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Citalopram (Citalopram Hydrobromide) - Indications and Dosage



Citalopram tablets are indicated for the treatment of depression.

The efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The antidepressant action of citalopram tablets in hospitalized depressed patients has not been adequately studied.

The efficacy of citalopram tablets in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


Initial Treatment

Citalopram tablets 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 teh 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended. Citalopram tablets 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. Citalopram tablets should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester

Neonates exposed to citalopram 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 citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram 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 citalopram tablets 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 citalopram tablets (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 citalopram tablets 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 Citalopram Tablets

Symptoms associated with discontinuation of citalopram 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 citalopram tablets therapy. Similarly, at least 14 days should be allowed after stopping citalopram tablets before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).


Citalopram tablets are supplied as:

10 mg TabletsPeach coloured, biconvex, round shaped film coated tablets debossed withA'on one side and05'on the other side.

Bottles of 30 NDC 65862-005-30
Bottles of 60 NDC 65862-005-60
Bottles of 90 NDC 65862-005-90
Bottles of 100 NDC 65862-005-01
Bottles of 500 NDC 65862-005-05
10 x 10 Unit Dose NDC 65862-005-10
30 Unit-of-use packaging NDC 65862-005-32

20 mg TabletsLight pink coloured, biconvex, capsule shaped film coated tablets debossed withA'on one side and with a score line in between0'and6'on other side.

Bottles of 30 NDC 65862-006-30
Bottles of 60 NDC 65862-006-60
Bottles of 90 NDC 65862-006-90
Bottles of 100 NDC 65862-006-01
Bottles of 500 NDC 65862-006-05
10 x 10 Unit Dose NDC 65862-006-10
30 Unit-of-use packaging NDC 65862-006-32

40 mg TabletsWhite coloured, biconvex, capsule shaped film coated tablets debossed withA'on one side and with a score line in between0'and7'on other side.

Bottles of 30 NDC 65862-007-30
Bottles of 60 NDC 65862-007-60
Bottles of 90 NDC 65862-007-90
Bottles of 100 NDC 65862-007-01
Bottles of 500 NDC 65862-007-05
10 x 10 Unit Dose NDC 65862-007-10
30 Unit-of-use packaging NDC 65862-007-32

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