Buprenex is an opioid medicine used to treat pain. An opioid is sometimes called a narcotic.

Buprenex Injection is used to relieve moderate pain that is severe enough to require an opiate pain killer and for which other medicines (e.g., non-opiate pain killers or opiate-containing combination medicines) have not been, or are not expected to be sufficient.

This medication guide provides information about the Buprenex brand of buprenorphine injection. Sublocade is another brand of buprenorphine injection used to treat opioid addiction.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using Buprenex 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.

Buprenex is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection. Buprenex is usually given by injection only if you are unable to take the medicine by mouth or use another form of buprenorphine.

Buprenex is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if Buprenex does not relieve your pain within 1 hour after an injection.

Buprenex can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.

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.

Usual Adult Dose for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)
Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Usual Pediatric Dose for Pain:

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours
-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established

Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

You should not use Buprenex if you are allergic to buprenorphine, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

To make sure Buprenex is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizures;

• alcoholism, drug addiction, mental illness;

• urination problems;

• liver or kidney disease;

• a heart rhythm disorder (especially if you take medication to treat it);

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• abnormal curvature of the spine that affects breathing;

• Addison's disease (adrenal gland disorder); or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid 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 opioids may need medical treatment for several weeks.

Buprenorphine can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are using Buprenex.

Because you will receive Buprenex in a clinical setting, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Buprenex can be fatal, especially in a person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, slow heart rate, weak pulse, very slow breathing, or coma.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Buprenex will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Buprenex: 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 give naloxone and/or 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, breathing that stops during sleep;

• slow heartbeat or weak pulse;

• blue lips or fingernails;

• severe constipation;

• confusion, feelings of extreme happiness;

• little or no urination; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

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.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

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 Buprenex side effects may include:

• drowsiness;

• constipation;

• dizziness, spinning sensation;

• nausea, vomiting;

• increased sweating;

• headache; or

• blurred vision, double vision.

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.

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:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.