SPC changes
Cerazette
The “missed pill window” for Cerazette (desogestrel) has
been extended (Organon). The summary of product characteristics now states
that contraceptive protection may be reduced if more than 36 hours have
elapsed between two tablets. If the user is less than 12 hours late in
taking any tablet, the missed tablets should be taken as soon as it is
remembered and the next tablet should be taken at the usual time. If
she is more than 12 hours late, she should use an additional method of
contraception for the next seven days. See SPC.
Epilim
The summaries of product characteristics for Epilim (sodium valproate),
Epilim Chrono and Epilim intravenous have been updated (Sanofi-Synthelabo).
A section on sodium valproate use in patients with hepatic insufficiency
has been added, stating that salicylates should not be used concomitantly
with valproate since they employ the same metabolic pathway. The SPCs
state that liver dysfunction, including hepatic failure resulting in
fatalities has occurred in patients whose treatment included valproic
acid. The concomitant use of salicylates should be avoided in children
under three years old due to the risk of liver toxicity. This is in
addition to the warning that salicylates should not be used in children
under 16 years old. See SPCs.
Etopophos
The summary of product characteristics for Etopophos (etoposide phosphate)
injection now states that caution should be exercised when administering
it with drugs that are known to inhibit phosphatase activities, eg
levamisole hydrochloride (Bristol-Myers Squibb). High dose cyclosporin
administered with oral etoposide has led to an increase in etoposide
exposure. In childen, elevated SGPT levels are associated with reduced
drug total body clearance. Prior use of cisplatin may also result in
a decrease of etoposide total body clearance in children. The SPC now
states that etoposide can cause fetal harm when administered to pregnant
women. If the drug is used during pregnancy, or if the patient becomes
pregnant while receiving it, the patient should be told of the potential
hazard to the fetus. It is not known whether etoposide is excreted
in human milk and a decision should be made whether to discontinue
nursing or to discontinue etoposide. See SPC.
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