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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. A low starting dose is advised to reduce the likelihood of a paradoxical anxiogenic effect (see Dosage & Administration).
Hyponatraemia: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs. Especially elderly female patients seem to be a risk group.
Suicide: The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.
Patients being treated with antidepressants should be monitored carefully, especially at the beginning of treatment, for clinical worsening and/or the emergence of suicidality (suicidal ideation and behaviour).
This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.
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.
Seizures: Although animal experiments have shown that citalopram has no epileptogenic potential, it should, like other antidepressants, be used with caution in patients with a history of seizures.
Diabetes: As described for other psychotropics, citalopram may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients; in addition, the depressive illness itself may affect patients' glucose balance.
Serotonin syndrome: 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.
Haemorrhage: There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly with concomitant use of oral anticoagulants; drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole) as well as in patients with a history of bleeding disorders (see Interactions).
QT interval prolongation: Citalopram has been found to cause a dose-dependent prolongation of the QT interval. Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of the female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases. Dose escalations over 20 mg/day in CYP2C19 poor metabolisers or patients taking concomitant cimetidine or another CYP2C19 inhibitor are not recommended (see Contraindications, Interactions, Adverse Reactions, Overdosage, and Pharmacology: Pharmacodynamics under Actions).
Caution is advised in patients with significant bradycardia or in patients with recent acute myocardial infarction or uncompensated heart failure.
Electrolyte disturbances, such as hypokalaemia and hypomagnesaemia, increase the risk for malignant arrhythmias and should be corrected before treatment with citalopram is started. Caution is advised in treating patients with diseases or conditions that causes hypokalaemia or hypomagnesaemia.
If patients with stable cardiac diseases are treated, an ECG review should be considered before treatment is started.
If signs of cardiac arrhythmia occur during treatment with citalopram, the treatment should be withdrawn and an ECG should be performed.
Clinical experience with citalopram in patients with certain concomitant systemic illnesses is limited.
Withdrawal symptoms: After prolonged administration, abrupt cessation of SSRIs may produce withdrawal symptoms such as dizziness, paraesthesia, tremor, anxiety, nausea and palpitation in some patients. It is recommended that withdrawal of treatment should proceed by tapering off the dosage over one to two weeks to avoid occurrence of discontinuation symptoms. These symptoms are not indicative of addiction.
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 pre-disposed. Citalopram should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma.
Excipients: The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine.
Treatment of patients with reduced kidney and liver function: See Dosage & Administration.
Effects on ability to drive and use machines: Citalopram does not impair intellectual function and psychomotor performance. However, patients who are prescribed psychotropic medication may be expected to have some impairment of general attention and concentration and should be cautioned about their ability to drive a car and operate machinery.
Use in the Elderly: See Dosage & Administration.
Use in Children: Antidepressants 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 (predominately 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.
