Adult

Depression

A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse.

Panic disorder

Initial dose: 10mg once a day.
Dose may be increased gradually in 10mg steps, if considered necessary, to the recommended optimum dose of 20mg to 30mg a day.
Maximum daily dose should not exceed 40mg.

Dependant on individual patient response it may be necessary to continue treatment for several months to ensure that they are free from symptoms.

Elderly

Depression

10mg to 20mg once a day. Improvement may become more evident within the second week of treatment.
Maximum daily dose should not exceed 20mg.
A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse.

Panic disorder

A low starting dose is recommended in order to reduce the likelihood of a paradoxical anxiogenic effect.
Initial dose: 10mg once a day.
Dose may be increased gradually in 10mg steps, if considered necessary.
Maximum daily dose should not exceed 20mg.

Major depression

Children 12 to 18 years (unlicensed)

10mg once a day.
Dose may be increased in 20mg steps at intervals of 2 to 4 weeks.
Maximum daily dose should not exceed 40mg.

Contraindications

Children under 12 years
Family history of long QT syndrome
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Long QT syndrome
Mania
Uncontrolled epileptic disorder

Precautions and Warnings

Children aged 12 to 18 years
Electroconvulsive therapy
Patients over 65 years
Predisposition to narrow angle glaucoma
Suicidal ideation
CYP2C19 poor metaboliser genotype
Diabetes mellitus
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of coagulopathy
History of hypomania
History of mania
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Psychiatric disorder
Recent myocardial infarction
Renal impairment - creatinine clearance below 20ml/minute
Severe bradycardia
Uncontrolled cardiac failure

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain lactose
Discontinue treatment if patient develops seizures
Monitor ECG in patients at risk of QT prolongation
Monitor patients for adverse reactions including restlessness & agitation
Monitor patients with epilepsy while taking this treatment
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Do not increase dosage in patients who develop akathisia
Increased risk of fractures in patients over 50 years
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Discontinue at first sign of arrhythmia - perform ECG
Discontinue if patient enters a manic phase
Discontinue if serotonin syndrome develops
Reduce dose in elderly
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise patient concurrent illicit drug use may cause serious adverse effect

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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.

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, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.

Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition. If serotonin syndrome occurs treatment with citalopram should be discontinued immediately and symptomatic treatment be initiated. If citalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan, caution is advisable.

Review ECG before treatment is started in patients with stable cardiac disease. Monitor ECG in case of overdose or in conditions of altered metabolism with increased peak levels e.g. liver impairment. If signs of cardiac arrhythmia occur during treatment, withdraw treatment and perform an ECG.

In patients receiving SSRIs or TCAs, mainly those aged 50 years or older, a review of epidemiological studies showed an increased risk of bone fractures in these patients. The mechanism leading to this increased risk is unclear.

Depressive illness in children and adolescents
The CSM has advised that the balance of risks and benefits for the treatment of depressive illness in individuals under 18 years is considered unfavourable for the SSRIs citalopram, escitalopram, paroxetine and sertraline, and for mirtazapine and venlafaxine. Clinical trials have failed to show efficacy and have shown an increase in harmful outcomes. However, it is recognised that specialists may sometimes decide to use these drugs in response to individual clinical need; children and adolescents should be monitored carefully for suicidal behaviour; self harm or hostility, particularly at the beginning of treatment.

Only fluoxetine has been shown in clinical trials to be effective for treating depressive illness in children and adolescents. However, it is possible that, in common with other SSRIs, it is associated with a small risk of self-harm and suicidal thoughts. Over all, the balance of risks and benefits for fluoxetine in the treatment of depressive illness in individuals under 18 years is considered favourable, but children and adolescents must be carefully monitored.

Hyponatraemia and antidepressant therapy
Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants; however, it has been reported more frequently with SSRIs than with other antidepressants. The CSM has advised that hyponatraemia should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant.

Suspected drug interaction with cocaine
The MHRA advises there is a suspected drug interaction between citalopram and cocaine after a death of a patient. There are plausible mechanisms for an interaction between cocaine and citalopram that could lead to subarachnoid haemorrhage, including hypertension related to cocaine and an additive increased risk of bleeding in combination with citalopram. An adequate history should be obtained from the patient which considers recent use of other medicines including non-prescription medicines, herbal medicines, legal drugs and medicines purchased online. Possible interactions with illicit drugs should be considered in patients who present with suspected adverse reactions.

Pregnancy and Lactation

Pregnancy

Use citalopram with caution during pregnancy.

The safety of citalopram in human pregnancy has not been established; use only if the potential benefit outweighs the risk.

SSRI antidepressants, including citalopram, have been associated with several developmental toxicities, including spontaneous abortions (SABs), low birth weight, prematurity, neonatal behavioural syndrome (withdrawal), possible sustained abnormal neurobehaviour beyond the neonatal period, respiratory distress and persistent pulmonary hypertension of the newborn (PPHN). However, although the data are still limited, citalopram does not appear to be a major human teratogen and the inadvertent use of any SSRI does not require termination of pregnancy.

Schaefer suggests that a pregnant patient who is stable with a second-choice antidepressant should not be changed to another drug, because this may worsen her health. A detailed ultrasonography may be offered. Regular psychiatric and obstetric care is recommended to diagnose in time a relapse or pregnancy complications (intrauterine growth retardation, premature contractions).

In the later stages of pregnancy, epidemiological data suggest that the use of SSRIs may increase the risk of persistent pulmonary hypertension in the newborn. After birth, close observation of neonates exposed to SSRIs or SNRIs for signs of PPHN is recommended. SSRIs may also increase the risk of postpartum haemorrhage within the month prior to birth.

The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later stages of pregnancy, respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms may be due to either the serotoninergic effects or discontinuation symptoms. In the majority of instances the complications occur immediately or soon after birth. After SSRI treatment near term, it is important to be aware of an increased haemorrhagic tendency in the newborn.

During pregnancy maternal drug concentrations of citalopram may be lower than in non-pregnant women, and could lead to therapeutic failure. The database of the world health organisation (WHO) was used in a 2005 report on neonatal SSRI withdrawal syndrome. Of 93 suspected cases with either neonatal convulsions or withdrawal syndrome, 7 were linked to citalopram. (For comparison: 64 suspected cases were linked to paroxetine, 14 to fluoxetine and 9 to sertraline.)

A large amount of data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foetal or neonatal toxicity.

Animal reproduction studies have shown reduced fertility, foetal growth retardation, reduced survival and teratogenicity at very high doses.

Neonates should be observed if the maternal use of citalopram continues into the later stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should be avoided in pregnancy due to the risk of neonatal withdrawal symptoms. Observation of the neonate for withdrawal symptoms or adaptation problems for at least 2 days is recommended when SSRIs have been used up to delivery. To prevent neonatal adaptation disorders, dose reduction or even treatment interruption in the days immediately preceding delivery can be discussed with the patient if the clinical course allows. However, to prevent a relapse at this vulnerable stage, pre-pregnancy dosage should be started immediately after delivery.

Lactation

Citalopram is contraindicated during breastfeeding.

The safety of citalopram in breastfeeding has not been established. Manufacturers recommend that breastfeeding should be discontinued if treatment is considered necessary.

Citalopram is known to be excreted in breast milk and estimates of the dose a nursing infant may ingest range from 0.7% to 5.9% of the weight-adjusted maternal dose. The effects on the nursing infant are unknown but may be of concern because of the potential for toxicity.

Various case reports describe the effects on infants exposed to citalopram through lactation. Adverse affects on infants from citalopram exposure are low varying from no untoward effects to disruption of sleep patterns, restlessness, irritability, colic, somnolence, decreased feeding and weight loss.

Side Effects

Abdominal pain
Aggression
Agitation
Akathisia
Alopecia
Altered liver function tests
Amnesia
Anaphylactoid reaction
Angioedema
Anorexia
Anxiety
Apathy
Arthralgia
Asthenia
Bradycardia
Bruxism
Confusion
Constipation
Cough
Depersonalisation
Diarrhoea
Disturbances in accommodation
Disturbances of appetite
Dizziness
Dream abnormalities
Drowsiness
Dry mouth
Dyspepsia
Ecchymosis
Epistaxis
Euphoria
Extrapyramidal effects
Fatigue
Flatulence
Galactorrhoea
Gastrointestinal bleeding
Haemorrhage
Hallucinations
Headache
Hepatitis
Hostility
Hypersalivation
Hypersensitivity reactions including anaphylaxis
Hypokalaemia
Hypomania
Hyponatraemia
Impaired concentration
Impaired vision
Inappropriate secretion of antidiuretic hormone
Increased risk of fractures
Increased sweating
Insomnia
Malaise
Mania
Menorrhagia
Metrorrhagia
Micturition disorders
Migraine
Movement disturbances
Myalgia
Mydriasis
Narrow angle glaucoma
Nausea
Nervousness
Oedema
Palpitations
Panic attack
Paraesthesia
Photosensitivity
Postpartum haemorrhage
Postural hypotension
Prolongation of QT interval
Pruritus
Psychomotor restlessness
Purpura
Pyrexia
Rash
Rhinitis
Seizures
Serotonin syndrome
Sexual dysfunction
Sleep disturbances
Somnolence
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urticaria
Vasculitis
Ventricular arrhythmias
Visual disturbances
Vomiting
Weight changes
Withdrawal symptoms
Yawning