Temgesic Dosage/Direction for Use





Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Tablet: Adults: The usual recommended dose is 0.2 - 0.4 mg buprenorphine dissolved under the tongue every six to eight hours or as required. The recommended initial dose is one 0.2 mg tablet every eight hours. The tablets should be kept under the tongue until dissolved, which occurs in 5 to 10 minutes, and should not be chewed or swallowed.
Children 2 to 12 years of age: Temgesic 0.2 mg Sublingual Tablets may be administered to children who weigh at least 16 kg and are able to take a sublingual dosage form:
16 - 25 kg, one-half tablet (100 micrograms);
25 - 37.5 kg, on-half to one tablet (100 - 200 micrograms);
37.5 - 50 kg, one to one and one-half tablets (200 - 300 micrograms).
The tablets should be kept under the tongue until dissolved, which occurs in 5 to 10 minutes, and should not be chewed to swallowed. Doses may be repeated every six to eight hours.
Since not all children may clear buprenorphine faster than adults, fixed interval or "round-the-clock" dosing should not be undertaken until the proper inter-dose interval has been established by clinical observation of the child.
Ampoule: Administration by i.m. or slow i.v. injection.
Adults and children over 12 years: 1-2 ml (300 - 600 micrograms of buprenorphine) every 6 to 8 hours as required.
Children aged under 12 years: 3 - 6 micrograms/kg of body weight every 6 to 8 hours. In refractory cases up to 9 micrograms/kg may be administered. There is no clinical experience in infants below the age of 6 months.
There is no evidence that dosage need to be modified for the elderly.
Temgesic Injection maybe employed in balanced anaesthetic techniques as a pre-medication at a dose of 300 micrograms i.m., or as an analgesic supplement at doses of 300 to 450 micrograms i.v.
Hepatic impairment: The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a postmarketing study. Buprenorphine is extensively metabolized in the liver, and plasma levels were found to be higher for buprenorphine in patients with moderate and severe hepatic impairment compared to healthy subjects. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Temgesic should be used with caution in patients with moderate to severe hepatic impairment (See Pharmacology: Pharmacokinetics under Actions).
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