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Buprenex

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Buprenex

Buprenex Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Buprenex (buprenorphine hydrochloride) injectable is a narcotic drug indicated for the relief of moderate to severe pain. The usual dosage for persons 13 years of age and over is 1 ml Buprenex (buprenorphine) (0.3 mg buprenorphine) given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed. Side effects can include nausea, dizziness/vertigo, sweating, headache, hypotension, vomiting, and hypoventilation. Other side effects may occur.

It is not known whether Buprsenex is harmful to an unborn baby. Use of high doses of sublingual buprenorphine in pregnant women showed that buprenorphine passes into the mother's milk. Breast-feeding is therefore not advised in nursing mothers treated with Buprenex.

Our Buprenex Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Buprenex in Detail - Patient Information: Side Effects

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.

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

Call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing, feeling light-headed, fainting;
  • blue lips or fingernails;
  • confusion, feelings of extreme happiness;
  • fast or slow heart rate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dizziness, spinning sensation, weakness, tired feeling;
  • nausea, vomiting, constipation;
  • increased sweating, numbness or tingly feeling;
  • headache, depressed mood; 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.

Read the entire detailed patient monograph for Buprenex (Buprenorphine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Buprenex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

 

Other less frequent adverse reactions occurring in 5-10% of the patients were:
Nausea Dizziness/Vertigo
Occurring in 1-5% of the patients:
Sweating
Hypotension
Vomiting Miosis
Headache
Nausea/Vomiting
Hypoventilation

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.

Cardiovascular: hypertension, tachycardia, bradycardia.

Gastrointestinal: constipation.

Respiratory: dyspnea, cyanosis.

Dermatological: pruritus.

Ophthalmological: diplopia, visual abnormalities.

Miscellaneous: injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis.

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience of Buprenex and other buprenorphine- containing products. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to Buprenex.

In the United Kingdom, buprenorphine hydrochloride was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to buprenorphine hydrochloride were observed.

Drug Abuse And Dependence

Buprenorphine hydrochloride is a partial agonist of the morphine type; i.e., it has certain opioid properties which may lead to psychic dependence of the morphine type due to an opiate-like euphoric component of the drug. Direct dependence studies have shown little physical dependence upon withdrawal of the drug. However, caution should be used in prescribing to individuals who are known to be drug abusers or ex-narcotic addicts. The drug may not substitute in acutely dependent narcotic addicts due to its antagonist component and may induce withdrawal symptoms.

Read the entire FDA prescribing information for Buprenex (Buprenorphine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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