| Trade Names: Actiq, Oral Transmucosal Fentanyl |
| Type of Drug: Fentanyl citrate is an opioid analgesic. |
| How Drug Works: Fentanyl citrate relieves moderate to severe breakthrough pain; the pain relief is quick (onset within 5 minutes) with the maximum effect in 25 to 30 minutes. Fentanyl citrate binds to opioid receptors in the brain and central nervous system (CNS). It alters the perception of pain as well as the emotional response to it. The oral transmucosal fentanyl looks like a flat tablet attached to a handle. It is placed against the lining of the mouth (mucosa) where it is sucked, and the drug is absorbed into the blood. |
| How Drug Is Given: Remove the medicine from its foil pouch right before you are going to use it. Put it in your mouth between the cheek and the lower gum. Suck the medicine from the handle over 15 minutes. You can move the medicine from one side of the mouth to the other, but don't chew or swallow it. If you feel better before the 15 minutes is up or if you feel dizzy or unwell, stop and take the medicine out of your mouth. Take the medicine off its stick, wrap it in toilet tissue, and flush it down the toilet. The strengths are color coded and the color of the wrapper tells you the dose of the medicine. The dose depends on the relief you get. If you need more than 3 doses, then your long-acting pain medicine dose needs to be increased. Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets. Children and pets have died from taking the medicine by accident. |
| How Should I Take This Drug? Take this drug exactly as directed by your doctor. If you do not understand these instructions, ask your doctor or nurse to explain them to you. |
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Read the following information. If you do not understand it or if any of it causes you special concern, check with your doctor. |
| Before taking this drug, tell your doctor if you are taking any other
prescription or over-the-counter drugs, including vitamins and
herbals. |
| Should I avoid any other medicines, foods, alcohol,
and/or activities? Your prescription and nonprescription medicines may interact with other drugs, causing harm. Certain foods or alcohol can also interact with drug products. Never begin taking a new medicine"prescription or nonprescription"without asking your doctor or nurse if it will interact with alcohol, food, or other medicines. Some drug products can cause drowsiness and affect activities such as driving. |
| Precautions: Fentanyl citrate is an effective and safe drug when used correctly. However, it can be dangerous, and the relevant safety points should be remembered. This drug is only for people who have taken opioid analgesic drugs before and have some tolerance to this type of medicine. Otherwise, it can cause breathing problems (slow breathing or breathing may stop). |
| Fentanyl citrate should not be used by people with head injury or
increased pressure in the head, or by nursing mothers. The drug should be
used cautiously in people with liver disease, kidney problems, chronic
lung disease, heart disease (slow pulse), and the elderly. This drug MUST
be kept out of the reach of children or pets, as it may be lethal to
them. |
| Keep the medicine away from the eyes, skin, or other mucous membranes
when not sucking the medication. Wash your hands after discarding any
unused portion of the medicine. |
| Call your nurse or doctor if you take 4 of the same tablet within 60
minutes without relief, or if you find you have to take the drug more
than 4 times a day to control your pain. The dose should probably be
increased, and your doctor or nurse will tell you how to do
this. |
| Since fentanyl citrate affects the central nervous system (CNS), it
is important not to take other drugs or substances that are known CNS
depressants such as alcohol, sedatives, and hypnotics. |
| You should be on a bowel regimen to prevent constipation while you
are taking opioid pain relievers. Talk to your nurse or doctor about
this. |
| Take the smallest effective dose to prevent the development of
tolerance and physical dependence. Tolerance can develop (larger doses
needed to give the same effect) as well as physical dependence (body goes
into withdrawal if drug is suddenly stopped). This is different from
addiction, which is psychological dependence (take drug for psychological
effect not for the relief of pain). Tell your doctor or nurse if you
still have pain even though you are taking the medicine as
directed. |
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Tell all the doctors, dentists, and pharmacists you visit that you are taking this drug. |
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Side Effects: |
More Common Side Effects
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Less Common Side Effects
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Rare Side Effects
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| Side Effects / Symptoms of the Drug Stop taking the medicine and call your doctor or nurse right away if you have any difficulty breathing or walking. Tell your doctor or nurse right away if the dose of the drug does not take away the pain, if you need to take the drug more than 4 times a day, or if you are constipated and have not moved your bowels in 2 or more days. |
| Other side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop any problems. |
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FDA Approval: Yes |