SPC changes
Co-Diovan
The summary of product characteristics for Co-Diovan (valsartan/hydrochlorothiazide;
Novartis) has been updated. It now states that when angiotensin II antagonists
are administered simultaneously with non-steroidal anti-inflammatory
drugs, attenuation of the antihypertensive effect may occur. It also
now says that concomitant use of angiotensin II antagonists and NSAIDs
may lead to an increased risk of worsening renal function, including
possible acute renal failure and an increase in serum potassium, especially
in patients with poor pre-existing renal function, that this combination
should be administered with caution, especially in the elderly, and that
patients should be adequately hydrated and consideration should be given
to monitoring renal function after initiation of concomitant therapy,
and periodically thereafter. See SPC.
Diovan
The summary of product characteristics for Diovan (valsartan; Novartis)
has been updated. It now states that when angiotensin II antagonists
are administered simultaneously with non-steroidal anti-inflammatory
drugs, attenuation of the antihypertensive effect may occur, that the
combination should be administered with caution, especially in the
elderly, and that patients should be adequately hydrated and consideration
should be given to monitoring renal function after initiation of concomitant
therapy, and periodically thereafter. It also now says that reversible
increases in serum lithium concentrations and toxicity have been reported
during concomitant administration of lithium with angiotensin converting
enzyme inhibitors and with angiotensin II receptor antagonists. Co-administration
of lithium and valsartan should be undertaken with caution and, if
this combination proves essential, serum lithium level monitoring is
recommended during concomitant use. See SPC.
Hydrea
The summary of product characteristics for Hydrea (hydroxycarbamide;
Bristol-Myers Squibb) has been updated. It now states that cutaneous
vasculitic toxicities, including vasculitic ulcerations and gangrene,
have occurred in patients with myeloproliferative disorders during
therapy with hydroxycarbamide. There have also been changes made to
the handling requirements. See SPC.
Lyrinel XL
The summary of product characteristics for Lyrinel XL (oxybutynin; Janssen-Cilag)
has been updated. It now includes an indication for children over the
age of six years for “the symptomatic treatment of hyper-reflexia
secondary to a neurologic condition”. The initial dose for this
indication is 5mg once a day, increased in 5mg increments to a maximum
of 15mg once a day. See SPC.
Vfend
The summary of product characteristics for Vfend (voriconazole; Pfizer)
has been updated to include additional information about
co-administration of Vfend with efavirenz. See SPC.
Zometa
The summary of product characteristics for Zometa (zoledronic acid; Novartis)
contains additional information regarding bone pain reduction. See
SPC.
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