Abstral

Generic Name: fentanyl (sublingual) (FEN tan il sub LIN gwal)
Brand Names: Abstral

What is Abstral?

Abstral (fentanyl sublingual) is an opioid pain medication tablet that dissolves under your tongue. An opioid is sometimes called a narcotic.

Abstral is used to treat "breakthrough" cancer pain. Abstral is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Abstral may also be used for purposes not listed in this medication guide.

Important information about Abstral

Do not use Abstral to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, Subsys, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).

Before taking Abstral, tell your doctor if you have a breathing disorder (asthma, wheezing, COPD), slow heartbeats, seizures, mental illness, low blood pressure, liver or kidney disease, a debilitating condition, or a history of head injury, brain tumor, or addiction to drugs or alcohol.

Tell your doctor if there are children living in the home where you will store this medicine. Keep Abstral out of the reach of children. The amount of fentanyl in each Abstral tablet can be fatal to a child. Never share Abstral with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Before taking Abstral

Do not take Abstral unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. Do not take Abstral if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Tell your doctor if there are children living in the home where you will store this medicine. Keep Abstral out of the reach of children. The amount of fentanyl in each Abstral tablet can be fatal to a child.

To make sure you can safely take Abstral, tell your doctor if you have any of these other conditions:

• a breathing disorder such as wheezing, asthma, or chronic obstructive pulmonary disease (COPD);

• seizures, epilepsy, or a history of head injury or brain tumor;

• low blood pressure, slow heartbeats or other heart rhythm disorder;

• mental illness such as depression, schizophrenia, or hallucinations;

• liver or kidney disease; or

• a personal or family history of drug or alcohol addiction.

Abstral may be habit-forming and should be used only by the person it was prescribed for. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Abstral will harm an unborn baby. Abstral may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using Abstral. Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while you are taking Abstral.

See also: Abstral pregnancy and breastfeeding warnings (in more detail)

How should I take Abstral?

Use Abstral exactly as prescribed. Never use Abstral in larger amounts, or for longer than recommended by your doctor. Keep using your around-the-clock narcotic pain medicine but never take Abstral together with a second form of fentanyl. Do not use Abstral to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, Subsys, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device). If you switch to Abstral from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms). Your doctor may change your dose to make sure you get the best results.

Place the Abstral tablet under your tongue, as far back as you can. Do not break, chew, suck, or swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Do not drink or eat anything during this time.

You may use a second Abstral tablet 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after taking the second tablet. Do not take more than 2 tablets for each episode of breakthrough cancer pain. You must wait at least 2 hours after your last dose before you can treat a new pain episode.

Do not treat more than 4 pain episodes per day with Abstral. Call your doctor if you have breakthrough pain more than 4 times in one day.

Do not stop taking Abstral or your other narcotic pain medicine without your doctor's advice. Ask your doctor how to avoid withdrawal symptoms when you stop using pain medication. Store in the original carton at room temperature, away from heat and moisture. Keep track of the amount of medicine used from each carton. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Keep out of the reach of children. The amount of fentanyl in each Abstral tablet can be fatal to a child. Carefully follow the instructions for disposing of this medicine when it is no longer needed. Throw away any unused Abstral tablets by removing them from the blister pack and flushing them down a toilet.

See also: Abstral dosage (in more detail)

What happens if I miss a dose?

Since Abstral is used as needed, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal. Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking Abstral?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Abstral will affect you. Do not drink alcohol. It can increase your risk of a dangerous side effect while taking Abstral.

Grapefruit and grapefruit juice may interact with Abstral and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

See also: Abstral and alcohol (in more detail)

Abstral side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Abstral: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• slow heart rate, weak or shallow breathing, sighing, severe drowsiness;

• confusion, extreme fear, unusual thoughts or behavior; or

• feeling like you might pass out.

Less serious Abstral side effects may include:

• dry mouth, nausea, vomiting, constipation;

• headache, drowsiness, tired feeling; or

• white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Abstral side effects (in more detail)

What other drugs will affect Abstral?

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Abstral. Tell your doctor if you regularly use any of these medicines.

Many drugs can interact with Abstral. Below is just a partial list. Tell your doctor if you are using:

• phenobarbital (Solfoton) or other barbiturates;

• pioglitazone (Actos, Actoplus Met, Duetact);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), telithromycin (Ketek), and others;

• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV/AIDS medicine such as delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), nevirapine (Viramune), ritonavir (Norvir, Kaletra), and others;

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and others; or

• steroids such as prednisone and others.

This list is not complete and there are many other drugs that can interact with Abstral. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about Abstral.