Strattera hard capsules (Atomoxetine hydrochloride)-Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Atomoxetine hydrochloride, Strattera

Date published: 17/11/2011 15:59

Type of SPC Change: Revised SPC

Generic drug name: Atomoxetine hydrochloride

Drug brand name: Strattera

Legal status: POM - Black Triangle

Pharmaceutical manufacturer: Eli Lilly & Company Limited

Summary
by: Atisha Sharma

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

 

Change to section 4.4 - Special warnings and precautions for Use

 

Addition to hepatic effects. Strattera should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

 

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

 

CYP2D6 inhibitors (SSRIs (e.g. fluoxetine, paroxetine), quinidine, terbinafine): In patients receiving these drugs, atomoxetine exposure may be 6-to 8-fold increased and Css max 3 to 4 times higher, because it metabolised by the CYP2D6 pathway. Lower titration and final lower dosage of atomoxetine may be necessary in patients who are already taking CYP2D6 inhibitor drugs.

 

Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold (such as tricyclic antidepressants or SSRIs, neuroleptics, phenothiazines or butyrophenone, mefloquine, chloroquine, buproprion or tramadol). (see section 4.4). 

 

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

 

SPC

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