What is buprenorphine (oral)?
Buprenorphine is an opioid (narcotic) medication that is similar to morphine, codeine, and
heroin.
Buprenorphine is used to treat narcotic addiction.
Buprenorphine may also be used for purposes other than those listed in this medication
guide.
What should I discuss with my healthcare provider before taking buprenorphine (oral)?
Do not use this medication if you are allergic to buprenorphine or naloxone (Narcan),
or
if you have used another narcotic drug within the past 4 hours.
Before using buprenorphine, tell your doctor if you are allergic to any drugs, or if you
have:
-
asthma, COPD, sleep apnea, or other breathing disorders;
-
liver or kidney disease;
-
mental illness or a history of suicide attempt;
-
a history of alcoholism or IV drug use; or
-
a history of seizures, head injury, or brain tumor.
If you have any of these conditions, you may not be able to use
buprenorphine, or you may need a dosage adjustment or special tests during treatment.
Buprenorphine should be used only by the person it was prescribed for.
Buprenorphine should never be given to another person, especially someone who has a
history of drug abuse or addiction.
Buprenorphine can cause withdrawal effects in a
person who is addicted to narcotics. Keep the medication in a secure place where others cannot
get to it.
FDA pregnancy category C. This medication may be harmful to an unborn baby. It
could also cause addiction or withdrawal symptoms in a newborn if the mother takes
buprenorphine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant
during treatment.
Buprenorphine passes into breast milk and may be harmful to a nursing baby. It may
also decrease breast milk production.
Do not
use buprenorphine if you are
breast-feeding a baby.
Do not give this medication to a child.
How should I take buprenorphine (oral)?
Using buprenorphine improperly will increase your risk of serious side
effects or death.
Even if you have used other narcotic medications, you may still have
serious side effects from buprenorphine. Follow all dosing instructions carefully.
Take this medication exactly as it was prescribed for you. Do not take the medication in
larger amounts, or take it for longer than recommended by your doctor. Follow the directions on
your prescription label.
Never crush a tablet or other pill to mix into a liquid for injecting the
drug into your vein.
This practice has resulted in death with the misuse of
buprenorphine and similar prescription drugs.
Carry an ID card or wear a medical alert bracelet stating that you are using
buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider
who treats you should know that you are being treated for narcotic addiction. Make sure your
family members know you are using buprenorphine in case they need to speak for you during an
emergency.
The buprenorphine
sublingual tablet
should be placed under the tongue
and allowed to dissolve. 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.
To be sure this medication is not causing harmful effects, your blood will need to be
tested on a regular basis. Your liver function may also need to be tested. Do not miss any
scheduled visits to your doctor.
If you need to have any type of surgery, tell the surgeon ahead of time that you are
using buprenorphine. You may need to stop using the medicine for a short time.
You may have withdrawal symptoms when you stop using buprenorphine after using
it over a long period of time. Do not stop using this medication suddenly without first talking to
your doctor. You may need to use less and less before you stop the medication completely.
Store buprenorphine at room temperature away from moisture and heat.
Keep track of how many pills have been used from each new bottle of this medicine.
Buprenorphine is a drug of abuse and you should be aware if any person in the household is
using this medicine improperly or without a prescription.
Throw away any unused buprenorphine tablets down the toilet after your treatment has
ended.
What happens if I miss a dose of buprenorphine (oral)?
Take the missed dose as soon as you remember. If it is almost time for your next dose,
skip the missed dose and take the medicine at your next regularly scheduled time.
Do
not
take extra medicine to make up the missed dose.
Where can I get more information about buprenorphine (oral)?
Your pharmacist has information about buprenorphine (oral) written for health professionals that you may read.
What are the possible side effects of buprenorphine (oral)?
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur
if breathing becomes too weak.
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
slow or shallow breathing;
-
feeling light-headed, fainting;
-
confusion, unusual thoughts or behavior; or
-
nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may be more likely to occur, such as:
-
headache;
-
stomach pain, nausea, vomiting, constipation;
-
warmth or tingly feeling;
-
increased sweating;
-
weakness;
-
back pain;
-
anxiety, depression;
-
sleep problems (insomnia); or
-
runny nose.
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about buprenorphine (oral)?
Using buprenorphine improperly will increase your risk of serious side
effects or death.
Even if you have used other narcotic medications, you may still have
serious side effects from buprenorphine. Follow all dosing instructions carefully.
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur
if breathing becomes too weak.
Never crush a tablet or other pill to mix into a liquid for injecting the
drug into your vein.
This practice has resulted in death with the misuse of
buprenorphine and similar prescription drugs.
Carry an ID card or wear a medical alert bracelet stating that you are using
buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider
who treats you should know that you are being treated for narcotic addiction.
Taking buprenorphine together with other drugs that cause drowsiness can slow the
functions of your breathing and central nervous system to dangerous levels.
These
effects could result in a fatal overdose.
Avoid drinking alcohol, which can increase some of the side effects of
buprenorphine.
Using too much of this medicine in addition to drinking alcohol can
cause death.
You may have withdrawal symptoms when you stop using buprenorphine after using
it over a long period of time. Do not stop using this medication suddenly without first talking to
your doctor. You may need to use less and less before you stop the medication completely.
Buprenorphine can cause side effects that may impair your thinking or reactions. Be
careful if you drive or do anything that requires you to be awake and alert.
What should I avoid while taking buprenorphine (oral)?
Avoid using other medicines that make you sleepy (such as cold medicine, pain
medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to
sleepiness caused by buprenorphine.
Taking buprenorphine together with other drugs that cause drowsiness can slow the
functions of your breathing and central nervous system to dangerous levels.
These
effects could result in a fatal overdose.
Avoid drinking alcohol, which can increase some of the side effects of
buprenorphine.
Using too much of this medicine in addition to drinking alcohol can
cause death.
Buprenorphine can cause side effects that may impair your thinking or reactions. Be
careful if you drive or do anything that requires you to be awake and alert.
What other drugs will affect buprenorphine (oral)?
Before using buprenorphine, tell your doctor if you use any of the following drugs:
-
an antifungal antibiotic such as fluconazole (Diflucan),
ketoconazole (Nizoral), itraconazole (Sporanox), or voriconazole (Vfend);
-
an antibacterial antibiotic such as azithromycin
(Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), or
telithromycin (Ketek);
-
HIV medication such as nevirapine (Viramune), delavirdine
(Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase),
or nelfinavir (Viracept);
-
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
-
a sedative such as diazepam (Valium), midazolam (Versed),
alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion),
flurazepam (Dalmane), or temazepam (Restoril); or
-
seizure medication such as carbamazepine (Carbatrol,
Tegretol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton), and others.
If you are using any of these drugs, you may not be able to use
buprenorphine, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect buprenorphine. Tell your doctor about
all the prescription and over-the-counter medications you use. This includes vitamins, minerals,
herbal products, and drugs prescribed by other doctors. Do not start using a new medication
without telling your doctor.
What happens if I have an overdose of buprenorphine (oral)?