SPC changes
Arcoxia
The summary of product characteristics for Arcoxia (etoricoxib; Merck
Sharp & Dohme) has been updated. The SPC now includes warnings regarding
additional pharmacodynamic interactions with diuretics, angiotensin-converting
enzyme inhibitors and angiotensin II antagonists. It also states that
the combination of these agents and etoricoxib should be administered
with caution, especially in the elderly, that patients should be adequately
hydrated and that consideration should be given to monitoring of renal
function after initiation of concomitant therapy and periodically thereafter.
A warning about pharmacodynamic interactions with hormone replacement
therapy and a statement regarding an increased risk of cardiorenal events
have also been added. See SPC.
Botox
The summary of product characteristics for Botox (Clostridium botulinum type A neurotoxin complex; Allergan) now states that Botox is contraindicated
in the presence of infection at the proposed injection site. Facial
oedema has been added as a common undesirable effect. In addition,
there have been rare reports of seizures or convulsions, mostly in
patients who are predisposed to these events. Needle-related pain or
anxiety may result in vasovagal responses. See SPC.
Ezetrol
The summary of product characteristics for Ezetrol (ezetimibe; Merck
Sharpe & Dohme) now states that cases of myopathy and rhabdomyolysis
have been reported. Most patients who developed rhabdomyolysis were
also taking a statin. However, it has been reported very rarely in
patients taking ezetimibe alone or with other agents known to be associated
with increased risk of rhabdomyolysis. Ezetimibe, any statin and any
of these other agents should be immediately discontinued if myopathy
is suspected. All patients should be advised of the risk and told to
report promptly any unexplained muscle pain, tenderness or weakness.
Hepatitis and increased creatine phosphokinase values have been added
as rare side effects. Thrombocytopenia, cholelithiasis and cholecystitis
have been added as very rare side effects. The interactions section
has also been updated to include reports of increased international
normalised ratio in patients who have ezetimibe added to warfarin and
the need for routine monitoring of ciclosporin levels. See SPC.
Protium
A new indication has been added to the summary of product characteristics
for Protium (pantoprazole; Altana). Protium can now be used for “on
demand” relief of reoccuring symptoms in patients with healed
reflux disease. The dose for this indication is 20mg once daily, when
required. See SPC.
Simulect
The summary of product characteristics for Simulect (basiliximab; Novartis)
has been updated. A warning has been added that caution should be exercised
when patients previously given Simulect are re-exposed to a subsequent
course of therapy with this medicine. It states that there is accumulating
evidence that a subgroup of patients is at an increased risk of developing
hypersensitivity reactions. These are patients in whom, following the
initial administration of Simulect, the concomitant immunosuppression
was discontinued prematurely due, for example, to abandoned transplantation
or early loss of the graft. In addition, the SPC now states that rare
individual cases of suspected cytokine release syndrome have been reported.
See SPC.
Sinthrome
The summary of product characteristics for Sinthrome (acenocoumarol;
Alliance) now contains a warning that says cranberry juice and other
cranberry products should be avoided due to a theoretical risk of enhanced
coagulation. See SPC.
Correction
The SPC change for Sinthrome (acenocoumarol) tablets was incorrect. Alliance subsequently said that cranberry juice should be avoided in patients taking Sinthrome due to a theoretical risk of enhanced anti-coagulation, not coagulation. |
Zispin
The summary of product characteristics for Zispin Soltab (mirtazapine;
Organon Laboratories) has been updated. It now states that in a small
group of people antidepressants may increase the risk of suicidal thoughts
and self-harm. Patients with a history of suicide-related events, those
exhibiting a significant degree of suicidal ideation before treatment
and young adults should receive careful monitoring during treatment.
Patients and caregivers should be alerted about the need to monitor
and seek medical advice if symptoms present. Psychomotor restlessness
has also been added as a side effect. In addition, the SPC now states
that withdrawal symptoms are common and abrupt discontinuation should
be avoided. See SPC.
Back to Top
|
The
Pharmaceutical Journal