Buprenorphine and Naloxone 2 mg/1

Buprenorphine and Naloxone · TABLET · Bryant Ranch Prepack

6 Recalls on Record

Plain English

Buprenorphine and Naloxone is a tablet containing buprenorphine and naloxone at 2 mg/1, taken sublingual. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name: Buprenorphine and Naloxone
Generic Name: Buprenorphine and Naloxone
NDC Code (Product): 72162-1346
Manufacturer: Bryant Ranch Prepack
Strength: 2 mg/1
Dosage Form: TABLET
Route: SUBLINGUAL
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: ANDA205601
Marketing Start: 04/13/2020

Recall History

6 Recalls on Record

Class III06/29/2017

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

TerminatedVoluntary: Firm initiated

Class II02/26/2021

Alvogen, Inc

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

TerminatedVoluntary: Firm initiated

Class III06/29/2017

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

TerminatedVoluntary: Firm initiated

Class II10/18/2022

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance

TerminatedVoluntary: Firm initiated

Class II02/07/2017

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated

Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence170 reports

nausea140 reports

drug withdrawal syndrome101 reports

drug ineffective98 reports

injection site reaction90 reports

vomiting89 reports

pain87 reports

headache86 reports

foetal exposure during pregnancy85 reports

drug withdrawal syndrome neonatal82 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablets are indicated for 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 tablet 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 tablet 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 symp…

Contraindications

4 CONTRAINDICATIONS Buprenorphine and naloxone sublingual tablet is 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, can increase the risk of hypotension, 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…

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/naloxone 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 Rhodes Pharmaceuticals LLC at 1-888-873-5329, FDA at 1-800-FDA-1088, or www.fda.gov/medwa…

Frequently Asked Questions

What is Buprenorphine and Naloxone used for?

Buprenorphine and Naloxone contains Buprenorphine and Naloxone. It is a tablet taken sublingual. Consult your doctor for specific uses.

Is Buprenorphine and Naloxone a controlled substance?

Yes, Buprenorphine and Naloxone is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Buprenorphine and Naloxone?

The generic name for Buprenorphine and Naloxone is Buprenorphine and Naloxone. There are no other listed brand versions of Buprenorphine and Naloxone.

What is the NDC code for Buprenorphine and Naloxone 2 mg/1?

The NDC (National Drug Code) for Buprenorphine and Naloxone 2 mg/1 is 72162-1346, listed by Bryant Ranch Prepack.

Product NDC

72162-1346

Package NDC

Other Buprenorphine and Naloxone Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)