Buprenorphine patch

What is Buprenorphine patch?

• Buprenorphine Transdermal System is a partial opioid agonist used to manage severe pain.

Buprenorphine

Buprenorphine molecule from xtal ball

Buprenorphine molecule from xtal spacefill

What are the uses of this medicine?

• Buprenorphine transdermal system is a prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Limitations of Use:

• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Buprenorphine Transdermal System for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Not for use to treat pain that is not around-the-clock.

How does this medicine work?

• Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptors, an agonist at delta-opioid receptors, and a partial agonist at ORL-1 (nociceptin) receptors.
• The contributions of these actions to its analgesic profile are unclear.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What drug interactions can this medicine cause?

• Closely monitor patients with concurrent use of buprenorphine transdermal system and benzodiazepines.
• Initiating CYP3A4 inhibitors or discontinuing CYP3A4 inducers may result in an increase in buprenorphine plasma concentrations. Closely monitor patients starting CYP3A4 inhibitors or stopping CYP3A4 inducers for respiratory depression.
• Avoid use with buprenorphine transdermal system because they may reduce analgesic effect of buprenorphine transdermal system or precipitate withdrawal symptoms
• The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.

Is this medicine FDA approved?

• Buprenorphine was patented in 1965, and approved for medical use in the United States in 1981.

How should this medicine be used?

Recommended dosage:

• Buprenorphine transdermal system doses of 7.5, 10, 15, and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid-experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid.
• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
• For opioid-naïve patients, initiate treatment with a 5 mcg/hour patch.
• Instruct patients to wear buprenorphine transdermal system for 7 days and to wait a minimum of 3 weeks before applying to the same site.

Administration:

• To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.
• Do not change your dose. Apply buprenorphine transdermal system exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
• Do not apply a buprenorphine transdermal system patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
• Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
• You should wear 1 buprenorphine transdermal system patch continuously for 7 days.
• Call your healthcare provider if the dose you are using does not control your pain.
• Do not stop using buprenorphine transdermal system without talking to your healthcare provider.
• Discuss availability of naloxone with the patient and caregiver and assess each patient's need for access to naloxone, both when initiating and renewing treatment with buprenorphine transdermal system. Consider prescribing naloxone based on the patient's risk factors for overdose.
• Do not abruptly discontinue buprenorphine transdermal system in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Transdermal system: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour.

This medicine is available in fallowing brand namesː

• BUTRANS

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• itching
• redness or rash where the patch is applied

What special precautions should I follow?

• Do not take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps. These can cause an overdose that can lead to death.
• Do not drive or operate heavy machinery, until you know how buprenorphine transdermal system affects you. Buprenorphine transdermal system can make you sleepy, dizzy, or lightheaded.
• Do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with buprenorphine transdermal system may cause you to overdose and die.
• Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Monitor closely, particularly during initiation and titration.
• Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
• Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
• Buprenorphine transdermal system may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor during dose initiation and titration. Avoid use of buprenorphine transdermal system in patients with circulatory shock.
• In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), buprenorphine transdermal system may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with buprenorphine transdermal system.
• Buprenorphine transdermal system contains buprenorphine, a Schedule III controlled substance. As an opioid, buprenorphine transdermal system exposes users to the risks of addiction, abuse, and misuse.
• Prolonged use of buprenorphine transdermal system during pregnancy can result in withdrawal in the neonate. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Do not abruptly discontinue buprenorphine in a patient physically dependent on opioids. When discontinuing buprenorphine transdermal system in a physically dependent patient, gradually taper the dosage.
• Monitor patients wearing buprenorphine transdermal systems who develop fever or increased core body temperature due to strenuous exertion for opioid side effects.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory depression
• somnolence
• stupor
• coma
• skeletal muscle flaccidity
• cold and clammy skin
• constricted pupils
• pulmonary edema
• bradycardia
• hypotension
• partial or complete airway obstruction
• atypical snoring
• death
• hypoxia

Management of overdosage:

• Remove buprenorphine transdermal system immediately.
• In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
• Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.However, naloxone may not be effective in reversing any respiratory depression produced by buprenorphine.
• High doses of naloxone, 10-35 mg/70 kg, may be of limited value in the management of buprenorphine overdose.
• The onset of naloxone effect may be delayed by 30 minutes or more.
• Doxapram hydrochloride (a respiratory stimulant) has also been used.

Can this medicine be used in pregnancy?

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
• Available data with buprenorphine transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and efficacy of buprenorphine transdermal system in patients under 18 years of age has not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient:

Buprenorphine

• Inactive Ingredients:

ethyl levulinate oleyl oleate povidone, unspecified

Who manufactures and distributes this medicine?

Marketed by:

• Rhodes Pharmaceuticals L.P., Coventry, RI

Manufactured by:

• LTS Lohmann Therapy Systems Corp., West Caldwell, NJ

LTS Lohmann Therapie-Systeme AG, Andernach, Germany

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted between 15°C -30°C (59°F-86°F).
• Store buprenorphine transdermal system securely and dispose of properly.

• Dailymed label info on Buprenorphine patch
• FDA Buprenorphine patch

Buprenorphine patch Resources
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