Right Now — for your business and the lives of millions. Roxane.07 April 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)

    Deaths have been reported during initiation of methadone treatment for opioid dependence. In some cases, drug interactions with other drugs, both licit and illicit, have been suspected. However, in other cases, deaths appear to have occurred due to the respiratory or cardiac effects of methadone and too-rapid titration without appreciation for the accumulation of methadone over time. It is critical to understand the pharmacokinetics of methadone and to exercise vigilance during treatment initiation and dose titration (see DOSAGE AND ADMINISTRATION). Patients must also be strongly cautioned against self-medicating with CNS depressants during initiation of methadone treatment.

    Respiratory depression is the chief hazard associated with methadone hydrochloride administration. Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly in the early dosing period. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration.

    Cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed 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.


    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:

    1. During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21 CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis.
    2. 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 21 CFR 1306.07(b)).

    Revised February 2009

  • 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

    Deaths have been reported during initiation of methadone treatment for opioid dependence. In some cases, drug interactions with other drugs, both licit and illicit, have been suspected. However, in other cases, deaths appear to have occurred due to the respiratory or cardiac effects of methadone and too-rapid titration without appreciation for the accumulation of methadone over time. It is critical to understand the pharmacokinetics of methadone and to exercise vigilance during treatment initiation and dose titration (see DOSAGE AND ADMINISTRATION). Patients must also be strongly cautioned against self-medicating with CNS depressants during initiation of methadone treatment.

    Respiratory depression is the chief hazard associated with methadone hydrochloride administration. Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly in the early dosing period. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration.

    Cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed 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.

    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 (42CFR 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:

    1. During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21 CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis.
    2. 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 21 CFR 1306.07(b)).

    Revised October 2009

  • 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: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION,
          LIFE-THREATENING QT PROLONGATION, ACCIDENTAL EXPOSURE, and TREATMENT
                                                           FOR OPIOID ADDICTION

    Abuse Potential
    DOLOPHINE contains 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 (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing DOLOPHINE. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving DOLOPHINE for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

    Life-threatening Respiratory Depression
    Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to DOLOPHINE, and even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and DOLOPHINE should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of DOLOPHINE or following a dose increase. The peak respiratory depressant effect of DOLOPHINE occurs later, and persists longer than the peak analgesic 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. 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.

    Accidental Exposure
    Accidental ingestion of DOLOPHINE, especially in children, can result in a fatal overdose of methadone [see Warnings and Precautions (5.4)].

    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.

    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 July 2012

  • 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

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.

To learn more about Roxane Laboratories, please view our downloadable Fact Sheet. For a complete company history, view our Timeline.

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