Buprenex

DRUG DESCRIPTION

Proprietary name: Buprenex

Established name: buprenorphine HCI

Route of administration: INTRAVENOUS (C38276), INTRAMUSCULAR (C28161)

Active ingredients (moiety): buprenorphine HCI (buprenorphine)

# Strength Form Inactive ingredients
1 0.324 : 1 INJECTION, SOLUTION ( C42945) anhydrous dextrose, water for injection, hydrochloric acid

Buprenex (buprenorphine hydrochloride) is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine. Chemically, it is 17-(cyclopropylmethyl)-?-(1,1-dimethylethyl)-4, 5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-?-methyl-6, 14- ethenomorphinan-7-methanol, hydrochloride [5?, 7?(S)]. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water. Buprenex (buprenorphine) is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each ml of Buprenex contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection and HCI to adjust pH. Buprenorphine hydrochloride has the molecular formula, C29H41NO4HCI, and the following structure:

Buprenex (buprenorphine hydrochloride) structural formula illustration

What are the possible side effects of buprenorphine injection (Buprenex)?

Like other narcotic medicines, buprenorphine injection can slow your breathing. Death may occur if breathing becomes too weak.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or shallow breathing;
  • feeling light-headed, fainting;
  • confusion, unusual thoughts or behavior; or
  • nausea,...

Read All Potential Side Effects and See Pictures of Buprenex

What are the precautions when taking buprenorphine (Buprenex)?

Before using buprenorphine, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Buprenex


Buprenex Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using buprenorphine, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Tell your doctor promptly if you develop a fever, since this rise in body temperature may increase your risk for overdose (see also Warning section).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Buprenex Patient Information Including Side Effects

Brand Names: Buprenex

Generic Name: buprenorphine (injection) (Pronunciation: byoo pre NOR feen)

  • What is buprenorphine injection (Buprenex)?
  • What are the possible side effects of buprenorphine injection (Buprenex)?
  • What is the most important information I should know about buprenorphine injection (Buprenex)?
  • What should I discuss with my healthcare provider before receiving buprenorphine injection (Buprenex)?
  • How is buprenorphine injection given (Buprenex)?
  • What happens if I miss a dose (Buprenex)?
  • What happens if I overdose (Buprenex)?
  • What should I avoid while receiving buprenorphine injection (Buprenex)?
  • What other drugs will affect buprenorphine injection (Buprenex)?
  • Where can I get more information?

What is buprenorphine injection (Buprenex)?

Buprenorphine is an opioid (narcotic) medication that is similar to morphine, codeine, and heroin..

Buprenorphine injection is used to treat moderate to severe pain.

Buprenorphine injection may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of buprenorphine injection (Buprenex)?

Like other narcotic medicines, buprenorphine injection can slow your breathing. Death may occur if breathing becomes too weak.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or shallow breathing;
  • feeling light-headed, fainting;
  • confusion, unusual thoughts or behavior; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

  • headache;
  • stomach pain, nausea, vomiting, constipation;
  • warmth or tingly feeling;
  • increased sweating;
  • weakness;
  • back pain;
  • anxiety, depression;
  • sleep problems (insomnia); or
  • runny nose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about buprenorphine injection (Buprenex)?

Like other narcotic medicines, buprenorphine injection can slow your breathing, even after the pain-relieving effects wear off. Death may occur if breathing becomes too weak.

Using buprenorphine injection together with other drugs that cause drowsiness can slow the functions of your breathing and central nervous system to dangerous levels. These effects could result in a fatal overdose.

Avoid drinking alcohol, which can increase some of the side effects of buprenorphine injection. Using too much of this medicine in addition to drinking alcohol can cause death.

You may have withdrawal symptoms when you stop receiving buprenorphine after using it over a long period of time. Do not stop using this medication suddenly unless your doctor instructs you to. You may need to use less and less before you stop the medication completely.

Buprenorphine injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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