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

Buprenex is an opioid medicine used to treat moderate to severe pain.

Buprenex may also be used for purposes not listed in this medication guide.

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.

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.

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

Use Buprenex (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 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 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.

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

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