Butrans

Uses

Butrans treats moderate to severe, around-the-clock pain. Butrans is for patients who need long-term relief from chronic pain.

This medication is not for patients experiencing mild pain, intermittent pain or acute pain expected to last a short time. Surgeons should not prescribe Butrans to relieve postoperative pain unless the patient had already been using long-term opioid treatment, or if surgeons expect the patient’s postoperative pain to be severe or last a long time.

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Administration/Dosage

Purdue Pharma L.P. distributes Butrans in a transdermal patch, worn on the skin. Consumers should apply Butrans patches to dry hairless or nearly hairless skin on the upper outer arm, upper chest, upper back or side of chest. Patients should wear a Butrans patch for seven days before replacing, rotating application sites and waiting at least 21 days before re-applying to a site.

Each Butrans patch releases a pre-determined amount of buprenorphine, an opioid pain reliever sometimes called a narcotic. Butrans patches are available in strengths of five micrograms per hour, 10 mcg per hour and 20 mcg per hour.

Butrans is not for use in children. Accidental exposure is a medical emergency and potentially fatal in a child.

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Action

The buprenorphine in Butrans interacts with the central nervous system, or CNS, to change the way the brain perceives pain.

The buprenorphine in Butrans also acts on respiratory centers in the brain to affect breathing. Additionally, buprenorphine works on smooth muscle groups, including those lining the intestines that propel food through the digestive tract.

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Warnings

Respiratory Depression

The primary risk of using Butrans is respiratory depression, a serious and sometimes fatal breathing condition. The buprenorphine in Butrans reduces the brain’s urge to breathe, decreasing respiratory rates and sometimes causing deep breaths separated by long pauses. During respiratory depression, the lungs do not adequately exchange oxygen for carbon dioxide and other gases, resulting in oxygen starvation and high levels of carbon dioxide.

Respiratory depression may occur at any time during Butrans therapy but this risk is greater during the first few doses or following a dose increase. Proper dosing is essential in reducing the risk for overdose.

Accidental Exposure

Consumers should be alert to accidental exposure to Butrans, especially in children. A single exposure can result in a fatal overdose of buprenorphine.

Special Risk Patients

Some consumers are at greater risk for respiratory depression, including the elderly, emaciated individuals and debilitated patients. This increased risk is because these consumers are more likely to suffer from poor fat storage, muscle wasting or slow buprenorphine elimination from the body. Physicians should monitor the condition of these patients closely while administering Butrans.

Physicians will monitor patients with breathing problems including COPD, high carbon dioxide levels and pre-existing respiratory depression who take Butrans. Even therapeutic doses of Butrans may decrease the brain’s urge to breathe to the point of stopped breathing in these patients.

Interactions with Alcohol, CNS Depressants and Illicit Drugs

Butrans may cause low blood pressure, extreme sleepiness, coma or respiratory depression if combined with other CNS depressants including sedatives, anti-anxiety drugs, hypnotics, muscle relaxants and other opioids. Alcohol and illegal drugs may enhance these effects.

Cardiovascular Effects

Butrans doses higher than 40 mcg per hour may cause prolonged QTc interval, a type of irregular heartbeat. This affects patients with low blood potassium levels or some types of unstable heart disease. Individuals with a personal or family history of prolonged QTc interval or people taking certain medications for heart rhythm problems should avoid using Butrans.

In ambulatory consumers, Butrans may cause dizziness, low blood pressure and blood pressure that drops when the individual stands up. Patients with certain types of blood pressure problems are at increased risk for these Hypotensive effects.

Head Injury or Increased Intracranial Pressure

Respiratory depression and high carbon dioxide levels increases fluid pressure surrounding the brain and spinal cord. Head injuries and brain tumors can further increase this pressure. Butrans can obscure the healing process in a head injury patient. Butrans is not appropriate for patients with impaired consciousness or coma.

Application Site Skin Reactions

In rare cases, Butrans has caused severe skin reactions at the site of application. These skin reactions may appear days or months after Butrans treatment.

Anaphylactic/Allergic Reactions

Butrans may cause an allergic reaction. Symptoms include hives, itching and rash. Some consumers have suffered breathing problems, fluid under the skin and anaphylaxis, a dangerous form of an allergic reaction. Patients who are hypersensitive to the effects of buprenorphine should not use Butrans.

External Heat

Butrans consumers should avoid exposing the application site and the surrounding area to external heat sources including electric blankets, heat lamps, heating pads, saunas or hot tubs; doing so increases the absorption rate of buprenorphine and result in overdose and death. The consumer should avoid prolonged exposure to sunlight or hot water.

Convulsive or Seizure Disorders

Butrans may induce, aggravate or worsen seizures in consumers with seizure disorders. Prescribing physicians should monitor patients with seizure disorders during Butrans therapy.

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Precautions

Butrans may cause dizziness, drowsiness or impair mental and physical performance. Consumers should avoid driving a car or operating heavy machinery until they know how Butrans affects them.

Contraindications

Butrans use is not appropriate for patients at risk for suffering significant respiratory depression. Consumers with acute or severe bronchial asthma should not use Butrans in an unmonitored setting or in an environment without resuscitative equipment.

Patients with a known or suspected paralytic ileus should not use Butrans. Individuals who are hypersensitive to buprenorphine should not use Butrans.

Pregnancy, Labor and Delivery, Breastfeeding

Butrans is a Pregnancy Category C, meaning researchers are still working to determine the effects this medication may have on a woman and her unborn baby.

Using Butrans during delivery may show signs of respiratory depression after delivery. Babies born to women who have taken Butrans late in pregnancy may be born physically dependent on buprenorphine and suffer withdrawal symptoms in the first days of life. Women should not use Butrans while breastfeeding a baby, as small amounts of buprenorphine pass into human milk.

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Drug Interactions

Butrans may interact with other medications to produce unsafe or unfavorable results.

In some cases, taking benzodiazepines while using Butrans has caused coma and death. Most, but not all, of these victims had crushed and injected buprenorphine tablets. Benzodiazepines enhance the respiratory depressive effects of buprenorphine.
Muscle relaxants may interact with Butrans to enhance muscle relaxation and increase respiratory depression.

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Side effects

The most commonly reported side effects are nausea, dizziness, headache, itching at the application site, sleepiness, vomiting and constipation.

Serious adverse reactions may occur, including respiratory depression, irregular heartbeat, low blood pressure, skin reactions at the application site, serious allergic reactions and seizures.

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Overdose

Prescription painkiller overdose kill nearly 15,000 people every year in the United States. There have been reports of death from use and abuse of buprenorphine, like that in Butrans. Using Butrans along with alcohol or other CNS depressants, including other opioids, increases the risk for fatal overdose.

Symptoms of Butrans overdose include respiratory depression, sleepiness that worsens to stupor or coma, limp muscles, cold and clammy skin, pinpoint pupils, slow heartbeat, low blood pressure, partial or complete airway obstruction, unusual snoring sounds and death.

In cases of suspected overdose, the victim or rescuers should remove Butrans patches immediately. Buprenorphine levels may continue to rise even after the patch is gone and the patient’s condition seems to improve as the body continues to absorb Butrans through the skin.

Butrans overdose requires immediate medical care. Emergency department nurses will establish an airway to help the patient breathe. Doctors may administer high doses of naloxone to reverse the effects of respiratory depression, although this medication has limited value in cases of buprenorphine overdose.

The buprenorphine in Butrans is long acting with a half-life lasting approximately 26 hours. The patient will require care for at least 24 hours after the toxic dose.

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Abuse

Recreational users target Butrans because of the way buprenorphine gets them high. Many recreational users chew, swallow, snort or inject buprenorphine extracted from a Butrans patch. This uncontrolled delivery can result in overdose and death.

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

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Withdrawal

Anyone who uses Butrans for more than a few weeks may develop physical dependence on the opioid, buprenorphine. An opioid-dependent person experiences withdrawal symptoms when he stops using Butrans patches. These symptoms last five or more days.

Symptoms of withdrawal include restlessness, watery eyes, stuffy or runny nose, yawning, sweating, chills, muscle aches and dilated pupils. Severe and prolonged vomiting and diarrhea may cause significant fluid loss.

Physicians recommend tapering Butrans use to avoid withdrawal. Overpowering and persistent symptoms prevent many individuals from weaning themselves from opioids like buprenorphine.

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Detox

Professional detoxification helps patients overcome opioid dependence after efforts at self-tapering have failed. Physicians administer drugs to reduce opioid levels along with a variety of drugs to ease the ensuing withdrawal symptom. These procedures reduce symptoms but do not shorten the duration of the withdrawal syndrome.

Rapid detox shortens the detoxification procedure from a few days to a few hours. Board-certified anesthesiologists sedate and anesthetize the patient before administering the standard detoxification and anti-withdrawal drugs. The rapid detox patient dozes in a pleasant “twilight sleep” during the difficult detoxification process, unaware of uncomfortable withdrawal symptoms.

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Storage

Consumers should store Butrans at temperatures between 59 degrees and 86 degrees Fahrenheit, in a tightly sealed container. Keep Butrans away from light.

The consumer should place used Butrans patches in the Patch-Disposal Unit before throwing old patches in the household trash. The consumer may also flush used patches down the toilet.

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Miscellaneous information

Butrans was first approved for use in the United States in 1981.

Facts

  • Butrans