Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, United Kingdom
Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia
Butec is not suitable for the treatment of acute pain.
Butec is indicated in adults.
Butec should be administered once per week on the same day each week.
The lowest Butec dose (Butec 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient.
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).
During initiation of treatment with Butec, short-acting supplemental analgesics may be required as needed until analgesic efficacy with Butec is attained.
The dose of Butec may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient’s analgesic response to the patch.
To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour. A new patch should not be applied to the same skin site for the subsequent 3-4 weeks (see section 5.2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.
Butec can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose (Butec 5 microgram/hour transdermal patch) and continue taking short-acting supplemental analgesics during titration, as required.
The safety and efficacy of Butec in children below 18 years of age has not been established. No data are available.
No dosage adjustment of Butec is required in elderly patients.
No special dose adjustment of Butec is necessary in patients with renal impairment.
Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore patients with hepatic insufficiency should be carefully monitored during treatment with Butec.
Patients with severe hepatic impairment may accumulate buprenorphine during Butec treatment. Consideration of alternate therapy should be considered, and Butec should be used with caution, if at all, in such patients.
Route of administration:
Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.
In order to ensure effective analgesia of buprenorphine and to minimise the potential for skin reactions (see section 4.4) the following directions of use should be followed.
Butec should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars. Butec should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven.
If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. Butec should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear. The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch. If a patch falls off, a new one should be applied and worn for 7 days.
Butec should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Butec is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Butec is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. At present, only limited information is available on the starting dose of other opioids administered after discontinuation of the transdermal patch (see section 4.5).
While wearing the patch, patients should be advised to avoid exposing the application site to external heat sources, such as heating pads, electric blankets, hot water bottles, heat lamps, sauna, hot tubs, and heated water beds, etc., as an increase in absorption of buprenorphine may occur.
When treating febrile patients, one should be aware that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and thereby increased risk of opioid reactions.
Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.
Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.
Remove any patches from the patient’s skin. Establish and maintain a patent airway, assist or control respiration as indicated and maintain adequate body temperature and fluid balance. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone may be less effective in reversing the effects of buprenorphine than other mu-opioid agonists. Treatment with continuous intravenous naloxone should begin with the usual doses but high doses may be required.
2 years.
Do not store above 25°C.
Sealed child resistant sachet, composed of identical top and bottom layers of heat-sealable laminate, comprising (from outside to inside) paper, PET, polyethylene-based copolymer, aluminium and poly(acrylic acid-co-ethylene).
Pack Sizes: 1, 2, 3, 4, 5, 8, 10 and 12 transdermal patches.
Not all pack sizes may be marketed.
The patch should not be used if the seal is broken.
Disposal after use:
When changing the patch, the used patch should be removed, the adhesive layer folded inwards on itself, and the patch disposed of safely and out of sight and reach of children.
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