Buprenorphine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Opiate Dependence

Induction dose:
-Day 1: 8 mg sublingually once a day
-Day 2: 16 mg sublingually once a day
Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear.
-Following induction, combination buprenorphine/naloxone is preferred; use of buprenorphine alone should be limited to those patients who cannot tolerate naloxone.

Use: For the treatment of opioid dependence, preferably induction only. This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.

Usual Adult Dose for Pain

Parenteral:
Initial dose: 0.3 mg deep IM or slow IV; may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.6 mg (IM only)

Comments:
-Use extra caution with IV administration, especially the first dose
-IV administration of maximum doses are not recommended

Use: For the relief of moderate to severe pain

Usual Adult Dose for Chronic Pain

Individualize dosing taking into account prior analgesic treatment; 7.5 mg, 10 mg, 15 mg, and 20 mg patches are for opioid-experienced patients only.

-As first opioid analgesic: Initiate with 5 mcg/hr patch every 7 days

Conversion from Other Opioids to Buprenorphine:
-Discontinue all other around-the-clock opioid drugs when initiating therapy
For patients whose prior total opioid dose is less than 30 mg/day of oral morphine equivalents:
-Initiate with 5 mcg/hr patch every 7 days at next dosing interval
For patients whose prior total opioid dose is between 30 and 80 mg/day of oral morphine equivalents:
-Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day of oral morphine equivalents, then initiate with 10 mcg/hr patch every 7 days starting at the next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained.
For patients whose prior total opioid dose is greater than 80 mg/day of oral morphine equivalents:
-Consider use of an alternate analgesic as 20 mcg/hr patch may not provide adequate analgesia

Conversion from Methadone:
-The ratio between methadone and other opioid agonists may vary widely due to its long half-life and accumulation in the plasma; close monitoring is of particular importance.

Titration: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
Maximum dose: 20 mcg/hr

Comments:
-Monitor patients closely for respiratory depression, especially within 24 to 72 hours after initiating therapy.
-If pain level increases after dose stabilization, attempt to identify source of increased pain before increasing buprenorphine dose
-Do not abruptly discontinue; use a gradual downward titration every 7 days, may consider introduction of an immediate-release opioid.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Usual Pediatric Dose for Pain

Parenteral:
13 years or older:
Initial dose: 0.3 mg deep IM or slow IV; may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.3 mg

2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours

Comments:
-Fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established: some patients may not need to be re-medicated for 6 to 8 hours.
-Use extra caution with IV administration, especially the first dose
-IV administration of maximum doses are not recommended

Use: For the relief of moderate to severe pain

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.

Transdermal:
-Severe hepatic impairment: consider use of an alternate analgesic that may permit more flexibility in dosing.

Dose Adjustments

Parenteral:
-Reduce dose by one/half in patients at high risk for respiratory depression, including, but not limited to patients with respiratory diseases, patients in the immediate postoperative period, the elderly, debilitated patients, and those concomitantly receiving CNS depressants.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Buprenorphine Transmucosal Products for Opioid Dependence and for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics. Each includes a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS: Transdermal Patch
ADDICTION, ABUSE, AND MISUSE:
-This drug exposes patients and other users to the risks of opioid addiction, abuse, or misuse which can lead to overdose and death. Assess each patient's risk before prescribing; regularly monitor for these behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION:
-Respiratory depression with fatal outcome can occur. Monitor closely upon initiation or following a dose increase. Misuse or abuse by chewing, swallowing, snorting, or injecting buprenorphine extracted from the transdermal patch will result in uncontrolled delivery of the drug and pose a significant risk of overdose and death.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in this life-threatening syndrome if not recognized and treated promptly. Treatment requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available.
ACCIDENTAL EXPOSURE:
-Accidental ingestion to even 1 dose, especially in children, can be fatal.

Safety and efficacy have not been established in patients younger than 2 years for buprenorphine injection.

Safety and efficacy have not been established in patients younger than 18 years for buprenorphine transdermal or buprenorphine sublingual products.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

Data not available

Other Comments

Administration advice:
Parenteral:
-Administer by deep IM injection or slow IV (over at least 2 minutes) injection.
Sublingual:
-Place tablets under tongue until dissolved; if dose requires multiple tablets, either place all tablets at once, or alternatively place 2 tablets at a time under the tongue and allow dissolving; do not swallow tablets at that reduces the bioavailability
Transdermal:
-Apply patch immediately after removal from sealed pouch; do not use if pouch seal is broken or the patch is damaged in any way.
-Apply to a hairless or nearly hairless skin site, if none exist, hair should be clipped, not shaven; do not apply to irritated skin,
-Rotate application sites: possible sites include upper outer arm, upper chest, upper back, or side of the chest; allow a minimum of 21 days before reapplying to the same skin site.
-If adhesion problems occur, first aid tape may be used; if the problem persists, the patch may be covered with waterproof or semipermeable dressing.
-If patch falls off, dispose of properly and place a new patch on a different skin site.
-For the use of 2 patches at the same time, apply adjacent to one another.

Disposal:
A Patch-Disposal Unit is provided for the transdermal system, follow instructions on the unit. Alternatively, dispose of patches by folding adhesive side to itself and flush down the toilet.

General:
Opiate dependence:
-Sublingual use of this drug is limited to treatment of opioid dependence; physician's prescribing this drug must meet certain qualifying requirements and registrations.
-Adequate treatment doses, titrated to clinical effectiveness should be achieved as rapidly as possible; gradual induction over several days may lead to higher drop-out rates during the induction period.
-The optimal method of tapering to discontinuation has not been reported.
-Patients must be informed about the loss of opioid tolerance after discontinuation and its dangerous impact in case of relapse.

Pain:
-Individualize the dosing regimen for each patient taking into account the patient's prior analgesic treatment experience and risk factors for respiratory depression, addiction, abuse, and misuse.
-The long-acting transdermal system should only be prescribed by healthcare professionals knowledgeable in the use of potent opioids for the management of chronic pain.
-Do not discontinue abruptly in physically dependent patients.

Monitoring:
-Closely monitor for respiratory depression, especially on initiation and following dose increases.
-Monitor for signs and symptoms of hypotension, especially in ambulatory patients.
-For patients at increased risk of hepatotoxicity, obtain baseline liver function tests and monitor periodically during treatment.

Patient advice:
-Patients should understand the risks of addiction, abuse, and misuse.
-Accidental ingestion, especially by children, can result in death; keep out of reach of children.
-Patients should understand the risk of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
-Prolonged exposure of the transdermal application site and surrounding areas to hot water or direct sunlight should be avoided.
-Patients should be instructed in proper disposal.

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