TM Owner GSK
Zyban 150mg Tablet
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Indications & Clinical Uses
- Zyban has been discontinued by its manufacturer in the United States: the US application (NDA 020711, GlaxoSmithKline) is on the FDA Discontinued Drug Product List, and in December 2022 the FDA determined it was not withdrawn for safety or effectiveness reasons, so approval has not been revoked.
- It remains marketed in the UK.
- Zyban 150 mg prolonged-release tablets contain bupropion hydrochloride and are an aid to smoking cessation, together with motivational support, in nicotine-dependent adults.
- In the UK you take one tablet daily for six days, then one tablet twice daily at least 8 hours apart (US label: 3 days), up to 300 mg a day, for about 7 to 9 weeks (US label: 7 to 12 weeks).
- It is not recommended under 18.
- Do not take it with other bupropion-containing medicines, including those prescribed for depression.
Side Effects
- The most common side effect is trouble sleeping (insomnia), very common in the UK label and reported in 40% of US trial participants versus 18% on placebo.
- Common effects include dry mouth, nausea, vomiting, abdominal pain, constipation, headache, dizziness, tremor, taste changes, rash, itching, sweating, anxiety, agitation, depression and fever.
- Rare but serious effects include seizures (about 1 in 1,000 at recommended doses), severe allergic reactions, Stevens-Johnson syndrome and raised blood pressure.
- BOXED WARNING (US label): antidepressants such as bupropion increase the risk of suicidal thinking and behaviour in children, adolescents and young adults.
- Mood changes, aggression, hallucinations and suicidal thoughts have also been reported.
- Stop the tablets and contact your healthcare provider immediately if you have seizures, a severe rash or unusual mood or behaviour changes.
Precautions & Warnings
- US boxed warning: suicidal thoughts and behaviour risk with antidepressants; watch for mood or behaviour changes.
- Do not use Zyban if you have a seizure disorder, a central nervous system tumour, current or past bulimia or anorexia nervosa, severe liver cirrhosis, bipolar disorder (UK), or are abruptly stopping alcohol, benzodiazepines, barbiturates or anti-seizure medicines.
- Do not exceed 300 mg a day; use 150 mg daily with liver or kidney impairment or in older adults (UK).
- Have your blood pressure checked before and during treatment, especially if using nicotine patches.
- Use in pregnancy is not advised in the UK and only if benefit justifies risk in the US.
- Bupropion passes into breast milk.
- It may cause dizziness or affect judgment, so take care driving.
- It can cause a false-positive urine amphetamine test.
Avoid Interactions
- Increase risk or effect: MAO inhibitors (contraindicated; wait 14 days), linezolid or intravenous methylene blue, other bupropion products, alcohol (minimise or avoid), medicines that lower the seizure threshold, levodopa and amantadine, SSRI or SNRI antidepressants (serotonin syndrome), and nicotine patches (blood pressure).
- Bupropion raises levels of CYP2D6 medicines such as desipramine, imipramine, paroxetine, risperidone, thioridazine, metoprolol, propafenone and flecainide, and lowers digoxin levels.
- Reduce efficacy: ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital and phenytoin lower bupropion levels; bupropion reduces the effect of tamoxifen.
- Tell your healthcare provider about all medicines and supplements.
References
Frequently Asked Questions
Zyban (bupropion) 150 mg prolonged-release tablets help nicotine-dependent adults stop smoking, alongside motivational support. It is not for use under 18. Do not take it with other bupropion medicines, including those prescribed for depression. Treatment lasts about 7 to 9 weeks in the UK label.
In the UK, take Zyban (bupropion) 150 mg once daily for six days, then twice daily, leaving at least 8 hours between doses. The maximum is 300 mg a day, for about 7 to 9 weeks. The US label starts with three days of once-daily dosing.
Zyban (bupropion) very commonly causes insomnia. Dry mouth, nausea, headache, dizziness, anxiety and constipation are common. Seizures occur in about 1 in 1,000 people. Stop and call your healthcare provider straight away for seizures, severe rash, or new mood changes or suicidal thoughts.
Avoid MAO inhibitors (wait 14 days), other bupropion products, and alcohol or minimise it. Do not take Zyban if you have seizures, an eating disorder, or are suddenly stopping alcohol or benzodiazepines. Tell your provider about antidepressants, antipsychotics, beta-blockers and HIV medicines.
Zyban (bupropion) is still marketed in the UK. GSK discontinued the US brand; the FDA found in 2022 that this was not for safety or effectiveness reasons, and approval was not revoked. Availability differs by country, so check with your healthcare provider or pharmacist.
The US Zyban (bupropion) label has a boxed warning that antidepressants raise the risk of suicidal thoughts and behaviour in children, adolescents and young adults. Report any new mood change, agitation or suicidal thought to your healthcare provider immediately and stop the tablets.
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