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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7323 p639
30 October 2004

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Products

    New medicines Prescription Products SPC changes Discontinued products Supply issues

New medicines

Raptiva
RaptivaComposition: Reconstitution yields efalizumab 100mg/ml .
Presentation: Powder and solvent for solution for injection.
Class: Selective immunosuppressive agent.
Indications: Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, have a contraindication to or are intolerant to other systemic therapies.
Dosage: An initial single dose of 0.7mg/kg, followed by weekly injections of 1mg/kg (maximum single dose 200mg). Duration of therapy is 12 weeks. See SPC.
Major cautions: Monitor patients developing an infection during treatment and discontinue Raptiva according to severity. Use with caution in patients with a history of significant recurring infections. Patients should not receive acellular, live and live-attenuated vaccines during treatment. Discontinue treatment if a malignancy develops. Platelet counts should be taken periodically during treatment. If manifestations of thrombocytopenia occur treatment should be discontinued imediately. See SPC.
Contraindications: Patients with active tuberculosis and other severe infections, history of malignancies, immunodeficiencies, or specific forms of psoriasis.
Side effects: Very common (>1/10); leukocytosis and lymphocytosis, flu-like symptoms including fever, headaches, chills, nausea and myalgia.
Legal category: POM.
Net price: 1 vial £169.20
Contact details: Serono Pharmaceuticals, Bedfont Cross, Stanwell Road, Feltham, Middlesex TW14 8NX. Tel 020 8818 7200.

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Prescription Products

Lisinopril and hydrochlorothiazide
Lisinopril and hydrochlorothiazide tablets are now available from Sandoz; net price 10mg/12.5mg 28 £13, 20mg/12.5mg 28 £14.70. Legal category: POM.

Rhumalgan
Rhumalgan (diclofenac) modified-release capsules are now available from Sandoz; net price, Rhumalgan SR 75mg 56 £13, Rhumalgan XL 100mg 28 £9.35. Legal category: POM.

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SPC changes

Remicade
Remicade (infliximab) is now additionally indicated for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying antirheumatic drugs, in combination with methotrexate (Schering-Plough). The dose for this indication is 5mg/kg administered as an intravenous infusion over a two– hour period followed by additional 5mg/kg infusion doses at two and six weeks after the first infusion, and then every eight weeks thereafter. Clinical trial data supporting this indication are now included and the undesirable effects section has been updated. See SPC.

AmBisome
The summary of product characteristics for AmBisome (liposomal amphotericin B) injection now states that loop diuretics or thiazides and related diuretics increase the risk of hypokalaemia when given with amphotericin (Gilead Sciences). Polymixins and tacrolimus have been added to the list of drugs that may increase the risk of nephrotoxicity in some patients and the undesirable effects section has been reformatted. The SPC now states that AmBisome may be stored for between four and seven days, dependent on final concentration, at 2–8C following reconstitution with water for injection and dilution with 5 per cent dextrose. See SPC.

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Discontinued products

Eugynon 30
Eugynon 30 (levonorgestrel and ethinylestradiol) tablets are being discontinued (Schering Heath Care). The company says that current stock levels will support demand until March 2005.

Vancocin capsules
Vancocin (vancomycin hydrochloride) capsules 125mg will be discontinued after
3 November (Eli Lilly). Vancocin injection remains available.

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Supply issues

Eccoxolac
Eccoxolac (etodolac) capsules 300mg are currently out of stock (Viatris). The company expects stock to be available again by the third week in November. Details on 01223 205999.

Deltastab
Deltastab (prednisolone acetate) injection 25mg/ml is now back in stock (Sovereign Medical).

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