neobookRx
DrugsLevel 4 LocalisationS5TAB · SRT · FCTEML

Bupropion Hydrochloride

Noradrenaline dopamine reuptake inhibitorAntidepressant

Indications

Registered South African indications:

  • Depression as defined by DSM IV Criteria

Contraindications (ZA)

Registered South African contraindications

  • Hypersensitivity to the active ingredient or any of its excipients
  • Patients with a seizure disorder
  • Administration to patients already being treated with any other preparation that contains bupropion, as the incidence of seizures is dose dependent
  • Patients undergoing abrupt discontinuation of alcohol or sedatives
  • Patients with a current or previous diagnosis of bulimia or anorexia nervosa, as a higher incidence of seizures was observed in these patients when an immediate-release form of bupropion was administered
  • Coadministration of monoamine oxidase inhibitors (MAOIs). At least 14 days is necessary between the discontinuation of MAOIs and the start of treatment with bupropion hydrochloride
  • Severe liver disease:
    - Child-Pugh grades B and C, range 7-13 (XL tab)
  • Patients under 18 years (sustained release tablet)

Warnings & precautions

South African recommendations

Caution in the following patient groups

  • Pregnancy
  • Breastfeeding
  • Renal impairment
  • Mild hepatic impairment
  • Elderly

Seizures

  • The recommended dose of bupropion should not be exceeded, since bupropion is associated with a dose-related risk of seizure
  • Bupropion should be discontinued promptly if patients experience hypersensitivity reactions during treatment. Medical practitioners should be aware that symptoms may persist beyond the discontinuation of bupropion and clinical management should be provided accordingly
  • The overall incidence of seizure with bupropion in clinical trials was approximately 0.1%
  • There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors, which lower the seizure threshold
  • Therefore, bupropion should not be administered to patients with one or more conditions predisposing to a lowered seizure threshold, which include:
    • history of head trauma
    • central nervous system (CNS) tumour
    • history of seizures
    • concomitant administration of other medications known to lower the seizure threshold, excessive use of alcohol or sedatives, diabetes treated with hypoglycaemics or insulin and use of stimulants or anorectic medicines
  • Bupropion should be discontinued and not recommenced in patients who experience a seizure while on treatment

Clinical worsening and suicide risk in adults associated with psychiatric disorders

  • Patients with major depressive disorder may experience worsening of their depression and or the emergence of suicidal ideation and behaviour. This risk may persist until significant remission occurs
  • Patients being treated with bupropion should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy or at any time of dose changes, either increases or decreases
  • Patients with a history of suicidal behaviour or thoughts, young adults and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment are at a greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment
  • Symptoms reported in patients being treated with antidepressants for major depressive disorder as well as for other indications include: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania
  • A meta-analysis showed an increased risk of suicidal thinking and behaviour associated with antidepressant use compared to placebo in patients less than 25 years old
  • Patients and caregivers should be alerted about the need to monitor for any worsening of their condition and/or the emergence of suicidal ideation/behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present
  • Consideration should be given to changing the therapeutic regimen, including possibly discontinuing bupropion, in patients who experience clinical worsening and/or the emergence of suicidal ideation/behaviour, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms
  • The patient should be monitored for worsening of depressive symptoms following discontinuation

Neuropsychiatric symptoms including mania and bipolar disorder

  • Neuropsychiatric symptoms have been reported. Psychotic and manic symptomatology has been reported. Bupropion may precipitate a manic episode in patients with bipolar disorder. Aggression, rage and violent behaviour may occur

Cardiovascular disease

  • There is limited clinical experience of the use of bupropion to treat depression in patients with cardiovascular disease
  • A causal relationship between the use of bupropion and sudden death cannot be excluded. Care should be exercised if bupropion is used in these patients

Brugada syndrome

  • Bupropion may unmask Brugada syndrome, a rare hereditary disease of the cardiac sodium channel with characteristic ECG changes (right bundle branch block and ST segment elevation in right precordial leads), which may lead to cardiac arrest or sudden death
  • Caution is advised in patients with Brugada syndrome or a family history of cardiac arrest or sudden death

Children and adolescents less than 18 years

  • Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviour in children and adolescents with major depressive disorder and other psychiatric disorders

Effects on ability to drive and use machines

  • Bupropion may affect the ability to perform tasks that require judgement or motor and cognitive skills. Patients should therefore exercise caution before driving or use of machinery until they are reasonably certain bupropion does not adversely affect their performance

Adult dosage (ZA)

Forms avail. in SA and covered in this monograph: extended release tab (XL tab, XR tab) (tab, fct), sustained release tab (SR tab)

South African registered indications and dosages

Depression as defined by DSM IV Criteria

  • Oral (XL tab, XR tab): Initial: 150mg, dly; In those not responding to dose of 150mg/day, may be increased to: 300mg, dly (usual target dose); There should be an interval of at least 24hrs between successive doses
  • Oral (SR tab): Initial: 150mg, dly; In those not responding to dose of 150mg/day, may be increased to: 150mg, twice dly with an interval of at least 8hrs between successive doses; Maintenance: 150-300mg/day; Max: 300mg/24hrs; Treatment duration: Up to 1 year

Therapy should be initiated by medical practitioners experienced in the treatment of depression

The full antidepressant effect of bupropion hydrochloride may not be evident until after several weeks of treatment. Patients who are not responding adequately to a dose of 150mg/day may benefit from dose increases up to a maximum of 300mg/day. Doses of bupropion sustained release tablet greater than 150mg/day should be taken as a twice daily dose with an interval of at least 8 hours between successive doses

Following a satisfactory response, continuation with bupropion hydrochloride therapy is effective in preventing relapse and preventing recurrence of further depressive episodes

Insomnia is a very common adverse event. Insomnia may be reduced by avoiding dosing at bedtime (provided there is at least 8 hours between doses) or, if clinically indicated, dose reduction

Switching patients from sustained release tablets
When switching patients from sustained release tablets to extended release tablets; give the same total daily dose when possible. Patients who are currently being treated with sustained release tablets at 300mg/day (e.g. 150mg twice daily) may be switched to extended release tablets 300mg once daily

Method of administration
Bupropion sustained-release and extended release tablets should be swallowed whole and not crushed or chewed

Paediatric dosage (ZA)

Not established for use in children below 18 years

Pregnancy & lactation

Pregnancy 

South African recommendations

  • Caution
  • Safety in pregnancy has not been established
  • Epidemiological studies of pregnancy outcomes following maternal exposure to bupropion in the first trimester have reported an association with increased risk of some congenital cardiovascular malformations, including ventricular septal defects and left ventricular outflow tract defects. These findings are not consistent across studies

Breastfeeding

South African recommendations

  • Caution; not recommended
  • Safety in breastfeeding has not been established. As bupropion and its metabolites are excreted in human breast milk, mothers should be advised not to breastfeed while taking bupropion

Fertility

South African recommendations

  • No information available

Renal impairment

South African recommendations

  • Caution; dose adjustment recommended
    Treatment of patients with renal impairment should be initiated at a reduced frequency and/or dose, as bupropion and its metabolites may accumulate in such patients to a greater extent than usual

Hepatic impairment

South African recommendations

  • Mild (Child-Pugh grade A, range 5-6): Caution; dose adjustment recommended
    Because of increased variability in the pharmacokinetics in patients with mild hepatic cirrhosis, a reduced frequency of dosing should be considered
  • Moderate to severe (Child-Pugh grades B & C, range 7-13): Contraindicated

Elderly

South African recommendations

  • Caution; dose adjustment recommended

Adverse reactions

Blood and lymphatic system disorders

Frequency unknown

  • Ecchymosis
  • Anaemia
  • Leukocytosis
  • Leukopenia
  • Lymphadenopathy
  • Pancytopenia
  • Thrombocytopenia
  • Altered PT and/or INR, associated with haemorrhagic or thrombotic complications, when co-administered with warfarin

Immune system disorders

Frequent

  • Hypersensitivity reactions such as urticaria

Less frequent

  • More severe hypersensitivity reactions including angioedema
  • Dyspnoea/bronchospasm
  • Anaphylactic shock
  • Arthralgia
  • Myalgia
  • Fever
  • Rash (symptoms resemble serum sickness)

Endocrine disorders

Frequency unknown

  • Hyperglycaemia
  • Hypoglycaemia
  • Syndrome of inappropriate antidiuretic hormone secretion

Metabolism and nutrition disorders

Frequent

  • Anorexia
  • Weight loss

Less frequent

  • Blood glucose disturbances

Frequency unknown

  • Glycosuria

Psychiatric disorders

Frequent

  • Insomnia
  • Agitation
  • Anxiety

Less frequent

  • Confusion
  • Depression
  • Aggression
  • Hostility
  • Irritability
  • Restlessness
  • Hallucinations
  • Abnormal dreams
  • Depersonalisation
  • Delusions
  • Paranoid ideation

Frequency unknown

  • Suicide attempt

Nervous system disorders

Frequent

  • Headache
  • Tremor
  • Dizziness
  • Taste disorders

Less frequent

  • Concentration disturbances
  • Seizures (see section 4.4)
  • Dystonia
  • Ataxia
  • Parkinsonism
  • Incoordination
  • Memory impairment
  • Paraesthesia
  • Syncope

Frequency unknown

  • Emotional lability
  • Derealization
  • Euphoria
  • Abnormal coordination
  • Hyperkinesia
  • Hypertonia
  • Hyperesthesia
  • Vertigo
  • Amnesia
  • Abnormal electroencephalogram (EEG)
  • Akinesia
  • Aphasia
  • Coma
  • Dysarthria
  • Dyskinesia
  • Extrapyramidal syndrome
  • Hypokinesia
  • Increased libido
  • Neuralgia
  • Neuropathy
  • Unmasking tardive dyskinesia

Eye disorders

Frequent

  • Visual disturbance

Frequency unknown

  • Accommodation abnormality
  • Dry eye
  • Increased intraocular pressure angle-closure glaucoma
  • Mydriasis

Ear and labyrinth disorders

Frequent

  • Tinnitus

Frequency unknown

  • Deafness

Cardiac disorders

Less frequent

  • Tachycardia
  • Palpitations

Frequency unknown

  • Complete atrioventricular block
  • Extrasystoles
  • Myocardial infarction

Vascular disorders

Frequent

  • Increased blood pressure (sometimes severe)
  • Flushing

Less frequent

  • Vasodilation
  • Postural hypotension

Frequency unknown

  • Hypertension
  • Stroke
  • Phlebitis
  • Pulmonary embolism

Respiratory, thoracic and mediastinal disorders

Frequency unknown

  • Bronchospasm
  • Pneumonia

Gastrointestinal disorders

Frequent

  • Dry mouth
  • Gastrointestinal disturbance including nausea and vomiting
  • Abdominal pain
  • Constipation

Frequency unknown

  • Gastric reflux
  • Stomatitis
  • Thirst
  • Colitis
  • Esophagitis
  • Gastrointestinal haemorrhage
  • Intestinal perforation
  • Stomach ulcer

Hepato-biliary disorders

Less frequent

  • Elevated liver enzymes
  • Jaundice
  • Hepatitis

Frequency unknown

  • Abnormal liver function
  • Liver damage
  • Pancreatitis

Skin and subcutaneous tissue disorders

Frequent

  • Rash
  • Pruritus
  • Sweating

Less frequent

  • Erythema multiforme
  • Stevens-Johnson syndrome

Frequency unknown

  • Maculopapular rash
  • Alopecia
  • Angioedema
  • Exfoliative dermatitis
  • Hirsutism

Musculoskeletal, connective tissue and bone disorders

Less frequent

  • Twitching

Frequency unknown

  • Leg cramps
  • Fever/rhabdomyolysis
  • Muscle weakness

Renal and urinary disorders

Less frequent

  • Urinary frequency and/or retention

Frequency unknown

  • Dysuria
  • Urinary incontinence
  • Cystitis

Reproductive system and breast disorders

Frequency unknown

  • Impotence
  • Prostate disorder
  • Abnormal ejaculation
  • Dyspareunia
  • Gynaecomastia
  • Menopause
  • Painful erection
  • Salpingitis
  • Vaginitis

General disorders and administrative site conditions

Frequent

  • Fever
  • Asthenia
  • Chest pain

Frequency unknown

  • Bruxism
  • Gingivitis
  • Glossitis
  • Increased salivation
  • Mouth ulcers
  • Oedema of tongue
  • Gum haemorrhage

Interactions

  • CYP2B6 isoenzyme affecting medicines
  • Orphenadrine
  • Cyclophosphamide
  • Ifosfamide
  • Ticlopidine
  • Clopidogrel
  • CYP2D6 metabolised agents
  • Beta-blockers
  • Anti-dysrhythmics
  • Selective serotonin re-uptake inhibitors (SSRls)
  • Tricyclic antidepressants (TCAs)
  • Antipsychotics
  • Citalopram
  • Agents inducing or inhibiting metabolism
  • Carbamazepine
  • Phenobarbitone
  • Phenytoin
  • Ritonavir
  • Ritonavir/lopinavir combinations
  • Levodopa
  • Amantadine
  • Nicotine Transdermal System (NTS)
  • Monoamine oxidase inhibitors (MAOIs)

Other interactions

  • Alcohol

Monitoring

Specific cases may require

  • Renal function
  • Hepatic function

Additional observations

  • Worsening of condition

Mechanism of action

Bupropion is an inhibitor of the neuronal re-uptake of catecholamines (noradrenaline (norepinephrine) and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and does not inhibit monoamine oxidase. The mechanism of action of bupropion is unknown.

Dosage forms

  • Tablet
  • Slow release tablet
  • Film-coated tablet

Formulation

Film-coated tablet 150mg

Slow release tablet 150mg

  • Wellbutrin SR (GSK) originator

Tablet 150mg

  • Nicolift (Pharmaplan)
  • Zyban (GSK) originator
  • Bupropion XR 150 Adco (Adcock Ingram Limited)
  • Voxra XL 150 (GSK)
  • Weldep XR 150 (Ranbaxy Pharmaceuticals)
  • Wellbutrin XL 150 (GSK) originator

Film-coated tablet 300mg

Tablet 300mg

  • Voxra XL 300 (GSK)
  • Wellbutrin XL 300 (GSK) originator
  • Weldep XR 300 (Ranbaxy Pharmaceuticals)

References

1. PI - Prodyna XR 150mg and 300mg extended release tablets - Pharma dynamics -Date of revision of text - 15 November 2024 - Downloaded online 30 September 2025.pdf [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/11/Approved-PI-15-November-2024.pdf] 2. PI - DIRENTO SR 150 mg sustained-release tablet - Trinity pharma - Date of revision of text - 02 May 2023 - Downloaded online 01 October 2025.pdf [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/06/pi-direntosr150mg-post-reg-cl-20230502-clean.pdf] 3. NAPOS - N06AX12 - Bupropion - Downloaded online 02 October 2025.pdf [https://drugs-porphyria.org/monograph/4009/N06AX12] 4. SAIDS - Medication Check - Drug Free Sport - Bupropion - Downloaded online 02 October 2025.pdf [https://drugfreesport.org.za/online-medication-check/] Old references (updated content excludes below refs) 1. SAMF_12th Edition_Page 503 2. SmPC: Zyban 150 mg prolonged release tablets, GlaxoSmithKline UK: Last updated on eMC: 26 Mar 2018 ; Downloaded online; 25 Jul 2018 https://www.medicines.org.uk/emc/medicine/2948 3. https://drive.google.com/drive/folders/1RC7RrYkOSHz3yZFGbA8BgJg5xHvLiZpl (01/03/2013_GSK_Zyban_sr tab) 4. https://drive.google.com/drive/folders/1RC7RrYkOSHz3yZFGbA8BgJg5xHvLiZpl (01/03/2013_GSK_Wellbutrin_150mg, 300mg_xl tab) 5. U2D: Bupropion: Drug information; Uptodate; Downloaded online ; 31 Oct 2018 https://www.uptodate.com/contents/bupropion-drug-information?search=bupropion&source=panel_search_result&selectedTitle=1~137&usage_type=panel&kp_tab=drug_general&display_rank=1#F5708639 5.1 U2D: Bupropion: Drug information; Uptodate; Downloaded online: 20 Jul 2020 https://www.uptodate.com/contents/bupropion-drug-information?search=bupropion&source=search_result&selectedTitle=1~143&usage_type=panel&kp_tab=drug_general&display_rank=1#F143181 6.NAPOS The Drug Database for Acute Porphyria: Bupropion; Accessed online 30 Oct 2018 http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N07BA02 7. South African Institute for Drug-Free Sport; Wellbutrin; Accessed online 30 Oct 2018 [http://www.drugfreesport.org.za/online-medication-check/] 8. Afritox: Bupropion hydrochloride; Accessed online 16 July 2020 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=9585] 9. SmPC: Zyban 150 mg prolonged release tablets, GlaxoSmithKline UK; Last updated on eMC: 25 Nov 2019; Downloaded online: 25 May 2020 [https://www.medicines.org.uk/emc/product/3827/smpc/print] 10. PI: VOXRA XL, 150 mg/300 mg Extended-Release Tablets; GlaxoSmithKline South Africa (Pty) Ltd. Date of last revision: 24 Oct 2019 [https://drive.google.com/drive/folders/1r9S_cktKFd2gb3S5P-da54vFmFNrwIS-] 11. Dr Irhuma - Clinical pharmacologist. Feedback received from dose queries [https://trello.com/c/lLwiXEqz/381-query-for-dosing-bupropion] 12. Afritox: Bupropion hydrochloride; Accessed online 24 Nov 2020 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=9585] [https://docs.google.com/document/d/1DoNkVnT64pBx7M932D8_KWw6iZ0V44lvgPRLm0_Ye40/edit#]

Brands & products

12 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days old

tabletGeneric· 9 products

from R8.06/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Prodyna 150 Mg Xr150 mg30S5R241.70R8.06R91.703006765001
Prodyna 300 Mg Xr300 mg30S5R241.70R8.06R91.703006766001
Nicolift150 mg60S5R543.03R9.05R164.35721257001
Zyban 150 mg60S5R831.67R13.86R206.81703659001
Bupropion 300 Xl Drl300 mg30S5R464.60R15.49R153.023008901001
Bupropion 150 Xl Drl150 mg30S5R464.60R15.49R153.023008900001
Bupyra Xl 300300 mg30S5R480.12R16.00R155.093006369001
Bupyra Xl 150150 mg30S5R480.12R16.00R155.093006368001
Voxra Xl 300300 mg30S5R560.76R18.69R166.963001582001

SrtGeneric· 3 products

from R13.86/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Wellbutrin Sr150 mg60S5R831.67R13.86R206.81704070001
Wellbutrin xl150 mg30S5R778.62R25.95R199.01711008001
Wellbutrin xl300 mg30S5R778.62R25.95R199.01711009001
Trade names (7)
  • Budep
  • Bupropion Adco
  • Nicolift
  • Voxra
  • Weldep
  • Wellbutrin
  • Zyban

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 9 known drugs

Check against other drugs →

Cited in 2 documents

NeoHealth® ID 15497 · updated 4/1/2026