Buprenorphine hydrochloride and naloxone hydrochloride dihydrate is the generic equivalent of the brand-name drug BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Buprenorphine hydrochloride and naloxone hydrochloride dihydrate through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug 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 are indicated for the maintenance treatment of opioid dependence. (1) Buprenorphine and naloxone sublingual tablets should be used as a part of a complete treatment plan that includes counseling and psychosocial support. (1)
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…
Drug Interactions
7 DRUG INTERACTIONS Table 3 Includes clinically significant drug interactions with buprenorphine and naloxone sublingual tablets. Table 3. Clinically Significant Drug Interactions 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 benzo…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer buprenorphine and naloxone sublingual tablets sublingually as a single daily dose. (2.1) Strongly consider prescribing naloxone at the time Buprenorphine and naloxone sublingual tablets 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 sublingual tablets should be undertaken when objectiv…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store buprenorphine and naloxone sublingual tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions (5.1 , 5.4) , Drug Abuse and Dependence (9.2) ] . Inform patients that leaving buprenorphine and naloxone sublingual tablets unsecured can pose a deadly risk to other…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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