BuTrans®  5 µg/h, 10 µg/h and 20 µg/h Transdermal Patch

Prescribing Information

United Kingdom

Presentation

Transdermal beige coloured patch with rounded corners, containing buprenorphine.
5 µg/h square patch marked: BuTrans 5 µg/h.
10 µg/h rectangular patch marked: BuTrans 10 µg/h.
20 µg/h square patch marked: BuTrans 20 µg/h.

Indications

For the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics.

Dosage and administration

BuTrans should be administered every 7 days and is not suitable for the treatment of acute pain.

Elderly and adults over 18 years
Initially, the lowest dose (5 µg/h patch) should be used. The patient’s previous opioid history and their medical status should be considered.  The dose should not be increased before 3 days. Analgesia can be increased by increasing the patch strength or by adding another patch. Do not use more than two patches at a time. Short acting supplemental analgesia may be used during initiation and titration until effective analgesia with BuTrans is achieved. 

Patients under 18 years
Not recommended.

Contra-indications

Known buprenorphine or excipient hypersensitivity, treatment of opioid dependency or narcotic withdrawal, respiratory depression, concurrent administration of monoamine oxidase inhibitors or within 2 weeks discontinuation of their use, myasthenia gravis, delirium tremens or pregnancy.

Precautions and warnings

Convulsive disorders, head injury, shock, reduced consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, hepatic impairment, history of drug abuse. Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route. As with all opioids, chronic use of buprenorphine can result in the development of physical dependence. Withdrawal symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesias, tremor and gastrointestinal disorders. Not recommended immediately post operatively or for situations characterised by a narrow therapeutic index, or a rapidly varying analgesic requirement.

The ability to drive and operate machinery may be impaired especially during treatment initiation or titration to a higher dose. Patients affected should not drive or use machines while wearing a patch and for at least 24 hours after the patch has been removed. A general restriction is not necessary in cases where a stable dose is used.

Interactions

BuTrans patches interact with benzodiazepines (this combination can potentiate respiratory depression of central origin, with risk of death), other CNS depressants, other opioid derivatives, certain antidepressants, sedatives, alcohol, anxiolytics, neuroleptics, clonidine and related substances. 

Effects may be intensified with inhibitors of CYP 3A4 and weakened by inducers.

Pregnancy and lactation

Contra-indicated in pregnancy.  Avoid during lactation.

Side-effects

Serious adverse reactions that may be associated with BuTrans patches are similar to those observed with other opioid analgesics, including respiratory depression and hypotension.

Common side-effects are anorexia, confusion, depression, insomnia, nervousness, anxiety, headache, dizziness, somnolence, paraesthesia, vasodilation, dyspnoea, constipation, dry mouth, nausea, vomiting, abdominal pain, diarrhoea, dyspepsia, pruritus, erythema, rash, sweating, exanthema, tiredness, asthenia, pain, peripheral oedema, application site reaction, oedema, chest pain.

Some side-effects, that are not common, but may be serious, are allergic reactions, psychotic disorder, psychotomimetic disorders, dependence, dysarthria, migraine, syncope, visual disturbances, circulatory disorders, angina pectoris, palpitations, tachycardia, hypotension, hypertension, aggravated asthma, hypoxia, respiratory failure, diverticulitis, dysphagia, ileus, biliary colic, urticaria, myalgia, micturition disorders, dehydration, agitation, depersonalisation, memory impairment, sedation, respiratory depression, visual disturbance, urinary retention, pyrexia, rigors, increase in alanine aminotransferase levels and withdrawal symptoms.

Please refer to the SPC for further details of other uncommon side-effects.

Legal category

CD (Sch3) POM

Package quantities and price

5 µg/h transdermal patch:   2 individually sealed patches, £9.16
10 µg/h transdermal patch: 4 individually sealed patches, £33.32
20 µg/h transdermal patch: 4 individually sealed patches, £60.68

Marketing Authorisation numbers

PL 16950/136-138
Marketing Authorisation holder

Napp Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge   CB4 0GW
UK

Tel:  01223 424444

Member of the Napp Pharmaceutical Group
Further information is available from Napp Pharmaceuticals Limited.

Date of preparation June 2007

® BuTrans and the NAPP device are Registered Trade Marks.
© Napp Pharmaceuticals Limited 2007.