Buccastem 3mg (Prochlorperazine Buccal)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Prochlorperazine

Date published: 20/01/2012 15:03

Generic drug name: Prochlorperazine

Drug brand name: Buccastem

Legal status: POM

Summary
by: Syed Ali


There have been significant updates to several sections of the SPC, including the following:



 

Change to section 4.6- Pregnancy and lactation

 

Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

 

Please refer to SPC link below for full information on all changes.

SPC

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