The Pharmaceutical Journal
Vol 270 No 7255 p885
28 June 2003

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Products

Prescription Products
• Augmentin Duo
SPC changes
• Epilim use during pregnancy
• Depakote use during pregnancy
• Biliscopin and hepato-biliary disorders
Discontinued products
• Flagyl Compak
• Urografin 325
Supply problems
• Quinine bisulphate
Counter medicines
• Cetirizine tablets

Prescription Products

Augmentin Duo

A strawberry flavoured, sugar-free Augmentin Duo (amoxicillin, clavulanic acid) Suspension 400/57 has been launched by GlaxoSmithKline; net price 70ml £6.61.

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SPC changes

Epilim use during pregnancy

The summary of product characteristics for Epilim (sodium valproate) has been updated to strengthen the warnings relating to its use during pregnancy (Sanofi-Synthelabo). The SPC now states that women of childbearing potential should not be started on Epilim without specialist neurological advice because of the potential teratogenic risk to the fetus. It adds that the incidence of neural tube defects rises with increasing dosage, particularly above 1,000mg daily. A statement on the rate of malformations in offspring born to mothers receiving anti-epilepsy treatment, demonstrated to be two to three times higher than the rate reported in the general population, is now included. The SPC also says that women should be advised to start taking folic acid supplements (5mg) as soon as contraception is discontinued and that antiepileptic therapy should not be stopped suddenly. Valproate anti-epileptic treatment should not be discontinued during pregnancy if it has been effective.

Depakote use during pregnancy

The summary of product characteristics for Depakote (valproate semisodium) has been updated to strengthen the warnings relating to its use during pregnancy (Sanofi-Synthelabo). The SPC now states that women of childbearing potential should receive specialist psychiatric advice before starting Depakote and if planning a pregnancy while taking Depakote because of the potential teratogenic risk to the fetus. It adds that the incidence of neural tube defects rises with increasing dosage, particularly above 1,000mg daily. The SPC also says that women should be advised to start taking folic acid supplementation (5mg) as soon as contraception is discontinued.

Biliscopin and hepato-biliary disorders

The summary of product characteristics for Biliscopin (meglumine iotroxate) has been updated. The following statement has been added to the undesirable effects section: "A transient elevation of liver values in blood serum (eg, ALT [GPT], AST [GOT], GGT, LDH, ALP, bilirubin) may occur especially in patients with pre-existing hepato-biliary disorders."

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Discontinued products

Flagyl Compak

Flagyl Compak (metronidazole and nystatin) pessaries (Hawgreen Ltd) have been discontinued. Any outstanding orders with Distriphar will be cancelled. Queries should be directed to Distriphar customer services on 0870 513 3347.

Urografin 325

Urografin 325 (meglumine amidotrizoate and sodium amidotrizoate) solution for injection, 10 x 20ml has been discontinued. The 10 x 50ml pack size remains available.

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Supply problems

Quinine bisulphate

Quinine bisulphate 300mg tablets are now back in stock (Alpharma). Queries should be directed to the company's 24-hour medical helpline (tel 01271 311257).

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Counter medicines

Cetirizine tablets

Alpharma has launched cetirizine dihydrochloride 10mg tablets. Price 1 x 7 £2.21, 1 x 30 £7.42.

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