Buprenorphine transdermal patch 7 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 non-malignant pain requiring 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.
Adults
The lowest dose (5micrograms/hour) should be used as the initial dose. Consideration should be given to the opioid history of the patient, as well as to the general clinical condition of the patient.
During initiation and titration, breakthrough pain can be managed with short acting supplemental analgesics.
Due to the delayed onset of action, the dose should not be increased for at least 72 hours after the patch is applied. Where dose increases are being considered, take into account any additional short acting supplemental analgesics the patient is taking. Increased doses should be administered using a higher strength patch or a combination of patches to achieve the desired dose.
Conversion from Other Opioids
Buprenorphine may be used as an alternative to other opioids. Such patients should be started on the lowest dose, 5micrograms/hour. During initiation and titration, patients should also use the usual recommended doses of short acting supplemental analgesics to manage any breakthrough pain (as above).
Contraindications
Children under 18 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Coma
Delirium tremens
Head trauma
Myasthenia gravis
Opioid dependence
Pregnancy
Raised intracranial pressure
Severe respiratory impairment
Precautions and Warnings
Acute alcohol intoxication
Constipation
Debilitation
Elderly
Febrile disorder
Females of childbearing potential
Impaired consciousness
Shock
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Gastrointestinal obstruction
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of seizures
Hypotension
Hypothyroidism
Inflammatory bowel disease
Intracranial lesion
Psychiatric disorder
Respiratory impairment
Seizures
Sleep apnoea
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 this medicine may be subject to driving restrictions
May reduce seizure threshold
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 at regular intervals as withdrawal symptoms & dependence may occur
Monitor for signs of tolerance and dependence
Monitor patient for signs and symptoms of respiratory depression
Monitor patients on prolonged therapy
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with hepatic impairment
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Potential for drug abuse
Supervise patient closely during drug withdrawal
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction if sleep-related breathing disorders occur
Consider dose reduction or discontinuation if serotonin syndrome suspected
Increased risk of central sleep apnoea and sleep-related hypoxemia
May cause dependence
Neonate exposed in labour: Risk of respiratory depression
Potential for withdrawal symptoms
Prolonged use at high doses may result in hyperalgesia
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
Discontinue treatment if allergic contact dermatitis is confirmed
Consider dose reduction or alternative opioid in cases of hyperalgesia
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Female: Ensure adequate contraception during treatment
Buprenorphine may accumulate in patients with severe hepatic impairment during buprenorphine treatment. Consider alternative treatment in patients with severe impairment.
Buprenorphine is not recommended for analgesia in the immediate post-operative period.
Pregnancy and Lactation
Pregnancy
Buprenorphine is contraindicated during pregnancy.
The manufacturers do not recommend the use of buprenorphine patches during pregnancy and in women of childbearing potential who are not using effective contraception due to the highly limited data of its use in pregnant women. The potential risk for humans is unknown.
Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the newborn infant. Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in newborns even after a short period of administration.
Animal studies have demonstrated dose-related maternal, embryo, and foetal toxicity and dose-related behavioural changes in offspring but no congenital malformations. Because there is substantially more published human pregnancy experience for other narcotic analgesics, they are preferred to buprenorphine, especially during early gestation (Briggs 2015).
Lactation
Buprenorphine is contraindicated during breastfeeding.
Buprenorphine is excreted into breast milk and may cause respiratory depression in the infant. In animal studies buprenorphine has been found to inhibit lactation.
Schaefer (2015) states that the use of buprenorphine does not require any limitation on breastfeeding when given as a single dose. LactMed (2020) also states its use is acceptable with monitoring of the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants.
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
Advise patients to apply buprenorphine patches to non-irritated, intact skin on the upper outer arm, upper chest, upper back or the side of the chest, avoiding any scars. The skin site should be hairless or relatively hairless and if necessary, hair should be cut with scissors, not shaven. New patches should not be applied to the same area of skin 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. The use of creams, oils or lotions may reduce adhesion of the patch.
Advise patients to avoid exposing the application site to external heat sources, such as electric blankets, heat lamps, saunas etc. as an increase in absorption of buprenorphine may occur.
Advise patients after 7 days use, the patch should be removed and discarded immediately and safely. Fold with the adhesive edges facing inwards and press firmly, then discard immediately according to product literature and local guidelines. Wash hands after removing patches.
Advise patients if the patch falls off before it is due to be changed, a new patch can be applied straight away. The new patch can be left on for 7 days.
Advise patients and carers, patches must be disposed of immediately. They may contain significant residue of the active substance which can prove fatal to children. Patches should be kept out of the reach or sight of children.
Advise that effects are potentiated by CNS depressants.
Advise patient to avoid alcohol during treatment.
Advise patients to risk of developing tolerance. Discuss a strategy for ending treatment with buprenorphine prior to initiating treatment, in order to minimise the risk of addiction and drug withdrawal syndrome.
Advise women of childbearing potential to use adequate contraception during treatment.
Buprenorphine can seriously affect the ability to drive and operate machinery. Advise patients to assess the affect of buprenorphine on their reactions before driving or operating machinery. Patients who are affected during treatment initiation or dose titration should not drive or use machines for at least 24 hours after removal of the patch.
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
Hyperalgesia
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
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
Effects on Laboratory Tests
Buprenorphine may cause a positive result in a doping test.
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: November 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd 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: Bunov 5 microgram/hour transdermal patch. Glenmark Pharmaceuticals Europe Ltd. Revised September 2020.
Summary of Product Characteristics: Bunov 10 microgram/hour transdermal patch. Glenmark Pharmaceuticals Europe Ltd. Revised September 2020.
Summary of Product Characteristics: Bunov 20 microgram/hour transdermal patch. Glenmark Pharmaceuticals Europe Ltd. Revised September 2020.
Summary of Product Characteristics: Bupramyl 5 microgram/hour transdermal patch. Mylan Ltd. Revised May 2018.
Summary of Product Characteristics: Bupramyl 10 microgram/hour transdermal patch. Mylan Ltd. Revised May 2018.
Summary of Product Characteristics: Bupramyl 20 microgram/hour transdermal patch. Mylan Ltd. Revised May 2018.
Summary of Product Characteristics: Butec 5, 10, 15 and 20 mcg/hr transdermal patch. Qderm Pharmaceuticals Ltd. Revised June 2021.
Summary of Product Characteristics: BuTrans 5, 10, 15 and 20 mcg/hr transdermal patch. Napp Pharmaceuticals Ltd. Revised October 2020.
Summary of Product Characteristics: Panitaz 5, 10 and 20 mcg/hr transdermal patch. DR Reddy's Laboratories (UK) Ltd. Revised July 2020.
Summary of Product Characteristics: Rebrikel 5 microgram/hour transdermal patch. Zentiva Pharma UK Ltd. Revised September 2020.
Summary of Product Characteristics: Rebrikel 10 microgram/hour transdermal patch. Zentiva Pharma UK Ltd. Revised June 2021.
Summary of Product Characteristics: Rebrikel 20 microgram/hour transdermal patch. Zentiva Pharma UK Ltd. Revised June 2021.
Summary of Product Characteristics: Reletrans 5, 10 and 20 mcg/hr transdermal patch. Sandoz Limited. Revised January 2020.
Summary of Product Characteristics: Sevodyne 5 microgram/hour transdermal patch. Aspire Pharma Ltd. Revised October 2020.
Summary of Product Characteristics: Sevodyne 10 microgram/hour transdermal patch. Aspire Pharma Ltd. Revised October 2020.
Summary of Product Characteristics: Sevodyne 15 microgram/hour transdermal patch. Aspire Pharma Ltd. Revised October 2020.
Summary of Product Characteristics: Sevodyne 20 microgram/hour transdermal patch. Aspire Pharma Ltd. Revised October 2020.
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: 09 November 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 November 2020
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: 17 August 2020
Last accessed: 09 November 2020
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