouth, you can use water to moisten it before taking Abstral.
What should I avoid while taking Abstral?Do not drive, operate machinery, or engage in dangerous activities until you know how Abstral affects you. Abstral can make you sleepy. Ask your doctor when it is okay to do these activities.
Do not drink alcohol while you are using Abstral. It can increase your chance of having dangerous side effects.
What are possible food and drug interactions associated with Abstral?If Abstral is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Abstral may interact with numerous medications. Therefore, it is very important that you tell your doctor about any other medications you are taking.
What are the possible side effects of Abstral?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: constipation, decreased blood pressure, headache, nausea, shortness of breath, sleepiness
Can I receive Abstral if I am pregnant or breastfeeding?Abstral can cause harm to your unborn baby if you take it during pregnancy. Abstral passes through breast milk and can cause serious harm to your baby. Do not use Abstral while you are pregnant or breastfeeding. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
What should I do if I miss a dose of Abstral?Abstral is not a regularly scheduled medicine. It should only be used for breakthrough cancer pain. Remember to continue taking your regularly used around-the-clock opioid medicine and take Abstral only when you experience an episode of breakthrough pain and exactly as prescribed.
How should I store Abstral?Store at room temperature.