Special populations
Pregnancy and breast populations
Reproductive studies in animals have demonstrated no risk during pregnancy, nor has there been any evidence to suggest that there is any risk to the embryo or fetus during pre- or post-natal development (data on file). However, there are very few clinical data available on the use of escitalopram in pregnant women. Administration of Cipralex to pregnant women should therefore be undertaken with caution.
Children
While the results from a single study did show some indication that Cipralex may be effective in treating childhood and adolescent depression and is safe and well tolerated, the data are limited and Lundbeck does not recommend the use of Cipralex in this population. (ref.1)
The elderly
Because of a somewhat prolonged Cipralex half-life and reduced clearance in patients >65 years, it is recommended to initiate treatment with half the usual recommended dose and to consider a lower maximal dose than in younger patients.
Hepatic insufficiency
In patients with mild or moderate hepatic impairment, the half-life of Cipralex was found to be twice as long, and exposure approximately 60% higher than in patients with normal liver function. An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on the patient response, the dose may be increased to 10 mg. (ref.2)
Renal insufficiency
Dosage adjustment is not necessary in patients with mild to moderate renal impairment. Caution is advised in patients with severely reduced (CLCR <30 ml/min) renal function.
Diabetes
In diabetic patients, treatment with SSRIs may alter glycaemic control. Such reports are, however, extremely rare (citalopram < 1/1 000 000 patients) (data on file). (ref.3)
References:
1. Wagner et al., 2004
2. Areberg et al., 2005
3. Goodnick et al.,1995