Talk:Citalopram

Copyright
This text. Drug labels from what I understand are written by third parties and simply approved by the FDA. They are not written by the FDA and thus per my understanding are not under an open license. Doc James (talk · contribs · email) 10:42, 1 April 2019 (UTC)

"The mechanism of action of 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 , α1-, α2-, and β-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. "

Proposed changes
·Information to be added:

Suicide/suicidal thoughts or clinical worsening.

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

·Explanation of issue: At the top of the page, there is a mention to serious side effects related to suicide ("Serious side effects include an increased risk of suicide in those under the age of 25,"). This mention is a section of the SmPC and miss essential information related to Suicide/suicidal thoughts clinical worsening. It is important to include the full class label related to the SmPC as stated above with the below reference.

·References supporting change: https://www.medicines.ie/medicines/cipramil-10mg-tablets-31636/patient-info AudreyDufour (talk) 10:09, 5 February 2020 (UTC)

Reply 5-FEB-2020
Regards, Spintendo  20:21, 5 February 2020 (UTC)
 * Wikipedia is WP:NOT a package insert, and thus this expanded information from the product's PI is not necessary here in full. Several links to monographs and such are already included elsewhere in the article, such that expanding the text through this edit request allows no more information than what is already provided for the reader to access, if desired.