citalopram tablet
INDICATIONS AND USAGE Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
camber pharmaceuticals
ROUND WHITE IG 208
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citalopram 40 mg
Exelan Pharmaceuticals Inc.
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HOW SUPPLIED Citalopram Tablets, USP 10 mg. They are supplied in Bottle of 30 NDC # 31722-206-30, Bottle of 100 NDC # 31722-206-01, Bottle of 500 NDC # 31722-206-05 and 1000 NDC # 31722-206-10 beige, film coated round, bi-convex tablets de-bossed with IG on one side and “ 206 ” on the other. 20 mg. They are supplied in Bottle of 30 NDC # 31722-207-30, Bottle of 100 NDC # 31722-207-01, Bottle of 500 NDC # 31722-207-05 and 1000 NDC # 31722-207-10 pink, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “ 207 ” on the other. 40 mg. They are supplied in Bottle of 30 NDC # 31722-208-30, Bottle of 100 NDC # 31722-208-01, Bottle of 500 NDC # 31722-208-05 and 1000 NDC # 31722-208-10 white, film coated, round, bi-convex tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “208” on the other. Store at 20°C to 25° C (68° F to 77° F) [see USP Controlled Room Temperature] ANIMAL TOXICOLOGY Retinal Changes in Rats Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with citalopram. There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day (13 times the maximum recommended daily human dose of 60 mg on a mg/m2 basis). Similar findings were not present in rats receiving 24 mg/kg/day for two years, in mice treated for 18 months at doses up to 240 mg/kg/day, or in dogs treated for one year at doses up to 20 mg/kg/day (4, 20, and 10 times, respectively, the maximum recommended daily human dose on a mg/m2 basis). Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established. Cardiovascular Changes in Dogs In a one-year toxicology study, 5 of 10 beagle dogs receiving oral doses of 8 mg/kg/day (4 times the maximum recommended daily human dose of 60 mg on a mg/m2 basis) died suddenly between weeks 17 and 31 following initiation of treatment. Although appropriate data from that study are not available to directly compare plasma levels of citalopram (CT) and its metabolites, demethylcitalopram (DCT) and didemethylcitalopram (DDCT), to levels that have been achieved in humans, pharmacokinetic data indicate that the relative dog-to-human exposure was greater for the metabolites than for citalopram. Sudden deaths were not observed in rats at doses up to 120 mg/kg/day, which produced plasma levels of CT, DCT, and DDCT similar to those observed in dogs at doses of 8 mg/kg/day. A subsequent intravenous dosing study demonstrated that in beagle dogs, DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs. This effect occurred in dogs at doses producing peak DDCT plasma levels of 810 to 3,250 nM (39 to 155 times the mean steady state DDCT plasma level measured at the maximum recommended human daily dose of 60 mg). In dogs, peak DDCT plasma concentrations are approximately equal to peak CT plasma concentrations, whereas in humans, steady state DDCT plasma concentrations are less than 10% of steady state CT plasma concentrations. Assays of DDCT plasma concentrations in 2,020 citalopram-treated individuals demonstrated that DDCT levels rarely exceeded 70 nM; the highest measured level of DDCT in human overdose was 138 nM. While DDCT is ordinarily present in humans at lower levels than in dogs, it is unknown whether there are individuals who may achieve higher DDCT levels. The possibility that DCT, a principal metabolite in humans, may prolong the QT interval in dogs has not been directly examined because DCT is rapidly converted to DDCT in that species. Rev: 12/14
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