The Pharmaceutical Journal
Vol 274 No 7345 p449
16 April 2005

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Products

Prescription Products
• Arixtra
• Domperidone
• MabCampath
• Metoclopramide
• Oxbutynin hydrochloride
SPC changes
• Taxol
• Emtriva
Discontinued products
• Hydergine
Products miscellany
• Hibiscrub

Recall Bextra

Prescription Products

Arixtra
Arixtra (fondaparinux) 5mg (0.4ml), 7.5 mg (0.6ml) and 10mg (0.8ml) pre-filled syringes are now available from GlaxoSmithKline, indicated for use in deep vein thrombosis and acute pulmonary embolism, except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy. The recommended dose is 5mg (patients with body weight <50kg), 7.5mg (patients with body weight >=50kg and <=100kg) or 10mg (patients with body weight >100kg) once daily, administered by subcutaneous injection. Net price 10 £123.70. Legal category: POM.

Domperidone
Domperidone tablets 10mg are now available from Almus. Net price 30 £2.11, 100 £4.86. Legal category: POM.

MabCampath
MabCampath (alemtuzumab) single-use vials 30mg/ml are now available from Schering Health Care. Net price 3x2ml (containing 1ml of concentrate) £824.50. Legal category: POM.

Metoclopramide
Metoclopramide tablets 10mg are now available from Almus. Net price 28 £1.32. Legal category: POM.

Oxbutynin hydrochloride
Oxbutynin hydrochloride tablets 2.5mg are now available from Almus. Net price 84 £8.13. Legal category: POM.

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SPC changes

Taxol
The summary of product characteristics for Taxol (paclitaxel; Bristol-Myers Squibb) now includes an additional indication for adjuvant use in breast cancer. It states that in the adjuvant setting, Taxol is indicated for the treatment of patients with node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy and that adjuvant therapy with Taxol should be regarded as an alternative to extended AC therapy. The recommended dose for this indication is 175mg/m² administered over a period of three hours every three weeks for four courses following AC therapy. The SPC also now includes an additional indication for the initial treatment of locally advanced or metastatic breast cancer. This is either in combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with trastuzumab in patients who over-express HER-2 at a 3+ level as determined by immunohistochemistry and for whom an anthracycline is not suitable. When used in combination with doxorubicin (50mg/m²) taxol should be administered 24 hours after doxorubicin. The recommended dose for this indication is 220mg/m² administered intravenously over three hours, with a three-week interval between courses. A warning about cardiac dysfunction has been added to the special warnings and precautions for use section. See SPC.

Emtriva
The summary of product characteristics for Emtriva (emtricitabine; Gilead) now states that the 200mg capsules and the 10mg/ml oral solution may be taken with or without food. See SPC.

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Discontinued products

Hydergine
Hydergine (co-dergocrine mesylate; Novartis) tablets 1.5mg are being discontinued once current stocks are exhausted. Novartis expects this to be by 30 June.

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Products miscellany

Hibiscrub
Hibiscrub (4 per cent chlorhexidine gluconate; SSL) now contains hand moisturising emollients.

Correction Hibiscrub is a Regent Medical product, not an SSL product.

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