Fixed-dose combination
Buprenorphine and Naloxone is a fixed-dose combination of an opioid antagonist and a partial opioid agonist indicated for treatment of opioid dependence. It is available as sublingual tablets, buccal films and orally disintegrating tablets. MedsAcross supplies Buprenorphine and Naloxone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
SUBOXONE sublingual film contains buprenorphine and naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Source: US FDA prescribing information
Administer SUBOXONE sublingual film as a single daily dose. 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. 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. 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.
Source: US FDA prescribing information
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. Hypersensitivity to buprenorphine or naloxone.
Source: US FDA prescribing information
Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBOXONE sublingual film. Unintentional Pediatric Exposure: Store SUBOXONE sublingual film safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse Respiratory and CNS Depression Neonatal Opioid Withdrawal Syndrome Adrenal Insufficiency Opioid Withdrawal Hepatitis, Hepatic Events Hypersensitivity Reactions Orthostatic Hypotension Elevation of Cerebrospinal Fluid Pressure Elevation of Intracholedochal Pressure 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Store SUBOXONE sublingual film securely and dispose of properly.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
20 presentations of Buprenorphine and Naloxone, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Buprenorphine and Naloxone 8 mg/2 mg sublingual tabletSublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone 2 mg/0.5 mg sublingual tabletSublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone 2 mg/0.5 mg buccal filmBuccal, sublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone 12 mg/3 mg buccal filmBuccal, sublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone 4 mg/1 mg buccal filmBuccal, sublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone 8 mg/2 mg buccal filmBuccal, sublingualGeneric name | Buprenorphine and Naloxone | — | US FDA | Available on request |
| Buprenorphine and Naloxone Sublingual Film 8 mg/2 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Alvogen | US FDA | Available on request |
| Zubsolv 0.7 mg/0.18 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Zubsolv 1.4 mg/0.36 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Zubsolv 11.4 mg/2.9 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Zubsolv 2.9 mg/0.71 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Zubsolv 5.7 mg/1.4 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Zubsolv 8.6 mg/2.1 mg orally disintegrating tabletSublingual | Buprenorphine and Naloxone | Edenbridge Pharmaceuticals | US FDA | Available on request |
| Buprenorphine and Naloxone Sublingual Film 12 mg/3 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Alvogen | US FDA | Available on request |
| Buprenorphine and Naloxone Sublingual Film 2 mg/0.5 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Alvogen | US FDA | Available on request |
| Buprenorphine and Naloxone Sublingual Film 4 mg/1 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Alvogen | US FDA | Available on request |
| Suboxone 12 mg/3 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Indivior | US FDA | Available on request |
| Suboxone 2 mg/0.5 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Indivior | US FDA | Available on request |
| Suboxone 4 mg/1 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Indivior | US FDA | Available on request |
| Suboxone 8 mg/2 mg buccal filmBuccal, sublingual | Buprenorphine and Naloxone | Indivior | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Buprenorphine and Naloxone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 20 presentations of Buprenorphine and Naloxone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Buprenorphine and Naloxone, including Buprenorphine and Naloxone Sublingual Film, Suboxone, Zubsolv.
Yes. The US FDA first approved Buprenorphine and Naloxone on 8 October 2002, according to Drugs@FDA.
Yes. Buprenorphine and Naloxone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Buprenorphine and Naloxone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Buprenorphine and Naloxone is classified under ATC code N07BC51 (Buprenorphine and Naloxone).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.