Buprenex

Uses

Doctors prescribe Buprenex to treat moderate to severe pain.

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Administration/Dosage

Reckitt Benckiser Pharmaceuticals Inc., distributes Buprenex in cartons containing five glass snap-ampules, each containing 1 ml of Buprenex for intravenous or intramuscular use.

The usual dose for individuals aged 13 and older is 1 ml of Buprenex injected into a vein or muscle every six hours. Nurses may administer a one-time second dose 30 to 60 minutes after the initial dose.

In cases of high-risk patients, such as those using other narcotics, the elderly, debilitated or those with breathing problems, physicians should administer half-doses.

Pediatricians may administer 2 - 6 micrograms for every kilogram of a child’s body weight every four to six hours in children between the ages of 2-years and 12-years old. Researchers have not yet established the safety or effectiveness in Buprenex use in children younger than two years old.

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Action

Buprenorphine is the active ingredient in Buprenex; buprenorphine is an opioid drug, sometimes called a narcotic. Buprenorphine works with the central nervous system, or CNS, to relieve pain. Other CNS effects of Buprenex include sedation, slowed breathing and a pleasant sense of euphoria.

Buprenex begins working in as little as 15 minutes after injection into a muscle; effects may last as long as six hours. Peak analgesia occurs about one hour after intramuscular injection. Intravenous administration of Buprenex shortens onset time and peak analgesia times.

The liver metabolizes the active ingredient in Buprenex, clearing this drug from the system.

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Warnings

Respiratory Depression

The buprenorphine in Buprenex depresses the breathing centers in the brain, making the brain apathetic about the need to breathe. This may cause respiratory depression, a dangerous and sometimes fatal breathing condition. During respiratory depression, the lungs do not adequately exchange oxygen for carbon dioxide and other toxins. This causes oxygen starvation and buildup of carbon dioxide in the blood and body tissues.

Patients who have trouble breathing should use Buprenex with caution; respiratory depression can occur even at therapeutic doses. Physicians should consider half doses for these patients.

Other drugs that cause CNS or respiratory depression can enhance CNS and respiratory depressive effects of Buprenex.

Emergency department physicians usually use naloxone to reverse the effects of respiratory depression caused by opioid use but naloxone is not effective for reducing adverse respiratory effects of Buprenex.

Head Injury and Increased Intracranial Pressure

Buprenex can increase fluid pressure surrounding the brain and spinal cord, therefore consumers with head injuries, brain tumors and pre-existing elevated pressure within the skull should use Buprenex with cause. Buprenex can also cause pinpoint pupils and change the consumer’s level of conscious in a way that can obscure the diagnoses or progression of a head injury.

Buprenex may cause withdrawal symptoms in consumers who are physically dependent on opioid drugs.

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Precautions

Buprenex may cause drowsiness; alcohol and the type of drugs known as benzodiazepines enhance this effect. Buprenex consumers should not operate motor vehicles or other heavy machinery until they know how Buprenex affects them.

The liver metabolizes buprenorphine, clearing this medication from the body. Consumers with liver problems should use Buprenex with care.

Buprenex may increase pressure in the ducts surrounding the liver; patients with liver, gallbladder or biliary ducts should not use Buprenex.

Contraindications

Patients who are hypersensitive to buprenorphine should not use Buprenex.

Pregnancy, Labor and Delivery, Breastfeeding

Buprenex is a Pregnancy Category C, meaning no adequate studies have been performed on humans to determine the harm Buprenex may pose to a woman and her unborn baby. Pregnant women should only use Buprenex when the benefits clearly outweigh the risks.

The buprenorphine in Buprenex may pass into breast milk and onto a nursing baby. Women should not breastfeed while taking Buprenex.

Allergic Reactions

Consumers with a known hypersensitivity to buprenorphine should not take Buprenex. The most common symptoms of hypersensitivity include itching, rash and hives. Signs of a serious reaction include severe breathing problems, swelling just under the skin and a serious form of an allergic reaction, anaphylactic shock.

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Drug Interactions

Consumers should use special care when combining Buprenex with other CNS depressants and MAO inhibitors. Respiratory depression and cardiovascular collapse may occur in patients taking therapeutic doses of Buprenex and diazepam.

Some medications may slow the rate at which the liver clears Buprenex from the body. These medications include some types of antibiotics such as erythromycin, certain antifungal agents and some types of anti-infection drugs, especially ritanovir. If the patient needs both drugs, physicians will reduce dosages of either Buprenex or the other medication.

Some drugs, including rifampin, carbamazepine, and phenytoin, increase the rate at which the body clears Buprenex. Physicians should caution patients regarding these effects and adjust medication dosages as necessary.

Taking Buprenex with other CNS depressants, including alcohol, other pain relievers, general anesthetics, antihistamines, benzodiazepines, phenothiazines, tranquilizers or sedatives may enhance CNS depression. When the patient needs both medications, the prescribing physician may reduce dosages or one or both drugs.

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Side effects

About two-thirds of Buprenex consumers reported sedation in clinical trials of this product. Despite this sedation, these consumers were easily aroused to an alert state.

Other common side effects include nausea and vomiting, dizziness, sweating, headache, rapid breathing and pinpoint pupils.

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Overdose

Buprenex overdose is a serious medical condition that may result in death. Overdose of prescription painkillers claim the lives of nearly 15,000 people every year in the United States. All victims of suspected overdose should seek immediate medical care.

Emergency room personnel will establish an airway to help the patient breathe; it may be necessary to place the patient on a ventilator. Unlike the respiratory depression caused by other opioids, naloxone does little to reverse the effects of respiratory depression caused by Buprenex. Physicians may try Doxapram to stimulate respiration.

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Abuse

Recreational users target Buprenex because of the pleasant euphoria buprenorphine provides. While there is little risk for drug dependence among most consumers, physicians should use care when prescribing Buprenex to drug abusers or to those who have suffered from drug dependence or addiction in the past.

The DEA classifies Buprenex as a schedule III narcotic, meaning it poses the same relative potential for abuse as anabolic steroids. To reduce this risk, Buprenex is available only with a prescription.
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Withdrawal

Opioid-dependent individuals who use Buprenex may experience withdrawal symptoms, including nausea and vomiting, stomach cramps, diarrhea, muscle aches, runny nose and excessive sweating.

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Detox

Many institutions now offer inpatient detoxification services to help individuals stop using opioids. During detoxification, physicians administer drugs to lower opioid levels along with multiple medications to relieve the many withdrawal symptoms.

Rapid detox offers an effective and humane form of detoxification. During rapid detox, board-certified anesthesiologists administer sedatives and anesthesia along with the usual detoxification and anti-withdrawal drugs. The rapid detox patient dozes in a comfortable “twilight sleep” during the difficult detoxification process, blissfully unaware of withdrawal symptoms.

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Storage

Consumers should keep Buprenex away from prolonged exposure to light and away from extreme heat over 104 degrees Fahrenheit.

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Miscellaneous information

Drug makers first offered buprenorphine as a pain reliever in 1985. Buprenorphine was only available in low dose injectable form under the brand name Buprenex until 2002, when the FDA approved two buprenorphine-containing drugs, Suboxone and Subutex, for the treatment of narcotic addiction. Since 2003, buprenorphine trafficking and abuse in the U.S. have become more common.

One 1 ml dose Buprenex provides approximately the same analgesic and respiratory depressive effects as 10 mg of morphine.

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Facts

  • Buprenex