Prescription Products
Simvastatin tablets
Simvastatin tablets have been launched by CP Pharmaceuticals;
net price 10mg 28 £17.13, 20mg 28 £28.21, 40mg 28 £28.21.
SPC changes
Actilyse
Actilyse (alteplase, recombinant human tissue-type plasminogen activator,
rt-PA) has been licensed for use in acute ischaemic stroke in addition
to its use in acute myocardial infarction and pulmonary embolism. The
recommended dose is 0.9mg/kg body weight infused intravenously over 60
minutes, with 10 per cent of the total dose administered as an initial
IV bolus. The maximum dose is 90mg and treatment must be started within
three hours of the onset of symptoms. Boehringer Ingelheim says that Actilyse
will only be used in specialist stroke units registered with SITS-MOST
(Safe Implementation of Thrombolysis in Stroke Monitoring System). See
SPC.
Multiparin
CP Pharmaceuticals has replaced the preservative chlorocresol with benzyl
alcohol and methyl parahydroxybenzoate in Multiparin (heparin sodium)
vials 1,000 IU/ml, 5,000 IU/ml and 25,000 IU/ml. Benzyl alcohol can increase
the risk of jaundice in neonates and can cause toxic reactions in infants
and children up to three years old. Methyl parahydroxybenzoate can also
cause allergic reactions, possibly delayed. The shelf-life of the reformulated
product has been cut from 36 months to 18 months. See SPC.
Antepsin
Chugai Pharma is transferring the production of Antepsin suspension (sucralfate)
from Wyeth to E. Merck and repackaging the product in 250ml glass bottles
in order to harmonise production with Germany, France and Spain. The distributor
from 1 May is Distriphar (tel 0870 513 3347, fax 0870 513 3329). The minimum
order is 2 x 250ml, price £8.75.
Taxol
Taxol (paclitaxel) has been licensed for the initial treatment of advanced
or metastatic breast cancer in combination with trastuzumab in patients
who overexpress HER-2 at a 3+ level as determined by immunohistochemistry
and for whom an anthracycline is not suitable. As a result changes have
been made to the following sections of the Taxol SPC: posology and method
of administration, special warnings and special precautions for use, undesirable
effects, and pharmacodynamic properties. See SPC
Lipostat
The SPC for Lipostat (pravastatin) has been amended following re-evaluation
of all HMG-CoA reductase inhibitors after the worldwide withdrawal of
cerivastatin. It now includes more information on the muscle effects of
statins, with a reduced upper limit of creatinine kinase for treatment.
Additional undesirable effects include myopathy and rhabdomyolysis with
renal dysfunction
secondary to myogloblinuria. Parasthesiae and polyneuropathy are also
included as being reported rarely in patients treated with statins. Additional
information on interactions and pharmacokinetics has been included. See
SPC.
Questran
A new special warning has been added to the SPC for Questran (cholestyramine).
Patients with diabetes should now be warned that each Questran sachet
contains 3.79g sucrose. See SPC.
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