Buprenorphine Hydrochloride

Buprenorphine Hydrochloride Manufacturers

• A-s Medication Solutions Llc
  

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  Buprenorphine Hydrochloride | A-s Medication Solutions Llc

  

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  Buprenorphine HCl sublingual tablets are administered sublingually as a single daily dose. Buprenorphine HCl sublingual tablets contain no naloxone and is preferred for use only during induction. Following induction, buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets are preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets; for example, those patients who have been shown to be hypersensitive to naloxone.

  Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.

  2.1 Induction

  Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

  It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. In a one-month study, patients received 8 mg of buprenorphine HCl sublingual tablets on Day 1 and 16 mg buprenorphine HCl sublingual tablets on Day 2. From Day 3 onward, patients received either buprenorphine and naloxone sublingual tablets or buprenorphine

  HCl sublingual tablets at the same buprenorphine dose as Day 2 based on their assigned treatment. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period.

  Patients taking heroin or other short-acting opioids: At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when moderate objective signs of opioid withdrawal appear.

  Patients on methadone or other long-acting opioids: There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal signs and symptoms are possible during induction onto buprenorphine. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. Buprenorphine HCl sublingual tablet dosing should be initiated preferably when moderate objective signs of opioid withdrawal appear.

  2.2 Maintenance Buprenorphine HCl and naloxone is preferred for maintenance treatment. Where buprenorphine HCl sublingual tablets are used in maintenance in patients who cannot tolerate the presence of naloxone, the dosage of buprenorphine HCl sublingual tablets should be progressively adjusted in increments / decrements of 2 mg or 4 mg buprenorphine to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The maintenance dose is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient.
  Doses higher than this have not been demonstrated to provide any clinical advantage. 2.3 Method of Administration

  Buprenorphine HCl sublingual tablets should be placed under the tongue until it is dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  Proper administration technique should be demonstrated to the patient.

  2.4 Clinical Supervision

  Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient's clinical stability permits. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine HCl and naloxone, for example those patients with known hypersensitivity to naloxone. Buprenorphine and naloxone and buprenorphine HCl sublingual tablets are both subject to diversion and abuse. When determining the size of the prescription quantity for unsupervised administration, consider the patient's level of stability, the security of his or her home situation, and other factors likely to affect the ability of the patient to manage supplies of take-home medication.

  Ideally, patients should be seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress.

  Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the physician's evaluation of treatment outcomes and objectives such as:

  Absence of medication toxicity. Absence of medical or behavioral adverse effects. Responsible handling of medications by the patient. Patient's compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities). Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use).

  If treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continuing the current treatment.

  2.5 Unstable Patients

  Physicians will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the physician does not feel that he/she has the expertise to manage the patient. In such cases, the physician may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment.

  Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.

  2.6 Stopping Treatment

  The decision to discontinue therapy with buprenorphine and naloxone or buprenorphine HCl sublingual tablets after a period of maintenance should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation of buprenorphine has been used, but the data are insufficient to determine the best method of dose taper at the end of treatment.

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• Hospira, Inc.
  

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  Buprenorphine Hydrochloride | Hospira, Inc.

  

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  Adults: The usual dosage for persons 13 years of age and over is 1 mL buprenorphine hydrochloride injection (0.3 mg buprenorphine) given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed. Repeat once (up to 0.3 mg) if required, 30 to 60 minutes after initial dosage, giving consideration to previous dose pharmacokinetics, and thereafter only as needed. In high-risk patients (e.g., elderly, debilitated, presence of respiratory disease, etc.) and/or in patients where other CNS depressants are present, such as in the immediate postoperative period, the dose should be reduced by approximately one-half. Extra caution should be exercised with the intravenous route of administration, particularly with the initial dose.

  Occasionally, it may be necessary to administer single doses of up to 0.6 mg to adults depending on the severity of the pain and the response of the patient. This dose should only be given IM and only to adult patients who are not in a high risk category (see WARNINGS and PRECAUTIONS). At this time, there are insufficient data to recommend single doses greater than 0.6 mg for long-term use.

  Children: Buprenorphine hydrochloride has been used in children 2 to 12 years of age at doses between 2 to 6 micrograms/kg of body weight given every 4 to 6 hours. There is insufficient experience to recommend a dose in infants below the age of two years, single doses greater than 6 micrograms/kg of body weight, or the use of a repeat or second dose at 30 to 60 minutes (such as is used in adults). Since there is some evidence that not all children clear buprenorphine faster than adults, fixed interval or "round-the-clock" dosing should not be undertaken until the proper inter-dose interval has been established by clinical observation of the child. Physicians should recognize that, as with adults, some pediatric patients may not need to be remedicated for 6 to 8 hours.

  Safety and Handling: Buprenorphine hydrochloride injection is supplied in sealed cartridges and poses no known environmental risk to health care providers. Accidental dermal exposure should be treated by removal of any contaminated clothing and rinsing the affected area with water.

  Buprenorphine is a potent narcotic, and like all drugs of this class has been associated with abuse and dependence among health care providers. To control the risk of diversion, it is recommended that measures appropriate to the health care setting be taken to provide rigid accounting, control of wastage, and restriction of access.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• American Regent, Inc.
  

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  Buprenorphine Hydrochloride | American Regent, Inc.

  

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  Adults:

  The usual dosage for persons 13 years of age and over is 1 mL buprenorphine hydrochloride injection (0.3 mg buprenorphine) given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed. Repeat once (up to 0.3 mg) if required, 30 to 60 minutes after initial dosage, giving consideration to previous dose pharmacokinetics, and thereafter only as needed. In high-risk patients (e.g., elderly, debilitated, presence of respiratory disease, etc.) and/or in patients where other CNS depressants are present, such as in the immediate postoperative period, the dose should be reduced by approximately one-half.  Extra caution should be exercised with the intravenous route of administration, particularly with the initial dose.

  Occasionally, it may be necessary to administer single doses of up to 0.6 mg to adults depending on the severity of the pain and the response of the patient. This dose should only be given I.M. and only to adult patients who are not in a high risk category (see WARNINGS and PRECAUTIONS). At this time, there are insufficient data to recommend single doses greater than 0.6 mg for long-term use.

  Children:

  Buprenorphine hydrochloride injection has been used in children 2 to 12 years of age at doses between 2 to 6 mcg/kg of body weight given every 4 to 6 hours. There is insufficient experience to recommend a dose in infants below the age of two years, single doses greater than 6 mcg/kg of body weight, or the use of a repeat or second dose at 30 to 60 minutes (such as is used in adults).  Since there is some evidence that not all children clear buprenorphine faster than adults, fixed interval or "round-the-clock" dosing should not be undertaken until the proper inter-dose interval has been established by clinical observation of the child. Physicians should recognize that, as with adults, some pediatric patients may not need to be remedicated for 6 to 8 hours.

  Safety and Handling:

  Buprenorphine hydrochloride injection is supplied in sealed vials and poses no known environmental risk to health care providers. Accidental dermal exposure should be treated by removal of any contaminated clothing and rinsing the affected area with water.

  Buprenorphine hydrochloride injection is a potent narcotic, and like all drugs of this class has been associated with abuse and dependence among health care providers. To control the risk of diversion, it is recommended that measures appropriate to the health care setting be taken to provide rigid accounting, control of wastage, and restriction of access.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Rebel Distributors Corp
  

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  Buprenorphine Hydrochloride | Rebel Distributors Corp

  

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  Adults: The usual dosage for persons 13 years of age and over is 1 mL buprenorphine hydrochloride injection (0.3 mg buprenorphine) given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed. Repeat once (up to 0.3 mg) if required, 30 to 60 minutes after initial dosage, giving consideration to previous dose pharmacokinetics, and thereafter only as needed. In high-risk patients (e.g., elderly, debilitated, presence of respiratory disease, etc.) and/or in patients where other CNS depressants are present, such as in the immediate postoperative period, the dose should be reduced by approximately one-half. Extra caution should be exercised with the intravenous route of administration, particularly with the initial dose.

  Occasionally, it may be necessary to administer single doses of up to 0.6 mg to adults depending on the severity of the pain and the response of the patient. This dose should only be given IM and only to adult patients who are not in a high risk category (see WARNINGS and PRECAUTIONS). At this time, there are insufficient data to recommend single doses greater than 0.6 mg for long-term use.

  Children: Buprenorphine hydrochloride has been used in children 2 to 12 years of age at doses between 2 to 6 micrograms/kg of body weight given every 4 to 6 hours. There is insufficient experience to recommend a dose in infants below the age of two years, single doses greater than 6 micrograms/kg of body weight, or the use of a repeat or second dose at 30 to 60 minutes (such as is used in adults). Since there is some evidence that not all children clear buprenorphine faster than adults, fixed interval or "round-the-clock" dosing should not be undertaken until the proper inter-dose interval has been established by clinical observation of the child. Physicians should recognize that, as with adults, some pediatric patients may not need to be remedicated for 6 to 8 hours.

  Safety and Handling: Buprenorphine hydrochloride injection is supplied in sealed cartridges and poses no known environmental risk to health care providers. Accidental dermal exposure should be treated by removal of any contaminated clothing and rinsing the affected area with water.

  Buprenorphine is a potent narcotic, and like all drugs of this class has been associated with abuse and dependence among health care providers. To control the risk of diversion, it is recommended that measures appropriate to the health care setting be taken to provide rigid accounting, control of wastage, and restriction of access.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Remedyrepack Inc.
  

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  Buprenorphine Hydrochloride | Remedyrepack Inc.

  

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  Buprenorphine HCl Sublingual Tablets and Buprenorphine and Naloxone Sublingual Tablets are administered sublingually as a single daily dose in the range of 12 to 16 mg/day. When taken sublingually, Buprenorphine and Naloxone Sublingual Tablets and Buprenorphine HCl Sublingual Tablets have similar clinical effects and are interchangeable. There are no adequate and well-controlled studies using Buprenorphine and Naloxone Sublingual Tablets as initial medication. Buprenorphine HCl Sublingual Tablets contains no naloxone and is preferred for use during induction. Following induction, Buprenorphine and Naloxone Sublingual Tablets, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of Buprenorphine HCl Sublingual Tablets for unsupervised administration should be limited to those patients who cannot tolerate Buprenorphine and Naloxone Sublingual Tablets, for example those patients who have been shown to be hypersensitive to naloxone.

  Method of Administration

  Buprenorphine and Naloxone Sublingual Tablets and Buprenorphine HCl Sublingual Tablets should be placed under the tongue until they are dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  Induction

  Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with Buprenorphine HCl Sublingual Tablets should be undertaken when objective and clear signs of withdrawal are evident.

  In a one-month study of Buprenorphine and Naloxone Sublingual Tablets induction was conducted with Buprenorphine HCl Sublingual Tablets. Patients received 8 mg of Buprenorphine HCl Sublingual Tablets on day 1 and 16 mg Buprenorphine HCl Sublingual Tablets on day 2. From day 3 onward, patients received Buprenorphine and Naloxone Sublingual Tablets at the same buprenorphine dose as day 2. Induction in the studies of buprenorphine solution was accomplished over 3 to 4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.

  Patients Taking Heroin or Other Short-Acting Opioids

  At treatment initiation, the dose of Buprenorphine HCl Sublingual Tablets should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

  Patients on Methadone or Other Long-Acting Opioids

  There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

  Maintenance

  Buprenorphine and Naloxone Sublingual Tablets are preferred for maintenance treatment due to the presence of naloxone in the formulation.

  Adjusting the Dose Until the Maintenance Dose is Achieved

  The recommended target dose of Buprenorphine and Naloxone Sublingual Tablets is 16 mg/day. Clinical studies have shown that 16 mg of Buprenorphine HCl Sublingual Tablets or Buprenorphine and Naloxone Sublingual Tablets are a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients. The dosage of Buprenorphine and Naloxone Sublingual Tablets should be progressively adjusted in increments/decrements of 2 mg or 4 mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4 mg to 24 mg per day depending on the individual.

  Reducing Dosage and Stopping Treatment

  The decision to discontinue therapy with Buprenorphine and Naloxone Sublingual Tablets or Buprenorphine HCl Sublingual Tablets after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.

  
  

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• Remedyrepack Inc.
  

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  Buprenorphine Hydrochloride | Remedyrepack Inc.

  

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  Buprenorphine HCl sublingual tablets are administered sublingually as a single daily dose in the range of 12 to 16 mg/day. Buprenorphine HCl sublingual tablets contain no naloxone and is preferred for use during induction. Following induction, buprenorphine and naloxone HCl sublingual tablets, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual tablets, for example those patients who have been shown to be hypersensitive to naloxone.

  Method of Administration

  Buprenorphine HCl sublingual tablets should be placed under the tongue until they are dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  Induction

  Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

  In a one-month study of buprenorphine and naloxone sublingual tablets induction was conducted with buprenorphine HCl sublingual tablets. Patients received 8 mg of buprenorphine HCl sublingual tablets on day 1 and 16 mg buprenorphine HCl sublingual tablets on day 2. From day 3 onward, patients received buprenorphine and naloxone sublingual tablets at the same buprenorphine dose as day 2. Induction in the studies of buprenorphine solution was accomplished over 3 to 4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.

  Patients Taking Heroin or Other Short-Acting Opioids

  At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

  Patients on Methadone or Other Long-Acting Opioids

  There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

  Adjusting the Dose Until the Maintenance Dose is Achieved

  Clinical studies have shown that 16 mg of buprenorphine HCl sublingual tablets is a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients.

  Reducing Dosage and Stopping Treatment

  The decision to discontinue therapy with buprenorphine HCl sublingual tablets after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.

  
  

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• Teva Pharmaceuticals Usa Inc
  

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  Buprenorphine Hydrochloride | Prasco Laboratories

  

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  2.1 Recommended Dosing Schedule
  

  Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

  
  
  Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.
  ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
  *** Controlled studies did not extend beyond 12 months Indication
  Dose
  Frequency
  Short-Term Treatment of Erosive Esophagitis Associated With GERD
  Adults
  40 mg
  Once daily for up to 8 weeks*
  Children (5 years and older)
   
   
  ≥ 15 kg to < 40 kg
  20 mg
  Once daily for up to 8 weeks
  ≥ 40 kg
  40 mg
   
  Maintenance of Healing of Erosive Esophagitis
  Adults
  40 mg
  Once daily***
  Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
  Adults
  40 mg
  Twice daily**
  
  2.2 Administration Instructions
  

  Directions for method of administration of pantoprazole sodium delayed-release tablets are presented in Table 2.

  Table 2: Administration Instructions * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed. Formulation
  Route
  Instructions*
   Delayed-Release Tablets
  Oral
   Swallowed whole, with or without food
  
  

  Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.

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• Bryant Ranch Prepack
  

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  Buprenorphine Hydrochloride | Bryant Ranch Prepack

  

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  SUBUTEX or SUBOXONE is administered sublingually as a single daily dose in the range of 12 to 16mg/ day. When taken sublingually, SUBOXONE and SUBUTEX have similar clinical effects and are interchangeable. There are no adequate and well-controlled studies using SUBOXONE as initial medication. SUBUTEX contains no naloxone and is preferred for use during induction. Following induction, SUBOXONE, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of SUBUTEX for unsupervised administration should be limited to those patients who cannot tolerate SUBOXONE, for example those patients who have been shown to be hypersensitive to naloxone.

  Method of administration:

  SUBOXONE and SUBUTEX tablets should be placed under the tongue until they are dissolved.

  For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  Induction:

  Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with SUBUTEX should be undertaken when objective and clear signs of withdrawal are evident.

  In a one-month study of SUBOXONE tablets induction was conducted with SUBUTEX tablets. Patients received 8mg of SUBUTEX on day 1 and 16mg SUBUTEX on day 2. From day 3 onward, patients received SUBOXONE tablets at the same buprenorphine dose as day 2. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.

  Patients taking heroin or other short-acting opioids:

  At treatment initiation, the dose of SUBUTEX should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

  Patients on methadone or other long-acting opioids:

  There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

  Maintenance:

  SUBOXONE is the preferred medication for maintenance treatment due to the presence of naloxone in the formulation.

  Adjusting the dose until the maintenance dose is achieved:

  The recommended target dose of SUBOXONE is 16 mg/day. Clinical studies have shown that 16mg of SUBUTEX or SUBOXONE is a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients. The dosage of SUBOXONE should be progressively adjusted in increments / decrements of 2mg or 4mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4mg to 24mg per day depending on the individual.

  Reducing dosage and stopping treatment:

  The decision to discontinue therapy with SUBOXONE or SUBUTEX after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.

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• Hi-tech Pharmacal Co., Inc.
  

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  Buprenorphine Hydrochloride | Hi-tech Pharmacal Co., Inc.

  

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  Buprenorphine HCl sublingual tablets are administered sublingually as a single daily dose. Buprenorphine HCl sublingual tablets contain no naloxone and is preferred for use only during induction. Following induction, buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets are preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets; for example, those patients who have been shown to be hypersensitive to naloxone.

  Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.

  2.1 Induction

  Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

  It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. In a one-month study, patients received 8 mg of buprenorphine HCl sublingual tablets on Day 1 and 16 mg buprenorphine HCl sublingual tablets on Day 2. From Day 3 onward, patients received either buprenorphine and naloxone sublingual tablets or buprenorphine HCl sublingual tablets at the same buprenorphine dose as Day 2 based on their assigned treatment. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period.

  Patients taking heroin or other short-acting opioids: At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when moderate objective signs of opioid withdrawal appear.

  Patients on methadone or other long-acting opioids: There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal signs and symptoms are possible during induction onto buprenorphine. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. Buprenorphine HCl sublingual tablet dosing should be initiated preferably when moderate objective signs of opioid withdrawal appear.

  2.2 Maintenance Buprenorphine HCl and naloxone is preferred for maintenance treatment. Where buprenorphine HCl sublingual tablets are used in maintenance in patients who cannot tolerate the presence of naloxone, the dosage of buprenorphine HCl sublingual tablets should be progressively adjusted in increments / decrements of 2 mg or 4 mg buprenorphine to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The maintenance dose is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient.
  Doses higher than this have not been demonstrated to provide any clinical advantage. 2.3 Method of Administration

  Buprenorphine HCl sublingual tablets should be placed under the tongue until it is dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  Proper administration technique should be demonstrated to the patient.

  2.4 Clinical Supervision

  Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient's clinical stability permits. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine HCl and naloxone, for example those patients with known hypersensitivity to naloxone. Buprenorphine and naloxone and buprenorphine HCl sublingual tablets are both subject to diversion and abuse. When determining the size of the prescription quantity for unsupervised administration, consider the patient's level of stability, the security of his or her home situation, and other factors likely to affect the ability of the patient to manage supplies of take-home medication.

  Ideally, patients should be seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress.

  Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the physician's evaluation of treatment outcomes and objectives such as:

  Absence of medication toxicity. Absence of medical or behavioral adverse effects. Responsible handling of medications by the patient. Patient's compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities). Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use).

  If treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continuing the current treatment.

  2.5 Patients With Hepatic Impairment

  Severe hepatic impairment: Consider reducing the starting and titration incremental dose by half compared to patients with normal liver function, and monitor for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

  Moderate hepatic impairment: Although no dose adjustment is necessary for patients with moderate hepatic impairment, buprenorphine HCl sublingual tablets should be used with caution in these patients and prescribers should monitor patients for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

  Mild hepatic impairment: No clinically significant differences in pharmacokinetic parameters were observed in subjects with mild hepatic impairment. No dose adjustment is needed in patients with mild hepatic impairment . [see Warnings and Precautions (5.11)].

  2.6 Unstable Patients

  Physicians will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the physician does not feel that he/she has the expertise to manage the patient. In such cases, the physician may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment.

  Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.

  2.7 Stopping Treatment

  The decision to discontinue therapy with buprenorphine and naloxone or buprenorphine HCl sublingual tablets after a period of maintenance should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation of buprenorphine has been used, but the data are insufficient to determine the best method of dose taper at the end of treatment.

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  Buprenorphine HCl sublingual tablets is administered sublingually as a single daily dose in the range of 12 to 16 mg/day. Buprenorphine HCl sublingual tablets contains no naloxone and is preferred for use during induction. Following induction, buprenorphine and naloxone sublingual tablets, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual tablets, for example those patients who have been shown to be hypersensitive to naloxone.

   

  Buprenorphine HCl sublingual tablets should be placed under the tongue until they are dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

   

  Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

  In a one-month study of buprenorphine and naloxone sublingual tablets induction was conducted with buprenorphine HCl sublingual tablets. Patients received 8 mg of buprenorphine HCl sublingual tablets on Day 1 and 16 mg buprenorphine HCl sublingual tablets on Day 2. From Day 3 onward, patients received buprenorphine and naloxone sublingual tablets at the same buprenorphine dose as Day 2. Induction in the studies of buprenorphine solution was accomplished over 3 to 4 days, depending on the target dose.

  In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.

   

  At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

   

  There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

   

  Buprenorphine and naloxone sublingual tablets is the preferred medication for maintenance treatment due to the presence of naloxone in the formulation.

   

  The recommended target dose of buprenorphine HCl sublingual tablets is 16 mg/day. Clinical studies have shown that 16 mg of buprenorphine HCl sublingual tablets is a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients. The dosage of buprenorphine HCl sublingual tablets should be progressively adjusted in increments / decrements of 2 mg or 4 mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4 to 24 mg/day depending on the individual.

   

  The decision to discontinue therapy with buprenorphine HCl sublingual tablets after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.

   

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• Remedyrepack Inc.
  

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  Buprenorphine Hydrochloride | Remedyrepack Inc.

  

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  Buprenorphine HCl sublingual tablets is administered sublingually as a single daily dose in the range of 12 to 16 mg/day. Buprenorphine HCl sublingual tablets contains no naloxone and is preferred for use during induction. Following induction, buprenorphine and naloxone sublingual tablets, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual tablets, for example those patients who have been shown to be hypersensitive to naloxone.

   

  Buprenorphine HCl sublingual tablets should be placed under the tongue until they are dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

   

  Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

  In a one-month study of buprenorphine and naloxone sublingual tablets induction was conducted with buprenorphine HCl sublingual tablets. Patients received 8 mg of buprenorphine HCl sublingual tablets on Day 1 and 16 mg buprenorphine HCl sublingual tablets on Day 2. From Day 3 onward, patients received buprenorphine and naloxone sublingual tablets at the same buprenorphine dose as Day 2. Induction in the studies of buprenorphine solution was accomplished over 3 to 4 days, depending on the target dose.

  In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.

   

  At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

   

  There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

   

  Buprenorphine and naloxone sublingual tablets is the preferred medication for maintenance treatment due to the presence of naloxone in the formulation.

   

  The recommended target dose of buprenorphine HCl sublingual tablets is 16 mg/day. Clinical studies have shown that 16 mg of buprenorphine HCl sublingual tablets is a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients. The dosage of buprenorphine HCl sublingual tablets should be progressively adjusted in increments / decrements of 2 mg or 4 mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4 to 24 mg/day depending on the individual.

   

  The decision to discontinue therapy with buprenorphine HCl sublingual tablets after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.

   

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