Temgesic Uses

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Temgesic microgram Sublingual tablets PIL. Sign up to bookmark this SPC already have an account? Find medicines with the same active ingredients. Find medicines from the same company. Temgesic microgram Sublingual Tablets 2. Adults and children over The recommended starting dose for moderate to severe pain of the type typically presenting in general practice is 1 to 2 tablets, 8 hourly. There is no evidence that dosage needs to be modified for the elderly. Children under 12 years: Temgesic Sublingual is suitable for use in children under 12 as follows: 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 micrograms. Special populations 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 section 5. Hypersensitivity to any of the constituents. Although volunteer studies have indicated that opiate antagonists may not fully reverse the effects of Temgesic, clinical experience has shown that Naloxone may be of benefit in reversing a reduced respiratory rate. Respiratory stimulants such as Doxapram are also effective. The intensity and duration of action may be affected in patients with impaired liver failure. Controlled human and animal studies indicate that buprenorphine has a substantially lower dependence liability than pure agonist analgesics. In patients abusing opioids in moderate doses substitution with buprenorphine may prevent withdrawal symptoms. In man limited euphorigenic effects have been observed. This has resulted in some abuse of the same product and caution should be exercised when prescribing it to patients known to have, or suspected of having, problems with drug abuse. Diversion of Temgesic has been reported. Diversion refers to the introduction of buprenorphine into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients of pharmacies. This diversion may lead to new addicts using buprenorphine as the primary drug of abuse, with the risks of overdose, spread of blood borne viral infections and respiratory depression. Hepatic impairment The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a postmarketing study. Since buprenorphine is extensively metabolized, plasma levels were found to be elevated for buprenorphine in patients with moderate and severe hepatic impairment. Temgesic sublingual tablets should be used with caution in patients with moderate to severe hepatic impairment See section 5. However, in individuals on high doses of opioids buprenorphine may precipitate abstinence effects due to its properties as a partial agonist. Temgesic may cause some drowsiness which may be potentiated by other centrally acting agents, including alcohol, tranquillisers, sedatives and hypnotics. Temgesic should be used with caution in patients receiving monoamine oxidase inhibitors, although animal studies have given no evidence of interactions. Although interaction studies have not been performed, since this drug is metabolised by CYP3A4 see section 5. Alternatively, inducers of this enzyme such as phenobarbital, carbamazepine, phenytoin and rifampicin may reduce the levels of the drug. Since the magnitude of an inducing or inhibitory effect is unknown, such drug combinations should be avoided. Temgesic has no know effects on diagnostic laboratory tests. Animal studies indicate that the amounts of buprenorphine excreted in milk are very low in human use are unlikely to be of clinical significance to the baby. There is indirect evidence in animal studies to suggest that Temgesic may cause a reduction in milk flow during lactation. Although this occurred only at doses well in excess of the human dose, it should be borne in mind when treating lactating women. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told: Elderly patients would be expected to be more susceptible to these effects. Hypotension leading to syncope may occur. Rashes, headache, urinary retention and blurring of vision have occasionally been reported. Rarely, a serious allergic reaction may occur following a single dose. Temgesic occasionally causes significant respiratory depression see section 4. Cases of bronchospasm, angioneurotic oedema and anaphylactic shock have also been reported. During use of buprenorphine as substitution treatment the following adverse reactions have also been observed: The expected symptoms of overdose would be drowsiness, nausea and vomiting; marked miosis may occur. The use of this medication by oral route is therefore inappropriate. Peak plasma concentrations are achieved 90 minutes after sublingual administration. Distribution The absorption of buprenorphine is followed by a rapid distribution phase and a half - life of 2 to 5 hours. Metabolism and elimination Buprenorphine is oxidatively metabolised by N-dealkylation to N-desalkyl-buprenorphine also known as norbuprenorphine via cytochrome P CYP3A4 and by glucuroconjungation of the parent molecule and the dealkylated metabolite. Elimination of buprenorphine is bi- or tri- exponential, with long terminal elimination phase4 of hours, due in part to reabsorption of buprenorphine after intestinal hydrolysis of the conjugated derivative, and in part to the highly lipophilic nature of the molecule. HDPE bottle consisting of 50 tablets. Date of revision of the text 01 July Before you contact this company: Please check that this is the correct company before contacting them. This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Temgesic microgram Sublingual tablets. Find medicines with the same active ingredients Find medicines from the same company. Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text Name of the medicinal product. As a strong analgesic for the relief of moderate to severe pain. Administration by the sublingual route. Special populations Hepatic impairment The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a postmarketing study. Not to be given to patients who are known to be allergic to Temgesic or other opiates. Temgesic occasionally causes significant respiratory depression and, as with other strong centrally acting analgesics, care should be taken when treating patients with impaired respiratory function or patients who are receiving drugs which can cause respiratory depression. There is evidence to indicate that therapeutic doses of buprenorphine do not reduce the analgesic efficacy of standard doses of an opioid agonist and that when buprenorphine is employed within the normal therapeutic range, standard doses of opioid agonist may be administered before the effects of the former have ended without compromising analgesia. Temgesic is not recommended for use during pregnancy. If you feel drowsy after taking these tablets do not use machines. Nausea, vomiting, dizziness, sweating and drowsiness have been reported and may be more frequent in ambulant patients. Supportive measures should be instituted and if appropriate Naloxone or respiratory stimulants can be used. Absorption When taken orally, buprenorphine undergoes first-pass hepatic metabolism with N-dealkylation and glucuroconjungation in the small intestine. To be dissolved under the tongue and not to be chewed or swallowed. Find out more here.

Temgesic Uses

buprenorphine

What is temgesic used for

Temgesic Uses

Temgesic 200 microgram Sublingual tablets

Temgesic 200 microgram Sublingual tablets

buprenorphine

Temgesic 200 microgram Sublingual tablets

What is temgesic used for

Temgesic 200 microgram Sublingual tablets

buprenorphine

Temgesic Uses

Temgesic Uses

buprenorphine

Temgesic Uses

Temgesic Uses

Temgesic 200 microgram Sublingual tablets

Temgesic Uses

buprenorphine

buprenorphine

Temgesic Uses

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