Buprenex

Buprenex is a prescription medication used to treat moderate to severe pain. Buprenex belongs to a group of drugs called opioid partial agonist-antagonists, which help to relieve pain by binding to certain opioid receptors in the body.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

Some of the common side effects of Buprenex include constipation, nausea, and headache. Buprenex can cause dizziness and drowsiness. Do not drive or operate machinery until you know how Buprenex will affect you. Do not drink alcohol while taking this medication.

Buprenex is a prescription medicine used to treat moderate to severe chronic pain. This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Reckitt Benckiser Pharmaceuticals Inc.

Buprenex can cause serious side effects that can lead to death, including:

Serious breathing problems that can be life threatening.
Call your doctor or get emergency medical help right away if you:

• have trouble breathing,
• have extreme drowsiness with slowed breathing
• have slow shallow breathing (little chest movement with breathing)
• feel faint, very dizzy, confused, or have any other unusual symptoms

Allergic reactions. Rash, itching, and hives are the most common symptoms of an allergic reaction. Call your doctor if you have these symptoms. Get medical help right away if you have any of these symptoms of an allergic reaction while taking Buprenex:

• swelling of your lips or tongue
• breathing problems
• wheezing
• chest pain
• Buprenex can cause a drop in your blood pressure. Low blood pressure can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
• Liver problems. Your skin or the white part of your eyes can turn yellow (jaundice), urine can turn dark, stools can turn light in color, you may have less of an appetite, and nausea. Your doctor may do tests before you start and while you take Buprenex.
• Buprenex can increase your chances of having a seizure if you have history of seizures. Tell your doctor if you have a seizure or convulsion while taking Buprenex .
• Buprenex can cause physical dependence. Do not stop using Buprenex or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
• There is a chance of abuse or addiction with Buprenex. The chance is higher if you are or have been addicted to or abused other medicines, street drugs or alcohol in the past. You may have a greater risk of developing abuse or addiction again while using Buprenex.

The most common side effects of Buprenex include:

• nausea
• headache
• dizziness
• constipation
• drowsiness
• vomiting
• dry mouth and
• itching, redness, or rash (patch form)

Constipation (incomplete or hard bowel movements) is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using Buprenex.

Talk to your doctor about any side effect that bother you or do not go away.

These are not all the possible side effects of Buprenex. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with Buprenex. Sometimes, the doses of certain medicines and Buprenex need to be changed if used together.

Especially tell your doctor if you take:

• other pain medicines
• antidepressant medicines
• sleeping pills
• antihistamines
• anti-anxiety medicines
• muscle relaxants
• anti-nausea medicines
• sedative or tranquilizer medicines (medicines that make you sleepy)
• a medicine for abnormal heartbeats

You should not take Buprenex if you already take a monoamine oxidase inhibitor medicine (MAOI) or within 14 days after you stop taking an MAOI medicine.

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist. Your doctor will tell you if it is safe to take other medicines while you are using Buprenex.

Buprenex overdose can cause serious and life threatening breathing problems. Serious and life-threatening breathing problems can happen with Buprenex, especially during the first 24 to 72 hours after you apply a new patch. This can happen because of an overdose or if the dose you are using is too high for you. 

Call your doctor right away or get emergency medical help if you:

• have trouble breathing
• have changes in breathing
• unusual deep “sighing” breathing
• slow or shallow breathing
• new or unusual snoring
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally

Do not use Buprenex if you:

• have trouble breathing, severe asthma or severe lung problems
• have a bowel blockage called paralytic ileus
• are allergic to any of the ingredients in Buprenex

You should not drive, operate heavy machinery, or do other dangerous activities, until you know how you react to this medicine. Buprenex can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react. Ask your doctor when it is okay to do these activities.

You should not drink alcohol or use prescription or non-prescription medicines that have alcohol in them while using Buprenex. Alcohol can increase your chances of having serious side effects including death.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Buprenex, grapefruit and grapefruit juice may interact with Buprenex and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before receiving Buprenex, tell your doctor about all of your medical conditions including if you have:

• breathing or lung problems
• history of a heart problem called Long QT syndrome (or if a family member has this condition)
• head injury or brain problems
• low blood pressure
• liver problems
• kidney problems
• hepatitis B or hepatitis C
• had convulsions or seizures
• severe scoliosis
• thyroid problems
• prostate problems or trouble urinating
• Addison’s disease
• alcoholism, or a family history of this problem
• depression or hallucinations (seeing or hearing things that are not there)
• drug abuse or addiction problem, or a past problem, or a family history of this problem
• have any other medical conditions

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to breastfeed while being treated with Buprenex. Talk to your doctor about the best way to feed your baby if you take Buprenex.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

The usual dosage for Buprenex injectable will vary according to age, severity of the condition, and other factors.

If you inject too much Buprenex call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Buprenex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Buprenex at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep Buprenex in a safe place out of the reach of children.
• Buprenex is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs. Prevent theft, misuse and abuse. Keep Buprenex in a safe place to protect from being stolen. Never give Buprenex to anyone else, even if they have the same symptoms you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USE 

Potential for Abuse:

Buprenex is a mu opioid partial agonist and a Schedule III controlled substance. Buprenex can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Buprenex in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. 

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction.