The Pharmaceutical Journal
Vol 270 No 7238 p297
1 March 2003

This article
Reprint
Photocopy

Products

Prescription Products
• Arcoxia tablets
SPC changes
• Prostap SR injection
• Enbrel injection
Discontinued products
• Aserbine cream

Prescription Products

Arcoxia tablets

A 28-tablet pack of Arcoxia (etoricoxib) 120mg has been launched (Merck Sharp & Dohme). Net price, £22.96. The seven-tablet pack remains available.

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SPC changes

Prostap SR injection

The summary of product characteristics for Prostap (leuprorelin) SR injection has been updated (Wyeth). Hypersensitivity to synthetic gonadotrophin releasing hormone (Gn-RH) or Gn-RH derivatives has been added to the contraindications section. Under special warnings, the words "Spinal fracture, paralysis, hypotension and worsening of depression have been reported" have been added. On use in pregnancy, the SPC now states that studies in animals have shown reproductive toxicity and there have been reports of fetal malformation when Prostap has been given during pregnancy. Patients' ability to drive or use machinery may be impaired by visual disturbances and dizziness. Pulmonary embolism and hot flushes have been added to the list of undesirable effects that have been reported infrequently. See SPC.

Enbrel injection

The summary of product characteristics for Enbrel (etanercept) has been updated (Wyeth). The treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate has been added to the therapeutic indications section. The SPC notes that for this indication doses other than 25mg administered twice weekly have not been studied. A neurological assessment is now recommended for patients with pre-existing or recent onset of central nervous system demyelinating disease and for those considered to have an increased risk of developing the disease. In the adverse effects section, chest pain, syncope and kidney calculus have been added. No patients in clinical trials for psoriatic arthritis developed malignancies in studies up to six month's duration. See SPC.

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Discontinued products

Aserbine cream

Aserbine cream for wound desloughing (benzoic acid, malic acid, propylene glycol and salicylic acid), pack size 100g, has been discontinued (Goldshield).

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