The Pharmaceutical Journal
Vol 277 No 7427 p605
18 November 2006

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Products

New medicines
• Erdotin
Prescription Products
• Etopan XL
SPC changes
• Avastin
• Bondronat and Bonviva
• Invirase
• Loron
• Rebetol
• Remicade
• ViraferonPeg
• Xenical
Discontinued products
• Zamadol Melt

Recall Tri-iodothyronine injection

New medicines

Erdotin

Composition: Erdosteine.

Presentation: Capsule.

Class: Mucolytic agent.

Indication: As an expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.

Dosage: The recommended dose for the elderly and adults over 18 years of age is one 300mg capsule swallowed whole with a glass of water twice a day for a maximum of 10 days.

Contraindications: Erdotin is not recommended for patients with creatinine clearance <25ml/min or for those with severe liver failure. Erdotin is contraindicated for patients with active peptic ulcer.

Precautions: The dose for patients with mild liver failure should not exceed 300mg per day.

Legal category: POM.

Net price: 20 x 300mg, £5.

Contact details: Galen Ltd, Seagoe Industrial Estate, Craigavon, County Armagh BT63 5UA (tel 02838 334974).

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Prescription Products

Etopan XL
Etopan XL (etodolac) tablets 600mg are now available from Winthrop. Net price: 30, £15.50. Legal category: POM.

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SPC changes

Avastin
The summary of product characteristics for Avastin (bevacizumab; Roche) has been updated. The special warnings and the undesirable effects sections now include new information on reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy and gastrointestinal perforations. See SPC.

Bondronat and Bonviva
The summaries of product characteristics for Bondronat (ibandronic acid; Roche) and Bonviva (ibandronic acid; Roche) have been updated and now include warnings about osteonecrosis of the jaw. See SPCs.

Invirase
The summaries of product characteristics for Invirase (saquinavir; Roche) now include a special warning about increased risk of liver toxicity with Invirase/ritonavir used in combination with efavirenz. The interactions sections of the SPCs now contain information about an interaction between Invirase/ritonavir and omeprazole. See SPCs.

Loron
The summary of product characteristics for Loron (disodium clodronate; Roche) has been updated to include warnings about osteonecrosis of the jaw. See SPC.

Rebetol
The summary of product characteristics for Rebetol (ribavirin; Schering-Plough) has been updated. It now states that pure red cell aplasia has been reported in patients taking Rebetol. See SPC.

Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough) has been updated. Hepatosplenic T-cell lymphona (in adolescent and young adult patients with Crohn’s disease) and lymphoma (including non-Hodgkin’s lymphoma and Hodgkin’s disease) have been added as rare undesirable effects reported in post-marketing studies. See SPC.

ViraferonPeg
The summary of product characteristics for ViraferonPeg (peginterferon alfa-2b; Schering-Plough) has been updated. It now states that, very rarely, ViraferonPeg used alone or in combination with ribavirin may be associated with aplastic anaemia and that pure red cell aplasia has been reported. See SPC.

Xenical
The summary of product characteristics for Xenical (orlistat; Roche) has been updated and now includes additional warnings about the possible failure of contraception in cases of severe diarrhoea when taking Xenical. The special warnings and the undesirable effects sections of the SPC now include rare reports of rectal bleeding. See SPC.

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Discontinued products

Zamadol Melt
Meda Pharma has discontinued Zamadol Melt (tramadol) 100 x 50mg packs. Zamadol Melt remains available in 60 x 50mg packs.

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