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RX ITEM-Sublocade- Buprenorphine Solution 100Mg Sol


 NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less
 12496-0300-2, 12496-0300-5
 Packager: Indivior Inc.

 Category: HUMAN PRESCRIPTION DRUG LABEL
 DEA Schedule: CIII
 MarBRAND: SUBLOCADE NDC: RX12496-0100-2 ,RX1249601002  UPC: 312496-100028,312496100028 
 NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less
 12496-0300-2, 12496-0300-5
 PackagOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Sublocade- Buprenorphine Solution 100Mg Sol

$0.00

Item No.: RX12496-0100-2 NDC No.RX1249601002 UPC No.:312496100028 Item No.: RX12496-0100-2
NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less
12496-0300-2, 12496-0300-5
Packager: Indivior Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: CIII
Marketing Status: New Drug Application
Only Physician,Pharmacy or Licensed Facility-must be Licensed by DEA can order this Rx Item NDC No.: 1249601002,12496-100-2,124961002 UPC:312496100028,

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For: Opioid Use Disorder Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD). These highlights do not include all the information needed to use SUBLOCADE� safely and effectively. See full prescribing information for SUBLOCADE. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use CIII Initial U.S. Approval: 2002 WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY See full prescribing information for complete boxed warning. Serious harm or death could result if administered intravenously. (5.1) SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. (5.2) INDICATIONS AND USAGE SUBLOCADE contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. (1) SUBLOCADE should be used as part of a complete treatment program that includes counseling and psychosocial support. (1) DOSAGE AND ADMINISTRATION Prescription use of this product is limited under the Drug Addiction Treatment Act. (2.1) SUBLOCADE should only be prepared and administered by a healthcare provider. (2.2) SUBLOCADE is administered monthly only by subcutaneous injection in the abdominal region. (2.2) The recommended dose of SUBLOCADE is two monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses. (2.3) Increasing the maintenance dose to 300 mg monthly may be considered for patients in which the benefits outweigh the risks. (2.3) Examine the injection site for signs of infection or evidence of tampering or attempts to remove the depot. (2.5) See Full Prescribing Information for administration instructions. (2.6) DOSAGE FORMS AND STRENGTHS Injection: 100 mg/0.5 mL and 300 mg/1.5 mL provided in a prefilled syringe with a 19 Gauge 5/8-inch needle. (3) CONTRAINDICATIONS Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. (4) WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. (5.3) Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. (5.4, 5.5) Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. (5.6) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.7) Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. (5.8) Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. (5.9) Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. (5.11) Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. (5.12) ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ?5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact Indivior Inc. at 1-877-782-6966 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing. (7) Serotonergic Drugs: If concomitant use is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug. (7) USE IN SPECIFIC POPULATIONS Lactation: Buprenorphine passes into the mother's milk. (8.2) Geriatric Patients: Monitor for sedation or respiratory depression. (8.5) Moderate to Severe Hepatic Impairment: Not recommended. (5.14, 8.6) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2018


 NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less
 12496-0300-2, 12496-0300-5
 Packager: Indivior Inc.

 Category: HUMAN PRESCRIPTION DRUG LABEL
 DEA Schedule: CIII
 Mar
RX ITEM-Sublocade- Buprenorphine Solutio
NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less 12496-0300-2, 12496-0300-5 Packager: Indivior Inc. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: CIII Mar

BRAND: SUBLOCADE NDC: RX12496-0100-2 ,RX1249601002  UPC: 312496-100028,312496100028 
 NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less
 12496-0300-2, 12496-0300-5
 Packag
Sublocade- Buprenorphine Solution 100Mg
BRAND: SUBLOCADE NDC: RX12496-0100-2 ,RX1249601002 UPC: 312496-100028,312496100028 NDC Code(s): 12496-0100-1, 12496-0100-2, 12496-0100-5, 12496-0300-1, view less 12496-0300-2, 12496-0300-5 Packag

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
American Pharma Wholesale
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.