SPC changes
Fungizone
The summary of product characteristics for Fungizone (amphotericin; Bristol-Myers
Squibb) has been updated. The undesirable effects section now clarifies
that abnormal renal function includes renal impairment, renal insufficiency,
acute renal failure and nephrogenic diabetes insipidus. See SPC.
Lyrica
The summary of product characteristics for Lyrica (pregabalin; Pfizer)
has been updated. The SPC now states that Lyrica should not be used
during pregnancy unless clearly necessary. The undesirable effects
section now includes information about withdrawal symptoms after discontinuation
of short-term and long-term treatment. See SPC.
Prograf
The summaries of product characteristics for Prograf (tacrolimus; Astellas
Pharma) hard capsules and concentrate for solution for infusion have
been updated. The licensed indications are now: prophylaxis of transplant
rejection in liver, kidney or heart allograft recipients and treatment
of allograft rejection resistant to treatment with other immunosuppressive
medicines. Several dosage recommendations in the SPCs have been updated
as follows: for prophylaxis of liver transplant rejection in adults,
oral therapy should commence approximately 12 hours after surgery;
for prophylaxis of kidney transplant rejection in adults, oral therapy
should commence at 0.2–0.3mg/kg/day; and for prophylaxis of kidney
transplant rejection in children, if oral dosing is not possible, the
initial intravenous dose should be 0.075–0.1mg/kg/day. Dosing
recommendations for heart transplantation and for rejection therapy
for other allografts are now included in the SPCs. The SPCs now state
that Prograf is no longer contraindicated for use in pregnancy and
the interactions sections now include new guidance on concomitant use
of Prograf with corticosteroids and statins. See SPCs.
Refolinon
The summary of product characteristics for Refolinon (calcium folinate/leucovorin;
Pfizer) now states that calcium folinate should not be administered
intrathecally. The interactions section now includes information on
the interaction of folic acid with other medicines. The SPC now states
that calcium folinate may enhance the toxicity of fluorouracil; details
of the interaction are included in the undesirable effects section.
The word “parenteral” has been replaced by “intravenous
and intramuscular” in the undesirable effects section, and a
statement about allergic reactions has been added. See SPC.
Singulair
The summaries of product characteristics for Singulair (montelukast;
Merck Sharp & Dohme) paediatric granules and chewable tablets have
been updated to include a new indication as an alternative treatment
to low-dose inhaled corticosteroids for children over two years of
age with mild persistent asthma who do not have a recent history of
serious asthma attacks that required oral corticosteroid use, and who
have demonstrated that they are not capable of using inhaled corticosteroids.
The “posology and method of administration” sections now
provide a definition of mild persistent asthma and information about
the follow-up of patients given Singulair for this new indication.
See SPCs.
Transtec
The summary of product characteristics for Transtec (buprenorphine; Napp)
has been updated to reflect the change in dosing regimen which allows
patients to use a Transtec patch for up to 96 hours. See SPC.
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Tramadol PR tablets are now available from Actavis in Morningside livery
(as Mabron). Net price, 60 x 100mg £11.87,
60 x 150mg £17.80, 60 x 200mg £23.74. Legal category: POM.
Bonjela teething gel and teether pack, containing Bonjela (lidocaine
hydrochloride 0.33 per cent w/w, cetalkonium chloride 0.01 per cent w/w)
teething gel 15g and tooth-shaped teether, is now available from Reckitt
Benckiser. Recommended retail price, £4.99. Legal category: GSL.