SPC changes
Cipralex
The summary of product characteristics for Cipralex (escitalopram; Lundbeck)
has been updated to include an additional indication for the treatment
of generalised anxiety disorder. The usual dosage for this indication
is 10mg once daily. Depending on individual patient response, the dose
may be increased to a maximum of 20mg daily. See SPC.
Cozaar
Cozaar (losartan; Merck Sharp & Dohme) is now indicated for the treatment
of hypertension for children and adolescents from six to 16 years old.
The summary of product characteristics states that there are limited
data on the efficacy and safety of losartan in this group. For patients
who can swallow tablets, the recommended dose is 25mg once daily for
patients weighing 20 to 50kg. The dose can be increased to a maximum
of 50mg once daily. In patients >=50kg, the starting dose is 50mg
once daily, with a maximum of 100mg daily. Losartan is not recommended
for children with a glomerular filtration rate of <30ml/min/1.73m2 or for those with hepatic impairment.
Femara
The summary of product characteristics for Femara (letrozole; Novartis)
has been updated to include an additional indication for the adjuvant
treatment hormone receptor-positive invasive early breast cancer in
postmenopausal women. In the adjuvant setting, treatment with Femara
should continue for five years or until tumour relapse occurs, whichever
comes first. During treatment with Femara, women with osteoporosis
or at risk of osteoporosis should have their bone mineral density formally
assessed by bone densitometry, eg dual energy x-ray absorptiometry.
See SPC.
Reyataz
The summary of product characteristics for Reyataz (atazanavir; Bristol-Myers
Squibb) has been updated. It now states that concomitant administration
of Reyataz/ritonavir with fluticasone or other glucocorticoids that
are metabolised by CYP3A4 is not recommended unless the potential benefits
of treatment outweigh the risk of systemic corticosteroid effects.
It adds that a dose reduction of glucocorticoid should be considered,
or a switch to a glucocorticoid which is not affected by CYP3A4, eg,
beclometasone. The SPC says that the absorption of atazanavir may be
reduced when gastric pH is increased. It recommends that Reyataz with
ritonavir should be taken with food, two hours before and at least
10 hours after administration of an H2 receptor antagonist. See SPC.
Correction
Cozaar (losartan; Merck Sharp & Dohme) does not have a new indication for use in children as stated above. However, information regarding its use in children has been added to the summary of product characteristics. |
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