Wednesday, August 12, 2009

enSarfe Precaution


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Buprenorphine sublingual tablets are recommended only for the treatment of major opioid drug dependence.

It is also recommended, especially at the beginning of treatment, that a limited number of buprenorphine risk sublingual tablets are prescribed. If possible, controlled or partial dispencing is recommended. This will reduce the risk of misuse, especially by the IV route, and will facilitate dosage adjustment and patient compliance.

Respiratory Depression, Some cases of death due to respiratory depression have been reported, particularly when used in combination wth benzodiazepines, or when buprenorphine was not used according to labelling.

Hepatitis, hepatic events: Hepatic necrosis and hepatitis with jaundice, which generally have resolved favourably, have been reported with the use of buprenorphine. Causality has not been clearly established. When a hepatic event is suspected and the causality is unknown, further evaluation is required. If the drug treatment is suspected to be the cause of hepatic necrosis or jaundice, it must be discontinued as rapidly as the patient's clinical condition permits. If the drug treatment is continued, hepatic function should be monitored.

Buprenorphine can cause opioid withdrawal symptoms if administered to an addicted patient below 4 hours after the last use of the drug.

Buprenorphine can cause drowsiness which may be exacerbated by other centrally-acting agents eg, alcohol, tranquilizers, sedatives, hypnotics.

Buprenorphine can cause orthostatic hypotension.

Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce a low level of dependence.

Athletes should be aware that this medicine may cause a positive reaction to anti-doping tests.

Buprenorphine should be used with care in patients with: Asthma or respiratory insufficiency (cases of respiratory depression have been reported with buprenorphine); renal insufficiency (20% of the administered dose is eliminated by the renal route; thus, renal elimination may be prolonged); hepatic insufficiency (hepatic metabolism of buprenorphine may be altered).

Buprenorphine may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants. Therefore, caution is advised when driving motor vehicles or operating machinery.




Usage in Pregnancy & Lactation

Data are insufficient to evaluate the effects of buprenorphine on pregnant women. At the end of pregnancy, high doses, even for short duration of time, may induce respiratory depression in neonates. During the last 3 months of pregnancy, chronic use of buprenorphine may be responsible for a withdrawal syndrome in neonates. Consequently, the use of buprenorphine is not recommended during pregnancy.

As evidenced in rats, buprenorphine has the potential to inhibit lactation or milk production. In addition, because buprenorphne passes into the mother's milk, breastfeeding is contraindicated.




Usage in Children

No data are available in children below 15 years; therefore, buprenorphine should not be used in children below 15 years.




Interactions:

Buprenorphine should not be taken together with alcoholic drinks or medications containing alcohol. Alcohol increases the sedative effect of buprenorphine, which can make driving vehicles and operating machinery hazardous.

Buprenorphine should be used cautiously together with:

Benzodiazepines: This combination may potentiate respiratory depression of central origin, with risk of death; therefore, dosages must be limited. The risk of drug abuse should also be considered.

Other central nervous system depressants; other opioid derivatives (analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances. This combination increases central nervous system depression and can make driving vehicles and operating machinery hazardous.

Monoamine oxidase inhibitors (MAOI): Possible exaggeration of the effects of opioids, based on experience with morphine. Patients established on buprenorphine should be closely monitored to be sure buprenorphine coverage is maintained adequately, if inhibitors or inducers of CYP3A4 are to be co-administered.

To date, no notable interaction has been observed with cocaine, the agent most frequently used by multi-drug abusers in association with opioids.

A suspected interaction between buprenorphine injection and phenprocoumon, resulting in purpura, has been reported.


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