Abstral (Fentanyl Citrate)

Sentynl Therapeutics, Inc

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Narcotic Analgesics

Severe Ongoing Pain

This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. Fentanyl belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

Use fentanyl sublingual tablets as directed by your doctor. If your mouth is dry, take a sip of water to moisten it before using this medication. Spit out or swallow the water. With dry hands, open the blister pack unit just before using. Do not push the tablet through the foil of the blister pack because this could damage the tablet. Place the tablet in your mouth under your tongue, as far back as you can. If your dose is for more than one tablet, spread them around the floor of your mouth under your tongue. Do not break, bite, chew, suck, or swallow the tablet whole. Do not eat or drink anything until the tablet dissolves completely. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. If you need a second dose, wait 30 minutes after starting the first dose. Do not use more than 2 doses per episode of breakthrough pain. Wait at least 2 hours before using fentanyl sublingual tablets again for another episode of breakthrough pain. Do not increase your dose or use this drug more often or for longer than prescribed. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. You should continue to also take your around-the-clock opioid medication as directed by your doctor. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using fentanyl safely with other drugs.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Tell your doctor right away if any of these serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss). Get medical help right away if any of these serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), opioid antagonists (such as naltrexone). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include cimetidine, nefazodone, azole antifungals including itraconazole/ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including erythromycin, rifamycins including rifampin, certain anti-seizure medicines including carbamazepine, among others. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Some examples are street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (such as SSRIs like fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222

Not applicable.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.