Nitrofurantoin switch application made for cystitis
Views
are being sought on the reclassification of nitrofurantoin to a pharmacy medicine for the treatment of bacterial cystitis.
Goldshield Pharmaceuticals has applied for the reclassification of Cystobid
100mg capsules from POM to P, saying: “The priority for women with
typical symptoms is rapid alleviation of suffering. Prompt access to
a doctor to obtain a suitable prescription is not always possible and
so other access routes to antibiotic supply through patient group directions
and nurse prescribing have been set up for specific antibiotics. Extension
of availability of suitable antibiotics for uncomplicated cystitis to
pharmacies is a logical extension of the present arrangements.”
Under the new proposals Cystobid capsules will be available over the
counter in packs of six to otherwise healthy non-pregnant women aged
16 to 70 years with typical symptoms of a new episode of uncomplicated
acute bacterial cystitis.
Goldshield points out that current clinical guidelines do not recommend
urine testing before treatment of symptoms typical of uncomplicated cystitis,
and that a pharmacy protocol and a patient questionnaire have been developed
to ensure that supply is limited to eligible women, thus helping to minimise
the risk of bacterial resistance.
Comments on the new proposal can be sent to Veronica Popo, Medicines
and Healthcare products Regulatory Agency, Room 14–138, Market
Towers, 1 Nine Elms Lane, London SW8 5NQ, until 14 April 2008.
The full consultation document can be accessed online
Trimethoprim In
2005 a similar proposal for reclassification was put forward by
Alpharma for trimethoprim, but a decision has not yet
been reached.
A spokesman
for the Medicines and Healthcare products Regulatory Agency said that the
trimethoprim proposal is still under review and that the MHRA is
considering responses to
the consultation and advice from the Commission on Human Medicines. |
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