The Pharmaceutical Journal
Vol 274 No 7347 p515
30 April 2005

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Products

Prescription Products
• Cefadroxil capsules
• Cefalexin capsules
• Combigan
• Novolizer
SPC changes
• Seroxat
• Vepesid
Discontinued products
• Humaject prefilled pen
Counter products
• Vitalux Plus

Drug alert Losec capsules 10mg

Prescription Products

Cefadroxil capsules
Cefadroxil capsules 500mg are now available from Sandoz. Net price, 20 £5.64. Legal category: POM.

Cefalexin capsules
Cefalexin capsules 250mg and 500mg are now available from PLIVA Pharma. Net price, 28 x 250mg £2.62, 21 x 500mg £4.06. Legal category: POM.

Combigan
Combigan (brimonidine tartrate 2mg/ml and timolol 5mg/ml) eye drops have been launched by Allergan. Net price, 5ml (in a 10ml bottle) £10. Legal category: POM.

Novolizer
Novolizer (budesonide) 200µg refill cartridges have been launched by Viatris. Net price, 100 doses £9.59. Legal category: POM.

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SPC changes

Seroxat
The summary of product characteristics for Seroxat (paroxetine; GlaxoSmithKline) has been updated. It now states that paroxetine should not be used in the treatment of children and adolescents under the age of 18 years. It says that in clinical trials increased suicidal-related behaviours and hostility were more frequently observed in children and adolescents treated with paroxetine compared with placebo. In addition, efficacy has not been adequately demonstrated and long-term safety data are lacking in this group. See SPC.

Vepesid
The summary of product characteristics for Vepesid (etoposide; Bristol-Myers Squibb) capsules and injection has been updated. The special warnings and precautions for use section now says that tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide with other chemotherapeutic drugs. Close monitoring of patients is needed to detect early signs, especially in patients with risk factors such as bulky treatment-sensitive tumours and renal insufficiency. It recommends that appropriate preventive measures should be considered in at risk patients. The undesirable effects section has been updated accordingly. In addition, the SPC for Vepesid capsules now says that neither the cumulative risk nor the predisposing factors related to the development of secondary leukaemia are known and that the roles of both administration schedules and cumulative doses of etoposide have been suggested but not clearly defined. In the interactions section, it now says co-administration of oral etoposide with high doses of ciclosporin has led to an 80 per cent increase in etoposide exposure. The storage section has been updated and states that capsules should not be stored above 25C. See SPC.

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Discontinued products

Humaject prefilled pen
Humaject prefilled pens are being discontinued from June 2006 (Lilly). The pens contain Humulin M3 (biphasic isophane insulin) or Humulin S (soluble insulin). Sleeves will appear on the packs in January 2006 notifying patients of appropriate action to take. These insulins will continue to be available in reusable pens and 10ml vials. In addition, Humulin M3 will be available in new prefilled pens from June 2005.

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Counter products

Vitalux Plus
Vitalux Plus (lutein 10mg, vitamin C 60mg, vitamin E 10mg, zinc 10mg, copper 0.25mg and niacin 10mg) capsules have been launched by Novartis. Recommended retail price, 28 £11.95. Legal category: P.

Correction Vitalux Plus (Novartis) is not classified as a pharmacy medicine. The product is a food supplement and is not classified as a medicinal product.

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