Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Distributed on behalf of Mundipharma New Zealand Limited by: Pharmaco (N.Z.) Ltd, Fisher Crescent, Mt Wellington, Auckland 1060 Ph: (09) 377-3336 Toll Free [Medical Enquiries]: 0800 773 310
Management of moderate to severe pain.
For application to the skin only (transdermal use) over 7 days.
The lowest dose, NORSPAN patch 5 micrograms per hour should be used as the initial dose. Consideration should be given to the previous opioid history of the patient, including opioid tolerance, if any, as well as current general condition and medical status of the patient. No dosage adjustment is necessary in the elderly.
Discontinue all other around-the-clock opioid drugs when NORSPAN patch is initiated. During initiation and titration with NORSPAN patch, patients should take the usual recommended doses of short-acting supplemental analgesics as needed until analgesic efficacy with NORSPAN patch is attained.
During the titration process, the dose may be adjusted every 3-days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Changes in NORSPAN patch dosage may be individually titrated based on the need for supplemental when necessary (PRN) analgesia and the patient’s response to NORSPAN patch.
To increase the dose, the patch that is currently being worn should be removed and a higher strength of NORSPAN patch or a combination of patches should be applied at a different skin site to achieve the required dose. A new patch should not be applied to the same skin site for three. It is recommended that no more than two patches be applied at the same time, up to a maximum total dose of 40 micrograms/hr.
Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. Titration should continue every three to seven days until adequate analgesia and improvement in function is achieved. If adequate pain relief cannot be achieved with maximal doses of NORSPAN patch, the patient should be converted to an around-the-clock strong opioid.
In situations when it is clinically indicated to initiate opioid therapy with a maintenance (around-theclock) opioid in an opioid naïve patient, clinical trials have shown that NORSPAN patch is an appropriate opioid product. The lowest dose available (NORSPAN patch 5 micrograms per hour) should be used as the initial dose. If the patient is taking supplemental analgesics, these may be continued on a PRN basis as the dose of NORSPAN patch is adjusted.
NORSPAN patch has been used as a treatment alternative in patients taking lower doses of opioids (up to 90mg of oral morphine-equivalents a day) and combination analgesics. Patients who have had previous exposure to oral opioids should be started on a low dose of Norspan. Titration of Norspan to the optimal dose should be supported by the use of rescue analgesics.
Use in children is not recommended due to lack of clinical safety and efficacy data in patients under 18 years of age.
No dosage adjustment is required in patients with renal impairment or mild to moderate hepatic impairment. Patients with severe hepatic impairment may accumulate buprenorphine and NORSPAN patch should be used with caution, if at all, in such patients.
During chronic therapy, periodically reassess the continued need for opioid analgesics. After the removal of a NORSPAN patch buprenorphine serum concentrations decrease gradually, and the analgesic effect is maintained for a certain amount of time. This needs to be considered when use of NORSPAN patch is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours of removal of a NORSPAN patch.
When the patient no longer requires therapy with NORSPAN patch, use a gradual downward titration of the dose every 7 days to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Do not abruptly discontinue NORSPAN patch.
In order to ensure effective analgesia of buprenorphine and to minimise the potential of skin reactions (see section 4.4), the following directions of use should be followed:
NORSPAN patch 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. Application sites should be rotated whenever a system is replaced or added. A new patch should not be applied to the same application site for 3-4 weeks. NORSPAN patch 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 should not be used. The skin should be dry before the patch is applied. NORSPAN patch should be applied immediately after removal from the sealed pouch packaging. Following removal of the release liner, the 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, they may be taped down with suitable skin tape. 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.
While wearing the NORSPAN patch patients should be advised to avoid exposing the application site to direct external heat sources, such as heating pads, electric blankets, hot water bottles, heat lamps, etc; as an increase in the absorption of buprenorphine may occur. The effects of use in hot tubs and sauna has not been studied.
When changing a patch, patients should be instructed to remove the used NORSPAN patch, fold it over on itself (bringing the adhesive sides together) and dispose of safely, out of reach of children.
The manifestations of buprenorphine overdose are an extension of its pharmacologic actions. Respiratory depression has been absent in some cases of buprenorphine overdose. However, respiratory depression, including apnoea, has occurred in other overdose situations. Additional symptoms include sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.
Remove any patch in contact with the patient and dispose of it properly. 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 µ-agonists. Treatment with continuous intravenous naloxone should begin with the usual doses but high doses may be required.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800764766).
36 months.
Store below 25°C.
NORSPAN patch is supplied a heat-sealed aluminium/anionic methacrylate laminate pouch. Each carton contains two individually packaged patches.
Disposal after use: When changing the transdermal system, remove the used NORSPAN, fold it over on itself (bringing the adhesive sides together) and dispose of safely, out of the reach of children.
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