SYNTHETIC MORPHINE 2mg. Sublingual Tablets.
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Description
Buprenorphine 0.2mg
BOXED WARNING
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. In the event of buprenorphine implant protrusion or expulsion from the arm, keep the implant away from pediatric patients. Extended-release subcutaneous injectable buprenorphine should be used only in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for at least 7 days, and are transitioning to this injection for maintenance treatment. Prescription use of this product in the treatment of opioid dependence requires an experienced clinician who is certified in the Sublocade Risk Evaluation and Mitigation Strategy (REMS) program. Clinical data are limited related to the surgical removal of the injection depot. Buprenorphine products should be kept out of the reach of pediatric patients and pets, as accidental exposure can cause serious injury or death. Accidental exposure to buprenorphine from any route can cause severe, possibly fatal, respiratory depression, particularly in pediatric patients.
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 medication-assisted treatment (MAT) with buprenorphine for opioid use disorder, since withholding MAT may increase the risk of morbidity and mortality from the opioid use disorder. Discontinuation of other CNS depressants is preferred in most cases; co-therapy may require more intensive counseling and monitoring, possible adjustments to induction procedures, gradual tapering of the CNS depressant to the lowest effective dose, and development of strategies to manage prescribed or illicit CNS depressant use. Educate patients at initiation of buprenorphine treatment about the risk of concurrent use of benzodiazepines, alcohol, and other CNS depressants. In patients receiving MAT with buprenorphine, benzodiazepines are not a preferred treatment for anxiety or insomnia. Prior to co-prescribing benzodiazepines, ensure there is an appropriate diagnosis for use, consider alternatives for insomnia or anxiety, develop a system for alerting other healthcare providers of the patient’s buprenorphine treatment, coordinate care to minimize risks, and confirm the proper use of prescribed medication and assess for illicit benzodiazepine use through toxicology screening. There is no evidence to support dose limitations of buprenorphine to address benzodiazepine use in buprenorphine-treated patients; however, in patients who are sedated at the time of buprenorphine dosing, a medically-trained healthcare provider should evaluate the cause of sedation, and delay or omit the buprenorphine dose if needed. 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 for pain treatment, 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.
There have been no well-controlled studies of buprenorphine in pregnant women. Limited published data on the use of buprenorphine injection 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. Pregnant women receiving treatment for opioid addiction may require dose adjustments of buprenorphine in order maintain abstinence from illicit drug use; closely monitor patients for withdrawal signs and symptoms and adjust dose as necessary. If the benefit of treatment with the subdermal implant (Probuphine) is determined to outweigh the risks during pregnancy, dosage adjustments cannot be made and the patient should be closely monitored to ensure adequate treatment. Because the implant dose cannot be adjusted, this formulation may not be an appropriate treatment option to initiate in patients who are pregnant. The subcutaneous extended-release injection may also not be the optimal dosage form for use in pregnancy in the opioid dependent patient. In published animal reproduction studies with NMP, an excipient in the extended-release subcutaneous injection (Sublocade), preimplantation losses, delayed ossification, reduced fetal weight, developmental delays and reduced cognitive function were reported at doses equivalent to the doses of NMP via the human usual injection dose; inform women of the potential fetal risk. 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. The prolonged maternal use of 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 in the neonate 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 postmarketing reports with sublingual use, 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 treatment for opioid dependence with buprenorphine of the risk of NOWS and ensure that appropriate treatment will be available. The risk for NOWS must be balanced against the risk of untreated opioid addiction in the mother 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. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. As with all opioids, use of buprenorphine prior to delivery may result in respiratory depression in the newborn. Closely monitor neonates for signs of respiratory depression. An opioid antagonist such as naloxone should be available for reversal of opioid induced respiratory depression in the neonate. Transdermal and buccal buprenorphine are not for analgesic use during and immediately prior to labor, when shorter acting analgesics or other therapies are more appropriate.
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 a ceiling to its pharmacological effects
Immediate-release parenteral form used for moderate to severe pain; transdermal and buccal forms used for continuous therapy for chronic severe pain
Sublingual tablets, dermal implant, and extended-release subcutaneous injection are used for opioid dependence in conjunction with the Drug Addiction Treatment Act (DATA)
COMMON BRAND NAMES
Belbuca, Buprenex, Butrans, Probuphine, Sublocade, 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 Subdermal Imp: 74.2mg
Sublocade Subcutaneous Inj: 0.5mL, 100mg
DOSAGE & INDICATIONS
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.
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.
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.
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.
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.
Consider the use of an alternate analgesic. The 20 mcg/hour transdermal buprenorphine may not provide adequate analgesia.
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.
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.
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.
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.
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.
Consider the use of an alternate analgesic. The buccal/transmucosal film may not provide adequate analgesia.
NOTE: Buprenorphine 0.3 mg IM provides analgesia roughly equivalent to morphine 10 mg IM.
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.
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.
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.
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.
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) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
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) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
Initially, 300 mg subcutaneously once monthly in the abdominal region for the first 2 months, then 100 mg once monthly given subcutaneously in the abdominal region as a maintenance dose. Administer monthly with a minimum of 26 days between doses. May consider an increase in the maintenance dose to 300 mg per month in patients for which the benefits outweigh the risks. Each month, examine injection site for signs of infection or evidence of tampering or attempts to remove the depot. Use as a part of a comprehensive treatment program which includes counseling and psychosocial support. This product is indicated for the treatment of moderate to severe opioid use disorder in patients who have first initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
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. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
Initially, 13.2 to 15.9 mcg/kg/day sublingually divided every 8 hours. Titration schedules vary, but may be titrated by either 0.8 mcg/kg increments or by 25% per day based on targeted NAS scores (Max: 60 mcg/kg/day sublingually). Phenobarbital may be added when a maximum buprenorphine dose has been achieved or if unable to wean after 24 to 48 hours. Once symptoms are controlled, taper dosage. After infant symptoms have been stable for at least 24 to 48 hours, dosage may be decreased by 0.8 mcg/kg increments back down to 4.4 mcg/kg/dose every 8 hours for 3 doses, with additional fixed incremental reductions in dose and interval (2.6 mcg/kg/dose every 8 hours for 3 doses, 1.7 mcg/kg/dose every 8 hours for 3 doses, 1.7 mcg/kg/dose every 12 hours for 2 doses, and 1.7 mcg/kg/dose every 24 hours for 1 dose) or 10% per day until within 10% of starting dose. Dosage, interval, length of treatment, and taper schedule are variable and must be individualized to control symptoms of withdrawal. Weaning may take several weeks to months.
†Indicates off-label use
MAXIMUM DOSAGE
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, 300 mg/month extended-release subcutaneous injection, or 4 implants/6 months subdermally for opioid dependence (each implant contains 74.2 mg of buprenorphine).
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, 300 mg/month extended-release subcutaneous injection, or 4 implants/6 months subdermally for opioid dependence (each implant contains 74.2 mg of buprenorphine).
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 have not been established; safety and efficacy of buprenorphine SL and extended-release SQ injection 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 other dosage forms have not been established.
2 years and older: 6 mcg/kg/dose IV/IM every 4 to 8 hours for pain. Safety and efficacy of other dosage forms have not been established.
Younger than 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
60 mcg/kg/day sublingually has been used off-label for neonatal abstinence syndrome.
DOSING CONSIDERATIONS
Immediate-release parenteral dosage forms (e.g., Buprenex or generic equivalent):
Specific guidelines for dosage adjustments in hepatic impairment are not available; however, dosage adjustments may be necessary. Adjust based on clinical response.
Extended-release subcutaneous injection (e.g., Sublocade or generic equivalent):
Moderate to severe hepatic impairment (e.g., Child Pugh B or C): Use is not recommended.
Mild hepatic impairment (e.g., Child Pugh A): No dosage adjustments are needed.
Sublingual dosage form (e.g., Subutex or generic equivalents):
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 (e.g., Butrans):
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 (e.g., Belbuca):
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 (i.e., Probuphine):
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.
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.
Sublingual tablets (e.g., Subutex or generic equivalents)
Buprenorphine tablets 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) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
Pharmacists who wish to verify whether a physician is qualified under DATA to prescribe buprenorphine sublingual tablets may contact 1-866-BUP-CSAT(1-866-287-2728).
Buccal film Administration (i.e., Belbuca buccal film)
Do not use if the package seal is broken or 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 or misuse of the film by swallowing may cause choking, overdose, and death.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
Pharmacists who wish to verify whether a physician is qualified under DATA to prescribe buprenorphine may contact 1-866-BUP-CSAT(1-866-287-2728).
Extemporaneous 0.075 mg/mL buprenorphine oral suspension:
Open one 0.3 mg/mL ampule of buprenorphine.
Add 1.26 mL of 95% ethanol to 0.3 mg buprenorphine (obtained from the 0.3 mg/mL ampule).
Add simple syrup to obtain a final total volume of 4 mL.
Storage: The solution is stable in amber glass bottles (for 30 days) and oral dispensing syringes (for 7 days) when stored at room temperature at 68 to 77 degrees F (20 to 25 degrees C).
Administration
Using a syringe, place under the tongue for sublingual administration.
A pacifier may be placed in the neonate’s mouth to maximize contact with the sublingual mucosa.
If the volume is greater than 0.5 mL, divide into 2 administrations separated by at least 2 minutes.
Immediate-release injection solution (e.g., Buprenex or generic equivalent):
No dilution is necessary. Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit.
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 the intramuscular route only.
Immediate-release injection solution (e.g., Buprenex or generic equivalent)
No dilution is necessary. Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit.
May give the immediate-release injection solution of buprenorphine by deep IM injection.
Extended-release once-monthly subcutaneous injection (i.e., Sublocade)
-General Information for use:
Only a healthcare professional should prepare and administer this injection.
Healthcare settings and pharmacies that order and dispense this injection must be certified in the Sublocade REMS program and comply with the REMS requirements.
Approved for use in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for at least 7 days, and are transitioning to this injection for maintenance treatment. This product should be used as part of a comprehensive treatment program that includes counseling and psychosocial support.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
Pharmacists who wish to verify whether a physician is qualified under DATA to prescribe buprenorphine may contact 1-866-BUP-CSAT(1-866-287-2728).
-Subcutaneous Administration of extended-release injection (Sublocade):
Only for subcutaneous injection in the abdominal region. DO NOT administer intramuscularly or intravenously. Serious harm or death could result if administered intravenously.
Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit. Each dose is a clear, colorless to yellow to amber solution.
Administer monthly with a minimum of 26 days between doses.
Only use the syringe and safety needle included with the product for administration. Do not attach the needle until the time of administration.
Choose an injection site in the abdominal region. Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred in any way.
Do not rub the injection area after the injection. If bleeding occurs, use a gauze pad or bandage but only use minimal pressure.
Advise the patient that there may be a lump for several weeks after the injection that will decrease in size over time.
To avoid irritation, rotate the injection site with each monthly injection.
The injection site should be examined for infection, evidence of tampering, or attempts to remove the depot.
Storage: Store the unopened prefilled syringes in the refrigerator in the original packaging; do not freeze. Once outside the refrigerator this product may be stored in its original packaging at room temperature, 15 to 30 degrees C (59 to 86 degrees F), for up to 7 days prior to administration. Discard the injection if left at room temperature for longer than 7 days.
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.
Transdermal patch system (Butrans transdermal system)
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.
Avoid exposing the patch application site and surrounding areas to external heat sources (e.g., heating pads, electric blankets, heated water beds, hair dryers, tanning beds, hot baths or saunas, excessive sun exposure, or hot climate).
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.
Disposal: 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.
Subdermal Implant Administration
Probuphine (buprenorphine) implant
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 buprenorphine or buprenorphine/naloxone 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) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements.
In the Case of Spontaneous Expulsion of the Probuphine implant:
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
Sublocade:
– Discard product if it contains particulate matter, is cloudy, or discolored
– Discard product that has been exposed to conditions other than those recommended
– Discard unused portion. Do not store for later use.
– Discard unused product 7 days after first opening the pouch
– May be stored at room temperature for up to 1 week
– Refrigerated product should reach room temperature before administration
– Store between 35 to 46 degrees F
Subutex:
– Store at controlled room temperature (between 68 and 77 degrees F)
Additional information
| Sublingual Tablets | 30 Sublingual tablets, 60 Sublingual tablets +20 Free Product, 90 Sublingual tablets +45 Free Product |
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