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The Pharmaceutical Journal
Vol 269 No 7209 p155
3 August 2002

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Products

    Prescription Products SPC changes

Recall Becotide, Becloforte and Ventide metered dose inhalers


Prescription Products

Varilrix vaccine

Varilrix vaccine, containing live attenuated varicella-zoster (Oka strain) virus, has been launched (GlaxoSmithKline); net price, 1 £29.37. Varilrix is indicated for active immunisation against varicella in healthy adults and adolescents (Ž13 years) who have been found to be seronegative with respect to varicella-zoster virus and are, therefore, at risk of developing chickenpox. Two doses should be given with an interval of approximately eight weeks between doses (minimum interval of six weeks). The vaccine is not indicated for routine use in children. However, it may be administered to seronegative healthy children, aged one to 12 years, who are in close contact with people considered to be at high risk of severe varicella infections. A single dose should be given.

IVAX products

IVAX Pharmaceuticals has redesigned the packaging for its patient packs (as shown right).

Lagap products

Lagap Pharmaceuticals has launched the following products:

• Cetirizine dihydrochloride 10mg tablets, net price, 30 £8.73

• Co-zidocapt (captopril 25mg, hydrochlorothiazide 12.5mg), net price, 30 £12.05

• Co-zidocapt (captopril 50mg, hydrochlorothiazide 25mg), net price, 30 £15.15

• Warfarin 5mg tablets, net price, 500 £33.93

• Zolpidem tartrate tablets, net price, 5mg 28 £3.08, 10mg 28 £4.48

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SPC changes

Lustral tablets

The licensed indications for Lustral (sertraline hydrochloride) tablets have been extended (Pfizer). Lustral tablets are now additionally indicated for the treatment of post-traumatic stress disorder (PTSD) in women and under the therapeutic indications section it states: "Clinical trials in PTSD demonstrated efficacy in female patients but no evidence of efficacy was seen in males. Treatment with Lustral cannot normally therefore be recommended for male patients with PTSD. A therapeutic trial in males might on occassion be justified, but treatment should subsequently be withdrawn unless there is clear evidence of therapeutic benefit". Treatment should be initiated at a dose of 25mg daily, which should be increased to a dose of 50mg daily after one week. See SPC.

Rapamune preparations

The summary of product characterisitics for Rapamune (sirolimus) tablets and oral solution has been updated (Wyeth Pharmaceuticals). The special warnings and precautions for use section states that during treatment with immuno-suppressants, including Rapamune, vaccination may be less effective. The use of live vaccines should be avoided during treatment with Rapamune. "The incidence of adverse events may increase as the trough sirolimus level increases" has been added to the undesirable effects section, as have the following adverse events: peripheral oedema, increased serum glutamic oxalacetic transaminase, increased serum glutamic pyruvic transaminase, pneumonitis; pancytopenia. Hepatotoxicity has been reported. See SPC.

Schering products

The blister packaging for Logynon ED calander packs and Femodene ED packs has been changed so that the first tablet taken is always an active tablet (Schering Health Care). The summaries of product characteristics have been updated accordingly. See SPC.

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