Prescription Products
Xeloda tablets
Composition: Capecitabine 150mg and 500mg.
Presentation: Film-coated tablets.
Storage and stability: Do not store above 30C.
Action: Cytostatic antimetabolite.
Indications: First-line mono-therapy of metastatic colorectal cancer.
Contraindications: Hypersensitivity to capecitabine, fluorouracil
or excipients; history of severe or unexpected reactions to fluoropyrimidine
therapy; dihydropyrimidine dehydrogenase deficiency; pregnancy and lactation;
severe leucopenia, neutropenia or thrombocytopenia; severe hepatic impairment;
severe renal impairment (creatinine clearance below 30ml/min); concomitant
treatment with sorivudine or its chemically related analogues, such as
brivudine.
Dosage and administration: Recommended dose 1250mg/m2
body surface, twice daily (morning and evening) for 14 days followed by
a seven-day rest period. Tablets should be swallowed with water and taken
within 30 minutes after a meal. Treatment should be discontinued if progressive
disease or intolerable toxicity is observed. See SPC for dose calculation
and management of toxicity during treatment.
Hepatic impairment, insufficient data available to provide
dose adjustment recommendation.
Mild renal impairment (creatinine clearance 51-80ml/min at baseline),
no adjustment of starting dose. Moderate renal impairment (creatinine
clearance 30-50ml/min at baseline), dose reduction of 75 per cent of starting
dose. See SPC for treatment interruption and monitoring.
Children (<18 years), safety and efficacy have not been
studied.
Elderly, no adjustment of starting dose needed. See SPC.
Overdosage: Manifestations of acute overdose include nausea, vomiting,
diarrhoea, mucositis, gastrointestinal irritation and bleeding and bone
marrow depression. See SPC for management.
Precautions: Caution must be exercised in patients with:
- history of significant cardiac disease, arrhythmias and angina
pectoris
- central or peripheral nervous system disease, eg, brain metastases
or neuropathy
- diabetes mellitus or electrolyte disturbances
See SPC for dose-limiting toxicities, including diarrhoea and hand-foot
syndrome.
Drug interactions: Altered coagulation parameters and/or bleeding
have been reported in patients taking capecitabine concomitantly with
coumarin- derivative anticoagulants such as warfarin and phenprocoumon.
Increased phenytoin plasma concentrations have been reported during concomitant
use of capecitabine with phenytoin. Concomitant use of allopurinol should
be avoided. See SPC for further details.
Side effects: Very common undesirable effects (>10 per cent) included
diarrhoea, nausea, vomiting, abdominal pain, stomatitis, hand-foot syndrome,
dermatitis, fatigue, anorexia. Common effects (>1 per cent, <10 per cent)
include constipation, dyspepsia, upper abdominal pain, dry mouth, flatulence,
loose stools, alopecia, dry skin, erythematous rash, skin hyperpigmentation,
pruritus, nail disorders, localised exfoliation, pyrexia, weakness, asthenia,
lethargy, limb pain, lower limb oedema, headache, paraesthesia, taste
disturbance, dizziness, insomnia, hyperaesthesia, dehydration, dyspnoea,
increased lacrimation, conjunctivitis, decreased appetite, epistaxis,
weight decrease, back pain, arthralgia and depression. See SPC for uncommon,
rare and very rare undesirable effects and for haematological and biochemical
laboratory abnormalities.
Net price: 150mg 60 £44.47, 500mg 120 £295.06.
Supplier: Roche Products, 40 Broadwater Road, Welwyn Garden City,
Hertfordshire AL7 3AY. Tel 0800 7315711, fax 01707 367555.
Legal class: POM.
Oral Cymevene
The licensed indications for Roche Product’s oral Cymevene (ganciclovir)
have been extended. Cymevene 250mg and 500mg capsules are now additionally
licensed for the prevention of cytomegalovirus disease in kidney transplant
recipients. The recommended dose for this indication is 1,000mg three
times a day.
Singulair tablets
Singulair (montelukast) Paediatric 4mg chewable tablets have been launched
by Merck Sharp & Dohme for children aged two to five years. The dosage
in this age group is one 4mg tablet daily at bedtime (net price, 28 £25.69).
Insuman Optiset disposable pens
Aventis Pharma has launched a range of Insuman Optiset disposable pens
for Insuman Rapid 100iu/ml, Insuman Basal 100iu/ml, Insuman Comb 15 100iu/ml,
Insuman Comb 25 100iu/ml and Insuman Comb 50 100iu/ml.
Eltroxin tablets
Goldshield Pharmaceuticals has added Eltroxin (thyroxine sodium) 25µg
tablets, pack size 28, to its Eltroxin range (net price, 85p).
Discontinued
Alcon Laboratories has discontinued the Isopto Carpine (pilocarpine)
range of eye-drops.
Pharmacia supplies
Pharmacia says that, following supply problems, the following products
are now available: Elleste Duet 1mg tablets, pack size 84; Elleste Solo
2mg tablets, pack size 84; Loniten 2.5mg and 5mg tablets, pack size 60.
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