Buprenorphine HCl 8 mg/1
Buprenorphine HCl · TABLET · REMEDYREPACK INC.
Buprenorphine HCl is a tablet containing buprenorphine hcl at 8 mg/1, taken sublingual. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- Buprenorphine HCl
- Generic Name
- Buprenorphine HCl
- NDC Code (Product)
70518-2014- Manufacturer
- REMEDYREPACK INC.
- Strength
- 8 mg/1
- Dosage Form
- TABLET
- Route
- SUBLINGUAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA078633
- Marketing Start
- 04/12/2019
Recall History
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.
PAR Sterile Products LLC
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Aidapak Services, LLC
Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014.
Hikma Pharmaceuticals USA Inc.
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
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 and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and Naloxone Sublingual Tablets 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 and Naloxone Sublingual Tablets sublingually as a single daily dose. ( 2.1 ) Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time Buprenorphine and Naloxone Sublingual Tablets are 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 Tablets should be undertaken when objective and clear signs of withdrawal are evident. After induction, doses of Buprenorphine and Naloxone Sublingual Tablets should be progressively adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. ( 2.3 ) The maintenance dose of Buprenorphine and Naloxone Sublingual Tablets is generally in the range of 4 mg/1 mg to 24 mg/6 mg per day and should be based on clinical response. ( 2.3 ) Administer Buprenorphine and Naloxone Sublingual Tablets as directed in the Full Prescribing Information. ( 2.3 , 2.4 ) When discontinuing treatment, gradually taper to avoid signs and s…
Contraindications
4 CONTRAINDICATIONS Buprenorphine and Naloxone Sublingual Tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9) ] . Hypersensitivity to buprenorphine or naloxone. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with buprenorphine and naloxone sublingual tablets. Table 3. Clinically Significant Drug Interactions with Buprenorphine and Naloxone Sublingual Tablets 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 other 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 recommending or prescribing an opioid overdo…
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 and Naloxone Sublingual Tablets 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 Amneal Pharmaceuticals at 1-877-835-5472, FDA at 1-800-FDA-1088, or…
Frequently Asked Questions
What is Buprenorphine HCl used for?
Buprenorphine HCl contains Buprenorphine HCl. It is a tablet taken sublingual. Consult your doctor for specific uses.
Is Buprenorphine HCl a controlled substance?
Yes, Buprenorphine HCl is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Buprenorphine HCl?
The generic name for Buprenorphine HCl is Buprenorphine HCl. There are no other listed brand versions of Buprenorphine HCl.
What is the NDC code for Buprenorphine HCl 8 mg/1?
The NDC (National Drug Code) for Buprenorphine HCl 8 mg/1 is 70518-2014, listed by REMEDYREPACK INC..
Other Buprenorphine HCl Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)