BUPRENORPHINE 2mg. Sublingual Tablets.

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SKU: BUPRENORPHINE-2

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Description

This Product belong to the Opioid Narcotic Pain Medication Group, Classified by the F.D.A. On Schedule # II of Controlled Substances, for Exclusive use of Clinics & Hospitals; This is why is hard for other Sources to get this from the Original Laboratory approved by the F.D.A. Like the ones We Offer, and also in a Lower Price, because of all the Expenses they represent

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FORMULATION:

Buprenex 2mg.

 

 

BOXED WARNING

DOSAGE & INDICATIONS

 

Accidental exposure, alcoholism, depression, implant insertion and removal complications, potential for overdose or poisoning, requires an experienced clinician, substance abuse

Buprenorphine is an opioid and therefore has abuse potential and risk of fatal overdose from respiratory failure. Addiction may occur in patients who obtain buprenorphine illicitly or in those appropriately prescribed the drug. The risk of addiction in any individual is unknown. However, patients with mental illness (e.g., major depression) or a family history of substance abuse (including alcoholism) have an increased risk of opioid abuse. Assess patients for risks of addiction, abuse, or misuse before drug initiation, and monitor patients who receive opioids routinely for development of these behaviors or conditions. A potential risk of abuse should not preclude appropriate pain management in any patient, but requires more intensive counseling and monitoring. Abuse and addiction are separate and distinct from physical dependence and tolerance; patients with addiction may not exhibit tolerance and symptoms of physical dependence. The misuse of transdermal buprenorphine by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death. Abuse or misuse of the buccal film may cause choking, overdose, and death. To discourage abuse, the smallest appropriate quantity of buprenorphine should be prescribed, and proper disposal instructions for unused drug should be given to patients. Like other opioids, buprenorphine use is associated with a significant potential for overdose or poisoning; proper patient selection and counseling is recommended. Transdermal and transmucosal buprenorphine are not intended for use on an as-needed basis; use is intended only for patients requiring continuous, around-the-clock opioid analgesia for an extended period of time and requires an experienced clinician who is knowledgeable in the use of long-acting opioids for the management of chronic pain. When used to treat addiction, sublingual buprenorphine should be initiated only after clear and objective symptoms of narcotic withdrawal are present to avoid precipitating such symptoms due to the antagonist activity of buprenorphine. Buprenorphine subdermal implants should be initiated only in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product. To minimize implant insertion and removal complications, subdermal implants requires an experienced clinician who is certified in the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program. Buprenorphine should be kept out of the reach of pediatric patients and pets, as accidental exposure can cause serious injury or death. In the event of buprenorphine implant protrusion or expulsion from the arm, keep the implant away from pediatric patients. Accidental exposure to buprenorphine can cause severe, possibly fatal, respiratory depression, particularly in pediatric patients.

Acute intoxication of CNS depressants, asthma, bronchitis, chronic obstructive pulmonary disease (COPD), CNS depression, coadministration with other CNS depressants, cor pulmonale, driving or operating machinery, emphysema, ethanol intoxication, heart failure, obesity, psychosis, pulmonary disease, respiratory depression, respiratory insufficiency, scoliosis, sleep apnea, status asthmaticus

As with other opioid agonists, buprenorphine should be avoided in patients with severe pulmonary disease. Additionally, avoid coadministration with other CNS depressants unless no other alternatives are available, as coadministration significantly increases the risk for respiratory depression, low blood pressure, and death. The potential risk of serious adverse effects with concomitant use of buprenorphine and other CNS depressants should not preclude the appropriate treatment of opioid addiction with buprenorphine, but requires more intensive counseling and monitoring. If buprenorphine must be administered to patients with pulmonary disease, use extreme caution and initiate treatment at the lowest effective dose. Clinically significant respiratory and CNS depression may occur with therapeutic doses of any form of buprenorphine; patients with pre-existing respiratory or CNS impairment may be at an increased risk of adverse events. Buprenorphine should be used with caution in patients with asthma; use of transdermal buprenorphine or the buccal film is contraindicated in patients with significant respiratory depression and/or acute or severe bronchial asthma (e.g., status asthmaticus) in an unmonitored setting or in the absence of resuscitative equipment. The manufacturer of buprenorphine subdermal implants recommends caution in patients with compromised respiratory function such as occurs with chronic obstructive pulmonary disease (COPD), cor pulmonale, decreased respiratory reserve, or pre-existing respiratory depression. Respiratory depression, if left untreated, may cause respiratory arrest and death. Symptoms of respiratory depression include a reduced urge to breathe, a decreased respiratory rate, or deep breaths separated by long pauses (a “sighing” breathing pattern). Prior to initiation of therapy, it is important to note that naloxone may not be effective in reversing buprenorphine effect. Proper dosing and titration are essential; patients should be monitored for respiratory depression, particularly during initiation or after a dose increase. Caution should be exercised when converting from a different opioid to buprenorphine, as overestimation of the buprenorphine dose may lead to fatal overdose. In patients pulmonary disease such as chronic obstructive pulmonary disease (COPD), cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, emphysema, chronic bronchitis, respiratory insufficiency, or preexisting respiratory depression, it is recommended that non-opioid analgesics be considered as alternatives to transdermal buprenorphine, as even usual therapeutic doses may decrease respiratory drive and cause apnea in these patient populations. If sublingual or intravenous buprenorphine are used in patients with compromised respiratory function, it is recommended that the dose be reduced by approximately one-half. Use buprenorphine with caution in patients with an acute intoxication of CNS depressants (e.g., ethanol intoxication); a history of delirium tremens; heart failure; obesity or sleep apnea; or kyphoscoliosis. Retention of carbon dioxide from respiratory depression may also aggravate the sedative effects of opioids. Patients with kyphoscoliosis (a type of scoliosis) may be at an increased risk of breathing difficulties due to their spine curvature. Patients with toxic psychosis may not be good candidates for buprenorphine receipt due to the possible CNS depressive effects. Caution is advised for use of buprenorphine in elderly, cachectic, or debilitated patients, who are more likely to a have a co-morbid disease that affects buprenorphine kinetics and since they may be more sensitive to the respiratory and CNS depressant effects of the drug. Careful monitoring is required, particularly when CYP450 3A4 inhibitors or inducers are used concomitantly; concurrent use of a CYP3A4 inhibitor or discontinuation of a concurrently used CYP3A4 inducer may increase plasma buprenorphine concentrations and potentiate the risk of fatal respiratory depression. Warn all patients that buprenorphine can impair the mental and physical abilities required for the performance of potentially dangerous tasks such as driving or operating machinery. These effects may persist for varying periods of time after dosing. Impairment of mental or physical abilities may change during dosage adjustments.

Labor, neonatal opioid withdrawal syndrome, neonates, obstetric delivery, pregnancy

There have been no well-controlled studies in pregnant women. Limited published data on the use of buprenorphine in pregnancy have not shown an increased risk of major malformations. However, buprenorphine should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, since opioid dependence in pregnancy is generally associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. If the benefit of treatment with the subdermal implant is determined to outweigh the risks during pregnancy, dosage adjustments cannot be made and the patient should be closely monitored to ensure adequate treatment. It should be noted that because the implant dose cannot be adjusted, this formulation may not be an appropriate treatment option to initiate in patients who are pregnant. Pregnant women receiving treatment for opioid addiction may require dose adjustments of sublingual buprenorphine in order maintain abstinence from illicit drug use; closely monitor patients for withdrawal signs and symptoms and adjust dose as necessary. In animal studies, embryofetal death during organogenesis was observed in rats and rabbits treated with oral buprenorphine at doses approximately 53 and 11 times the maximum recommended human dose (MRHD), respectively. Pre- and post-natal development studies in rats demonstrated increased neonatal death after oral, IM, and subcutaneous doses approximately 4, 3, and 0.5 times the times the MRHD, respectively. No teratogenic effects were observed in rats or rabbits given a range of doses more than the MRHD during organogenesis; however, events such as acephalus, omphalocele, and skeletal abnormalities have been reported in a few studies. Neonates exposed during gestation may experience respiratory effects at birth. Further, the prolonged maternal use of long-acting opioids, such as buprenorphine, during pregnancy may result in neonatal opioid withdrawal syndrome (NOWS). Unlike opiate withdrawal in adults, NOWS may be life-threatening if not recognized and treated. Neonates should be observed for signs of NOWS (e.g., irritability, hyperactivity, abnormal sleep pattern, high-pitched crying, tremor, vomiting, diarrhea, failure to gain weight) and managed accordingly. Severe symptoms may require pharmacologic therapy managed by clinicians familiar with neonatal opioid withdrawal. Onset, duration, and severity of opioid withdrawal may vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination by the newborn. From post-marketing reports, the time to onset of neonatal withdrawal signs ranged from day 1 to day 8 of life with most cases occurring on day 1. Advise pregnant women receiving opioid addiction treatment with buprenorphine of the risk of NOWS and ensure that appropriate treatment will be available. This risk must be balanced against the risk of untreated opioid addiction which often results in continued or relapsing illicit opioid use and is associated with poor pregnancy outcomes. The safety of injectable buprenorphine given during labor and obstetric delivery has not been established. Transdermal and buccal buprenorphine are not for use during and immediately prior to labor, when shorter acting analgesics or other therapies are more appropriate. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.

Infection, intramuscular administration

Intramuscular administration or other routes of deep insertion of buprenorphine implant may result in rare but serious complications (e.g., neural or vascular injury), difficult localization of the implant, or result in the need for a surgical procedure to remove the implant. Improper placement may lead to local migration, protrusion, and expulsion. Buprenorphine implant should be inserted subdermally only, on the inner side of the upper arm. The implant should be palpable after insertion, and this should be confirmed by palpation immediately after insertion to ensure proper positioning. Complicated removal can occur if the implant is not inserted correctly, is inserted too deeply (intramuscular or in the fascia), is not palpable, or has migrated. Injury to deeper neural or vascular structures in the arm may occur when removing deeply inserted implants. Incomplete insertion or infection may lead to protrusion or expulsion. Infection may occur at the site of the insertion or removal. Excessive palpation shortly after insertion of the implants may increase the chance of infection. Improper removal carries a risk of infection at the implant site. Buprenorphine implants should be used cautiously in patients with a history of recurrent MRSA infections.

DEA CLASS

Rx, schedule III

DESCRIPTION

Semisynthetic mixed opiate agonist-antagonist; partial mu-receptor agonist with ceiling to its pharmacological effects
Parenteral form used for moderate to severe pain while transdermal and buccal forms used for continuous therapy for chronic severe pain
Sublingual tablets and transdermal implant used for opioid dependence, which requires compliance with the Drug Addiction Treatment Act (DATA)

COMMON BRAND NAMES

Belbuca, Buprenex, Butrans, Probuphine, Subutex

HOW SUPPLIED

Belbuca/Buprenorphine/Buprenorphine Hydrochloride Buccal Film: 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, 900mcg
Belbuca/Buprenorphine/Buprenorphine Hydrochloride Transmucosal Film: 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, 900mcg
Buprenex/Buprenorphine/Buprenorphine Hydrochloride Intramuscular Inj Sol: 0.3mg, 1mL
Buprenex/Buprenorphine/Buprenorphine Hydrochloride Intravenous Inj Sol: 0.3mg, 1mL
Buprenorphine/Buprenorphine Hydrochloride/Subutex Sublingual Tablet, SL: 2mg, 8mg
Buprenorphine/Butrans Transdermal Film ER: 1h, 5mcg, 7.5mcg, 10mcg, 15mcg, 20mcg
Probuphine Intradermal Imp: 74.2mg

DOSAGE & INDICATIONS

For the treatment of moderate pain or severe pain.
For treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment.
NOTE: Transdermal and buccal buprenorphine should be reserved for patients in 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. Discontinue all other around-the-clock opioid drugs upon initiation of transdermal buprenorphine.
NOTE: Transdermal buprenorphine doses of 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour are for use in opioid-experienced patients only.
NOTE: Buccal doses of 600 mcg, 750 mcg, and 900 mcg are for use following titration from lower doses of the buccal film.
Transdermal dosage for use as the first opioid analgesic (Butrans)
Adults

5 mcg/hour, applied topically to intact skin, every 7 days; titrate to response and tolerance. While the patch is intended to be worn for 7 days, doses may be titrated after a minimum interval of 72 hours; titrate the dose in 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour increments by using no more than 2 patches of the 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour systems. Do not exceed a dose of 20 mcg/hour due to the risk of QT prolongation.

Transdermal dosage for conversion from other opioid agonist analgesics (Butrans)

NOTE: There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. Overestimating dose when converting from another opioid can be fatal with first dose.

Adults whose daily opioid dose is less than 30 mg oral morphine (or equivalent)

5 mcg/hour, applied topically to intact skin, every 7 days. Begin treatment with buprenorphine at the next dosing interval. Use extreme caution when converting patients from methadone as the ratio between methadone and other opioid agonists can vary widely. While the patch is intended to be worn for 7 days, doses may be titrated after a minimum interval of 72 hours; titrate the dose in 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour increments by using no more than 2 patches of the 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour systems. Do not exceed a dose of 20 mcg/hour due to the risk of QT prolongation.

Adults whose daily opioid dose is 30 to 80 mg oral morphine (or equivalent)

Taper the patient’s current around-the-clock opioid for up to 7 days to no more than 30 mg of oral morphine or equivalent per day before beginning transdermal buprenorphine. Initiate buprenorphine 10 mcg/hour, applied topically to intact skin, every 7 days. Begin treatment with buprenorphine at the next dosing interval. Use extreme caution when converting patients from methadone as the ratio between methadone and other opioid agonists can vary widely. While the patch is intended to be worn for 7 days, doses may be titrated after a minimum interval of 72 hours; titrate the dose in 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour increments by using no more than 2 patches of the 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour systems. Do not exceed a dose of 20 mcg/hour due to the risk of QT prolongation.

Adults whose daily opioid dose is more than 80 mg oral morphine (or equivalent)

Consider the use of an alternate analgesic. The 20 mcg/hour transdermal buprenorphine may not provide adequate analgesia.

Transmucosal dosage for use as the first opioid analgesic (Belbuca)
Adults

75 mcg transmucosally once daily, or every 12 hours if tolerated, placed against the inside of the cheek. After 4 days, increase dosage to 150 mcg every 12 hours. Titrate in increments of 150 mcg every 12 hours no more frequently than every 4 days to provide adequate analgesia. Maximum: 900 mcg every 12 hours. Do not exceed 900 mcg every 12 hours due to the potential for QT prolongation. For patients with known or suspected mucositis, reduce the starting dosage and titration dosage by half.

Transmucosal dosage for conversion from other opioid agonist analgesics (Belbuca)

NOTE: There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. Overestimating dose when converting from another opioid can be fatal with first dose.

Adults whose daily opioid dose is less than 30 mg oral morphine (or equivalent)

75 mcg transmucosally once daily, or every 12 hours if tolerated, placed against the inside of the cheek. After 4 days, increase dosage to 150 mcg every 12 hours. Titrate in increments of 150 mcg every 12 hours no more frequently than every 4 days to provide adequate analgesia. Maximum: 900 mcg every 12 hours. Do not exceed 900 mcg every 12 hours due to the potential for QT prolongation. For patients with known or suspected mucositis, reduce the starting dosage and titration dosage by half. Use extreme caution when converting patients from methadone as the potency ratio between methadone and other opioid agonists can vary widely.

Adults whose daily opioid dose is 30 to 89 mg oral morphine (or equivalent)

Taper the patient’s current around-the-clock opioid to no more than 30 mg of oral morphine or equivalent per day before beginning transmucosal buprenorphine. Initiate 150 mcg transmucosally every 12 hours, placed against the inside of the cheek. Titrate in increments of 150 mcg every 12 hours no more frequently than every 4 days to provide adequate analgesia. Maximum: 900 mcg every 12 hours. Do not exceed 900 mcg every 12 hours due to the potential for QT prolongation. For patients with known or suspected mucositis, reduce the starting dosage and titration dosage by half. Use extreme caution when converting patients from methadone as the potency ratio between methadone and other opioid agonists can vary widely.

Adults whose daily opioid dose is 90 to 160 mg oral morphine (or equivalent)

Taper the patient’s current around-the-clock opioid to no more than 30 mg of oral morphine or equivalent per day before beginning transmucosal buprenorphine. Initiate 300 mcg transmucosally every 12 hours, placed against the inside of the cheek. Titrate in increments of 150 mcg every 12 hours no more frequently than every 4 days to provide adequate analgesia. Maximum: 900 mcg every 12 hours. Do not exceed 900 mcg every 12 hours due to the potential for QT prolongation. For patients with known or suspected mucositis, reduce the starting dosage and titration dosage by half. Use extreme caution when converting patients from methadone as the potency ratio between methadone and other opioid agonists can vary widely.

Adults whose daily opioid dose is more than 160 mg oral morphine (or equivalent)

Consider the use of an alternate analgesic. The buccal/transmucosal film may not provide adequate analgesia.

Intramuscular or Intravenous dosage

NOTE: Buprenorphine 0.3 mg IM provides analgesia roughly equivalent to morphine 10 mg IM.

Adults and Adolescents

0.3 mg IM or slow IV push. The dose may be repeated once if needed 30 to 60 minutes after the initial dose and then every 6 to 8 hours as needed. Depending on the severity of the pain, single doses of up to 0.6 mg IM, may be needed; this dose should only be given IM. Do not exceed 0.6 mg/dose IM or 0.3 mg/dose IV.

Geriatric, Debilitated, and other high-risk Adults or Adolescents, such as those with respiratory disease or on other CNS depressants

0.15 mg IM or slow IV push. The dose may be repeated once if needed 30 to 60 minutes after the initial dose and then every 6 to 8 hours as needed. Extra caution should be exercised with the IV route, particularly with the initial dose.

Children 2 years and older

2 to 6 mcg/kg/dose IM or slow IV push every 4 to 8 hours as needed. Buprenorphine elimination is variable in pediatric patients, and some pediatric patients may not need to be remedicated for 6 to 8 hours. A fixed dosing interval is not recommended until the child’s specific needs for analgesia are established. The use of a repeat dose 30 to 60 minutes after the initial dose, as is used in Adult and Adolescent patients, is not recommended in this population.

Epidural dosage†
Adults

In a study of post-operative patients, buprenorphine 4 mcg/kg or 2 mcg/kg via epidural injection had a slower onset of analgesia than the same dose given IV. However, the duration of spinal analgesia was significantly longer in patients receiving epidural administration. A greater duration of effect was found with the higher dosage as compared to the lower dosage. The incidence of side effects was not significantly different among the buprenorphine groups.

For the treatment of opiate agonist dependence, including opiate agonist withdrawal symptoms.
For the prevention of undue symptoms of opiate agonist withdrawal during induction of opiate agonist dependence treatment.
Sublingual dosage
Adults

Administer first dose of buprenorphine when early signs of opioid withdrawal appear and at least 4 hours after the last used short-acting opioid or 24 hours after last used long-acting opioid. To achieve an adequate treatment dose, rapidly titrate dose, in 2 mg to 4 mg increments, until clinical effect is achieved. In some studies, gradual induction over several days resulted in high drop-out rates. Buprenorphine should be used as part of a complete treatment program to include counseling and psychosocial support. Initiate treatment with supervised administration. Use of single-agent buprenorphine during induction may result in fewer withdrawal symptoms than if buprenorphine with naloxone is used. Under the Drug Addiction Treatment Act (DATA), physicians with a current waiver to provide medication-assisted treatment (MAT) to a maximum of 100 opioid-dependent patients and who have maintained the waiver in accordance with applicable statutory requirements without interruption for at least 1 year may become eligible to provide MAT to a total of 275 opioid-dependent patients at any one time if the requirements of DATA are met.

For maintenance treatment of opiate agonist dependence.
Sublingual dosage
Adults

A target dose of 16 mg sublingually once daily is suggested; however, doses ranging from 4 to 24 mg/day may be required. Titrate dosage in increments of 2 to 4 mg/day to a level that holds the patient in treatment and suppresses opiate withdrawal symptoms. Higher dosages (12 to 16 mg/day) have been associated with reduced opiate craving and fewer opiate-positive urine tests. Doses higher than 24 mg SL once daily have not shown any added benefit. Use as part of a comprehensive treatment plan which includes counseling and psychosocial support. Initiate treatment with supervised administration, and progress to unsupervised administration. When determining prescription quantity for unsupervised administration, consider frequency of visits, patient’s stability, and security of home. REDUCING DOSAGE AND STOPPING TREATMENT: Patients may remain on treatment indefinitely as long as the drug is beneficial. If the decision is made to discontinue maintenance therapy, the dose should be tapered to reduce the occurrence of withdrawal signs and symptoms. Additional, patients should be advised of the potential for relapse to illicit drugs use. ALTERNATIVE MAINTENANCE DOSE REGIMEN†: Buprenorphine is indicated for daily administration; however, efficacy has been demonstrated when extending the dosing interval to 3 times per week. In one study, comparable reductions in illicit opioid usage were found with 3 treatments for opioid dependence: buprenorphine, methadone, and levomethadyl. The dosages were individually optimized within a range of 16 to 48 mg 3 times a week for buprenorphine, 60 to 100 mg daily for methadone, and 75 to 161 mg 3 times a week for levomethadyl acetate. Buprenorphine with naloxone is preferred over buprenorphine alone for maintenance treatment, especially when drug administration will not be supervised. Only use single-agent buprenorphine for unsupervised administration in those patients who cannot tolerate buprenorphine with naloxone. Under the Drug Addiction Treatment Act (DATA), physicians with a current waiver to provide medication-assisted treatment (MAT) to a maximum of 100 opioid-dependent patients and who have maintained the waiver in accordance with applicable statutory requirements without interruption for at least 1 year may become eligible to provide MAT to a total of 275 opioid-dependent patients at any one time if the requirements of DATA are met.

For maintenance treatment of opioid agonist dependence in 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 per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent).
Subdermal implant dosage
Adults and Adolescents 16 years and older

Each dose consists of 4 implants inserted subdermally in the inner side of the upper arm. The implants are intended to be in place for 6 months. New implants may be inserted subdermally in an area of the inner side of either upper arm that has not been previously used at the time of removal, if continued treatment is desired. If new implants are not inserted on the same day as the removal of old implants, maintain patients on their previous dose of transmucosal buprenorphine prior to insert of the implant. Following 1 insertion in each arm, most patients should be transitioned back to a transmucosal buprenorphine-containing product for continued treatment. There is no experience with a second insertion into a previously-used administration site, other site on the arm, or a site other than the upper arm. Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for as-needed transmucosal buprenorphine. Patients who feel the need for supplemental dosing should be seen and evaluated promptly. Ongoing use of supplemental dosing with transmucosal buprenorphine indicates that the amount of buprenorphine delivered by the buprenorphine implant is not adequate for stable maintenance. In these cases, consider use of alternate buprenorphine products for maintenance of treatment. Buprenorphine should be used as part of a complete treatment program to include counseling and psychosocial support. NOTE: Under the Drug Addiction Treatment Act (DATA), physicians with a current waiver to provide medication-assisted treatment (MAT) to a maximum of 100 opioid-dependent patients and who have maintained the waiver in accordance with applicable statutory requirements without interruption for at least 1 year may become eligible to provide MAT to a total of 275 opioid-dependent patients at any one time if the requirements of DATA are met.

For the treatment of cocaine dependence†.
Sublingual dosage
Adults

The use of sublingual buprenorphine was evaluated in a 12-week, open-label study involving 11 patients with cocaine and morphine dependence. These patients were administered a maintenance therapy of 4 mg sublingual buprenorphine and 50 mg naltrexone once daily, for 6 days/week. Of the 11 study patients, 4 were abstinent from cocaine and opioids, 1 was abstinent over the last 9 weeks of the study, and 6 dropped out of the 12-week study.

†Indicates off-label use

MAXIMUM DOSAGE

Adults

0.6 mg/dose IM, 0.3 mg/dose IV, 20 mcg/hour transdermally, or 900 mcg transmucosal every 12 hours for pain; 24 mg/day SL, or 4 implants/6 months subdermally for opioid dependence (each implant contains 74.2 mg of buprenorphine).

Geriatric

0.6 mg/dose IM, 0.3 mg/dose IV, 20 mcg/hour transdermally, or 900 mcg transmucosal every 12 hours for pain; 24 mg/day SL, or 4 implants/6 months subdermally for opioid dependence (each implant contains 74.2 mg of buprenorphine).

Adolescents

16 to 17 years: 0.6 mg/dose IM and 0.3 mg/dose IV for pain. Four implants/6 months subdermally for opioid dependence (each implant contains 74.2 mg of buprenorphine). Safety and efficacy of the buprenorphine patch and buprenorphine buccal film for pain or buprenorphine SL for opioid dependence have not been established.
13 to 15 years: 0.6 mg/dose IM and 0.3 mg/dose IV for pain. Safety and efficacy of the buprenorphine patch and buprenorphine buccal film for pain or buprenorphine SL and buprenorphine subdermal implants for opioid dependence have not been established.

Children

2 years and older: 6 mcg/kg/dose IV/IM every 4 to 8 hours for pain. Safety and efficacy of the buprenorphine patch and buccal film for pain or buprenorphine SL and buprenorphine subdermal implants for opioid dependence have not been established.
Younger than 2 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

DOSING CONSIDERATIONS

Hepatic Impairment

Parenteral dosage form:
Specific guidelines for dosage adjustments in hepatic impairment are not available; however, dosage adjustments may be necessary. Adjust based on clinical response.

Sublingual dosage form:
Severe hepatic impairment: Consider reducing the starting and titration incremental dose by half, and monitor for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.
Moderate hepatic impairment: No dosage adjustment is needed; however, patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.
Mild hepatic impairment: No dosage adjustment or specific monitoring is required.

Transdermal patch:
In patients with mild to moderate hepatic impairment where the patch is the first opioid analgesic, initiate patients on 5 mcg/hour transdermally. Otherwise, cautiously select a dose that corresponds to the patient’s oral morphine equivalents per day and other factors that influence initial patch selection (see manufacturer’s literature). In some patients, alternate therapy should be considered. Closely monitor the patient for the first 24 to 72 hours of treatment with the patch for respiratory depression. Individually titrate the dose thereafter to a level that provides adequate analgesia and tolerable side effects. The buprenorphine transdermal system has not been evaluated in patients with severe hepatic impairment and is only intended for 7-day application. Consider the use of an alternate analgesic with more flexibility of dosing in patients with severe hepatic impairment.

Buccal film:
Severe hepatic impairment (Child-Pugh C): Reduce starting dose and titration dose by half that of patients with normal liver function, from 150 mcg to 75 mcg.
Mild to moderate hepatic impairment: No dose adjustment necessary.

Subdermal implant:
Moderate to severe hepatic impairment: Do not use as dose titration cannot be performed. Patients who develop moderate or severe hepatic impairment during treatment should be monitored for sedation and respiratory depression; implant removal may be necessary.
Mild hepatic impairment: No dose adjustment necessary.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears no dosage adjustments are needed. Some manufacturers recommend cautious use in severe renal impairment.

ADMINISTRATION

For storage information, see specific product information within the How Supplied section.

Oral Administration
Oral Solid Formulations

Buprenorphine tablets (Subutex) are for sublingual use only.
Do not swallow or chew the tablets. The tablets need to completely dissolve under the tongue. It is important that patients are consistent with tablet administration, since swallowing the tablet will reduce the bioavailability of the drug.
For doses requiring more than 2 tablets, patients are advised to either place all the tablets at once under the tongue or, if they cannot fit more than 2 tablets comfortably, place 2 tablets at a time under the tongue. With either option, patients should hold the tablets under the tongue until they completely dissolve.
Prior to induction, determine the type of opioid dependence (i.e., long- or short-acting opioids).
Induction: To avoid precipitating withdrawal, induction with buprenorphine should be undertaken only after objective and clear signs of withdrawal are present.
Short-acting opioid: Administer first dose at least 4 hours or longer after the patient last used heroin or other short-acting opioid.
Longer-acting opioid (e.g., methadone): Administer first dose at least 24 hours or longer after the patient last long-acting opioid use.
Maintenance: Buprenorphine; naloxone combination tablets are preferred to buprenorphine single-ingredient tablets for maintenance treatment.
Under the Drug Addiction Treatment Act (DATA), physicians with a current waiver to provide medication-assisted treatment (MAT) to a maximum of 100 opioid-dependent patients and who have maintained the waiver in accordance with applicable statutory requirements without interruption for at least 1 year may become eligible to provide MAT to a total of 275 opioid-dependent patients at any 1 time. The requirements of DATA must be met.
Pharmacists who wish to verify whether a physician is qualified under DATA to prescribe Subutex may contact 1-866-BUP-CSAT(1-866-287-2728).

Other Oral Formulations

Buccal film Administration
Do not use if the package seal is broken of the film is cut, damaged, or changed in any way.
Use the tongue to wet the inside of the check or rinse the mouth with water to wet the area for placement.
Apply the film immediately after removal from the package.
Place the yellow side of the film against the inside of the cheek. Hold the film in place with clean, dry fingers for 5 seconds. Leave the film in place until it fully dissolves, usually within 30 minutes.
Do not manipulate the film with the tongue or fingers. Avoid eating food and drinking liquids until the film has dissolved.
To dispose of unused films, remove all films from their foil packages. Flush the films down the toilet and discard foil packaging in the trash.
Abuse of misuse of the film by swallowing may cause choking, overdose, and death.

Injectable Administration

Buprenorphine injection may be given as an intramuscular or intravenous injection.
No dilution is necessary.
Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit.

Intravenous Administration

Give buprenorphine by slow IV injection over 2 minutes directly into a vein or into the tubing of a freely flowing, compatible IV solution. Rapid IV injection may result in an increased frequency of adverse effects.
Do not exceed maximum of 0.3 mg/dose IV; if an adult patient (not in a high-risk category) requires a single dose more than 0.3 mg, then administer via IM route only.

Intramuscular Administration

Give buprenorphine by deep IM injection.

Other Injectable Administration

Epidural Administration
NOTE: Buprenorphine is not approved by the FDA for epidural administration.
This route of administration should only be used by specially trained health care professionals.
Placement of epidural catheter and administration should be at a site near the dermatomes covering the field of pain to decrease dose requirements and increase specificity. For example, for thoracic surgery placement at T2 to T8, upper abdominal surgery, T4 to L1, lower abdominal surgery, T10 to L3, upper extremity surgery, C2 to C8 and lower extremity surgery, T12 to L3.
After ensuring proper placement of the needle or catheter, inject appropriate dose into the epidural space.

Topical Administration
Transdermal Patch Formulations

Apply to intact skin only.
Do not use if the pouch seal is broken or the patch is cut, damaged, or changed in any way. Do not cut the buprenorphine transdermal system.
Instruct patients to apply immediately after removal from the individually sealed pouch.
Each buprenorphine transdermal system is intended to be worn for 7 days.
Apply to the upper outer arm, upper chest, upper back, or the side of the chest. Rotate buprenorphine transdermal system application among the 8 described sites (each present on both sides of the body). After removal of the patch, wait a minimum of 21 days before reapplying to the same skin site.
Apply to a hairless or nearly hairless skin site. If necessary, hair should be clipped, not shaven. Do not apply to irritated skin.
If necessary, clean site with water only and allow to dry completely before application. Do not use soaps, alcohol, oils, lotions, or abrasive devices.
The patch may be worn while bathing or showering.
If the adhesive matrix (which contains buprenorphine) of the patch accidentally touches skin, wash the area with water. Do not use soap, alcohol, or other solvents to remove the adhesive; doing so may enhance drug absorption.
If problems arise with the adherence of the patch, the edges of the patch may be taped with first aid tape. If problems with the patch not sticking continue, cover the patch with special see-through adhesive dressings (e.g., Bioclusive or Tegaderm).
If the buprenorphine transdermal system falls off during the 7 day dosing interval, dispose of the patch properly and place a new patch at a different skin site.
Avoid exposing the patch application site and surrounding areas to external heat sources (e.g., heating pads, electric blankets, heated water beds, tanning beds, hot baths or saunas, excessive sun exposure, or hot climate).
Dispose of damaged, used, and unneeded buprenorphine patches right away by folding patch in half so that the adhesive side is inward and immediately flush down the toilet. Alternatively, buprenorphine patches may be sealed in the Patch-Disposal Unit provided and then disposed of in the trash. Never dispose of a buprenorphine patch in the trash without sealing it in the Patch-Disposal Unit.

Other Administration Route(s)

Subdermal Implant Administration
All prescribing healthcare providers performing implant insertions and/or removals must successfully complete a live training program on insertion and removal procedures, including demonstrating competency in Probuphine procedures, and become certified in the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program.
Patients eligible for the implant must currently be on a maintenance dose of 8 mg/day or less of a Subutex or Suboxone sublingual tablet or its transmucosal buprenorphine product equivalent (the dose of transmucosal buprenorphine providing blood levels comparable or lower than the level provided by buprenorphine subdermal implants) and have been stable on this dose without any need for supplemental dosing for 3 months or longer. Additionally, patients should be clinically stable as well as a suitable candidate for treatment (social support system, stable living environment, etc.).
For details on insertion and removal of the inserts, see prescribing information.
Under the Drug Addiction Treatment Act (DATA), physicians with a current waiver to provide medication-assisted treatment (MAT) to a maximum of 100 opioid-dependent patients and who have maintained the waiver in accordance with applicable statutory requirements without interruption for at least 1 year may become eligible to provide MAT to a total of 275 opioid-dependent patients at any 1 time. The requirements of DATA must be met.

In the Case of Spontaneous Expulsion of Implants:
The patient should contact the prescribing healthcare provider as soon as possible.
Instruct the patient to place the implant in a plastic bag, store it safely out of reach of children, and to bring it to the healthcare provider office to determine whether the full implant has been expelled.
The prescribing healthcare provider must carefully monitor patient until the implant is replaced to evaluate for withdrawal or other clinical indicators that supplemental transmucosal buprenorphine may be needed.

STORAGE

Belbuca:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Buprenex:
– Discard product if it contains particulate matter, is cloudy, or discolored
– Protect from light
– Store at controlled room temperature (between 68 and 77 degrees F)
Butrans:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Probuphine:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Subutex:
– Store at controlled room temperature (between 68 and 77 degrees F)

Additional information

Tablets

25 tablets, 50 tablets, 100 tablets

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