citalopram tablet
INDICATIONS & USAGE Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram tablets, USP in the treatment of depression was established in 4 to 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, USP in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram tablets, USP 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, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
aurolife pharma llc
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Aurolife Pharma LLC
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HOW SUPPLIED Citalopram tablets, USP are supplied as: 10 mg Tablets – peach colored, biconvex, round shaped film coated tablets debossed with ‘A’ on one side and ‘05’ on the other side. Bottles of 30 NDC 13107-005-30 Bottles of 60 NDC 13107-005-60 Bottles of 90 NDC 13107-005-90 Bottles of 100 NDC 13107-005-01 Bottles of 500 NDC 13107-005-05 10 x 10 Unit Dose NDC 13107-005-10 30 Unit-of-use packaging NDC 13107-005-32 20 mg Tablets – Light pink colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘6’ on other side. Bottles of 30 NDC 13107-006-30 Bottles of 60 NDC 13107-006-60 Bottles of 90 NDC 13107-006-90 Bottles of 100 NDC 13107-006-01 Bottles of 500 NDC 13107-006-05 10 x 10 Unit Dose NDC 13107-006-10 30 Unit-of-use packaging NDC 13107-006-32 40 mg Tablets – white colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘7’ on other side. Bottles of 30 NDC 13107-007-30 Bottles of 60 NDC 13107-007-60 Bottles of 90 NDC 13107-007-90 Bottles of 100 NDC 13107-007-01 Bottles of 500 NDC 13107-007-05 10 x 10 Unit Dose NDC 13107-007-10 30 Unit-of-use packaging NDC 13107-007-32 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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