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Buprenorphine Dosage

Applies to the following strength(s): 0.3 mg/mL ; 2 mg ; 8 mg ; 10 mcg/hr ; 20 mcg/hr ; 74.2 mg ; 5 mcg/hr ; 7.5 mcg/hr ; 15 mcg/hr ; 75 mcg ; 150 mcg ; 300 mcg ; 450 mcg ; 600 mcg ; 750 mcg ; 900 mcg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Opiate Dependence

To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):
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.

Buprenorphine IMPLANT for Subdermal Administration:
-For opioid tolerant patients only
-Insert 1 dose subdermally in the inner side of the upper arm
-Remove implant at the end of the sixth month

Comments:
-Insertions and removals of implant should be performed by a certified healthcare provider.
-One dose consists of 4 implants; each implant contains buprenorphine 74.2 mg (equivalent to 80 mg buprenorphine hydrochloride).
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal product for continued treatment; there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Use: For the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a BTOD.

Patients chosen for implant use should meet all of the following criteria:
-Achieved and sustained prolonged clinical stability on an acceptable BTOD maintenance dose for 3 months or longer without any need for supplemental dosing or adjustments
Acceptable BTOD maintenance doses include:
--buprenorphine sublingual tablets (Subutex[R]) or generic equivalent at 8 mg or less per day
--buprenorphine/naloxone sublingual tablets (Suboxone[R]) or generic equivalent at 8 mg/2 mg or less per day
--buprenorphine/naloxone buccal film (Bunavail[R]) at 4.2 mg/0.7 mg or less per day
--buprenorphine/naloxone sublingual tablets (Zubsolv[R]) at 5.7 mg/1.4 mg or less per day
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Usual Adult Dose for Pain

Parenteral:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); 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 (IV) or 0.6 mg (IM)

Comments:
-Use extra caution with IV administration, especially the first dose

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 mcg, 10 mcg, 15 mcg, and 20 mcg/hr patches are for opioid-experienced patients only.

-As first opioid analgesic: Initiate with 5 mcg/hr patch applied transdermally 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 applied transdermally 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 applied transdermally 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 due to risk of QTc interval prolongation

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 (over at least 2 minutes) ; 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; some patients may not need to be remedicated for 6 to 8 hours

Comments:
-Fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established.
-Use extra caution with IV administration, especially the first dose

Use: For the relief of moderate to severe pain

Usual Pediatric Dose for Opiate Dependence

Aged 16 years or older: To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):
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.

Buprenorphine IMPLANT for Subdermal Administration:
-For opioid tolerant patients only
-Insert 1 dose subdermally in the inner side of the upper arm
-Remove implant at the end of the sixth month

Comments:
-Insertions and removals of implant should be performed by a certified healthcare provider.
-One dose consists of 4 implants; each implant contains buprenorphine 74.2 mg (equivalent to 80 mg buprenorphine hydrochloride).
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal product for continued treatment; there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Use: For the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a BTOD.

Patients chosen for implant use should meet all of the following criteria:
-Achieved and sustained prolonged clinical stability on an acceptable BTOD maintenance dose for 3 months or longer without any need for supplemental dosing or adjustments
Acceptable BTOD maintenance doses include:
--buprenorphine sublingual tablets (Subutex[R]) or generic equivalent at 8 mg or less per day
--buprenorphine/naloxone sublingual tablets (Suboxone[R]) or generic equivalent at 8 mg/2 mg or less per day
--buprenorphine/naloxone buccal film (Bunavail[R]) at 4.2 mg/0.7 mg or less per day
--buprenorphine/naloxone sublingual tablets (Zubsolv[R]) at 5.7 mg/1.4 mg or less per day
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

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.

Implant:
-Moderate to severe hepatic impairment: Not recommended
-For patients developing moderate to severe hepatic impairment while on treatment, monitor for signs and symptoms of toxicity or overdose, if signs and symptoms of toxicity or overdose are observed, the implant should be removed.

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 (BTOD), Suboxone(R)/Subutex(R), Extended-Release and Long-Acting (ER/LA) Opioid Analgesics and Probuphine(R) implant. Each includes a medication guide and elements to assure safe use. Additionally BTOD, Suboxone(R)/Subutex(R), and Probuphine(R) require an implementation system. For additional information: www.fda.gov/REMS

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.

US BOXED WARNING: Implant for Subdermal Administration
IMPLANT MIGRATION, PROTRUSION, EXPULSION, and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL:
-Risk Associated with Insertion and Removal: Insertion and removal of this drug is associated with the risk of implant migration, protrusion, and expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion. All healthcare providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing implants. Patients must be monitored to ensure that the implant is removed by a healthcare provider certified to perform insertions. Further information is available at www.PROBUPHINEREMS.com or 1-844-859-6341.

Drug Addiction Treatment Act:
Under the Drug Addiction Treatment Act (DATA) codified at 21 US Code 823(G), use of this product in the treatment of opioid dependence is limited to physicians who meet qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe or dispense this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Safety and efficacy of the injection have not been established in patients younger than 2 years.
Safety and efficacy of the sublingual or implant for subdermal administration have not been established in patients younger than 16 years.
Safety and efficacy of transdermal products have not been established in patients younger than 18 years.

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 as 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.
-A patch-disposal unit is provided for disposal of the transdermal system, follow instructions on the unit. Alternatively, dispose of patches by folding adhesive side to itself and flush down the toilet.
IMPLANT FOR SUBDERMAL ADMINISTRATION:
-Implants must be inserted and removed by trained healthcare providers only
-Insertion site should be examined 1 week following insertion for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin.

General:
Opiate dependence:
-Prescribing this drug in the treatment of opioid dependence is limited to physicians meeting qualifying requirements and registrations; a unique identification number should be included on every prescription for opioid dependence.
-This drug should be used as part of a complete treatment program to include counseling and psychosocial support.
-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.
-Use of the implant is appropriate for those patients who have achieved and sustained prolonged clinical stability on low to moderate doses of a transmucosal buprenorphine-containing product (i.e. doses of no more than 8 mg/day); if continued treatment is needed at the end of the first 6-month cycle, a second implant may be placed in the contralateral arm following the removal of the first implant; there is no experience with additional implants into other sites or reinsertion into previously-used site, in most cases patients should be transitioned back to a transmucosal product.

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.
-Monitor implant insertion site 1 week following insertion for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin.
-Monitor patients receiving this drug for opioid dependence for conditions indicative of diversion or progression of opioid dependence.

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 electing treatment with the implant should understand the risks associated with insertion and removal of the implant, they should be instructed on what to do if the implant protrudes or is expelled out of the arm, and they should know to contact their healthcare provider (e.g. bleeding or symptoms of infection at insertion site, numbness, weakness, or shortness of breath).
-Patients should be instructed in proper disposal.

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