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Drug Details

TEMGESIC

• Drug Class Description
  Opiates (opioids).
• Generic Name
  Buprenorphine
• Presentation
  Sublingual tablets
• Description
  Buprenorphine hydrochloride 216µg/tablet, equivalent to 200µg buprenorphine base.
• Indications
  

  As a strong analgesic for the relief of moderate to severe pain.

• Adult Dosage
  

  Administration by the sublingual route.

  Adults and children over 12 :

  1-2 tablets (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 1 to 2 tablets, 8 hourly.

• Child Dosage
  Temgesic Tablets: Under 16 kg, not recommended; 16 - 25 kg, 100 microgram; 25 - 37.5 kg, 100 - 200 microgram; 37.5 - 50 kg, 200 - 300 microgram. All sublingually 6 - 8 hourly or as required. Temgesic Injection: Under 6 months, not recommended; over 6 months, 3 - 6 microgram/kg 6 - 8 hourly. Maximum 9 microgram/kg.
• Elderly Dosage
  

  There is no evidence that dosage needs to be modified for the elderly

• Contra Indications
  

  Not to be given to patients who are known to be allergic to Temgesic or other opiates. Hypersensitivity to any of the constituents

• Special Precautions
  

  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. 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 product and caution should be exercised when prescribing it to patients known to have, or suspected of having, problems with drug abuse.

• Interactions
  

  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. 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 animals studies have given no evidence of interactions.

  Although interaction studies have not been performed, since this drug is metabolised by CYP3A4, it is expected that gestodene, troleandomycin, ketoconazole, norfluoxetine, ritonavir, indinavir and saquinavir inhibit its metabolism. 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 known effects on diagnostic laboratory tests.

• Adverse Drug Reactions
  

  Nausea, vomiting, dizziness, sweating and drowsiness have been reported and may be more frequent in ambulant patients. Hallucinations and other psychotomimetic effects have occurred although more rarely than with other agonists/antagonists. 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.

  Cases of bronchospasm, angioneurotic oedema and anaphylactic shock have also been reported