Adult Dosing
Moderate-severe chronic pain
Opioid-naive patients
- Start with 5 mcg/hr transdermal film; may titrate the dose to the next higher level after a minimum of 72 hrs (max: 20 mcg/hr)
Opioid-experienced patients
- Oral morphine equivalent <30 mg/day
- Start with 5 mcg/hr TDP; may titrate the dose to the next higher level after a minimum of 72 hrs (max: 20 mcg/hr)
- Oral morphine equivalent 30-80 mg/day
- Start with 10 mcg/hr TDP; may titrate the dose to the next higher level after a minimum of 72 hrs (max: 20 mcg/hr)
- Taper the patient’s current around-the-clock opioids for up to 7 days to no >30 mg of oral morphine or equivalent per day before beginning treatment with buprenorphine
Notes:- Do not cut/alter the patch
- Each patch is intended to be used for 7 days
- Immediate-release opioid and non-opioid medications can be used as supplemental analgesia during therapy. Establish a patient-specific weekly buprenorphine dose that will maintain adequate analgesia with minimum side effects for as long as pain management is necessary
- Gradually taper the dose and introduce an appropriate immediate-release opioid medication in order to discontinue therapy
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Respiratory depression, more common in the elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia or hypercapnia, is the major hazard of treatment with buprenorphine
- Buprenorphine may cause CNS depression manifested as somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma
- Concomitant administration with other CNS depressants (e.g., sedatives, anxiolytics, muscle relaxants, hypnotics, other opioids) may cause hypotension, profound sedation, coma or respiratory depression
- Do not exceed a dose of one 20 mcg/hr patch due to increased risk of QTc interval prolongation [US Black Box Warning]
- Caution should be exercised while prescribing buprenorphine to patients with hypokalemia or clinically unstable cardiac disease including unstable atrial fibrillation, symptomatic bradycardia, unstable CHF, or active myocardial ischemia. Avoid use in patients with a history of long QT syndrome or those receiving class IA or class III antiarrhythmic medications
- Therapy may elevate cerebrospinal fluid pressure, which may be exaggerated in head injury, intracranial lesions, or other circumstances where cerebrospinal pressure may be increased. Buprenorphine may produce miosis and changes in the level of consciousness, either of which may obscure the neurologic signs of raised ICP in individuals with head injuries
- May cause severe hypotension, and may produce orthostatic hypotension in ambulatory patients; use cautiously in patients with circulatory shock
- Buprenorphine is a mu-opioid receptor partial agonist and a schedule III controlled substance; it can be abused like other opioid agonists, legal or illicit. When prescribing or dispensing the drug, consider the abuse potential, particularly in situations where there is concern about an increased risk of misuse, abuse, or diversion [US Black Box Warning]
- The risk of opioid abuse is increased in patients with a personal or family history of substance abuse or mental illness. Prior to prescribing opioids, assess the patient for their clinical risks for opioid abuse or addiction. Monitor patients receiving opioids for signs of misuse, abuse, and addiction [US Black Box Warning]
- Instances of cytolytic hepatitis, hepatitis with jaundice, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy have been reported during therapy
- Application site skin reactions with signs of marked inflammation including burn, discharge and vesicles have been reported with patch use
- Incidences of acute and chronic hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients with buprenorphine use
- Avoid exposing application site and surrounding area to direct external heat sources as it increases the drug release, which may lead to overdose and death [Black Box Warning]
- Patients wearing buprenorphine patch who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the dose should be adjusted if necessary
- Advise patients to refrain from driving a vehicle or operating machinery as the mental and physical abilities required for performing such tasks may be impaired
- May exacerbate seizure disorders or lower seizure threshold, and may therefore induce seizures in certain clinical settings
- May cause spasm of the sphincter of Oddi and may also cause increased serum amylase
- Buprenorphine may obscure the diagnosis or clinical course in patients with acute abdominal conditions; use cautiously in patients who are at risk of developing ileus
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Severe pulmonary impairment
- Cor pulmonale or significant chronic obstructive pulmonary disease
- Severe obesity
- Sleep apnea
- Acute pancreatitis
- Myxedema
- Clinically-significant kyphoscoliosis
- Preexisting respiratory depression
- Alcoholism
- Asthma
- Delirium tremens
- Adrenocortical insufficiency
- Debilitated patients
- Hypothyroidism
- Prostatic hypertrophy or urethral stricture
- Biliary tract disease
- Toxic psychosis
- Volume depletion
- Acute abdomen
- GI motility disorder
Supplemental Patient Information
- Advise patients not to drive or operate machinery as the mental and physical abilities necessary for performing such tasks may be impaired
- Instruct patients not to drink alcohol during therapy
Pregnancy Category:C
Breastfeeding: Buprenorphine use is acceptable in nursing mothers because of the low levels in breastmilk, its poor oral bioavailability in infants, and the low drug concentrations found in serum and urine of breastfed infants. Monitor for drowsiness, adequate weight gain, and developmental milestones in exclusively breastfed infants. If any signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness are noticed in the baby, immediately contact a physician. Mothers taking buprenorphine for opiate addiction may have lower rate of breastfeeding than in other mothers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 16 May 2011). As per the manufacturer's data, breastfeeding is not advised in mothers receiving buprenorphine.
Pricing data from www.DrugStore.com in U.S.A.
- Butrans 20 MCG/HR PTWK [Box] (PURDUE PHARMA L.P.)
4 hr = $380
12 hr = $1110
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
