Drugplain

Zubsolv 8.6 mg/1

buprenorphine hydrochloride and naloxone hydrochloride · TABLET, ORALLY DISINTEGRATING · Orexo US, Inc.

No Recall History
Plain English

Zubsolv is a tablet, orally disintegrating containing buprenorphine hydrochloride and naloxone hydrochloride at 8.6 mg/1, taken sublingual. Manufactured by Orexo US, Inc..

Key Facts

Brand Name
Zubsolv
Generic Name
buprenorphine hydrochloride and naloxone hydrochloride
NDC Code (Product)
54123-986
Manufacturer
Orexo US, Inc.
Strength
8.6 mg/1
Dosage Form
TABLET, ORALLY DISINTEGRATING
Route
SUBLINGUAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
NDA204242
Marketing Start
12/11/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

drug dependence196 reports
drug withdrawal syndrome138 reports
nausea133 reports
wrong technique in product usage process109 reports
headache86 reports
vomiting85 reports
drug ineffective78 reports
anxiety73 reports
drug withdrawal syndrome neonatal72 reports
foetal exposure during pregnancy71 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Following induction, ZUBSOLV is administered 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 ZUBSOLV 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 ZUBSOLV should be undertaken when objective and clear signs of withdrawal are evident and Zubsolv 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 5.7 mg/1.4 mg of Zubsolv (in divided doses). On Day 2, administer up to a total dose of 11.4 mg/2.9 mg of Zubsolv 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 ZUBSOLV is generally in the range of 2.9 mg/0.71 mg to 17.2 mg/4.2 mg per day and should be based on clinical respons…

Contraindications

4 CONTRAINDICATIONS ZUBSOLV 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 ZUBSOLV. Table 4. Clinically Significant Drug Interactions with ZUBSOLV Benzodiazepines and other Central Nervous System (CN-S) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines and 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 t…

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 sublingual administration of ZUBSOLV are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals LLC DBA Dexcel Pharma USA at 1-877-381-3336, or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch. 6.1 C…

Frequently Asked Questions

What is Zubsolv used for?

Zubsolv contains buprenorphine hydrochloride and naloxone hydrochloride. It is a tablet, orally disintegrating taken sublingual. Consult your doctor for specific uses.

Is Zubsolv a controlled substance?

Yes, Zubsolv is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Zubsolv?

The generic name for Zubsolv is buprenorphine hydrochloride and naloxone hydrochloride. There are 9 other brand versions of buprenorphine hydrochloride and naloxone hydrochloride.

What is the NDC code for Zubsolv 8.6 mg/1?

The NDC (National Drug Code) for Zubsolv 8.6 mg/1 is 54123-986, listed by Orexo US, Inc..

Product NDC

54123-986

Package NDC

54123-986-30

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

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