SPC changes
Valcyte new indication
The licensed indications for Val-cyte (valganciclovir hydrochloride)
tablets have been extended (Roche). Valcyte is now additionally indicated
for the prevention of cytomegalovirus disease in CMV-negative patients
who have received a solid organ transplant from a CMV-positive donor.
The recommended dose is 900mg once daily, starting within 10 days of
transplantation and continuing until 100 days post-transplantation. The
tablets should be taken with food whenever possible. See SPC for further
details.
Lariam tablets
The summary of product characteristics for Lariam (mefloquine) tablets
has been updated (Roche). The special warnings and precautions for
use section now states that Lariam should be discontinued if psychiatric
disturbances occur during prophylactic use and an alternative prophylactic
agent should be recommended. The undesirable effects section notes
that
adverse reactions to Lariam may occur or persist for more than several
weeks after the last dose because of the long half-life of mefloquine.
It is noted that there have been rare reports of suicidal ideation
and suicide but no relationship to drug administration has been established.
See SPC.
Amias tablets
The summary of product characteristics for Amias (candesartan cilexetil)
has been revised (AstraZeneca, Takeda). The section on posology and
method of administration now recommends an initial starting dose of
8mg once daily, with no initial dosage adjustment necessary in elderly
patients. An initial dose of 4mg may be considered in patients with
intravascular volume depletion and in patients with renal impairment,
including patients on haemodialysis. The section on special warnings
and precautions for use has been updated to include a section on haemodialysis.
The undesirable effects section has been amended and the overdose section
now notes that candesartan is not removed by haemodialysis. The pharmacodynamic
properties section has been expanded to include more trial data. See
SPC.
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Merck Pharmaceuticals has launched a new range of once-daily hormone
replacement therapy tablets: FemTab (estradiol valerate 1mg and 2mg),
net price, 3x28 £7.72; FemTab Sequi (estradiol valerate 2mg,
estradiol valerate 2mg/levonorgestrel 75µg), net price, 3x28 £15.15;
FemTab Continuous (estradiol hemihydrate 2mg/norethisterone acetate
1mg), net price 3x28 £18.02. The FemTab products are indicated
for the treatment of the climacteric syndrome and the protection of
the skeleton against post-menopausal bone loss in menopausal women
with or without a uterus. See SPCs for further details.