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The Pharmaceutical Journal
Vol 269 No 7225 p739
23 November 2002

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Products

    Prescription Products SPC changes

Prescription Products

Malarone Paediatric tablets

Malarone Paediatric tablets containing atovaquone 62.5mg and proguanil 25mg have been launched (GlaxoSmithKline); net price, 12 £7.64. The product is indicated for prophylaxis of Plasmodium falciparum malaria in individuals weighing 11–40kg.

Depo-Provera vials

Depo-Provera (medroxyprogesterone acetate) 150mg/ml 1ml vials have been introduced (Pharmacia); net price, 1 £5.01.

Serevent Diskhalers

The number of disks provided with the Serevent (salmeterol) Diskhaler, is being increased from 14 to 15 (GlaxoSmithKline); net price, £35.28. The size of refill packs will also increase from 14 to 15 disks; net price, £34.65.

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SPC changes

Arimidex new indication

The licensed indications for Arimidex (anastrazole) tablets have been extended (AstraZeneca). Arimidex is now additionally indicated for adjuvant treatment of postmenopausal women with oestrogen receptor positive early breast cancer who are unable to take tamoxifen therapy because of high risk of thromboembolism or endometrial abnormalities. Other changes have also been made to the SPC. The posology and method of administration section states that for early disease, the recommended duration of treatment should be five years. Concurrent administration of anastrazole and tamoxifen is contraindicated. The special warnings and precautions for use section states that women with or at risk of osteoporosis should have their bone mineral density formally assessed. It also states that a combination of anastrazole and luteinising hormone releasing hormone analogues should not be used outside clinical trials. See SPC.

Cozaar new indication

The licensed indications for Cozaar (losartan potassium) tablets have been extended (Merck Sharp & Dohme). Cozaar is additionally indicated for renal protection in patients with type 2 diabetes with nephropathy (macroalbuminuria). See SPC.

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