Temgesic

Temgesic Adverse Reactions

buprenorphine

Manufacturer:

Indivior

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Adverse Reactions
Tablet: Sedation has been the most frequently reported side effect. Sleep, from which patients can easily be aroused, may also occur particularly during the post-operative period.
Cases of bronchospasm, angioneurotic edema and anaphylactic shock have also been reported.
Other less frequently reported adverse reactions occurring in 5 - 10% of the patients were nausea and dizziness/vertigo.
Reported adverse reactions occurring in 1 - 5% of the patients included sweating, hypotension, vomiting, miosis, heachache, hypoventilation.
The following adverse reactions were reported to have occurred in less than 1% of the patients: confusion, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia, hypertension, tachycardia, bradycardia, constipation, dyspnea, cyanosis, pruritus, diplopia, visual abnormalities, urinary retention, tinnitus, conjunctivitis, Wenckeback block, and psychosis.
Other effects observed infrequently include hallucination, depersonalization, coma, dyspepsia, apnea, rash, tremor, pallor, loss of appetite, dysphoria/agitation, diarrhea, urticarial, and convulsions/lack of muscle coordination.
During use of buprenorphine as substitution treatment the following adverse reactions have also been observed: insomnia, drowsiness, fainting, orthostatic hypotension, respiratory depression, hepatic necrosis and hepatitis.
Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported.
In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a withdrawal effect similar to that associated with naloxone.
The safety profile of Temgesic in children is comparable to that in adults.
Ampoule: 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 the 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 (see Precautions).
Cases of bronchospasm, angioneurotic edema and anaphylactic shock have also been reported.
During use of buprenorphine as substitution treatment the following adverse reactions have also been observed: hepatic necrosis and hepatitis.
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