The Pharmaceutical Journal
Vol 279 No 7463 p123
4 August 2007

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Products

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

Prescription Products
• Clipper
SPC changes
• Exjade
• Lyrica
• Vfend
• Zometa
Supply issues
• Retin-A Cream
Counter products
• Optrex Infected Eyes

Prescription Products

Clipper
Clipper (beclometasone dipropionate) tablets 5mg are now available from Trinity-Chiesi.
Net price: 30 x 5mg, £60.
Legal category: POM

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SPC changes

Exjade
Cases of acute renal failure have been reported following post-marketing use of Exjade (deferasirox; Novartis).

Exjade’s summary of product characteristics now states that patients with pre-existing renal conditions and patients taking medicines that depress renal function may be more at risk of complications. Care should be taken to maintain adequate hydration in patients who develop diarrhoea or vomiting.

Serious hypersensitivity reactions have been reported, in most cases occurring within the first month of treatment with Exjade. Proteinuria, rash and pruritus are now listed as common adverse effects (>=1/100, <1/10) in the product’s SPC. Increased blood creatinine is now included as a very common adverse effect (>=1/10).

Lyrica
The summary of product characteristics for Lyrica (pregabalin; Pfizer) now states that there have been post-marketing reports of loss of consciousness, confusion and mental impairment. Cases of renal failure have also been reported, which were shown to be reversible on discontinuation of pregabalin. When pregabalin was taken in overdose, the most commonly reported adverse events included somnolence, confusion, agitation and restlessness.

Vfend
Vfend (voriconazole; Pfizer) must not be infused into the same line or cannula concomitantly with other intravenous products, the summary of product characteristics for Vfend now states. Additionally, Vfend must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.

Total parenteral nutrition should be infused through a separate line when prescribed with Vfend. The concomitant use of voriconazole with St John’s Wort is now contraindicated; further information is provided in the interactions section of the SPC.

The SPC contains a new warning about monitoring pancreatic function: “Patients, especially children, with risk factors for acute pancreatitis (eg, recent chemotherapy, hematopoietic stem cell transplantation), should be monitored closely during Vfend treatment. Monitoring of serum amylase or lipase may be considered in this clinical situation.”

The SPC now states that each vial of Vfend powder for infusion contains 217.6mg of sodium, which should be taken into account for patients on a controlled sodium diet.

Zometa
Overhydration should be avoided in patients at risk of cardiac failure, the summary of product characteristics for Zometa (zoledronic acid; Novartis) now states. Renal deterioration, progression to renal failure and dialysis have been reported after the initial dose or a single dose of Zometa. The SPC contains new information about the risk of osteonecrosis of the jaw in patients receiving bisphosphonates, including Zometa, predominately in those with cancer.

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Supply issues

Retin-A Cream
Janssen-Cilag is currently out of stock of Retin-A Cream (tretinoin) 0.025 per cent due to manufacturing problems. Both strengths of Retin-A Gel remain available. Medical information on 0800 7318450.

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Counter products

Optrex Infected Eyes
Optrex Infected Eyes (chloramphenicol 1 per cent w/v) eye ointment is now available from Reckitt Benckiser.
Recommended retail price: 4g, £5.29
Legal category: P

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