Buprenorphine and Naloxone Sublingual Film 12 mg/1

Buprenorphine and Naloxone · FILM · Alvogen Inc.

2 Recalls on Record

Plain English

Buprenorphine and Naloxone Sublingual Film is a film containing buprenorphine and naloxone at 12 mg/1, taken buccal. Manufactured by Alvogen Inc..

Key Facts

Brand Name: Buprenorphine and Naloxone Sublingual Film
Generic Name: Buprenorphine and Naloxone
NDC Code (Product): 47781-358
Manufacturer: Alvogen Inc.
Strength: 12 mg/1
Dosage Form: FILM
Route: BUCCAL, SUBLINGUAL
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: ANDA205954
Marketing Start: 02/11/2019

Recall History

2 Recalls on Record

Class II02/26/2021

Alvogen, Inc

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

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

nausea123 reports

injection site reaction90 reports

drug ineffective88 reports

vomiting81 reports

headache76 reports

product substitution issue73 reports

withdrawal syndrome66 reports

drug withdrawal syndrome65 reports

drug abuse53 reports

pain51 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film should be used as a part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer buprenorphine and naloxone sublingual film as a single daily dose. ( 2.1 ) Strongly consider prescribing naloxone at the time buprenorphine and naloxone sublingual film 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 and naloxone sublingual film should be undertaken when objective and clear signs of withdrawal are evident and buprenorphine and naloxone sublingual film should be administered in divided doses when used as initial treatment. ( 2.3 ) For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 8 mg/2 mg buprenorphine and naloxone sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of buprenorphine and naloxone sublingual film as a single dose. ( 2.3 ) For patients dependent on methadone or long-acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment. ( 2.3 ) For maintenance treatment, the target dosage of buprenorphine and…

Contraindications

4 CONTRAINDICATIONS Buprenorphine and naloxone sublingual film 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 4 Includes clinically significant drug interactions with buprenorphine and naloxone sublingual film. Table 4. Clinically Significant Drug Interactions Benzodiazepines and 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 prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all …

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 the sublingual/buccal administration of the buprenorphine and naloxone sublingual film 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 Alvogen, Inc. at 1-866-770-30…

Frequently Asked Questions

What is Buprenorphine and Naloxone Sublingual Film used for?

Buprenorphine and Naloxone Sublingual Film contains Buprenorphine and Naloxone. It is a film taken buccal. Consult your doctor for specific uses.

Is Buprenorphine and Naloxone Sublingual Film a controlled substance?

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

What is the generic name for Buprenorphine and Naloxone Sublingual Film?

The generic name for Buprenorphine and Naloxone Sublingual Film is Buprenorphine and Naloxone. There are 12 other brand versions of Buprenorphine and Naloxone.

What is the NDC code for Buprenorphine and Naloxone Sublingual Film 12 mg/1?

The NDC (National Drug Code) for Buprenorphine and Naloxone Sublingual Film 12 mg/1 is 47781-358, listed by Alvogen Inc..

Product NDC

47781-358

Package NDC

47781-358-03

Other Buprenorphine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)