Cipram

Cipram Special Precautions

citalopram

Manufacturer:

Lundbeck

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Cipram should not be used in the treatment of children and adolescents <18 years. Suicide related behaviours (suicide attempts 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 patients should be carefully monitored for the appearance of suicidal symptoms.
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) or unusual changes in behavior.
Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.
As with other SSRIs, citalopram should not be given to patients receiving MAOIs. Treatment with citalopram may be instituted 14 days after discontinuation of nonselective MAOIs and minimum 1 day after discontinuation of moclobemide and selegiline. Treatment with MAOIs may be introduced 7 days after discontinuation of citalopram. Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs. Especially elderly patients seems to be a risk group. After prolonged administration, abrupt cessation of SSRIs may produce withdrawal symptoms eg, dizziness, paraesthesia, tremor, anxiety, nausea and palpitation in some patients. It is recommended that discontinuation of treatment should proceed by tapering off the dosage over 1-2 weeks to avoid occurrence of withdrawal symptoms. These symptoms are not indicative of addiction.
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. 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.
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.
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.
Effects on the Ability to Drive or Operate Machinery: Citalopram does not impair intellectual functions and psychomotor performance. However, patients who are prescribed psychotropics 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 pregnancy & lactation: Clinical experience of the use of citalopram in pregnant women is limited. Reproduction toxicity studies have not given evidence of an increased incidence of fetal damage or other deleterious effects on the reproductive process. Citalopram is secreted into breastmilk. It is estimated that the suckling infant will receive about 5% of the weight related maternal daily dose (mg/kg). No or only minor events have been observed in the infants. However, the existing information is sufficient for assessment of the risk to the child. Caution is recommended.
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