SPC changes
Dexamethasone injection
The summary of product characteristics for dexamathasone injection 4mg/ml
and 8mg/2ml (Organon) now carries the warning “corticosteroids
should not be used for the management of head injury or stroke because
they are unlikely to be of benefit and it may even be harmful”.
The dosing instructions have also been changed to express the dose as
mg dexamethasone base instead of mg dexamethasone sodium phosphate. Organon
says that the composition of the products has not changed and no dose
adjustment is necessary. See SPC.
Elidel
The summary of product characteristics for Elidel (pimecrolimus; Novartis)
now includes alcohol intolerance (in most cases flushing, rash, burning,
itching or swelling shortly after the intake of alcohol) and allergic
skin reactions (eg, dermatitis, urticaria) as rare side effects. See
SPC.
Florinef
The summary of product characteristics for Florinef (fludrocortisone;
Bristol-Myers Squibb) now states that caution should be used in the
event of exposure to chickenpox, measles or other communicable diseases.
It says that chickenpox, shingles and measles are of particular concern
since these illnesses can be fatal in immunosuppressed patients. Patients
should be advised to avoid exposure to these diseases and seek medical
advice without delay if exposure occurs. See SPC.
Voltarol
Voltarol (diclofenac; Novartis) suppositories 12.5mg and 25mg are now
additionally indicated for use in children aged six years and over,
as monotherapy or as adjunct therapy with morphine or other opiates
for the relief of acute post operative pain. The dose for children
aged six to 12 years is 1–2mg/kg per day in divided doses. Treatment
should be limited to four days. See SPC.
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