Buprenorphine
Indications
Registered South African indications:
- Pain
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
Cautions
- Pregnancy
- Breastfeeding
- Renal impairment
- Hepatic impairment
- Elderly
- Debiliated patient
- Impaired respiratory function
- Addiction history
- May impair ability to drive and operate machinery
Adult dosage
Forms avail. in SA and covered in this monograph: slt, inj
Acute pain - moderate to severe
- IM/IV: 0.3-0.6mg, 6-8hrly or as required
- Oral (slt): 0.2-0.4mg, 6-8hrly
Long-term use not recommended
Doses should be titrated to pain relief/prevention
Paediatric dosage
Not established for use in children below 12 years
Special populations
Pregnancy
Breastfeeding
Renal Impairment
Hepatic Impairment
- Mild to moderate: Caution; no dose adjustment recommended
- Severe: Caution; dose adjustment recommended
Elderly
Adverse reactions
Central Nervous System Disorders
- Sedation
- Dizziness
- Headache
- Weakness
- Fatigue
- Slurred speech
- Parasthesis
- Tinnitus
- Coma
- Tremor
- Dysphoria
- Agitation
- Convulsions
- Lack of muscle coordination
- Euphoria
- Psychosis
- Confusional state
- Nervousness
- Depression
- Hallucination
- Depersonalisation
Cardiovascular Disorders
- Hypotension
- Hypertension
- Pallor
- Tachycardia
- Bradycardia
- Cyanosis
- Second degree atrioventricular block
Respiratory Disorders
- Hypoventilation
- Dyspnoea
- Apnoea
- Bronchospasm
Gastrointestinal Disorders
- Nausea and vomiting
- Constipation
- Dyspepsia
- Flatulence
- Loss of appetite
- Diarrhoea
- Dry mouth
Genitourinary Disorders
- Urinary retention
Skin and Subcutaneous Tissue Disorders
- Sweating
- Pruritus
- Rash
- Urticaria
Sensory Disorders
- Miosis
- Diplopia
- Visual abnormalities
- Conjunctivitis
Interactions
- Central nervous system depressants
- Monoamine oxidase inhibitors
- Naltrexone
- CYP3A4 inhibitors
- CYP3A4 inducers
- Halothane
Monitoring
None routine
Prescribing points
Note that buprenorphine overdose may not be reversed completely with naloxone, and supportive measures may be required
Mechanism of action
Binds to various opioid receptors producing partial agonism at mu receptors, and antagonism at kappa receptors (opioid agonist-antagonist).
Dosage forms
- Injection
- Tablet
Formulation
Tablet SL 0,2mg
- Temgesic sublingual Tablets ( Indivior South Africa) originator
Injection (per ml) 0,3mg
- Temgesic ( Indivior South Africa) originator
Also available in the following form: Patch.
References
1. SmPC: Temgesic Injection 1ml, Indivior UK Ltd:Last updated on eMC: 17 Mar 2016; Downloaded online 30 Nov 2018 [https://drive.google.com/drive/u/0/folders/1QztD7l3Z7FdF4EDP6DRp3hXOzSZn82mA] [https://www.medicines.org.uk/emc/medicine/1875] 2. SmPC: Temgesic 200 microgram sublingual tablets, Indivior UK Ltd:Last updated on eMC: 31 May 2016; Downloaded online 30 Nov 2018 [https://drive.google.com/drive/u/0/folders/1QztD7l3Z7FdF4EDP6DRp3hXOzSZn82mA] [https://www.medicines.org.uk/emc/medicine/1876] 3. PI: Temgesic sublingual Tablets and Injection, Reckitt Benckiser Healthcare SA (Pty) Ltd:Date of registration: 24 Oct 2014 [https://drive.google.com/drive/u/0/folders/1QztD7l3Z7FdF4EDP6DRp3hXOzSZn82mA] 4. SAMF_Page 440 5. LexiComp 6. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49. 7. Welsh CJ, Suman M, Cohen A, et al, “The Use of Intravenous Buprenorphine for the Treatment of Opioid Withdrawal in Medically Ill Hospitalized Patients,” Am J Addict, 2002, 11(2): 135-40 8. Butrans (buprenorphine) [product monograph]. Pickering, Ontario, Canada: Purdue Pharma; January 2016 9. Dow K, Ordean A, Murphy-Oikonen J, et al, "Neonatal Abstinence Syndrome Clinical Practice Guidelines For Ontario," J Popul Ther Clin Pharmacol, 2012, 19(3):e488-506 10. AfriTox: Buprenorphine hydrochloride; Last accessed 22 July 2020 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=7810]
Brands & products
14 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days oldSltGeneric· 5 products
from R16.68/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Temgesic sublingual | 0.2 mg | 50 | S6 | R833.94 | R16.68 | R207.15 | 783072007 |
| Suboxone 2 Mg | 2 mg | 7 | S6 | R231.08 | R33.01 | R88.78 | 714063001 |
| Subutex sublingual | 2 mg | 7 | S6 | R322.44 | R46.06 | R113.91 | 702173003 |
| Suboxone 8 Mg | 8 mg | 7 | S6 | R768.55 | R109.79 | R197.53 | 714064001 |
| Subutex sublingual | 8 mg | 7 | S6 | R1077.44 | R153.92 | R242.97 | 702175003 |
injectionGeneric· 1 product
from R96.74/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Temgesic 1ml | 0.3 mg | 1 | S6 | R483.70 | R96.74 | R155.62 | 769517005 |
patchGeneric· 8 products
from R189.37/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Bupremed 5 | 5 mg | 4 | S6 | R757.49 | R189.37 | R195.90 | 3009431001 |
| Sovenor | 5 mg | 4 | S6 | R1089.08 | R272.27 | R244.68 | 715932001 |
| Bupremed 10 | 10 mg | 4 | S6 | R1157.20 | R289.30 | R254.71 | 3009434001 |
| Bupremed 20 | 20 mg | 4 | S6 | R1584.09 | R396.02 | R301.84 | 3009442001 |
| Sovenor | 10 mg | 4 | S6 | R1591.52 | R397.88 | R302.25 | 715941001 |
| Sovenor 10 Patch | 10 mg | 2 | S6 | R815.45 | R407.72 | R204.43 | 715941002 |
| Sovenor | 20 mg | 4 | S6 | R2165.22 | R541.31 | R333.44 | 715942001 |
| Sovenor 20 Patch | 20 mg | 2 | S6 | R1116.94 | R558.47 | R248.78 | 715942002 |
- Temgesic
- Temgesic sublingual
Medical aid coverage
data 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.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- 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 13 known drugs
Check against other drugs →Cited in 14 documents
- GuidelinesOpioid Analgesics12×
- GuidelinesPostoperative Pain10×
- GuidelinesOpioid Pharmacology9×
- GuidelinesIntensive Care Unit3×
- GuidelinesRoutes of Systemic Drug Administration: Enteral and Parenteral3×
- GuidelinesAcute Cancer Pain2×
- GuidelinesAnalgesic Medication for Children with Cancer Pain2×
- GuidelinesDrug Listings: Enteral and Parenteral2×
- GuidelinesReferences - Acute Pain2×
- GuidelinesAcute Burn Injuries
- GuidelinesGeneral Principles
- GuidelinesNeonatal Abstinence Syndrome (NAS)
- GuidelinesRecommendations for Chronic Opioid Therapy (COT) in Specific Pain Syndromes
- GuidelinesSymptom Management in ESKD