Temgesic Special Precautions





Agencia Lei Va Hong
Full Prescribing Info
Special Precautions
Tablet: Human and animal studies show burepnorphine to have a substantially lower dependence liability than pure agonist analgesics. However, Temgesic Sublingual Tablets should be prescribed and administered with caution to patients with a history of drug abuse and to patients with emotional instability. Temgesic Sublingual Tablets have certain opioid properties, which may lead to psychic dependence of the morphine type due to an opiate-like euphoric component of the drug.
Temgesic Sublingual Tablets should be administered for the relief of pain and not in anticipation of pain.
Caution and close patient observation are recommended when Temgesic Sublingual Tablets are used in ambulatory patients. Since Temgesic may cause drowsiness or dizziness, and these could be potentiated by other centrally acting agents, including alcohol, ambulant patients should be cautioned against engaging in activities requiring mental alertness, such as driving a car or operating machinery/appliances.
As with other potent opioids, respiratory depression may occur within the recommended therapeutic dose range in patients receiving buprenorphine. Therefore, Temgesic Sublingual Tablets should be used with caution in patients with impaired respiratory function: those with acute asthmatic attack, chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve or those with pre-existing respiratory depression, hypoxia or hypercapnia. Caution is also advised if Temgesic Sublingual Tablets are administered to patient taking drugs with respiratory depressant effects. In patients with these physical and/-or pharmacologic risk factors, the dose should be reduced by approximately on-half.
Hepatic impairment: Buprenorphine is metabolized by the liver and its clearance is related to hepatic blood flow. Decreased metabolism of the drug in patients with extensive liver disease may predispose such patients to an accentuation of drug effects at recommended therapeutic dosage. Therefore, Temgesic Sublingual Tablets should be administered with caution to patient with hepatic impairment and to those receiving other agents (e.g. halothane) that decrease hepatic clearance. Temgesic has been shown to increase intracholedochal pressure to a similar degree as other opioid analgesics and therefore, Temgesic Sublingual Tablets should be administered with caution to patients with biliary tract dysfunction. Temgesic Sublingual Tablets should be administered with caution to elderly or debilitated patients and to those with severe impairment of renal function, myxedema or hypothyroidism, adrenal insufficiency (e.g. Addison's disease), CNS depression or coma, toxic psychoses, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens or kyphoscoliosis.
As with other potent analgesics, Temgesic Sublingual Tablets have the potential for elevating cerebrospinal fluid pressure. This effect, coupled with a respiratory depressant effect, may be markedly exaggerated in the presence of head injury, other intracranial lesions or when there is a preexisting increase in intracranial pressure. Temgesic can produce miosis and changes in the level of consciousness which may obscure the clinical course of patients with head injuries. Therefore, in such patients Temgesic Sublingual Tablets should be used with caution.
Because Temgesic has narcotic antagonistic properties, it may precipitate withdrawal symptoms in narcotic addicts. Temgesic Sublingual Tablets are not recommended for patients who have developed physical dependence to narcotics except when buprenorphine is administered within a framework of medical, social and psychological treatment. Temgesic Sublingual Tablets should be administered with caution to patients previously treated with narcotic analgesics.
Use in children: Temgesic 0.2 mg Sublingual Tablets may be administered as recommended to children 2 to 12 years of age and who weigh at least 16 kg.
Ampoule: Temgesic occasionally causes 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 products and caution should be exercised when prescribing it to patients known to have, or suspected of having, problems with drug abuse.
Diversion: 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 or pharmacies. The diversion may lead to new cases of dependence 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. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Temgesic Injection should be used with caution in patients with moderate to severe hepatic impairment (See Pharmacology: Pharmacokinetics under Actions).
Athletes must be aware that this medicine may cause a positive reaction to 'anti-doping' tests.
Effects on ability to drive and Use Machines: Ambulant patients should be warned not to operate machinery until they are certain they can tolerate Temgesic.
This medicine can impair cognitive function and can affect a patient's ability to drive safely.
When prescribing this medicine, patients should be told: The medicine is likely to affect the ability to drive. Do not drive until the patient knows how the medicine affects him/her.
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