Buprenorphine transdermal patch 3 and 4 day release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Transdermal patches containing buprenorphine.
Drugs List
Therapeutic Indications
Uses
Relief of moderate to severe cancer pain resistant to non-opioid analgesia
Dosage
Buprenorphine patches should not be used for longer than necessary. If long-term treatment is necessary, careful and regular monitoring should be carried out, with breaks in the treatment if necessary, to establish whether and to what extent further treatment is necessary.
The dosage should be titrated individually for each patient according to pain intensity, suffering and individual reaction. Titrate to the lowest possible dosage providing adequate pain relief.
Adults
Patients who have previously not received any analgesics:
Start with lowest dose of 35micrograms/hour.
Patients previously on a non-opioid analgesic or a weak opioid analgesic:
Start with lowest dose of 35micrograms/hour.
Non-opioid analgesics can be continued alongside buprenorphine if appropriate.
Patients transferring from a strong opioid analgesic:
Consideration should be given to the nature of the previous medication, administration and mean daily dose, in order to choose the initial patch strength and avoid recurrence of pain. The strength must be adapted to the patient and checked at regular intervals. Generally it is advisable to commence treatment with the lowest strength of 35micrograms/hour and titrate the dose individually. Clinical experience has shown that for patients previously treated with higher doses of strong opioids (in the region of approximately 120mg oral morphine) may start treatment with the next highest patch strength of 52.5micrograms/hour.
In order to allow for individual dose adaptation within an adequate time period, supplementary immediate release analgesics should be available during dose titration.
After application of the first buprenorphine patch the buprenorphine serum concentrations rise slowly both in patients who have been treated previously with analgesics and in those who have not. Therefore initially, there is unlikely to be a rapid onset of effect. Consequently, a first evaluation of the analgesic effect should only be made after 24 hours.
Previous analgesic medication (excluding previous transdermal analgesics) should be maintained at the same dose during the first 12 hours after switching to buprenorphine patches. Appropriate rescue medication should also be made available during this period.
Three day patch dose titration and maintenance therapy
Replace the buprenorphine patch after 72 hours at the latest. The dose should be titrated individually until analgesic efficacy is attained. If analgesia is insufficient at the end of the initial application period (72 hours), the dose may be increased, either by applying more than one buprenorphine patch of the same strength or by switching to the next patch strength.
Four day patch dose titration and maintenance therapy
Replace the buprenorphine patch after 96 hours at the latest. For convenience of use, the patch can be changed twice a week at regular intervals e.g. always on a Monday morning and Thursday evening. The dose should be titrated individually until analgesic efficacy is attained. If analgesia is insufficient at the end of the initial application period (96 hours), the dose may be increased, either by applying more than one buprenorphine patch of the same strength or by switching to the next patch strength.
Contraindications
Children under 18 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Coma
Delirium tremens
Myasthenia gravis
Opioid dependence
Pregnancy
Severe respiratory impairment
Precautions and Warnings
Acute alcohol intoxication
Debilitation
Elderly
Febrile disorder
Females of childbearing potential
Impaired consciousness
Shock
Adrenal insufficiency
Asthma
Biliary tract disorder
Gastrointestinal obstruction
Head trauma
Hepatic impairment
History of drug misuse
Hypotension
Hypothyroidism
Inflammatory bowel disease
Prostate disorder
Raised intracranial pressure
Respiratory impairment
Seizures
Urethral stricture
Not suitable for acute pain relief
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient not to drive/operate machinery within 24 hours of treatment
Advise patient this medicine may be subject to driving restrictions
Some products may contain arachis (peanut) oil
Some products may contain soya or soya derivative
Advise patient to wash hands after use
Avoid exposing application site to direct external heat
Avoid the use of creams, oils or lotions as they may reduce patch adhesion
Discard used patches safely - fold with adhesive edges together
Do not apply more than 2 patches at any one time
Rotate application sites - avoid applying patch to the same site
Evaluate analgesic effect after 24 to 72 hours, depending on patch strength
Fever: Monitor patient for opiate side effects and adjust dose as required
Monitor patients on prolonged therapy
Monitor patients with hepatic impairment
Potential for drug abuse
Supervise patient closely during drug withdrawal
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction or discontinuation if serotonin syndrome suspected
May cause dependence
Potential for withdrawal symptoms
May affect results of some laboratory tests
Avoid abrupt withdrawal
Do not give other opioids for 24 hrs after removal of patch
Discontinue if allergic reaction occurs
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment
Athletes should be aware that this medicine may result in a positive reaction to sports doping control tests.
Pregnancy and Lactation
Pregnancy
Buprenorphine is contraindicated in pregnancy.
At the time of writing there is limited published information regarding the use of transdermal buprenorphine during pregnancy. Animal studies using high doses have shown effects on maternal, embryo, and foetal toxicity and dose-related behavioural changes in offspring but no congenital malformations. Human pregnancy data is very limited.
As with all opiates, buprenorphine readily crosses the placenta. Use during the late stages of pregnancy (including during labour) may cause neonatal respiratory depression. Prolonged use also increases the risk of neonatal withdrawal syndrome either following birth (if used to term) or following treatment discontinuation. As such, manufacturers state that buprenorphine should not be used during pregnancy.
Where an analgesic is required during pregnancy, a non-opioid analgesic should be used in preference of buprenorphine. If this is insufficient to manage pain and an opioid is required, an opioid with more experience during pregnancy (such as morphine) should be used. Any opiate use should be restricted to the lowest dose for the shortest period of time. Prolonged use (including maternal addiction) should be managed under the supervision of an appropriate specialist.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Buprenorphine is contraindicated in breastfeeding.
Buprenorphine is excreted into breast milk in small amounts. At the time of writing there is limited published information regarding the use of transdermal buprenorphine during breastfeeding. Data relating to sublingual buprenorphine suggests poor bioavailability in exposed infants. Due to the limited amount of data, use during breast feeding is not recommended by the manufacturers. Where analgesia is required, either a non-opioid analgesic or (if essential) an opioid analgesic with more experience should be considered instead.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Counselling
Buprenorphine can seriously affect the ability to drive and operate machinery. Advise patient to assess the affect of buprenorphine on their reactions before driving or operating machinery, and not drive during treatment initiation or dose titration, nor for at least 24 hours after the patch has been removed.
Advise patient to avoid applying more than 2 patches at the same time, regardless of the patch strength.
Advise patient patches should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The patches should not be applied to scars.
The skin site should be hairless or relatively hairless. Hair should be cut with scissors, not shaven. New patches should not be applied to the same skin as the previous for at least 3 to 4 weeks. If the patch application site needs to be cleaned, it should be done with clean water only. The skin must be dry before the patch is applied. If the patch falls off, a new one should be applied.
Advise patient to avoid exposing the application site to external heat sources, such as electric blankets, heat lamps, saunas etc.
Advise patient that used patches should be removed and discarded immediately and safely. Fold with the adhesive edges facing inwards and press firmly, then discard immediately as they may contain significant residue of the active substance which can prove fatal to children. Wash hands after removing patches. Patches should be kept out of the reach or discovery of children.
Side Effects
Accidental injury
Agitation
Alanine aminotransferase increased
Anaphylactic reaction
Angina pectoris
Anorexia
Anxiety
Application site reaction
Asthenia
Asthma
Attention disturbances
Biliary colic
Chest pain
Circulatory collapse
Confusion
Cough
Decreased appetite
Dehydration
Dependence
Depersonalisation
Depression
Diverticulitis
Dizziness
Dry eyes
Dry mouth
Dry skin
Dysarthria
Dysequilibrium
Dysphagia
Dyspnoea
Ear pain
Erectile dysfunction
Erythema
Euphoria
Exanthema
Eyelid oedema
Fasciculation
Formation of pustules
Gastrointestinal disorder
Hallucinations
Headache
Heartburn
Hiccups
Hot flushes
Hypersensitivity reactions
Hypertension
Hyperventilation
Hypoaesthesia
Hypotension
Hypoxia
Ileus
Impaired co-ordination
Impaired memory
Influenza-like syndrome
Insomnia
Lability of affect
Micturition disorders
Migraine
Miosis
Mood changes
Muscle weakness
Muscular cramps
Myalgia
Nervousness
Nightmares
Numbness
Oedema
Pain
Palpitations
Paraesthesia
Pruritus
Psychotic disorder
Pyrexia
Rash
Reduced libido
Respiratory depression
Restlessness
Retching
Rhinitis
Rigors
Sedation
Sleep disturbances
Somnolence
Speech disturbances
Sweating
Syncope
Tachycardia
Taste disturbances
Tinnitus
Tiredness
Tremor
Urinary retention
Urticaria
Vasodilatation
Vertigo
Vesicles
Visual disturbances
Weight loss
Wheezing
Withdrawal symptoms
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2017
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Bupeaze 35, 52.5 and 70 mcg/hr transdermal patch. Dr Reddys Laboratories (UK) Ltd. Revised September 2020.
Summary of Product Characteristics: Buplast 35 micrograms/h transdermal patches. Mylan Ltd. Revised January 2016
Summary of Product Characteristics: Buplast 52.5 micrograms/h transdermal patches. Mylan Ltd. Revised January 2016
Summary of Product Characteristics: Buplast 70 micrograms/h transdermal patches. Mylan Ltd. Revised January 2016
Summary of Product Characteristics: Carlosafine 35 micrograms/h transdermal patches. Glenmark Pharmaceuticals Europe Ltd. Revised December 2017
Summary of Product Characteristics: Carlosafine 52.5 micrograms/h transdermal patches. Glenmark Pharmaceuticals Europe Ltd. Revised December 2017
Summary of Product Characteristics: Carlosafine 70 micrograms/h transdermal patches. Glenmark Pharmaceuticals Europe Ltd. Revised December 2017
Summary of Product Characteristics: Hapoctasin 35 microgram/h transdermal patches. Actavis UK Ltd. Revised May 2013
Summary of Product Characteristics: Hapoctasin 52.5 microgram/h transdermal patches. Actavis UK Ltd. Revised May 2013
Summary of Product Characteristics: Hapoctasin 70 microgram/h transdermal patches. Actavis UK Ltd. Revised May 2013
Summary of Product Characteristics: Prenotrix 35, 52.5 and 70 mcg/hr transdermal patch. Genesis Pharmaceuticals Ltd. Revised February 2014
Summary of Product Characteristics: Relevtex 35 micrograms transdermal patch. Sandoz Ltd. Revised June 2016
Summary of Product Characteristics: Relevtex 52.5 micrograms transdermal patch. Sandoz Ltd. Revised June 2016
Summary of Product Characteristics: Relevtex 70 micrograms transdermal patch. Sandoz Ltd. Revised June 2016
Summary of Product Characteristics: Transtec 35, 52.5 and 70 micrograms transdermal patch. Napp Pharmaceuticals Ltd. Revised January 2009
Summary of Product Characteristics: Turgeon 35 micrograms/h transdermal patch. Teva UK Ltd. Revised August 2017
Summary of Product Characteristics: Turgeon 52.5 micrograms/h transdermal patch. Teva UK Ltd. Revised August 2017
Summary of Product Characteristics: Turgeon 70 micrograms/h transdermal patch. Teva UK Ltd. Revised August 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Buprenorphine Last revised: 02 June 2016
Last accessed: 18 August 2016
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.