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Lyrica approved for GAD in UK - dosing guidelines

Posted by ed_uk on April 25, 2006, at 15:42:07

The official UK data sheet for Lyrica is now available online.

The recommended dose for GAD (generalised anxiety disorder) is as follows....

Generalised Anxiety Disorder

The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Lyrica may be taken with or without food.

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week. Following an additional week the dosage may be increased to 450 mg per day. The maximum dosage of 600 mg per day may be achieved after an additional week.

Information RE withdrawal symptoms is provided....

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness. The patient should be informed about this at the start of the treatment.

Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.

Information RE clinical trials in GAD.....

Generalised Anxiety Disorder

Pregabalin has been studied in 6 controlled studies of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration.

Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.

In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.

The full data sheet is available here.....

http://emc.medicines.org.uk/emc/industry/default.asp?page=displaydoc.asp&documentid=14651

Ed


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