CITALOPRAM

Posology Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. Treatment should continue until the patient has been free of symptoms for 4-6 months. Citalopram should be withdrawn slowly; it is advised that the dose is gradually reduced over 1-2 week periods.

4). Adults The recommended starting dose is 20 mg per day. If necessary, the dose can be increased to a maximum of 40 mg per day, depending on the individual response of the patient. g. 10-20 mg daily. Depending on the individual response of the patient, the dose can be increased.

The recommended maximum dose for the elderly is 20 mg daily. Hepatic impairment An initial dose of 10mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to a maximum of 20mg daily.

Caution and extra careful diose titration is advised in patients with severely reduced hepatic function. Renal impairment Dosage adjustment is not necessary for patients with mild to moderate renal dysfunction. 2). Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19 an initial dose of 10 mg daily during the first two weeks of treatment is recommended.

2). Withdrawal symptoms seen on discontinuation of SSRI treatment Abrupt discontinuation should be avoided. 8). If intolerable symptoms occur following a decrease in the dose upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.

Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Method of administration Citalopram should be administered as a single oral dose, either in the morning or in the evening. The tablets can be taken with or without food, but with fluid.

The tablet can be divided into two equal doses.

Undesirable reactions observed with citalopram are in general mild and transient. They are most prominent during the first one or two weeks of treatment and usually attenuate subsequently.

For the following reactions a dose-response was discovered:

Sweating increased, dry mouth, insomnia, somnolence, diarrhoea, nausea and fatigue. Treatment emergent adverse events associated with SSRIs and/or citalopram seen in either ≥ 1% of patients in double-blind placebo-controlled trials or in the post-marketing period.

The following undesirable effects have been reported at the approximate frequencies shown: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (≤ 1/10000), not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reation Blood and lymphatic disorders Not known Thrombocytopenia Immune system disorders Not known Hypersensitivity, anaphylactic reaction Endocrine disorders Not known Inappropriate ADH secretion, hyperprolactinaemia Common Appetite decreased, weight decreased Uncommon Appetite increased, weight increased Rare Hyponatraemia Metabolism and nutrition disorders Not known Hypokalaemia Psychiatric disorders Common Agitation, nervousness, libido decreased, abnormal orgasm (female), anxiety, confusional state, anorexia, apathy, sleep disorders, abnormal dreams, amnesia Uncommon Aggression, depersonalisation, hallucination, mania, euphoria, increased libido Not known Panic attack, bruxism, restlessness, suicidal ideation, suicidal behaviour1 Very common Somnolence, insomnia, headache Common Tremor, paraesthesia, dizziness, disturbance in attention, migraine Uncommon Syncope Rare Convulsion grand mal, dyskinesia, tremor, taste disturbance Nervous system disorders Not known Convulsion, serotonin syndrome, extrapyramidal disorder, akathisia, movement disorder Very common Abnormal accommodation Uncommon Mydriasis Eye disorders Not known Visual disturbance Ear and labyrinth disorders Common Tinnitus Very common Palpitations Uncommon Bradycardia, tachycardia Cardiac disorders Not known Electrocardiogram QT prolonged, supraventricular and ventricular arrhythmia including Torsade de pointes Common Hypotension, hypertension Rare Haemorrhage (for example, gynaecological haemorrhage, gastrointestinal haemorrhage, ecchymosis and other forms of skin haemorrhage or bleeding in the mucous membranes) can occur on rare occasions Vascular disorders Not known Orthostatic hypotension Common Yawning, rhinitis, sinusitis Uncommon Coughing Respiratory, thoracic and mediastinal disorders Not known Epistaxis Very common Dry mouth, nausea Common Diarrhoea, constipation, vomiting.

2). 2). Paediatric population Citalopram should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.

If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Paradoxical anxiety Some patients with panic disorder may experience intensified anxiety symptoms at the start of treatment with antidepressants. This paradoxical reaction usually subsides within the first two weeks of starting treatment.

2). Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs and generally reverse on discontinuation of therapy. Elderly female patients seem to be at particularly high risk.

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 a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

1. • Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. 5). • MAOIs (monoamine oxidase inhibitors) Some cases presented with features resembling serotonin syndrome. • Citalopram should not be given to patients receiving Monoamine Oxidase Inhibitors (MAOIs) including selegiline in daily doses exceeding 10 mg/day.

Citalopram should not be given for fourteen days after discontinuation of an irreversible MAOI or for the time specified after discontinuation of a reversible MAOI (RIMA) as stated in the prescribing text of the RIMA. 5). 5).