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The Pharmaceutical Journal Vol 267 No 7174 p708-709
17 November 2001

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Products

    Prescription Products SPC changes Discontinued products Products miscellany

Prescription Products

Glivec capsules

Composition: Imatinib (as mesilate) 100mg.

Presentation: Capsules.

Class: Protein-tyrosine kinase inhibitor.

Indications: Treatment of adults (aged 18 years and over) with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

Major cautions and precautions: To minimise the risk of gastrointestinal irritations, imatinib should be taken with food and a large glass of water. Imatinib should not be used in patients with severe hepatic impairment unless clearly necessary. Caution is recommended in severe renal insufficiency. Patients should be weighed regularly. Caution should be taken when co-administering imatinib with: CYP3A4 inhibitors (eg, itraconazole, ketoconazole, clarithromycin, erythromycin); CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, St John's Wort); CYP3A4 substrates with a narrow therapeutic window (eg, ciclosporin, pimozide). Patients should be warned to avoid or restrict the use of over-the-counter and prescription medicines containing paracetamol. Imatinib should not be used during pregnancy unless clearly necessary. Women taking imatinib should not breast-feed.

Side effects: Very common (>10 per cent) adverse events include anaemia, neutropenia, thrombocytopenia, headache, nausea, vomiting, diarrhoea, dyspepsia, rash, oedema, muscle cramps.

Legal category: POM.

Net price: 120 capsules £1,557.36.

Contact details: Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR. Medical information, tel 01276 698370, fax 01276 698449; customer care (for orders), tel 0845 741 9442, fax 0845 741 9443.

See SPC for further details.

Metronidazole tablets

Metronidazole 200mg and 400mg tablets, pack size 21, have been launched (APS/Berk); net price, 200mg £1.31, 400mg £1.51.

Methadone injection

Synastone (methadone hydrochloride) 10mg/ml injection has been launched (Auden Mckenzie Pharma Division); net price, 10 ampoules 1ml £8.95, 2ml £14.50, 3.5ml £17.83, 5ml £19.23. Further information can be obtained from Auden Mckenzie Pharma Division, Unit 30, Stadium Business Centre, North End Road, Middlesex HA9 0AT.

Nitrofurantoin suspension

Nitrofurantoin suspension 25mg/5ml, pack size 300ml, is being launched and will be available from 1 December (Goldshield Pharmaceuticals); net price, £65.

Ephedrine injection

Ephedrine hydrochloride 30mg/ml concentrate for solution for injection is being launched in 1ml ampoules (Torbay Pharmaceutical Manufacturing Unit); net price, 10 £10. Further information can be obtained by contacting customer services, Torbay PMU (tel 01803 664707).

Miacalcic nasal spray

Miacalcic (synthetic salmon calcitonin) nasal spray, 200iu per metered dose, is now licensed for the treatment of established postmenopausal osteoporosis (Novartis Pharmaceuticals); net price, 2ml £20.99. The recommended dose is 200iu per day. Each 2ml bottle delivers 14 metered doses.

Neupogen Singleject

Neupogen (filgrastim) Singleject 30 million units (300µg) and 48 million units (480µg) in 0.5ml prefilled syringes have been launched (Amgen); net price, 30 million units 5 £367.80, 48 million units 5 £586.61. Neupogen Singleject prefilled syringes have a 27-gauge needle (length 12mm) attached. See below also.

Exelderm cream

Exelderm (sulconazole nitrate) 1 per cent cream, pack size 30g, previously a prescription only medicine, has been reclassified as a pharmacy medicine (Bioglan Laboratories); retail price, £5.29.

Isotard XL tablets

The marketing authorisations for Isotard XL (isosorbide mononitrate) 25mg, 40mg, 50mg and 60mg tablets are being transferred from Galen to Strakan. Strakan expects that this will happen by the end of December. In the meantime all medical enquiries should be directed to Galen. For order-related enquiries, Strakan should be contacted (tel 01264 325315, fax 01264 362108).

Kytril preparations

The marketing authorisations for all Kytril preparations have been transferred from GlaxoSmithKline to Roche Products.

Prograf preparations

From 3 December, the responsibility for distributing Prograf (tacrolimus) 0.5mg, 1mg and 5mg capsules and 5mg/5ml ampoules will be transferred from Healthcare Logistics to Farillon.

Tegretol liquid

Tegretol (carbamazepine) liquid is now slightly thinner in consistency because of a change in one of the excipients (Novartis Pharmaceuticals). Further information can be obtained from Cephalon UK (tel 0800 783 4869).

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SPC changes

Diprivan injection

The summaries of product characteristics for Diprivan (propofol) 1 per cent and 2 per cent have been updated (AstraZeneca). The following has been added to the posology and method of administration and the contraindications sections: Diprivan is contraindicated for the sedation of ventilated children aged 16 years or younger receiving intensive care.

Gammabulin injection

Gammabulin Normal Immunoglobulin injection is no longer licensed for the prevention or modification of measles and Rubella infections (Baxter Healthcare). It is now only licensed for the treatment of antibody deficiency syndrome and recurring bacterial infections in dys-, hypo- and agammaglobulin-aemia.

Zoton capsules and suspension

The summaries of product characteristics for Zoton (lansoprazole) 15mg and 30mg capsules and 30mg suspension have been updated. The posology and method of administration section now states: "Clinical trials in patients with liver disease indicate that metabolism of lansoprazole is prolonged when daily doses of 30mg are administered to patients with severe hepatic impairment. It is therefore recommended that the daily dose for patients with severe liver disease is individually adjusted to 15mg or 30mg. These patients should be kept under regular supervision and a daily dose of 30mg should not be exceeded". Agranulocytosis has been added to the undesirable effects section.

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Discontinued products

Neupogen injection

Neupogen (filgrastim) 30 million units in 1ml and Neupogen 48 million units in 1.6ml prefilled syringes will be discontinued at the end of November (Amgen). The company says that it is not offering to replace existing stock with Neupogen Singleject and that Neupogen 1ml and 1.6ml prefilled syringes can be used for the remainder of their two-year shelf life and should not be destroyed. Neupogen 30 million units and 48 million units in 1ml vials remain available.

Tagamet 100 tablets

Tagamet 100 (cimetidine) tablets, pack sizes 12 and 24, have been discontinued (GlaxoSmithKline).

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Products miscellany

Ensure Plus Yoghurt Style

Ensure Plus Yoghurt Style drink is being launched (Abbott Laboratories); net price, 220ml tetrapak £1.56. This nutritional supplement is available in strawberry swirl, pineapple twist and orchard peach flavours.

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