Buprenorphine 20 ug/h
Buprenorphine · PATCH · Rhodes Pharmaceuticals LLC
Buprenorphine is a patch containing buprenorphine at 20 ug/h, taken transdermal. Manufactured by Rhodes Pharmaceuticals LLC.
Key Facts
- Brand Name
- Buprenorphine
- Generic Name
- Buprenorphine
- NDC Code (Product)
42858-839- Manufacturer
- Rhodes Pharmaceuticals LLC
- Strength
- 20 ug/h
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA021306
- Drug Class
- Partial Opioid Agonist [EPC]
- Marketing Start
- 07/03/2017
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Teva Pharmaceuticals USA
Failed Stability Specifications: Below specification result for buprenorphine release rate.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Matthew 7:25 Inc dba Thrive Pharmacy
Subpotent Drug
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Alvogen, Inc
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Buprenorphine sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1) Buprenorphine sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer buprenorphine sublingual tablet sublingually as a single daily dose. (2.1) Strongly consider prescribing naloxone at the time buprenorphine sublingual tablet is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. (2.2) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablet should be undertaken when objective and clear signs of withdrawal are evident. (2.3) Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablet titration. (2.4) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information. (2.3, 2.4, 2.5) Buprenorphine sublingual tablet must be administered whole. Do not cut, chew, or swallow buprenorphine sublingual tablets. (2.5) When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. (2.9) 2.1 Important Dosage and Administration Instructions Buprenorphine sublingual tablet is administered sublingually as a single daily dose. Buprenorphine sublingual …
Contraindications
4 CONTRAINDICATIONS Buprenorphine sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9)]. Hypersensitivity to buprenorphine. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with buprenorphine. Table 3. Clinically Significant Drug Interactions Benzodiazepines or other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions (5.2, 5.3)]. If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use dis…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Respiratory and CNS Depression [see Warnings and Precautions (5.2, 5.3)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Adrenal Insufficiency [see Warnings and Precautions (5.6)] • Opioid Withdrawal [see Warnings and Precautions (5.7, 5.10)] • Hepatitis, Hepatic Events [see Warnings and Precautions (5.8)] • Hypersensitivity Reactions [see Warnings and Precautions (5.9)] • Orthostatic Hypotension [see Warnings and Precautions (5.16)] • Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.17)] • Elevation of Intracholedochal Pressure [see Warnings and Precautions (5.18)] Adverse events commonly observed with administration of buprenorphine are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 )To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088, or www.fda.…
Frequently Asked Questions
What is Buprenorphine used for?
Buprenorphine contains Buprenorphine. It is a patch taken transdermal. Consult your doctor for specific uses.
Is Buprenorphine a controlled substance?
Yes, Buprenorphine is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Buprenorphine?
The generic name for Buprenorphine is Buprenorphine. There are 7 other brand versions of Buprenorphine.
What is the NDC code for Buprenorphine 20 ug/h?
The NDC (National Drug Code) for Buprenorphine 20 ug/h is 42858-839, listed by Rhodes Pharmaceuticals LLC.