The Pharmaceutical Journal
Vol 271 No 7277 p737
29 November 2003

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Products

Prescription Products
• Emtriva capsules
• Gabapentin capsules
• Salofalk granules
SPC changes
• Sinemet
• Moduret 25 interaction
• Levonelle and Levonelle 2
Discontinued products
• Cymevene capsules

Prescription Products

Emtriva capsules
Composition: Emtricitabine.
Presentation: 200mg hard capsules.
Class/Action: Nucleoside reverse transcriptase inhibitor.
Indications: Treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Dosage: 200mg once daily. Dosing intervals should be longer in patients with renal impairment.
Major cautions: Emtriva should be used with caution in patients with pre-existing liver disease or who are also infected with hepatitis B. Therapy should be started by a prescriber experienced in the management of HIV infection.
Side effects: Headache, diarrhoea, nausea and elevated creatine kinease levels were very common (>1/10) in clinical trials. Anaemia, neutropenia, hypertriglyceraemia, hyperglycaemia, dizziness, asthenia, insomnia, abnormal dreams, vomiting, dyspepsia, elevated liver enzyme levels, skin rashes and general pain were common (>1/100).
Legal category: POM.
Net price: 30 £163.50.
Contact details: Gilead Sciences, Flowers Building, Granta Park, Abington, Cambridge CB1 6GT (tel 01223 897400). See SPC. Emtriva will be available from 1 December.

Gabapentin capsules
APS/Berk has launched gaba-
pentin capsules in packs of 100; net price, 100mg £20.57, 200mg £47.70, 300mg £55.20, 600mg, £95.40, 800mg £110.39.

Salofalk granules
Salofalk (mesalazine) granules have been launched (Provalis); net price 500mg 100 £31, 1,000mg 50 £31

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SPC changes

Sinemet
The summary of product characteristics for Sinemet, Half Sinemet CR and Sinemet CR (levodopa/carbidopa) has been updated (Bristol-Myers Squibb). It now states that a decrease in the bioavailability of carbidopa and/or levodopa has been demonstrated on ingestion with ferrous sulphate or ferrous gluconate, and that the excretion of levodopa in human breast milk has been reported in a single case. See SPC.

Moduret 25 interaction
The summary of product characteristics for Moduret 25 (amiloride hydrochloride and hydrochlorothiazide) has been amended to include increased risk of hyperkalaemia on concomitant administration of an angiotensin II receptor antagonist (Bristol-Myers Squibb). The patient information leaflet has been amended accordingly and the undesirable effects section has been reworded. See SPC.

Levonelle and Levonelle 2
The summary of product characteristics for Levonelle and Levonelle 2 (levonorgestrel) has been revised (Schering). It now states that two tablets should be taken together, as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse. If vomiting occurs within three hours of taking the tablets, another two tablets should be taken immediately (PJ, 15 November, p670). Efficacy data from clinical studies and new results from a pharmacokinetic study have been included, and the undesirable effects section has been rewritten. See SPC. Levonelle packs stating the new dosage regimen will be in circulation from mid-December. Meanwhile, for counter sales, pharmacists are advised to continue to recommend the current dosage as stated on the pack.

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Discontinued products

Cymevene capsules
Cymevene (ganciclovir) 250mg and 500mg capsules are being discontinued (Roche). The company expects stock to remain available until February 2004. Cymevene intravenous infusion remains available.

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