SPC changes
Aprovel
The summary of product characteristics for Aprovel (irbesartan; Bristol-Myers
Squibb) now has a precaution that the medicine should not be taken by
people with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption. The following
very rare undesirable effects have been added: arthralgia, myalgia, muscle
cramps and leukocytoclastic vasculitis. See SPC.
Neoclarityn
The summaries of product characteristics for Neoclarityn (desloratadine;
Schering-Plough) tablets and syrup have been updated to include psychomotor
hyperactivity and seizures as undesirable effects. See SPC.
Nebilet
Nebilet (nebibolol; A Menarini) is now indicated in the treatment of
stable mild and moderate chronic heart failure in addition to standard
therapies in elderly patients aged 70 years or over. The summary of
product characteristics states that initiation of therapy for this
indication should be supervised by the physician for at least two hours
and initial uptitration should be undertaken until the optimal individualised
dose is reached. Patients should be started on 1.25mg once daily, increasing
at one- to two-weekly intervals to 2.5mg once daily, then 5mg once
daily, up to a maximum of 10mg once daily if tolerated. Initiation
and titration should be regularly monitored. Treatment is usually long-term
and should not be stopped abruptly. Because doses are titrated to the
individual, dosage adjustment is not required in elderly patients or
individuals with renal insufficiency. The list of contraindications
has been updated and now lists acute heart failure, cardiogenic shock
and episodes of heart failure decompensation requiring intravenous
inotropic therapy. The drug interactions section has been updated and
expanded and a new section containing data on adverse reactions in
CHF has been added. Further data for the CHF indication have been added
to the pharmacodynamic properties section. See SPC.
Tamiflu
The summary of product characteristics for Tamiflu (oseltamivir; Roche)
has been updated to include an indication for post exposure prevention
in adults and children one year of age or older following contact with
a clinically diagnosed influenza case when influenza virus is circulating
in the community. New prophylactic dosage information is included for
children aged one to 12. The prophylactic course is taken once daily
for 10 days at the following doses: children 15kg or under, 30mg; 15kg
to 23kg, 45mg; 23kg to 40kg, 60mg; over 40kg or adult, one 75mg capsule
(or 75mg of suspension if unable to swallow capsules). See SPC.
Subutex
The summary of product characteristics for Subutex (buprenorphine hydrochloride;
Schering-Plough) now contains a warning for clinicians about the risk
of intravenous abuse and misuse, particularly at the beginning of treatment.
A warning is now included about severe acute hepatic injury in the
context of misuse, especially by the intravenous route. See SPC.
Sustiva
The summary of product characteristics for Sustiva (efavirenz; Bristol-Myers
Squibb) has been updated and the special warnings and precautions section
now contains information about seizures. Convulsions have been observed
rarely in patients, generally in those with known history of seizures.
Drug interaction information has been included for carbamazepine, phenytoin,
phenobarbital and other anticonvulsants. Co-administration with carbamazepine
has been shown to elicit a two-way interaction resulting in reduced
blood levels of both drugs. Co-administration with atorvastatin, pravastatin
or simvastatin has been shown to reduce statin levels, and cholesterol
levels should be periodically monitored with dosage adjustment of the
statins if required. The undesirable effects paragraph on lipids has
been amended. See SPC.
Zaditen
The summary of product characteristics for Zaditen (ketotifen hydrogen
fumarate; Novartis) now states that Zaditen is only indicated for symptomatic
treatment of allergic conditions including rhinitis and conjunctivitis,
and for children from three years of age, rather than two years. There
is now a warning that Zaditen may lower seizure threshold. Convulsions
have been reported very rarely and the SPC recommends using Zaditen
with caution in patients with a history of epilepsy. The SPC now lists
very rare increase in liver enzymes and hepatitis as undesirable effects.
New advice on the management of overdose is also included. See SPC.
Zometa
The summary of product characteristics for Zometa (zoledronic acid; Novartis)
now includes a special warning about infrequent reports of severe and
sometimes incapacitating bone, joint or muscle pain in patients taking
biphosphonates. Hypotension has been added to the list of uncommon
cardiovascular disorders. In very rare cases hypotension has led to
syncope or circulatory collapse, primarily in patients with underlying
risk factors. See SPC.
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