The Pharmaceutical Journal
Vol 279 No 7467 p229
1 September 2007

This article
Reprint   Photocopy

PDF 40K, Acrobat Reader

Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

Prescription Products
• Eptadone
SPC changes
• Actonel Once a Week
• Avastin
• Diovan
• Lescol
• Prexige
Products miscellany
• Humapen Luxura HD Pen
• Nicopatch

Prescription Products

Eptadone
Eptadone (methadone hydrochloride) oral solution 1mg/ml and 5mg/ml is now available from Dee Pharmaceuticals.
Net price:
1mg/ml (20mg), £0.29
1mg/ml (40mg), £0.58
1mg/ml (60mg), £0.87
5mg/ml (100mg), £1.47
1mg/ml x 100ml, £1.35
1mg/ml x 1,000ml, £13.48
5mg/ml x 1,000ml, £73.33
Legal category:
POM

Back to Top

SPC changes

Actonel Once a Week
Treatment of osteoporosis in men at high risk of fractures has been added as an indication in the summary of product characteristics for Actonel Once a Week (risedronate sodium; Procter and Gamble). The dose for this indication is 35mg once a week.

Avastin
First-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer (other than predominantly squamous cell histology) has been added as an indication in the summary of product characteristics for Avastin (bevacizumab; Roche).

For this indication, Avastin is administered in addition to platinum-based chemotherapy for up to six cycles of treatment, followed by Avastin as a single agent until disease progression. The recommended dose is 7.5mg/kg or 15mg/kg of body weight once every three weeks as an intravenous infusion.

Diovan
A recommendation that serum potassium should be monitored in renally impaired or elderly patients taking potassium supplements has been added to the summary of product characteristics for Diovan (valsartan; Novartis). In addition, the SPC also states: “The safety and efficacy of Diovan have not been established in children and adolescents (below the age of 18 years)”.

Further information about use in pregnancy and information about reports of overdose have also been added to the SPC.

Lescol
A warning about isolated cases of myopathy in patients with fluvastatin and colchicine has been added to the summaries of product characteristics for Lescol (fluvastatin; Novartis) and Lescol XL (fluvastatin). In addition, pancreatitis has been added to the SPCs as a very rare undesirable effect.

Prexige
Prexige (lumiracoxib; Novartis) is now contraindicated for patients who have any current hepatic disease, previous drug-induced significant elevations of transaminases (over three times the upper limit of the normal range [ULN]), or liver transaminases >1.5 x ULN at baseline or >3 x ULN during treatment, and for patients who are taking other medicines associated with clinically significant hepatotoxicity.

Liver function tests (LFTs) should be performed before starting treatment and once a month when treatment is for longer than a month, and the tests should be repeated after seven days if transamines are above 2 x ULN. In addition, patients reporting any systemic illness while taking lumiracoxib should undergo LFTs.

The summary of product characteristics also now states that liver damage has been reported following exposure to Prexige, that patients should be advised to remain vigilant for any symptoms compatible with hepatic injury during treatment (such as anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, pruritus).

Patients should stop Prexige if any such symptoms occur and should seek medical advice urgently. Patients should be reminded of normal limits of safe alcohol consumption while taking lumiracoxib and that excessive alcohol consumption could aggravate any drug-related liver reaction.

Back to Top

Products miscellany

Humapen Luxura HD Pen
The Humapen Luxura HD Pen injection device will be available to order from Eli Lilly and Company on 0870 8500896 from 3 September 2007
Net price: 1, £26.36

Nicopatch
Nicopatch (nicotine) transdermal patches 7mg/24 hours, 14mg/24 hours and 21mg/24 hours are now available from Wockhardt.
Net price: 7-pack (all strengths), £9.40
Recommended retail price: 7-pack (all strengths), £15.49
Legal category: GSL

Back to Top