September 2, 2015
Recommended Topic Related To:

Zubsolv

"Could drug addiction treatment of the future be as simple as an on/off switch in the brain? A study in rats has found that stimulating a key part of the brain reduces compulsive cocaine-seeking and suggests the possibility of changing addictiv"...

Zubsolv




Zubsolv Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/27/2015

Zubsolv (buprenorphine and naloxone) Sublingual Tablets is a partial opioid agonist used along with counseling and psychosocial support for maintenance treatment of opioid dependence. Common side effects of Zubsolv include headache, nausea, vomiting, increased sweating, constipation, insomnia, weakness, chills, infection, abdominal pain, back pain, diarrhea, runny or stuffy nose, and pain and swelling of the lower limbs.

The recommended target dosage of Zubsolv sublingual tablet is 11.4 mg/2.8 mg buprenorphine/naloxone/day (two 5.7/1.4 mg tablets) as a single daily dose. Zubsolv may interact with azole antifungals, antibiotics HIV protease inhibitors, efavirenz, phenobarbital, carbamazepine, phenytoin, rifampicin, benzodiazepines or other CNS depressants. Tell your doctor all medications and supplements you use. During pregnancy, Zubsolv should be used only if prescribed. Use of this drug during pregnancy may result in breathing problems in a newborn. The medications in Zubsolv pass into breast milk. It is unknown if this drug may harm a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Zubsolv (buprenorphine and naloxone) Sublingual Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zubsolv FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

ZUBSOLV for use as initial treatment was evaluated in two clinical trials that had identical, blinded, two-day induction phases, comparing ZUBSOLV to generic buprenorphine. On the first day, subjects received an initial dose of ZUBSOLV 1.4mg/0.36 mg or generic buprenorphine 2 mg, followed by ZUBSOLV 4.2mg/1.08 mg or generic buprenorphine 6 mg 1.5 hours later. In total, safety data were available for 538 opioid-dependent subjects exposed to ZUBSOLV (buprenorphine/naloxone) sublingual tablets when used for initial treatment.

Table 1: Adverse Reactions in ≥ 5% of Patients During the Induction Phase by System Organ Class and Preferred Term (Safety Population)

System Organ Class Preferred Term ZUBSOLV
(N=538)
Generic BUP
N=530)
Overall
(N=1068)
n (%)
Patients with any Adverse Reactions 139 (26%) 136 (26%) 275 (26%)
Gastrointestinal Disorders 64 (12%) 60 (11%) 124 (12%)
Nausea 29 (5%) 36 (7%) 65 (6%)
Vomiting 25 (5%) 26 (5%) 51 (5%)
Nervous System Disorders 48 (9%) 44 (8%) 92 (9%)
Headache 36 (7%) 35 ( 7%) 71 (7%)
BUP = buprenorphine
ZUBSOLV = buprenorphine/naloxone

The safety of buprenorphine/naloxone for longer-term use (up to 16 weeks of treatment) was evaluated in previous studies in 497 opioid-dependent subjects. The prospective evaluation of buprenorphine/naloxone was supported by clinical trials using buprenorphine tablets without naloxone and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction. See Table 2

Table 2: Adverse Events > 5% by Body System and Treatment Group in a 4-week Study

Body System / Adverse Event (COSTART Terminology) N (%) N (%)
Buprenorphine/ naloxone 16 mg/day
N=107
Placebo
N=107
Body as a Whole
Asthenia 7 (7%) 7 (7%)
Chills 8 (8%) 8 (8%)
Headache 39 (37%) 24 (22%)
Infection 6 (6%) 7 (7%)
Pain 24 (22%) 20 (19%)
Pain Abdomen 12 (11%) 7 (7%)
Pain Back 4 (4%) 12 (11%)
Withdrawal Syndrome 27 (25%) 40 (37%)
Cardiovascular System
Vasodilation 10 (9%) 7 (7%)
Digestive System
Constipation 13 (12%) 3 (3%)
Diarrhea 4 (4%) 16 (15%)
Nausea 16 (15%) 12 (11%)
Vomiting 8 (8%) 5 (5%)
Nervous System
Insomnia 15 (14%) 17 (16%)
Respiratory System
Rhinitis 5 (5%) 14 (13%)
Skin And Appendages
Sweating 15 (14%) 11 (10%)

The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 3 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 3: Adverse Events ( ≥ 5%) by Body System and Treatment Group in a 16-week Study

Body System /Adverse Event (COSTART Terminology) Buprenorphine dose*
Very Low*
(N=184)
Low*
(N=180)
Moderate*
(N=186)
High*
(N=181)
Total*
(N=731)
N (%) N (%) N (%) N (%) N (%)
Body as a Whole
Abscess 9 (5%) 2 (1%) 3 (2%) 2 (1%) 16 (2%)
Asthenia 26 (14%) 28 (16%) 26 (14%) 24 (13%) 104 (14%)
Chills 11 (6%) 12 (7%) 9 (5%) 10 (6%) 42 (6%)
Fever 7 (4%) 2 (1%) 2 (1%) 10 (6%) 21 (3%)
Flu Syndrome. 4 (2%) 13 (7%) 19 (10%) 8 (4%) 44 (6%)
Headache 51 (28%) 62 (34%) 54 (29%) 53 (29%) 220 (30%)
Infection 32 (17%) 39 (22%) 38 (20%) 40 (22%) 149 (20%)
Injury Accidental 5 (3%) 10 (6%) 5 (3%) 5 (3%) 25 (3%)
Pain 47 (26%) 37 (21%) 49 (26%) 44 (24%) 177 (24%)
Pain Back 18 (10%) 29 (16%) 28 (15%) 27 (15%) 102 (14%)
Withdrawal Syndrome 45 (24%) 40 (22%) 41 (22%) 36 (20%) 162 (22%)
Digestive System
Constipation 10 (5%) 23 (13%) 23 (12%) 26 (14%) 82 (11%)
Diarrhea 19 (10%) 8 (4%) 9 (5%) 4 (2%) 40 (5%)
Dyspepsia 6 (3%) 10 (6%) 4 (2%) 4 (2%) 24 (3%)
Nausea 12 (7%) 22 (12%) 23 (12%) 18 (10%) 75 (10%)
Vomiting 8 (4%) 6 (3%) 10 (5%) 14 (8%) 38 (5%)
Nervous System
Anxiety 22 (12%) 24 (13%) 20 (11%) 25 (14%) 91 (12%)
Depression 24 (13%) 16 (9%) 25 (13%) 18 (10%) 83 (11%)
Dizziness 4 (2%) 9 (5%) 7 (4%) 11 (6%) 31 (4%)
Insomnia 42 (23%) 50 (28%) 43 (23%) 51 (28%) 186 (25%)
Nervousness 12 (7%) 11 (6%) 10 (5%) 13 (7%) 46 (6%)
Somnolence 5 (3%) 13 (7%) 9 (5%) 11 (6%) 38 (5%)
Respiratory System
Cough Increase 5 (3%) 11 (6%) 6 (3%) 4 (2%) 26 (4%)
Pharyngitis 6 (3%) 7 (4%) 6 (3%) 9 (5%) 28 (4%)
Rhinitis 27 (15%) 16 (9%) 15 (8%) 21 (12%) 79 (11%)
Skin And Appendages
Sweat 23 (13%) 21 (12%) 20 (11%) 23 (13%) 87 (12%)
Special Senses
Runny Eyes 13 (7%) 9 (5%) 6 (3%) 6 (3%) 34 (5%)
*Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes: “Very low” dose (1 mg solution) would be less than a Suboxone tablet dose of 2 mg “Low” dose (4 mg solution) approximates a 6 mg Suboxone tablet dose “Moderate” dose (8 mg solution) approximates a 12 mg Suboxone tablet dose “High” dose (16 mg solution) approximates a 24 mg Suboxone tablet dose

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of buprenorphine and naloxone sublingual tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate a causal relationship to drug exposure.

The most frequently reported post-marketing adverse event not observed in clinical trials was peripheral edema.

Read the entire FDA prescribing information for Zubsolv (Buprenorphine and Naloxone Sublingual Tablets)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


From WebMD