The Medicines Control Agency is proposing four further extensions to the general sale list. The latest proposals concern clotrimazole, cetylpyridinium chloride, sodium fluoride and gum ammoniacum.
Clotrimazole for external use has been available as a pharmacy medicine since 1977 and in 1996 clotrimazole 1 per cent became GSL for the treatment of athlete's foot, in packs containing no more than 500mg clotrimazole. In 1978, clotrimazole powder was authorised as a treatment for fungal skin infections when used as an adjunct to clotrimazole cream or spray. On the advice of the Committee on Safety of Medicines, the MCA is now proposing that clotrimazole 1 per cent powder should become GSL for prevention of athlete's foot and as an adjunct to its treatment.
The MCA's proposal for cetylpyridinium chloride is to increase the maximum GSL dose from 3mg to 5mg for liquid oral preparations. The MCA says that while the drug is mainly used as an antiseptic for minor mouth and throat infections, it has also been used safely for many years in liquid cough preparations with a maximum dose of 5mg.
Sodium fluoride is already a GSL substance when contained in toothpastes with a maximum strength of 0.33 per cent (equivalent to 0.15 per cent fluorine). It is also freely available up to the same strength in mouthwashes marketed as cosmetics. The MCA now proposes to allow its use in mouth rinses for the prevention of tooth decay. The proposed maximum strength is 0.05 per cent for mouth rinses for daily use and 0.2 per cent for mouth rinses other than for daily use. The agency says that there are no safety considerations.
Gum ammoniacum has been available on general sale for several years in licensed medicinal products for the relief of coughs and catarrh. The MCA says that there are no concerns about its safety. It proposes to add the substance itself to the GSL Order.
The MCA's proposal are contained in a consultation letter (MLX 267) dated November 23. Comments are being sought by January 12, 20001, and should be addressed to Dugan Cummings, Room 619, Medicines Control Agency, 1 Nine Elms Lane, London SW8 5NQ (fax 020 7273 0293).