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The Pharmaceutical Journal
Vol 270 No 7251 p745
31 May 2003

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Products

    Prescription Products SPC changes Discontinued products

Prescription Products

Topamax

Topamax (topiramate) has been licensed as monotherapy for newly diagnosed epilepsy in adults and children over six years old. This is in addition to its authorisation for adjunctive treatment of epilepsy. The efficacy and safety of conversion from adjunctive therapy to Topamax monotherapy has not been demonstrated. Treatment should be started at a low dose followed by titration to an effective dose. It is not necessary to monitor topiramate plasma concentrations to optimise treatment. The initial dose for adults and children over 16 years is 25mg nightly for a week. The daily dose is then incrementally increased by 25mg or 50mg administered in two divided doses at one or two week intervals. The recommended initial target dose is 100mg daily and the maximum recommended daily dose is 400mg. In children aged six to 16 years the initial dose is 0.5 to 1mg/kg nightly for the first week. The dosage is then increased at one or two week intervals by increments of 0.5 to 1mg/kg/day in two divided doses. The recommended target dose range is 3 to 6mg/kg/day. See SPC.

Mucodyne syrup

Mucodyne syrup (carbocisteine 250mg/5ml) has been transferred from Aventis to Beacon Pharmaceuticals (customer services department 0870 513 3347). All orders outstanding from Aventis have been cancelled. Orders should be placed via the nominated distributor Distriphar (fax 0870 513 3329). Mucodyne paediatric syrup remains available via Aventis. Medical information for Mucodyne capsules and syrup is available on 01892 506958.

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SPC changes

Tazocin

A warning that all patients being treated with methotrexate should have their serum methotrexate levels monitored during concomitant treatment with piperacillin has been added to the SPC for Tazocin (piperacillin sodium/tazobactam sodium). Previously, it was believed that only patients on high doses of methotrexate needed monitoring. The SPC also now warns that Tazocin can cause nausea, vomiting and diarrhoea and that overdosage can cause neuromuscular excitability or convulsion, particularly in patients with renal failure. Excessive serum concentrations of piperacillin and tazobactam can be reduced by haemodialysis. Other additions to the SPC include incompatibility with lactated Ringer's solution and notes that Tazocin should not be reconstituted with bacteriostatic water for injections or diluted in Dextran 6 per cent plus 0.9 per cent sodium chloride solution. See SPC.

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Discontinued products

Zinamide

Merck Sharp & Dohme has stopped producing Zinamide (pyrazinamide) 500mg tablets for supply in the UK. Once stocks are exhausted, pyrazinamide can be obtained through international pharmacies or IDIS (tel 020 8410 0700).

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