CITALOPRAM

Posology Adults:

Treatment of major depressive episodes Citalopram should be administered as a single oral dose of 20 mg daily. As with all antidepressant medicinal products, dosage should be reviewed and adjusted, if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.

1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. Dependent on individual patient response, the dose may be increased to a maximum of 40 mg daily. 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 to give adequate protection against the possibility of a relapse. Treatment of panic disorder A single oral dose of 10 mg is recommended for the first week before increasing the dose to 20 mg daily.

Dependent on individual patient response, the dose may be increased gradually in 10 mg steps to a maximum of 40 mg daily. e. 4). The first therapeutic effects usually appear after 2 – 4 weeks. Full therapeutic response may take up to 3 months to develop.

It may be necessary to continue treatment for several months. Documentation from clinical efficacy studies exceeding 6 months is insufficient. g. 10-20 mg daily. The recommended maximum dose for the elderly is 20 mg daily. 4).

Reduced hepatic function:

An initial dose of 10 mg 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 20 mg daily.

2). These patients should be clinically monitored.

Reduced renal function:

Dosage adjustment is not necessary for patients with mild to moderate renal dysfunction. ) is not recommended, as no information is available on use in these patients.

Poor metabolisers regarding CYP2C19:

An initial dose of 10 mg daily during the first two weeks of treatment is recommended for patients who are known to be poor metabolisers with respect to CYP2C19. 2). For the different dosage regimens suitable strengths should be prescribed.

Withdrawal symptoms seen on discontinuation of citalopram Abrupt discontinuation should be avoided. 8). If intolerable symptoms occur following a decrease in the dose or 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.

Adverse reactions observed with citalopram are in general mild and transient. They are most prominent during the first weeks of treatment and usually attenuate subsequently. The adverse reactions are presented at the MedDRA Preferred Term Level.

For the following reactions a dose-response was discovered:

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

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1,000-to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (<1/10,000), not known (cannot be estimated from available data). 4 Ear and labyrinth disorders Common Tinnitus Very common Palpitations Cardiac disorders Common Tachycardia Uncommon Bradycardia Not known Ventricular arrhythmia including torsade de pointes, QT- prolongation on ECG2 Common Hypotension, hypertension, orthostatic hypotensionVascular disorders Rare Haemorrhage Common Yawning, rhinitis, sinusitis Uncommon Coughing Respiratory, thoracic and mediastinal disorders Not known Epistaxis (nose bleeding) Very common Dry mouth, nausea, constipation Common Diarrhoea, vomiting.

6). 4). 1). Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. Withdrawal symptoms seen on discontinuation of SSRI treatment Discontinuation of citalopram (particularly when abrupt) commonly leads to withdrawal symptoms.

Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions.

Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

2). 2). Paediatric Population Use in children and adolescents under 18 years of age 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 usually subsides within the first two weeks of starting treatment. . 2).

Hyponatraemia Hyponatraemia, possibly caused by syndrome of inappropriate secretion of antidiuretic hormone (SIADH), has been reported as a rare adverse reaction with the use of SSRIs; this reaction usually reverses upon treatment withdrawal.

The risk seems to be higher in older women. 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.

Other psychiatric conditions for which citalopram is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

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.

Akathisia/psychomotor restlessness The use of SSRIs/SNRIshas been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.

This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Mania In patients with manic-depressive illness a change towards the manic phase may occur.

Should the patient enter a manic phase citalopram should be discontinued. 8). In a recurrence prevention clinical trial with citalopram, adverse events after discontinuation of active treatment were seen in 40% patients versus 20% in patients continuing citalopram.

The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia and electrical sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions.

Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.

Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). 2).

Diabetes:

In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Angle-Closure Glaucoma SSRIs including citalopram may have an effect on pupil size resulting in mydriasis.

This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients […]

1. 5). 5). • 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).