Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom
As a strong analgesic for the relief of moderate to severe pain.
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).
200-400 micrograms to be dissolved under the tongue every 6-8 hours or as required. The recommended starting dose for moderate to severe pain of the type typically presenting in general practice is 200 to 400 micrograms, 8 hourly.
There is no evidence that dosage needs to be modified for the elderly.
Temgesic Sublingual is suitable for use in children under 12 as follows:
16-25 kg (35-55 lb): 100 micrograms.
25-37.5 kg (55-82.5 lb): 100-200 micrograms.
37.5-50 kg (82.5-110 lb): 200-300 micrograms.
The recommended dose should be administered every 6-8 hours.
Sublingual administration is not suitable for children under the age of six years.
Temgesic sublingual may be used in balanced anaesthetic techniques at a dose of 400 micrograms.
Buprenorphine is metabolised in the liver. The degree and duration of its action may be different in patients with hepatic impairment. Therefore, the Temgesic dose should be reduced for these patients accordingly (see section 4.4 and 5.2).
Administration by the sublingual route.
The tablet should not be chewed or swallowed whole as this will reduce efficacy.
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.
The expected symptoms of overdose would be drowsiness, nausea and vomiting; marked miosis may occur.
Supportive measures should be instituted and if appropriate Naloxone or respiratory stimulants can be used.
3 years – Nylon/aluminium/uPVC blister strip.
3 years – HDPE bottle.
Do not store above 30°C. Store in the original package- Nylon/aluminium/uPVC blister strip
Do not store above 30°C – HDPE bottle.
Nylon/aluminium/uPVC blister strips of 10 tablets each, packed in cartons of 50 tablets.
HDPE bottle consisting of 50 tablets.
To be dissolved under the tongue and not to be chewed or swallowed.
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