Citalopram (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/582

Statements in which the resource exists as a subject.
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Citalopram (Tablet, Film Coated)
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Medication Guide: 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
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Initial Treatment:<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester:<br/>Maintenance Treatment:<br/>Discontinuation of Treatment with Citalopram Tablets:<br/>Switching Patients To or From a Monoamine Oxidase Inhibitor:
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Pharmacodynamics:<br/>Pharmacokinetics:<br/>Absorption and Distribution:<br/>Metabolism and Elimination:<br/>Population Subgroups:<br/>Drug-Drug Interactions:<br/>Clinical Efficacy Trials:<br/>Comparison of Clinical Trial Results:
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ANIMAL TOXICOLOGY:<br/>Retinal Changes in Rats:<br/>Cardiovascular Changes in Dogs:
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BOXED WARNING:
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General:<br/>Discontinuation of Treatment with Citalopram Tablets:<br/>Abnormal Bleeding:<br/>Hyponatremia: Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including citalopram. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk (see Geriatric Use). Discontinuation of citalopram should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.<br/>Activation of Mania/Hypomania:<br/>Seizures:<br/>Interference with Cognitive and Motor Performance:<br/>Use in Patients with Concomitant Illness:<br/>Information for Patients:<br/>Laboratory Tests:<br/>Drug Interactions: Serotonergic Drugs Based on the mechanism of action of SNRIs and SSRIs including citalopram and the potential for serotonin syndrome, caution is advised when citalopram is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort . The concomitant use of citalopram with other SSRIs, SNRIs or tryptophan is not recommended . Triptans There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of citalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases .<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Carcinogenesis:<br/>Mutagenesis:<br/>Impairment of Fertility:<br/>Pregnancy: Pregnancy-Nonteratogenic Effects<br/>Labor and Delivery:<br/>Nursing Mothers:<br/>Pediatric Use:<br/>Geriatric Use: SSRIs and SNRIs, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event .
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Human Experience:<br/>Management of Overdose:
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Citalopram hydrobromide
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Citalopram (Tablet, Film Coated)
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Adverse Findings Observed in Short-Term, Placebo-Controlled Trials:<br/>Adverse Events Associated with Discontinuation of Treatment:<br/>Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients: Events reported by at least 2% of patients treated with citalopram tablets are reported, except for the following events which had an incidence on placebo���citalopram tablets: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain.<br/>Dose Dependency of Adverse Events:<br/>Male and Female Sexual Dysfunction with SSRIs:<br/>Vital Sign Changes:<br/>Weight Changes:<br/>Laboratory Changes:<br/>ECG Changes:<br/>Other Events Observed During the Premarketing Evaluation of Citalopram Tablets:<br/>Other Events Observed During the Postmarketing Evaluation of Citalopram Tablets:
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WARNINGS-Clinical Worsening and Suicide Risk:<br/>Clinical Worsening and Suicide Risk:<br/>Screening Patients for Bipolar Disorder:<br/>Potential for Interaction with Monoamine Oxidase Inhibitors:<br/>Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including citalopram treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of citalopram with MAOIs intended to treat depression is contraindicated If concomitant treatment of citalopram with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases . The concomitant use of citalopram with serotonin precursors (such as tryptophan) is not recommended .
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Citalopram