DOSAGE AND ADMINISTRATION
Initial Treatment
Celexa (citalopram HBr) should be administered at an initial dose
of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose
increases should usually occur in increments of 20 mg at intervals of no less
than one week. Although certain patients may require a dose of 60 mg/day, the
only study pertinent to dose response for effectiveness did not demonstrate an
advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are
therefore not ordinarily recommended.
Celexa should be administered once daily, in the morning or evening, with or
without food.
Special Populations
20 mg/day is the recommended dose for most elderly patients and
patients with hepatic impairment, with titration to 40 mg/day only for
nonresponding patients.
No dosage adjustment is necessary for patients with mild or moderate renal
impairment. Celexa should be used with caution in patients with severe renal
impairment.
Treatment of Pregnant Women During the Third
Trimester
Neonates exposed to Celexa and other SSRIs or SNRIs, late in the
third trimester, have developed complications requiring prolonged
hospitalization, respiratory support, and tube feeding (see
PRECAUTIONS). When treating pregnant women with Celexa
during the third trimester, the physician should carefully consider the
potential risks and benefits of treatment. The physician may consider tapering
Celexa in the third trimester.
Maintenance Treatment
It is generally agreed that acute episodes of depression require
several months or longer of sustained pharmacologic therapy. Systematic
evaluation of Celexa in two studies has shown that its antidepressant efficacy
is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial
treatment (32 weeks total). In one study, patients were assigned randomly to
placebo or to the same dose of Celexa (20-60 mg/day) during maintenance
treatment as they had received during the acute stabilization phase, while in
the other study, patients were assigned randomly to continuation of Celexa 20 or
40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates
of relapse to depression were similar for the two dose groups (see
Clinical Trials
under
CLINICAL PHARMACOLOGY). Based on these limited data, it is
not known whether the dose of citalopram needed to maintain euthymia is
identical to the dose needed to induce remission. If adverse reactions are
bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Celexa
Symptoms associated with discontinuation of Celexa and other
SSRIs and SNRIs have been reported (see
PRECAUTIONS). Patients should be monitored for these
symptoms when discontinuing treatment. A gradual reduction in the dose rather
than abrupt cessation is recommended whenever possible. If intolerable symptoms
occur following a decrease in the dose or upon discontinuation of treatment,
then resuming the previously prescribed dose may be considered. Subsequently,
the physician may continue decreasing the dose but at a more gradual rate.
Switching Patients To or From a Monoamine Oxidase
Inhibitor
At least 14 days should elapse between discontinuation of an MAOI
and initiation of Celexa therapy. Similarly, at least 14 days should be allowed
after stopping Celexa before starting an MAOI (see
CONTRAINDICATIONS
and
WARNINGS).
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