Prescription Products
Reductil capsules
Composition:
Sibutramine hydrochloride monohydrate 10mg and 15mg.
Presentation: Hard capsules.
Storage and stability: Do not store above 25C. Store
in original package and keep blister pack in outer carton.
Action: Anti-obesity agent.
Indications: Adjunctive therapy within a weight
management programme for: patients with nutritional obesity and a body
mass index (BMI) of 30kg/m2 or higher; patients with nutritional
excess weight and a BMI of 27kg/m2 or higher, if other obesity-related
risk factors such as type 2 diabetes or dyslipidaemia are present.
Contraindications: Hypersensitivity to sibutramine
or excipients; severe renal impairment; severe hepatic impairment; pregnancy
and lactation; children and young adults up to the age of 18 years; patients
above the age of 65 years; organic causes of obesity; history of major
eating disorders; psychiatric illness; Gilles de la Tourette’s syndrome;
concomitant use, or use during the past two weeks, of monoamine oxidase
inhibitors or of other centrally acting drugs for the treatment of psychiatric
disorders (such as antidepressants, antipsychotics) or for weight reduction,
or tryptophan for sleep disturbances; history of coronary artery disease,
congestive heart failure, tachycardia, peripheral arterial occlusive disease,
arrhythmia or cerebrovascular disease; inadequately controlled hypertension;
hyperthyroidism; benign prostatic hyperplasia with urinary retention;
phaeochromocytoma; narrow angle glaucoma; history of drug, medication
or alcohol abuse.
Dosage and administration: Adults, initial
dose 10mg once daily, in the morning. Capsules should be swallowed whole
with liquid and can be taken with or without food. In patients with an
inadequate response (ie, weight loss of less than 2kg after four weeks
of treatment) the dose may be increased to 15mg once daily, provided the
10mg dose was well tolerated. Discontinue treatment in those who have
responded inadequately to a 15mg dose. See SPC for duration of treatment.
Mild to moderate hepatic impairment, use
with caution.
Mild to moderate renal impairment, use with
caution.
Overdosage: Limited experience and no specific antidote.
Precautions: Blood pressure and pulse should be
monitored (see SPC). During routine check-ups, dyspnoea, chest pain and
ankle oedema should be looked for. Patients should be advised to consult
a doctor immediatley if these symptoms occur. Sibutramine should be given
with caution in patients with epilepsy and to patients who have a family
history of motor or verbal tics. Women of child-bearing age should use
adequate contraception while taking sibutramine.
Drug interactions: Caution should be exercised when
concomitantly administering sibutramine with drugs that affect CYP3A4
enzyme activity and when prescribing it to patients who are taking cough,
cold or allergy medicines, such as ephedrine and pseudoephedrine, and
decongestants, such as xylometazoline. It should not be used concomitantly
with other drugs that raise serotonin levels in the brain. Two weeks should
elapse between stopping sibutramine and starting monoamine oxidase inhibitors.
Side effects: Very frequent (>10 per cent) adverse
events include loss of appetite, constipation, dry mouth, insomnia. Frequent
adverse events (1 to 10 per cent) include tachycardia, palpitations, hypertension,
vasodilation (hot flushes), nausea, haemorrhoid aggravation, light-headedness,
headache, paraesthesia, anxiety, sweating, taste perversion.
Net price:10mg 28 £35, 15mg 28 £39.09.
Supplier: Knoll, 9 Castle Quay, Castle Boulevard,
Nottingham NG7 1FW. Tel 0115 912 5000, 0115 912 5069.
Legal class: POM.
Emadine eye-drops
Alcon
Laboratories’s Emadine (emedastine difumarate) eye-drops are now back
in stock and available from wholesalers.
Curosurf suspension
The
marketing and distribution rights for Curosurf (poractant alfa) suspension
have been transferred from Serono to Chiesi Pharmaceuticals. Enquiries
should now be passed to the company’s UK subsidiary, Trinity Pharmaceuticals,
customer services department (tel 01484 600614) and medical information
department (020 8944 9443).
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