The Pharmaceutical Journal
Vol 272 No 7300 p637
22 May 2004

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Products

Prescription Products
• Velcade
• Sulfasalazine tablets
SPC changes
• Xenical
• Rapamune
Discontinued products
• Mianserin
Supply issues
• Ledermycin capsules
• Lignostab
• Myocrisin shelf life
• Phenindone tablets
• Stelazine spansules
• Calpol and Calprofen
Products miscellany
• Rhinocort Aqua

Prescription Products

Velcade
Composition: Bortezomib 3.5mg (as a mannitol boronic ester)
Presentation: Powder for solution for injection. After reconstitution, 1ml of solution for injection contains 1mg bortezomib.
Action: Antineoplastic agent, proteasome inhibitor.
Indications: Treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
Dosage: Starting dose 1.3mg/m² body surface area administered as an intravenous injection twice weekly for two weeks (on days 1, 4, 8 and 11) followed by a 10-day rest period. See SPC for dosage adjustments.
Major precautions: Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Consecutive doses should not be given less than 72 hours apart. Complete blood counts should be frequently monitored. See SPC.
Contraindications: Severe hepatic impairment.
Side effects: Include thrombocytopenia, anaemia, neutropenia, anorexia, rash and gastrointestinal disorders. See SPC
Net price: 1 vial £762.38
Contact details: Ortho Biotech, Janssen-Cilag, Saunderton,
High Wycombe, Buckinghamshire
HP14 4HJ (tel 01494 567 567).

Sulfasalazine tablets
Sulfasalazine tablets 500mg (non enteric-coated) are now available from Alpharma; net price, 112 £7.55.

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SPC changes

Xenical
The summary of product characteristics for Xenical (orlistat) has been updated (Roche). The restriction of duration of treatment to two years has been removed. The SPC now states that no interactions with amitriptyline, atorvastatin, fluoxetine, losartan, phentermine, pravastatin or sibutramine have been observed. In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted since a small decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of cases. The SPC now states that in a four-year clinical trial the general pattern of adverse event distribution was similar to that reported for the one- and two-year studies with the total incidence of gastrointestinal related adverse effects occurring in year 1 decreasing over the four year period. The SPC states that these data suggest that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study. See SPC.

Rapamune
The summary of product characteristics for Rapamune (sirolimus) has been updated and now states that co-administration of sirolimus with strong inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin or rifabutin) is not recommended (Wyeth). See SPC.

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Discontinued products

Mianserin
All strengths of mianserin tablets have been discontinued from the Alpharma range.

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Supply issues

Ledermycin capsules
Ledermycin (demeclocycline hydrochloride) capsules 150mg x 28 are currently unavailable (Goldshield). The company expects normal supply to resume by the end of July.

Lignostab
Dentsply says there are potential delays in the supply of Lignostab A (lidocaine injection for dental use) caused by reworking of the packaging. Further details on 01932 837279 (website www.dentsply.co.uk).

Myocrisin shelf life
Distriphar says that the only stock of Myocrisin (sodium aurothiomalate) injection 20mg (40mg/ml) currently available has a shelf life of less than six months. Customers are asked to accept the stock on a sale or return basis. Queries should be directed to Distriphar customer services on 0870 513 3347.

Phenindone tablets
Phenindone tablets 25mg and 50mg are currently unavailable (Goldshield). The company expects normal supply to resume by the end of June. Phenindone tablets 10mg x 100 remain available from local suppliers or from Health Care Logistics (tel 01753 650099).

Stelazine spansules
Stelazine (trifluoperazine hydrochloride) spansules 2mg x 60 will be unavailable for the next six to 12 months (Goldshield). Other Stelazine presentations remain available from local suppliers or from Distriphar (tel 0870 871 0002).

Calpol and Calprofen
One litre bottles of Calpol (paracetamol) suspension have been discontinued (Pfizer Consumer Healthcare). They are replaced by prescription formats of 100ml bottles; net price, 47p. Branded prescription formats of 100ml and 150ml bottles of Calprofen (ibuprofen) suspension are also now available from Pfizer Consumer Healthcare; net price 100ml £1.69, 150ml £2.32.

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Products miscellany

Rhinocort Aqua
Rhinocort Aqua (budesonide) nasal spray now comes in packs of 64µg x 120 doses; net price £4.49 (AstraZeneca). Packs of 100µg x 100 dose have been discontinued.

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