Celexa (citalopram HBr) is indicated for the treatment of depression.
The efficacy of Celexa 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.
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 Celexa in hospitalized depressed patients has not been adequately studied.
The efficacy of Celexa 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 CelexaTM for extended periods should periodically re-evaluate the long term usefulness of the drug for the individual patient.
The mechanism of action of Celexa (citalopram HBr) as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from its inhibition of CNS neuronal reuptake of serotonin (5 HT) In vitro and in vivo studies in animals suggest that citalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake Tolerance to the inhibition of 5 HT uptake is not induced by long term (14 day) treatment of rats with citalopram. Citalopram is a racemic mixture (50/50), and the inhibition of 5-HT reuptake by citalopram is primarily due to the (S)-enantiomer. Citalopram has no or very low affinity for 5-HT1A, 5-HT2A, dopamine D1 and D2, apha1-, alpha2-, and beta-adrenergic histamine H1, gamma aminobutyric acid (GABA) muscarinic cholinergic, and benzodiazepine receptors. Antagonism of muscarinic, histaminergic and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative and cardiovascular effects of other psychotropic drugs.
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. Celexa 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.
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.
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 CelexaTM 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. 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.
At least 14 days should elapse between discontinuation of an M.O. and initiation of Celexa therapy. Similarly at least 14 days should be allowed after stopping CelexaTM before starting a M.O.
Although there were no reports of fatal citalopram overdose in Celexa clinical trials involving overdoses of up to 2000 mg, postmarketing reports of drug overdoses involving citalopram have included 12 fatalities, 10 in combination with other drugs and/or alcohol and 2 with citalopram alone (3920 mg and 2800 mg), as well as non-fatal overdoses of up to 6000 mg. Symptoms most often accompanying Celexa (citalopram) overdose, alone or in combination with other drugs and/or alcohol, included dizziness, sweating, nausea, vomiting, tremor, somnolence, and sinus tachycardia. In more rare cases, observed symptoms included amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis, and ECG changes (including QTc prolongation nodal rhythm ventricular arrhythmia and one possible case of Torsades de pointes).
Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of citalopram, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for Celexa .
In managing Celexa overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.
Concomitant use in patients taking monoamine oxidase inhibitors (MAOI's) is contraindicated.
Celexa is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in CelexaTM.
Patients should be told that, although Celexa has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of Celexa and alcohol in depressed patients is not advised.
| Bottle of 30 | NDC # 0456-4020-30 |
| Bottle of 100 | NDC # 0456-4020-01 |
| Bottle of 500 | NDC # 0456-4020-05 |
| 10 x 10 Unit Dose | NDC # 0456-4020-63 |
Pink, oval, scored film coated.
Imprint on scored side with "F" on the left side and "P" on the right side.
Imprint on the non-scored side with "20 mg".
| Bottle of 30 | NDC # 0456-4040-30 |
| Bottle of 100 | NDC # 0456-4040-01 |
| Bottle of 500 | NDC # 0456-4040-05 |
| 10 x 10 Unit Dose | NDC # 0456-4040-63 |
White, oval, scored film coated.
Imprint on scored side with "F" on the left side and "P" on the right side.
Imprint on the non scored side with "40 mg".