The Pharmaceutical Journal
Vol 280 No 7500 p533
3 May 2008

This article
Reprint   Photocopy

PDF 30K, 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
• Meningitec
• Pentasa
SPC changes
• Corticosteroids
• Hepsera
• Provigil
• Sandimmun

Caution in use alert Clexane syringes — use of contaminated stock

Prescription Products

Meningitec
Meningitec (meningococcal serogroup C oligosaccharide conjugate vaccine [adsorbed]; Wyeth) is now available in prefilled syringes. The 10 x 0.5ml vials are no longer available. Childhood immunisation programme supplies are available from Movianto UK on 0870 871 1891.

Net price: 10 x 0.5ml prefilled syringe, £75
Legal category: POM

Pentasa
Pentasa 2g sachets (mesalazine prolonged release granules) are now available from Ferring Pharmaceuticals.

Net price: 60 x 2g sachets, £72.05
Legal category: POM

Back to Top

SPC changes

Corticosteroids
The summaries of product characteristics for Medrone (methylprednisolone; Pharmacia) tablets, Solu-Medrone (methylprednisolone sodium succinate; Pharmacia) injections and Solu-Cortef (hydrocortisone sodium succinate; Pharmacia) injection have been updated to include a warning about potential psychiatric side effects occurring with systemic steroids.

Hepsera
In lamivudine-resistant patients, Hepsera (adefovir dipivoxil; Gilead) should be used in combination with lamivudine, not as monotherapy, to reduce the risk of resistance, the summary of product characteristics for Hepsera now states.

It adds: “In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ml at or beyond one year of treatment.”

The SPC also warns that resistance to Hepsera can result in viral load rebound, which could result in exacerbation of hepatitis B and, if hepatic function is reduced, lead to liver decompensation and mortality.

Virological response should be monitored closely and if viral rebound occurs resistance testing should be performed.

Renal failure, Fanconi syndrome, hypophosphatemia, proximal renal tubulopathy and associated myopathy and osteomalacia have been added to the list of undesirable effects (frequency not known) from post-marketing surveillance.

Provigil
Serious rash requiring admission to hospital and discontinuation of treatment has been reported with the use of Provigil (modafinil; Cephalon), occurring one to five weeks after treatment initiation, the summary of product characteristics for Provigil now states.

Isolated cases of serious rash have been reported after prolonged treatment (eg, three months), the SPC adds. It also says that patients with major anxiety should only receive treatment with Provigil in a specialist unit.

Psychiatric adverse experiences, including suicidal ideation, have been reported in patients treated with modafinil. In such circumstances, modafinil should be discontinued and not restarted.

Caution should be exercised in administering modafinil to patients with a history of psychosis, depression or mania, the SPC says.

Sandimmun
Patients on Sandimmun (ciclosporin; Novartis) concentrate for infusion should be warned to avoid excess ultraviolet light exposure in view of the potential risk of skin malignancy, the product’s summary of product characteristics now says.

The SPC also now states that renal function should be monitored with particular care in elderly patients and that caution should be exercised when co-administering lercanidipine with ciclosporin.

Back to Top