PJ Online | Products (19 April 2003)

The summary of product characteristics for Buscopan (hyoscine-N-butylbromide) tablets has been revised (Boehringer Ingelheim). The product is no longer indicated for spasmodic dysmenorrhoea.

Metalyse injection

The summary of product characteristics for Metalyse (tenectaplase) has been updated (Boehringer Ingelheim). Pulmonary haemorrhage has been added to the undesirable effects section, as has the following statement: "Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes." Haemorrhage is now listed as a very common undesirable effect rather than a common one, gastrointestinal or genitourinary bleeding and epistaxis as commonly rather than occasionally and retroperitoneal bleedings and cerebral haemorrhage as uncommonly observed instead of rarely. Isolated cases of events related to the nervous system (eg, somnolence, aphasia, convulsion) have been reported. Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions. The nature of the syringe is now noted as plastic instead of polypropylene. See SPC.

Rapamune products

The summary of product characteristics for Rapamune (sirolimus) tablets and oral solution has been revised (Wyeth Pharmaceuticals). The following paragraph has been added to the special warnings and precautions for use section: "In two clinical studies in de novo liver transplant patients the use of sirolimus plus ciclosporin or tacrolimus was associated with an increase in hepatic artery thrombosis, mostly leading to graft loss or death. The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver transplant patients, and therefore such use is not recommended." Fever has been added as a common adverse event. See SPC.

Discontinued products

Dutonin tablets

Following the discontinuation of Dutonin (nefazodone hydrochloride) tablets (PJ, 18 January, p77), remaining stocks are expected to run out at the end of May (Bristol-Myers Squibb Pharmaceuticals).

Sanofi-Synthelabo products

The following products are being discontinued with immediate effect (Sanofi-Synthelabo):

• Hexopal (inositol nicotinate) suspension

• Monit (isosorbide mononitrate) 20mg tablets

• Trifyba sachets

Modecate (fluphenazine decanoate) 25mg/ml 10ml vials will be discontinued from 31 May. Other Modecate products remain available.

Sofratulle dressing

Sofratulle 10cm x 10cm framycetin gauze dressing is being discontinued with immediate effect (Aventis). Outstanding back orders will be cancelled. Queries should be directed to the company's customer service department (tel 0870 5133347).

Zindaclin gel

Zindaclin (clindamycin) 1 per cent gel, pack size 15g, has been discontinued (Strakan). The 30g pack size remains available.

Supply problems

Palfium shortages

Roche Products reports that Palfium (dextromoramide) 10mg tablets are currently out of stock and Palfium 5mg tablets are likely to be out of stock shortly. The earliest expected date for the availability of new stock is the end of May and, therefore, some patients may have to be transferred to other products. Guidance on transferring patients to other narcotic analgesics is available from Roche drug information on 0800 328 1629.

Counter medicines

4head

4head, a topical treatment, containing levomenthol, for the relief of headaches has been launched (Dendron); retail price, £5.95. Legal category: general sale list.

Dandrazol Antidandruff

Dandrazol Antidandruff (ketoconazole) 2 per cent shampoo, in pack sizes of 60ml and 120ml, has been launched (Transdermal); retail price, 60ml £5.50, 100ml £8.50. Legal category: pharmacy medicine.

Zirtek Allergy solution

Zirtek Allergy (cetirizine hydro-chloride) 1mg/ml solution, pack size 75ml, has been launched (UCB Pharma); net price, £3.75, retail price, £5.99. Legal category: pharmacy medicine.