This dosage information may not include all the information needed to use Buprenorphine safely and effectively. See additional information for Buprenorphine.
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Opiate Dependence
Initial dose: 8 mg sublingually on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg sublingually.
The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.
For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.
Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.
The optimal method of tapering to discontinuation has not been reported.
Usual Adult Dose for Pain
IM or IV:
Initial: 0.3 mg slow IM or IV every 6 hours as needed. May repeat once 30 to 60 minutes after the initial dose. Maximum single dose: 0.6 mg (IM only)
Transdermal patches: Apply 1 patch to a hairless or nearly hairless intact skin site. There are 8 possible application sites: upper outer arm, upper chest, upper back, and side of the chest (on both sides of the body). The patch is worn for 7 days. Maximum dose: 20 mcg/hour
Usual Pediatric Dose for Pain
Less than 2 years: Safety and effectiveness have not been established.
2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours.
13 to 18 years: 0.3 mg IM or slow IV every 6 hours; may repeat dose in 30 to 60 minutes.
Renal Dose Adjustments
The pharmacokinetics of buprenorphine is not altered during the course of renal failure.
Liver Dose Adjustments
Dosage adjustments may be required in patients with moderate or severe hepatic impairment. Patients should be observed for symptoms of opioid withdrawal and adjustments made accordingly.
Buprenorphine transdermal patches: Mild to moderate hepatic impairment: Start with 5 mcg/hour. Thereafter, the dose should be titrated to a level that provides adequate analgesia and tolerable side effects, under the supervision of the prescriber. Severe hepatic impairment: Buprenorphine transdermal patches have not been evaluated in these patients. Since the patches are only intended for 7- day application, the prescriber should consider the use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment.
Parenteral doses should be reduced by approximately one-half in high-risk patients (elderly, debilitated, respiratory disease), patients receiving other CNS depressants, or in the immediate postoperative period.
The initial dose of buprenorphine transdermal patches in opioid-naÃ¯ve patients is 5 mcg/hour. Thereafter, the dose should be individually titrated, under close professional medical supervision, to a level that provides adequate analgesia with tolerable side effects. The dose may be titrated to the next higher level after a minimum of 72 hours.
There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. For conversion from other opioids to buprenorphine transdermal patches, the patient's current around-the-clock opioids should be tapered for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with buprenorphine transdermal patches. Patients may use short-acting analgesics as needed until analgesic efficacy with buprenorphine transdermal patches is attained.
For patients whose daily dose was less than 30 mg of oral morphine or equivalent, treatment with buprenorphine transdermal patches should be initiated at 5 mcg/hour. For patients whose daily dose was between 30 and 80 mg morphine equivalents, buprenorphine transdermal patches should be initiated at 10 mcg/hour. Thereafter, the dose should be individually titrated.
During periods of changing analgesic requirements, including initial titration of buprenorphine transdermal patches, frequent contact is recommended between the prescriber, other members of the healthcare team, the patient, and the caregiver/family.
During chronic opioid analgesic therapy with buprenorphine transdermal patches, a healthcare professional should periodically reassess the continued need for around-the-clock therapy.
When a patient no longer requires therapy with buprenorphine transdermal patches, the dose should be tapered gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient. The healthcare professional should consider introduction of an appropriate immediate-release opioid medication. Discontinuation of therapy should be undertaken as part of a comprehensive treatment plan.
Respiratory depression has been associated with buprenorphine, particularly after intravenous administration. Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants. Naloxone may not be effective in reversing buprenorphine-associated respiratory depression. In case of overdose, the primary concern is to establish adequate ventilation.
Sublingual buprenorphine may cause withdrawal symptoms in opioid dependent patients.
It is critical to initiate the dosing regimen of buprenorphine transdermal patches individually for each patient. Overestimating the dose when converting patients from another opioid medication can result in fatal overdose.
Caution should be exercised when prescribing buprenorphine transdermal patches to opioid-experienced patients requiring high doses of opioids (more than 80 mg/day of oral morphine equivalents). Buprenorphine transdermal patches 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents.
The maximum buprenorphine transdermal patches dosage is 20 mcg/hour. The maximum 20 mcg/hour dosage should not be exceeded due to the risk of QTc interval prolongation.
Buprenorphine transdermal patches are not indicated for use in patients with severe respiratory impairment, severe bronchial asthma, have or are suspected of having paralytic ileus, have acute pain requiring the use of opioid analgesics for a short period of time, are being treated for postoperative pain, including use after outpatient or day surgeries, or for those that have mild or intermittent pain.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for sublingual buprenorphine, buprenorphine transmucosal products for opioid dependence, and extended-release and long-acting opioid analgesics. They include a medication guide and elements to assure safe use; the sublingual and transmucosal products also include an implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
Sublingual tablets should be placed under the tongue to dissolve and kept in place for 10 minutes without swallowing. The sublingual tablets should not be chewed, crushed, or swallowed.
Buprenorphine transdermal patches should not be used if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
Buprenorphine transdermal patches are intended to be worn for 7 days.
Buprenorphine transdermal patches should only be applied to intact skin. After removal, a minimum of 21 days should pass before reapplying to the same site. There are 8 possible application sites: upper outer arm, upper chest, upper back, and side of the chest (on both sides of the body).
Buprenorphine transdermal patches should be applied to a hairless or nearly hairless skin site. If no hairless site is available, the hair at the site should be clipped, not shaven. Patches should not be applied to irritated skin. If the application site must be cleaned, clean with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Skin should be allowed to dry completely before applying patches. If problems with adhesion of the patch occur, the edges may be taped with first aid tape. If the patch falls off during the 7 days dosing interval, the patch should be properly disposed of and a new patch should be applied to a different skin site.
Direct external heat sources should not be applied to the buprenorphine transdermal patches site or the surrounding area. Temperature-dependant increases in buprenorphine release from the system may result in overdose and death.
The intent of the titration period for buprenorphine transdermal patches is to establish a patient-specific weekly dose that will maintain adequate analgesia with tolerable side effects for as long as pain management is necessary. Immediate-release opioid and non-opioid medications can be used as supplemental analgesia during buprenorphine transdermal patch therapy.
Proper disposal of patches should include folding the patch over on itself and bring the adhesive sides together.
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