Suboxone 12 mg/1
buprenorphine hydrochloride, naloxone hydrochloride · FILM, SOLUBLE · INDIVIOR INC.
Suboxone is a film, soluble containing buprenorphine hydrochloride, naloxone hydrochloride at 12 mg/1, taken buccal. Manufactured by INDIVIOR INC..
Key Facts
- Brand Name
- Suboxone
- Generic Name
- buprenorphine hydrochloride, naloxone hydrochloride
- NDC Code (Product)
12496-1212- Manufacturer
- INDIVIOR INC.
- Strength
- 12 mg/1
- Dosage Form
- FILM, SOLUBLE
- Route
- BUCCAL, SUBLINGUAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA022410
- Marketing Start
- 08/24/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBOXONE® sublingual film contains buprenorphine, a partial‐opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer SUBOXONE sublingual film as a single daily dose. ( 2.1 ) Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time SUBOXONE 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 SUBOXONE sublingual film should be undertaken when objective and clear signs of withdrawal are evident and SUBOXONE 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 SUBOXONE sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of SUBOXONE 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 ) The maintenance dose of SUBOXONE sublingual film is generally in the range of 4 mg/1 mg to 24 mg/6 mg pe…
Contraindications
4 CONTRAINDICATIONS SUBOXONE 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 SUBOXONE. 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 recommending or prescribing an opioid overdose reversal agent, as is recommended for all patients on buprenorphine treatment for …
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 SUBOXONE 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 Indivior Inc. at 1-877-782-6966 or FDA at 1-80…
Frequently Asked Questions
What is Suboxone used for?
Suboxone contains buprenorphine hydrochloride, naloxone hydrochloride. It is a film, soluble taken buccal. Consult your doctor for specific uses.
Is Suboxone a controlled substance?
Yes, Suboxone is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Suboxone?
The generic name for Suboxone is buprenorphine hydrochloride, naloxone hydrochloride. There are no other listed brand versions of buprenorphine hydrochloride, naloxone hydrochloride.
What is the NDC code for Suboxone 12 mg/1?
The NDC (National Drug Code) for Suboxone 12 mg/1 is 12496-1212, listed by INDIVIOR INC..
Other Suboxone Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)