New medicines
Emselex
Composition: Darifenacin (as hydrobromide).
Presentation: Prolonged-release tablets.
Class: Urinary antispasmodic.
Indication: Symptomatic treatment of urge incontinence and/or increased
urinary frequency and urgency as may occur in patients with overactive
bladder syndrome.
Dosage: The recommended starting dose is 7.5mg once daily. The dosage
can be increased to 15mg daily after two weeks for patients requiring
greater symptom relief.
Contraindications: Urinary retention; gastric retention; uncontrolled
narrow-angle glaucoma; myasthenia gravis; severe hepatic impairment;
severe ulcerative colitis; toxic megacolon; concomitant treatment with
potent CYP3A4 inhibitor drugs.
Precautions: Patients with moderate hepatic impairment should only be
treated if benefit outweighs risk and patients should be restricted to
a dose of 7.5mg per day. Patients taking concomitant potent inhibitors
of CYP2D6 or moderate inhibitors of CYP3A4 should start with a 7.5mg
daily dose of Emselex. The dose may be increased to 15mg if necessary
and well tolerated. Emselex should be used with caution for patients
with autonomic neuropathy, hiatus hernia, clinically significant bladder
outflow obstruction, risk for urinary retention, severe constipation,
gastrointestinal obstructive disorders such as pyloric stenosis, and
narrow angle glaucoma. Caution should also be exercised for patients
with risk of decreased gastrointestinal motility, gastro-oesophageal
reflux or who are concurrently taking medicines that can cause or exacerbate
oesophagitis (eg, bisphosphonates). Other causes of frequent urination
(eg, heart failure, renal disease) should be assessed before treatment
with Emselex.
Side effects: Very common (>=10 per cent) dry mouth, constipation.
Common (>=1 per cent, <10 per cent) headache, abdominal pain,
dyspepsia, nausea, dry eyes.
Legal category: POM.
Net price: 28 x 7.5mg, £26.13; 28 x 15mg, £26.13.
Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Surrey GU16 7SR (tel 01276 698370).
Back to Top
|
The
Pharmaceutical Journal