Haldol im agitation

There are no well controlled studies with HALDOL (haloperidol) in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of HALDOL along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to HALDOL, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment.

At the request of the Pharmacovigilance Department of the Italian Drug Agency (AIFA), the sponsor (Johnson & Johnson) performed two post-marketing analyses of QT interval prolongation and TdP with haloperidol administration (oral or injectable).  In one analysis, the sponsor searched their Benefit Risk Management worldwide safety database for QT prolongation -related adverse event reports received through June 30, 2005.  This search identified 229 reports, many of which the sponsor described as confounded by concomitant QT-prolonging drugs or medical conditions.  The reports included 73 cases of TdP, eleven of which were fatal.  Eight of the eleven fatal cases involved intravenous administration of various doses of haloperidol. 

3 to 12 years and 15 to 40 kg :
-Initial dose: mg/day orally in 2 to 3 divided doses
-Maintenance dose: to mg/kg/day

Comments :
-The daily dose may be increased every 5 to 7 days in mg increments.
-There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
-Limitation of use: Treatment should be reserved for patients with severe behavior problems and/or hyperactive children only after failure to respond to psychotherapy or medications (other than antipsychotics).

Uses :
-Treatment of severe behavior problems in children, including combative, explosive hyperexcitability not accounted for by immediate provocation
-Short-term treatment of hyperactive children with excessive motor activity and accompanying conduct disorder with impulsivity, difficulty sustaining attention, aggressiveness, mood lability, and/or poor frustration tolerance.

The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. About one-third of a haloperidol dose is excreted in urine, mostly as metabolites. Less than 3% of administered haloperidol is eliminated unchanged in the urine. Haloperidol metabolites are not considered to make a significant contribution to its activity, although for the reduced metabolite of haloperidol, back-conversion to haloperidol cannot be fully ruled out. Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section ).

As with all antipsychotic agents HALDOL has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary , dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.

Haldol im agitation

haldol im agitation

The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. About one-third of a haloperidol dose is excreted in urine, mostly as metabolites. Less than 3% of administered haloperidol is eliminated unchanged in the urine. Haloperidol metabolites are not considered to make a significant contribution to its activity, although for the reduced metabolite of haloperidol, back-conversion to haloperidol cannot be fully ruled out. Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section ).

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