Right Now — for your business and the lives of millions. Roxane.20 October 2014
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Roxane Laboratories is a recognized leader for the research, development, sales, and marketing of multisource pharmaceutical products. To help support the unique Addiction Therapy community of clinics and patients, we feature several products in our portfolio, as well as a team of dedicated service professionals.

Important safety information: Please click on links below to U.S. full prescribing information for each product to see indications for use and additional important safety information, including boxed warnings.

  • DISKETS® Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension, USP) CII

    DISKETS® Dispersible Tablets (Methadone Hydrochloride Tablets for Oral Suspension, USP), 40mg CII
    NDC# 0054-4538-25: Bottles of 100 Dispersible Tablets

    Please click the product name for full prescribing information which includes indications for use, additional important safety information and boxed warning

     

    Rx only
    FOR ORAL USE ONLY
    (Following Dispersion in a Liquid)

    WARNING: LIFE-THREATNING RESPIRATORY DEPRESSION, LIFE-THREATNING QT PROLONGATION, ACCIDENTAL EXPOSURE , ABUSE POTENTIAL AND TREATMENT FOR OPIOID ADDICTION

    Life-threatening Respiratory Depression

    Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.1)]. Proper dosing and titration are essential and DISKETS Dispersible Tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of DISKETS Dispersible Tablets or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period.

    Life-Threatening QT Prolongation

    QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone [see Warnings and Precautions (5.2)]. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of DISKETS Dispersible Tablets.

    Accidental Exposure

    Accidental ingestion of DISKETS Dispersible Tablets, especially in children, can result in fatal over dose of methadone [see Warnings and Precautions (5.3)]

    Abuse Potential

    DISKETS Dispersible Tablets contain methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.4)]. Routinely monitor all patients receiving DISKETS for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

    Conditions For Distribution And Use Of Methadone Products For The Treatment of Opioid Addiction

    For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration [see Indications and Usage (1)].



    Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction

    Code of Federal Regulations, Title 42, Sec 8

    Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.

    Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.

    Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment:

    During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis).

    During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).

    Revised September 2013

  • Methadone Hydrochloride Oral Concentrate USP, 10mg per mL CII

    Methadone Hydrochloride Oral Concentrate USP, 10mg per mL (Cherry) CII
    NDC# 0054-0392-68: Bottles of 1000mL

    Methadone Hydrochloride Oral Concentrate USP, 10mg per mL (Dye-Free, Sugar-Free, Unflavored) CII
    NDC# 0054-0391-68: Bottles of 1000mL

    Please click the product name for full prescribing information which includes indications for use, additional important safety information and boxed warning


    FOR ORAL USE ONLY
    Rx only

    WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION

    Addiction, Abuse, and Misuse

    Methadone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Methadone, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

    Life-threatening Respiratory Depression

    Serious, life-threatening, or fatal respiratory depression may occur with use of Methadone. Monitor for respiratory depression, especially during initiation of Methadone following a dose increase [see Warnings and Precautions (5.2)].

    Accidental Ingestion

    Accidental ingestion of even one dose of Methadone, especially by children, can result in a fatal overdose of methadone [see Warnings and Precautions (5.2)].

    Life-threatening QT Prolongation

    QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of Methadone [see Warnings and Precautions (5.3)].

    Neonatal Opioid Withdrawal Syndrome

    Prolonged use of Methadone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)].

    Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction

    WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION

    For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration [see Indications and Usage (1)].



    Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction

    Code of Federal Regulations, Title 42, Sec 8

    Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.

    Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.

    Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment:

    During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis).

    During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).

    Revised April 2014

  • Dolophine® (methadone hydrochloride) Tablets CII

    Dolophine® (methadone hydrochloride) Tablets 5mg CII
    NDC# 0054-4218-25: Bottles of 100 tablets
     

    Dolophine® (methadone hydrochloride) Tablets 10mg CII
    NDC# 0054-4219-25: Bottles of 100 tablets
     

    Please click the product name for full prescribing information which includes indications for use, additional important safety information and boxed warning


    Rx only

    WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION

    Addiction, Abuse, and Misuse

    DOLOPHINE exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DOLOPHINE, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

    Life-threatening Respiratory Depression

    Serious, life-threatening, or fatal respiratory depression may occur with use of DOLOPHINE. Monitor for respiratory depression, especially during initiation of DOLOPHINE or following a dose increase [see Warnings and Precautions (5.2)].

    Accidental Ingestion

    Accidental ingestion of even one dose of DOLOPHINE, especially by children, can result in a fatal overdose of methadone [see Warnings and Precautions (5.2)].

    Life-threatening QT Prolongation

    QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of DOLOPHINE [see Warnings and Precautions (5.3)].

    Neonatal Opioid Withdrawal Syndrome

    Prolonged use of DOLOPHINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4)].

    Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction

    WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION

    For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration [see Indications and Usage (1)].



    Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction

    Code of Federal Regulations, Title 42, Sec 8

    Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.

    Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.

    Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment:

    During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis).

    During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)).

    Revised April 2014

  • Buprenorphine Hydrochloride Sublingual Tablets CIII

    Buprenorphine Hydrochloride Sublingual Tablets, 2mg CIII
    NDC# 0054-0176-13: Bottles of 30 Tablets

    Buprenorphine Hydrochloride Sublingual Tablets, 8mg CIII
    NDC# 0054-0177-13: Bottles of 30 Tablets

    Please click the product name for full prescribing information which includes indications for use and additional important safety information

  • Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, 2mg/0.5mg CIII

Schedule II Ordering Information

Preparing your DEA Form – 222

A completed DEA 222 Order Form is required to place an order for our Schedule II Addiction Therapy Substances. Download our DEA 222 Order Form Guide to assist with proper form preparation. You can also order additional DEA 222 Forms.

For Schedule II orders, please mail your DEA Form – 222 to:

BI Roxane
1809 Wilson Road
Mail Stop 08-118
Columbus, OH 43228

 

For additional questions or information on DEA 222 Order Forms, please refer to the specifications mandated by the U.S. Department of Justice & Drug Enforcement Administration: Office of Diversion Control.

Contact Information

Find my dedicated addiction therapy representative.

Addiction Therapy Services Team – Customer Support
Phone: 888.831.2183
Fax: 614.308.3576
Email: coladdictiontherapy.col@boehringer-ingelheim.com

Technical Product Information
Phone: 800.962.8364

Payments may be mailed to:

Roxane Laboratories, Inc.
P.O. Box 5845
Carol Stream, IL 60197-5845

 

If you have specific requests regarding our addiction therapy products, please contact our Addiction Therapy Services team at 888-831-2183.

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