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Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.
Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication.
Buprenorphine and naloxone may also be used for purposes not listed in this medication guide.
Buprenorphine and naloxone is not for use as a pain medication.
buprenorphine and naloxone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
You should not use this medicine if you are allergic to buprenorphine or naloxone (Narcan).
Tell your doctor if you have ever had:
breathing problems, sleep apnea;
enlarged prostate, urination problems;
liver or kidney disease;
abnormal curvature of the spine that affects breathing;
problems with your gallbladder, adrenal gland, or thyroid;
a head injury, brain tumor, or seizures; or
alcoholism, drug addiction, mental illness.
Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
If you use this medicine 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. Tell your doctor if you are pregnant.
Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.
Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use buprenorphine and naloxone in larger amounts, or for longer than prescribed.
buprenorphine and naloxone may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine and naloxone is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Use dry hands when handling this medicine. Place the sublingual tablet or film under your tongue. Place the buccal film against the inside of your cheek. Allow the medicine to dissolve slowly. Do not chew or swallow it whole.
If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.
Do not stop using buprenorphine and naloxone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
You will need frequent blood tests to check your liver function.
All your medical care providers should know that you are being treated for opioid addiction, and that you take buprenorphine and naloxone. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.
Never crush or break a buprenorphine and naloxone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
Store this medicine in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to.
Keep track of your medicine. This medicine is a drug of abuse and you should be aware if anyone is using it improperly.
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, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using buprenorphine and naloxone without a prescription.
Overdose symptoms may include extreme drowsiness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, very slow breathing, or coma.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak. 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 or seek emergency medical attention if you have:
weak or shallow breathing, breathing that stops during sleep;
a light-headed feeling, like you might pass out;
confusion, loss of coordination, extreme weakness;
blurred vision, slurred speech;
liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.
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.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
withdrawal symptoms;
tongue pain, redness or numbness inside your mouth;
nausea, vomiting, constipation;
headache, back pain;
fast or pounding heartbeats, increased sweating; or
sleep problems (insomnia).
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.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Narcotic (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;
a sedative like Valium--diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others; or
drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.
This list is not complete. Other drugs may affect buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Buprenorphine Hcl (www.drugs.com/mtm/buprenorphine-and-naloxone-oral-sublingual.html).
Commonly reported side effects of buprenorphine/naloxone include: constipation, diarrhea, headache, and nausea. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to buprenorphine / naloxone: film, tablet
Along with its needed effects, buprenorphine/naloxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking buprenorphine / naloxone:
More common
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine / naloxone:
Symptoms of overdose
Some side effects of buprenorphine / naloxone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
For Healthcare Professionals
Applies to buprenorphine / naloxone: buccal film, sublingual film, sublingual tablet
GeneralThe most commonly observed adverse events included headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Additionally, oral hypoesthesia was reported with the sublingual film.
OtherVery common (10% or more): Pain (22.4%)
Common (1% to 10%): Asthenia, chills, pyrexia, malaise, injury, ear pain
Uncommon (0.1% to 1%): Hypothermia, heat stroke
Postmarketing reports: Vertigo
Nervous systemVery common (10% or more): Headache (36.4%)
Common (1% to 10%): Migraine, dizziness, hypertonia, paraesthesia, somnolence
Uncommon (0.1% to 1%): Amnesia, convulsion, hyperkinesia, speech disorder, tremor
Buprenorphine:
Postmarketing reports: Neonatal withdrawal syndrome including symptoms of hypertonia, neonatal tremor, neonatal agitation, and myoclonus; reports of neonatal convulsions, apnea, respiratory depression, and bradycardia
RespiratoryBuprenorphine-naloxone:
Common (1% to 10%): Pharyngitis, rhinitis, cough, sinusitis, upper respiratory infection, asthma, bronchitis, dyspnea, pneumonia, increased sputum
Uncommon (0.1% to 1%): Yawning
Frequency not reported: Rhinorrhea
Buprenorphine:
Frequency not reported: Significant respiratory depression, coma, death
There have been postmarketing reports coma and death associated with concomitant use of buprenorphine and benzodiazepines; many of these reports have involved misuse by self-injection.
GastrointestinalVery common (10% or more): Constipation (12.1%), nausea (15%), abdominal pain (11.2%)
Common (1% to 10%): Vomiting, diarrhea, dyspepsia, flatulence, oral hypoesthesia
Uncommon (0.1% to 1%): Mouth ulceration, tongue discoloration, tooth abscess, glossodynia, mucosal erythema (oral), toothache
Frequency not reported: Stomach discomfort,
Postmarketing reports: Stomatitis, glossitis, tongue disorder, pancreatitis
EndocrineCommon (1% to 10%): Erectile dysfunction, decreased libido
Uncommon (0.1% to 1%): Amenorrhea, ejaculation disorder, menorrhagia, metrorrhagia
Postmarketing reports: Disorders of pregnancy
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency
HypersensitivityBuprenorphine:
Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus
Naloxone:
Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus
LocalPostmarketing reports: Glossodynia, oral mucosal erythema, oral hypoesthesia, stomatitis
CardiovascularCommon (1% to 10%): Vasodilation, hypertension
Uncommon (0.1% to 1%): Angina pectoris, bradycardia, myocardial infarction, palpitations, tachycardia, hypotension, chest pain
Postmarketing reports: Peripheral edema, syncope, orthostatic hypotension, heart rate and rhythm disorders
OcularCommon (1% to 10%): Amblyopia, lacrimal disorder
Uncommon (0.1% to 1%): Conjunctivitis, miosis
HepaticBuprenorphine-naloxone:
Common (1% to 10%): Abnormal liver function tests
Buprenorphine:
Frequency not reported: Cytolytic hepatitis, hepatitis with jaundice, transient asymptomatic elevations of hepatic transaminases, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy.
In clinical trials and in postmarketing reports, cases of cytolytic hepatitis and hepatitis with jaundice have been reported in association with buprenorphine use. The spectrum of abnormalities has ranged from transient asymptomatic elevations of hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy. The presence of preexisting liver enzyme abnormalities, viral hepatitis, concomitant hepatotoxic drug use, and ongoing IV drug abuse may have played a causative or contributory role.
PsychiatricCommon (1% to 10%): Anxiety, depression, nervousness, abnormal thinking
Uncommon (0.1% to 1%): Abnormal dreams, agitation, apathy, depersonalization, drug dependence, euphoric mood, hostility
Frequency not reported: Restlessness, irritability
Postmarketing reports: Hallucination, attempted suicide, insomnia
DermatologicVery common (10% or more): Sweating (14%)
Common (1% to 10%): Pruritus, rash, urticaria, ecchymosis
Uncommon (0.1% to 1%): Acne, alopecia, dermatitis exfoliative, dry skin, skin mass, herpes simplex, skin nodule
Frequency not reported: Piloerection, cold sweat
GenitourinaryCommon (1% to 10%): Urine abnormality
Uncommon (0.1% to 1%): Urinary tract infection, vaginal infection, albuminuria, dysuria, hematuria, urinary retention
HematologicUncommon (0.1% to 1%): Anemia, leucocytosis, leukopenia, lymphadenopathy, thrombocytopenia
ImmunologicCommon (1% to 10%): Influenza, infection
MetabolicUncommon (0.1% to 1%): Decreased appetite, hyperglycemia, hyperlipidemia, hypoglycemia, decreased weight
MusculoskeletalCommon (1% to 10%): Back pain, arthralgia, muscle spasms, myalgia, rigid neck, leg cramps, joint disorder
Uncommon (0.1% to 1%): Arthritis
Frequency not reported: Arthralgia
RenalUncommon (0.1% to 1%): Nephrolithiasis, blood creatinine increased
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Buprenorphine Hcl (www.drugs.com/mtm/buprenorphine-and-naloxone-oral-sublingual.html).
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