Prescription Products
Starlix tablets
Composition:
Nateglinide 60mg, 120mg and 180mg.
Presentation: Film coated tablets; 60mg pink, 120mg
yellow and 180mg red.
Storage and stability: Do not store above 30C. Store
in original packaging.
Action: Antidiabetic.
Indications: Combination therapy with metformin
in type II diabetic patients inadequately controlled despite taking a
maximum tolerated dose of metformin on its own.
Contraindications: Hypersensitivity to active substance
or excipients; type I diabetes (insulin dependent diabetes mellitus, C-peptide
negative); diabetic ketoacidosis (with or without coma); pregnancy and
breast-feeding; severe hepatic impairment.
Dosage and administration: Should be taken within
30 minutes before meals. The recommended starting dose is 60mg three times
daily usually before breakfast, lunch and dinner. The dose may be increased
to 120mg three times daily. Dose adjustments should be based on periodic
glycosylated haemoglobin (HbA1c) measurements which may also
be monitored with one to two-hourly post-meal glucose. The maximum single
dose that can be taken before each of the three main meals (as above)
is 180mg. The maximum daily dose must not exceed 540mg.
Elderly (>75 years), limited experience.
Mild to moderate hepatic impairment, no dose
adjustment necessary, but use with caution in patients with moderate hepatic
impairment.
Mild to moderate renal impairment, no dose
adjustment required. Moderate to severe, dose adjustment may be
required (see SPC).
Children and adolescents (<18 years),
not recommended.
Overdosage: No experience of overdosage. Overdose
may result in an exaggerated glucose-lowering effect, with the development
of hypoglycaemic symptoms (see SPC for treatment).
Precautions: Should not be used as monotherapy.
Nateglinide is capable of producing hypoglycaemia. Careful titration is
required to avoid hypoglycaemic reactions in debilitated or malnourished
patients.
Drug interactions: Angiotensin-converting enzyme
inhibitors may enhance the hypoglycaemic effect of nateglinide. Diuretics,
corticosteroids and beta2 agonists may reduce the hypoglycaemic
effect of nateglinide. Concomitant use of cytochrome P450 enzymes could
result in a more prolonged effect and possibly increased risk of hypoglycaemia.
Side effects: Common adverse events (>1 per cent,
<10 per cent) include symptoms suggestive of hypoglycaemia. Rare events
(>0.01 per cent, <0.1 per cent) include hypersensitivity reactions
(such as rash, itching and urticaria) and elevations in liver enzymes.
Net price: 60mg 84 £19.75; 120mg 84 £22.50; 180mg
84 £22.50.
Supplier: Novartis Pharmaceuticals, Frimley Business
Park, Frimley, Camberley, Surrey GU16 7SR. Tel 0845 741 9442, fax 01276
698449.
Legal class: POM.
Rapamune oral solution
Composition: Sirolimus 1mg/ml.
Presentation: Oral solution in 60ml bottle and in
sachets.
Storage and stability: Store at 2–8C. Store in original
container to protect from light. Patients may store at room temperatures
of up to 25C for 24 hours. Once opened, 60ml bottles have a 30-day shelf
life.
Action: Immunosuppressant.
Indications: Prophylaxis of organ rejection in adult
patients at low to moderate immunological risk receiving a renal transplant.
Contraindications: Hypersensitivity to active substance
or excipients.
Dosage and administration: Adults, initial therapy
(two to three months post-transplantation), oral loading dose 6mg
administered as soon as possible after transplantation, followed by 2mg
once daily. The dose should then be individualised to obtain whole blood
trough levels of 4–12ng/ml and optimised with a tapering regimen of steroids
and ciclosporin microemulsion. Maintenance therapy, ciclosporin
should be progressively discontinued over four to eight weeks and the
dose of sirolimus adjusted to obtain whole blood trough levels of 12–20ng/ml.
See SPC for further details and therapeutic drug monitoring.
Children and adolescents, not recommended.
Elderly (>65 years), see SPC.
Renal impairment, no dosage adjustment required.
Mild to moderate hepatic impairment, not
necessary to modify loading dose. Sirolimus trough levels should be closely
monitored.
Pregnancy, should not be used unless clearly
necessary. Contraception must be used during therapy and for 12 weeks
after.
Lactation, breast-feeding should be discontinued
during therapy.
Overdosage: See SPC.
Precautions: Patients should be monitored for hyperlipidaemia.
Drug interactions: Co-administration of sirolimus
with strong inducers of CYP34A (eg, rifampicin, rifabutin) or inhibitors
(eg, ketoconazole) is not recommended and whole blood trough levels should
be monitored if co-administration takes place (see SPC). Grapefruit juice
should be avoided.
Side effects: Very common adverse events (Ž10 per
cent) include lymphocele, abnormal pain, diarrhoea, anaemia, thrombocytopenia,
hyperlipidaemia, hypercholesterolaemia, hypokal-aemia, increased lactic
dehydrogenase, arthralgia, acne and urinary tract infection.
Net price: 60ml bottle £148.20; sachets 1mg/ml,
30 £74.10, 2mg/2ml 30 £148.20.
Supplier: Wyeth Laboratories, Huntercombe Lane South,
Taplow, Maidenhead, Berkshire SL6 0PH. Tel 01628 604377, fax 01628 414878.
Legal class: POM.
Salamol inhaler
Norton Healthcare has
introduced a CFC-free Salamol (salbutamol) Easi-Breathe 100µg inhaler,
200 doses. The company says that the new inhaler is smaller than the previous
one (net price, £6.30).
Lamictal tablets
Lamictal (lamotrigine) chewable and dispersible tablets have been launched by GlaxoSmithKline
(net price, 30 £9.37).
Zopiclone tablets
Zopiclone 7.5mg tablets, pack size 28, have been launched by Dominion Pharma (net
price, £4.48).
Pulmicort inhaler
AstraZeneca's
Pulmicort (budesonide) 200µg inhaler is currently out of stock. Further
information on alternative products can be obtained from the company's
medical information department (tel 0800 783 0033).
Molipaxin CR tablets
Aventis Pharma's Molipaxin (trazodone hydrochloride) CR 150mg tablets are to be
discontinued with immediate effect.
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