Buprenorphine (bue-pre-NOR-feen)

Relieves moderate to severe pain. This medicine is a narcotic.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin, into a muscle, or into a vein.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it at room temperature, away from heat and direct light. Store the medicine in a safe and secure place. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. Throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how buprenorphine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cyclobenzaprine, erythromycin, ketoconazole, metaxalone, mirtazapine, phenobarbital, phenytoin, rifampin, tramadol, trazodone, valproic acid
  • Diuretic (water pill)
  • Medicine to treat depression, anxiety, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat heart rhythm problem
  • Medicine to treat HIV infection (including atazanavir, delavirdine, efavirenz, etravirine, indinavir, nevirapine, ritonavir, saquinavir)
  • Phenothiazine medicine
  • Triptan medicine for migraine headaches
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer (including cyclobenzaprine, metaxalone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, gallbladder problems, lung disease or breathing problems (including COPD, sleep apnea), pancreas problems, an underactive thyroid, an adrenal problem, a spine deformity, problems with urination, an enlarged prostate, or a history of seizures, depression, or mental health problems. Tell your doctor if you have heart disease, congestive heart failure, a slow heartbeat, or a history of heart rhythm problems (including long QT syndrome). Tell your doctor if you have ever had a head injury, brain tumor, or stroke. Tell your doctor if you have ever been addicted to alcohol or drugs.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Increased risk of serious injection site reactions
  • Worsening of pain
  • Adrenal gland problems
  • Liver problems
  • QT prolongation (heart rhythm problem)
  • Serotonin syndrome (when used with certain medicines)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Tell your doctor or anyone who treats you that you have been using Sublocade® injection within the last 6 months.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Fast, slow, or pounding heartbeat
• Lightheadedness, dizziness, fainting
• Severe constipation, stomach pain
• Shaking, trembling, hunger, confusion
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Drowsiness
• Mild nausea
• Pain, itching, burning, swelling, or lump under your skin where the needle is placed or shot given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088