Generic Name: buprenorphine (oral/sublingual) (BUE pre NOR feen (OR al / sub LIN gwal))
Brand Name: Subutex
The Subutex brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
What is Subutex sublingual?
Subutex is an opioid medication. This medicine oral/sublingual (given under the tongue) is used to treat opioid addiction.
Other forms of buprenorphine are used to treat moderate to severe pain. Subutex sublingual is not for use as a pain medication.
Subutex sublingual may also be used for purposes not listed in this medication guide.
Subutex sublingual tablets are not for use as a pain medication.
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Before taking this medicine
You should not use Subutex if you are allergic to it, or:
if you have used another narcotic drug within the past 4 hours.
Tell your doctor if you have ever had:
any type of breathing problem or lung disease;
abnormal curvature of the spine that affects breathing;
enlarged prostate, urination problems;
alcoholism, hallucinations, mental illness; or
problems with your stomach, gallbladder, adrenal gland, or thyroid.
If you use Subutex while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Buprenorphine can pass into breast milk and may cause drowsiness, and breathing problems in a nursing baby. Ask your doctor about any risk.
Subutex is not approved for use by anyone younger than 18 years old.
How should I take Subutex sublingual?
Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Never use Subutex in larger amounts, or for longer than prescribed.
Subutex sublingual is usually taken for only at the start of treatment for addiction. Most people are later switched to another medicine that contains this medicine (Bunavail, Sublocade, Suboxone, Zubsolv).
You may receive your first doses of buprenorphine sublingual in a hospital or clinic setting until your condition improves.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
Use dry hands when handling the tablet. Place the tablet under your tongue and allow it to dissolve with your mouth closed. Do not chew the tablet or swallow it whole.
If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.
Do not eat or drink anything until the tablet or film has completely dissolved in your mouth.
You may need frequent blood tests to check your liver function.
If you need surgery, tell the surgeon ahead of time that you are using Subutex.
Never crush or break a Subutex pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.
Any medical care provider who treats you should know that you are being treated for opioid addiction, and that you are taking Subutex sublingual. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.
Do not stop using Subutex suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Subutex.
Store at room temperature away from moisture and heat. Keep track of your medicine. Subutex is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Subutex overdose can be fatal, especially in a child or other person using the medicine without a prescription.
Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, slow heart rate, weak pulse, very slow breathing, or coma.
What should I avoid while taking buprenorphine sublingual?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how Subutex will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Subutex sublingual side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
noisy breathing, sighing, shallow breathing;
slow heartbeat or weak pulse;
a light-headed feeling, like you might pass out;
chest pain, trouble breathing;
liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may be more likely to occur, such as:
constipation, nausea, vomiting;
sleep problems (insomnia); or
pain anywhere in your body.
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.
What other drugs will affect Subutex sublingual?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
other narcotic medications--opioid pain medicine or prescription cough medicine;
drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Copyright 1996-2018 Cerner Multum, Inc. Version: 10.01.
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- FDA Alerts (2)