Buprenorphine HCl and Naloxone HCl 8 mg/1

Buprenorphine and Naloxone · TABLET · Amneal Pharmaceuticals LLC

No Recall History

Plain English

Buprenorphine HCl and Naloxone HCl is a tablet containing buprenorphine and naloxone at 8 mg/1, taken sublingual. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name: Buprenorphine HCl and Naloxone HCl
Generic Name: Buprenorphine and Naloxone
NDC Code (Product): 65162-415
Manufacturer: Amneal Pharmaceuticals LLC
Strength: 8 mg/1
Dosage Form: TABLET
Route: SUBLINGUAL
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: ANDA203136
Marketing Start: 02/22/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea124 reports

injection site reaction90 reports

vomiting79 reports

drug ineffective73 reports

drug abuse69 reports

drug withdrawal syndrome67 reports

toxicity to various agents67 reports

headache66 reports

product substitution issue52 reports

withdrawal syndrome51 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 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 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 Tablets 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 Tablets 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 s…

Contraindications

4 CONTRAINDICATIONS Buprenorphine and Naloxone Sublingual Tablets are 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, 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 overdo…

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 and Naloxone Sublingual Tablets 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 Amneal Pharmaceuticals at 1-877-835-5472, FDA at 1-800-FDA-1088, or…

Frequently Asked Questions

What is Buprenorphine HCl and Naloxone HCl used for?

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

Is Buprenorphine HCl and Naloxone HCl a controlled substance?

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

What is the generic name for Buprenorphine HCl and Naloxone HCl?

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

What is the NDC code for Buprenorphine HCl and Naloxone HCl 8 mg/1?

The NDC (National Drug Code) for Buprenorphine HCl and Naloxone HCl 8 mg/1 is 65162-415, listed by Amneal Pharmaceuticals LLC.

Product NDC

65162-415

Package NDC

65162-415-03

Other Buprenorphine Brands

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

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