Post by syedsanaullah on Feb 10, 2013 14:01:27 GMT -5
Pharmacy Times on behalf of Reckitt Benckiser Healthcare (UK) Ltd.
-----------------------------------------
Please see full Prescribing Information [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,gphm,6k0r,baq6,3cxm ] and Medication Guide [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,dkg6,g5ya,baq6,3cxm ] for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII).
For more about SUBOXONE (buprenorphine and naloxone) Sublingual Tablets (CIII), please see full Prescribing Information [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,4i8j,hn4e,baq6,3cxm ] and Medication Guide [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,iu28,5xt,baq6,3cxm ] .
January 28, 2013,
Dear Pharmacist:
Please be advised that Reckitt Benckiser Pharmaceuticals Inc. will discontinue the sale of SUBOXONE ® Tablets (buprenorphine and naloxone) Sublingual (CIII) and cease distribution as of March 18, 2013 in the United States. SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) is still available and will remain on the market.
Reckitt Benckiser Pharmaceuticals formally announced in September 2012 that the company is voluntarily discontinuing the supply of SUBOXONE Tablets after receiving an analysis based on U.S. Poison Control Centers data that found consistently and significantly higher rates of accidental pediatric exposure with SUBOXONE Tablets than seen with SUBOXONE Film. The different rates of pediatric exposure are not related to the active ingredient found in both SUBOXONE Tablets and SUBOXONE Film.
Reckitt Benckiser Pharmaceuticals recognizes that many patients have relied on SUBOXONE Tablets to manage their opioid dependence over the years and encourages patients currently taking SUBOXONE Tablets to talk to their healthcare professional to immediately transition to the same active ingredient with SUBOXONE Film to minimize any risk to the continuity of their treatment. In addition to the 2 mg and 8 mg dosage strengths, SUBOXONE Film is now available in 4 mg and 12 mg dosage strengths.
Indication
SUBOXONE ® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.
Selected Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.
Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.
NDC Product Dosage Packaging
12496-1283-2 SUBOXONE ® (buprenorphine and naloxone) Sublingual Tablets (CIII) 2 mg/0.5 mg 30 ct.
12496-1306-2 SUBOXONE ® (buprenorphine and naloxone) Sublingual Tablets (CIII) 8 mg/2 mg 30 ct.
Please see the important safety information on the following pages.
Reckitt Benckiser Pharmaceuticals remains committed to helping all patients and providers to ensure that managing this serious, chronic disease is not interrupted, and encourages SUBOXONE patients to visit SUBOXONE.com or call 866-973-HERE (866-973-4373) and providers to call our medical information unit at 877-SUBOXONE (877-782-6966) for more information.
Please see full Prescribing Information and Medication Guide for SUBOXONE Film at www.suboxone.com.
For more information about SUBOXONE Tablet, please see full Prescribing Information and Medication Guide at www.suboxone.com.
Sincerely,
Rolley E. Johnson, PharmD
Vice President, Treatment and Health Policy
Reckitt Benckiser Pharmaceuticals Inc.
Tim Baxter, MD
Global Medical Director
Reckitt Benckiser Pharmaceuticals Inc.
Please see the important safety information on the following pages.
Indication
SUBOXONE ® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.
Important Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.
Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.
SUBOXONE (buprenorphine and naloxone) Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE (buprenorphine and naloxone) Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.
Liver function should be monitored before and during treatment.
Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.
Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.
Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.
Neonatal withdrawal has been reported.
Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk.
Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.
Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list at www.suboxone.com/pdfs/SuboxonePI.pdf
To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Reckitt Benckiser Pharmaceuticals
10710 Midlothian Tpke, Suite 430
Richmond, VA 23235
T 804-379-1090
F 804-379-1215
info@reckittbenckiser.com
SBF-0010-oJan2013
----------------------------
Pharmacy Times | Pharmacy & Healthcare Communications, LLC
666 Plainsboro Rd | Bldg 300 | Plainsboro | NJ 08536
Phone: (609) 716-7777 | Fax: (609) 716-4747 | www.PharmacyTimes.com
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-----------------------------------------
Please see full Prescribing Information [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,gphm,6k0r,baq6,3cxm ] and Medication Guide [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,dkg6,g5ya,baq6,3cxm ] for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII).
For more about SUBOXONE (buprenorphine and naloxone) Sublingual Tablets (CIII), please see full Prescribing Information [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,4i8j,hn4e,baq6,3cxm ] and Medication Guide [ enews.hcplive.com/ct.html?ufl=8&rtr=on&s=lwo0yi,1003r,1qvv,iu28,5xt,baq6,3cxm ] .
January 28, 2013,
Dear Pharmacist:
Please be advised that Reckitt Benckiser Pharmaceuticals Inc. will discontinue the sale of SUBOXONE ® Tablets (buprenorphine and naloxone) Sublingual (CIII) and cease distribution as of March 18, 2013 in the United States. SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) is still available and will remain on the market.
Reckitt Benckiser Pharmaceuticals formally announced in September 2012 that the company is voluntarily discontinuing the supply of SUBOXONE Tablets after receiving an analysis based on U.S. Poison Control Centers data that found consistently and significantly higher rates of accidental pediatric exposure with SUBOXONE Tablets than seen with SUBOXONE Film. The different rates of pediatric exposure are not related to the active ingredient found in both SUBOXONE Tablets and SUBOXONE Film.
Reckitt Benckiser Pharmaceuticals recognizes that many patients have relied on SUBOXONE Tablets to manage their opioid dependence over the years and encourages patients currently taking SUBOXONE Tablets to talk to their healthcare professional to immediately transition to the same active ingredient with SUBOXONE Film to minimize any risk to the continuity of their treatment. In addition to the 2 mg and 8 mg dosage strengths, SUBOXONE Film is now available in 4 mg and 12 mg dosage strengths.
Indication
SUBOXONE ® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.
Selected Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.
Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.
NDC Product Dosage Packaging
12496-1283-2 SUBOXONE ® (buprenorphine and naloxone) Sublingual Tablets (CIII) 2 mg/0.5 mg 30 ct.
12496-1306-2 SUBOXONE ® (buprenorphine and naloxone) Sublingual Tablets (CIII) 8 mg/2 mg 30 ct.
Please see the important safety information on the following pages.
Reckitt Benckiser Pharmaceuticals remains committed to helping all patients and providers to ensure that managing this serious, chronic disease is not interrupted, and encourages SUBOXONE patients to visit SUBOXONE.com or call 866-973-HERE (866-973-4373) and providers to call our medical information unit at 877-SUBOXONE (877-782-6966) for more information.
Please see full Prescribing Information and Medication Guide for SUBOXONE Film at www.suboxone.com.
For more information about SUBOXONE Tablet, please see full Prescribing Information and Medication Guide at www.suboxone.com.
Sincerely,
Rolley E. Johnson, PharmD
Vice President, Treatment and Health Policy
Reckitt Benckiser Pharmaceuticals Inc.
Tim Baxter, MD
Global Medical Director
Reckitt Benckiser Pharmaceuticals Inc.
Please see the important safety information on the following pages.
Indication
SUBOXONE ® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.
Important Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.
Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.
SUBOXONE (buprenorphine and naloxone) Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE (buprenorphine and naloxone) Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.
Liver function should be monitored before and during treatment.
Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.
Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.
Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.
Neonatal withdrawal has been reported.
Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk.
Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.
Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list at www.suboxone.com/pdfs/SuboxonePI.pdf
To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Reckitt Benckiser Pharmaceuticals
10710 Midlothian Tpke, Suite 430
Richmond, VA 23235
T 804-379-1090
F 804-379-1215
info@reckittbenckiser.com
SBF-0010-oJan2013
----------------------------
Pharmacy Times | Pharmacy & Healthcare Communications, LLC
666 Plainsboro Rd | Bldg 300 | Plainsboro | NJ 08536
Phone: (609) 716-7777 | Fax: (609) 716-4747 | www.PharmacyTimes.com
----------------------------
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Update Profile:
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