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Posted by Liz on September 12, 2000 at 17:37:32:

In Reply to: Question about meds posted by Theresa on September 12, 2000 at 09:35:11:

: Has anyone heard of, or tried a medication called Seroquel? My eight year-old daughter's doctor has
: recommended it for her to help with her sleep problems. We have tried a number of other sleep aids,
: natural, herbal and medicinal, and so far nothing has helped very much. We feel we are being pressured somewhat into trying this even though it is not used for
: sleep problems by itself. It is marketed as a drug for schizophrenia. We aren't sure we are
: comfortable medicating her for symptoms she doesn't even have. Any information or comments would
: be very helpful. Thanks.
: Theresa

Dear Theresa:
I found the following information at

facts about Seroquel

• In September 1997, SEROQUEL was cleared for marketing by the US
Food and Drug Administration (FDA). SEROQUEL is an oral medication
indicated for the management of the manifestations of psychotic
disorders, including schizophrenia.

• SEROQUEL belongs to a new chemical class of atypical
antipsychotics known as dibenzothiazepine derivatives.

• Three, short-term (six weeks or less) controlled trials of psychotic
patients demonstrated that SEROQUEL is effective in treating both the
positive and negative symptoms associated with schizophrenia.

• Additionally, the incidence of extrapyramidal symptoms (EPS) with
SEROQUEL was no different from placebo across the clinical dose
range. Elevations in plasma prolactin levels among study participants in
the SEROQUEL groups were no different from the placebo-treated groups
across the clinical dose range.

• Studies showed SEROQUEL to exhibit a low incidence of
anticholinergic side effects (i.e., dry mouth, constipation) and no blood
monitoring is required.

• SEROQUEL is manufactured in the US and is currently available by
prescription throughout the US in strengths of 25 mg, 100 mg, and 200
mg tablets.

In one clinical trial, efficacy was demonstrated in a dose range of 150
mg/day to 750 mg/day. An initial target dose range of 300 - 400 mg can
be given in two divided doses daily. In other studies, doses in the range
of 400-800 mg/day were effective. A dosing regimen of two to three times
daily is recommended.

• The labeling for SEROQUEL (like other agents in its class) includes a
warning relative to a rare condition known as tardive dyskinesia, a
condition often associated with long term use of antipsychotic agents,
and neuroleptic malignant syndrome (NMS). Symptoms of NMS include
muscle rigidity or irregular pulse.

• Label precautions for SEROQUEL include orthostatic hypotension
(dizziness) and tachycardia (fast heartbeat). Also included is a
precaution for seizures. As with other antipsychotics, SEROQUEL
should be used cautiously in patients with a history of seizures or with
conditions that can potentially lower the seizure threshold.

• The most common adverse events exhibited across placebo-controlled
trials included somnolence (18%), headache (19%), and dizziness
(10%), and the majority of events rated as mild or moderate.

• The safety and effectiveness of SEROQUEL in pediatric patients less
than 18 years of age has not been established.

• Prior to the introduction of SEROQUEL, medications used to treat
schizophrenia include older, first-generation, "typical" agents (haloperidol)
and newer, atypical antipsychotics (clozapine, olanzapine, risperidone).

• SEROQUEL was discovered and developed by Zeneca
Pharmaceuticals, a business unit of Zeneca Inc., in its US research
laboratories in Wilmington, DE. Zeneca submitted a New Drug
Application (NDA) with the FDA for SEROQUEL tablets on July 29, 1996<<

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