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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7324 p676
6 November 2004

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Products

    New medicines Prescription Products SPC changes Discontinued products Supply issues Products miscellany

Recall Bricanyl and Pulmicort inhalers


New medicines

Protelos
ProtelosComposition: Strontium ranelate.

Presentation: Yellow granules for oral suspension.

Class: Bone disease treatment.

Indications: Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

Dosage: Recommended dose is one 2g sachet once daily by oral administration. Intended for long-term use. See SPC.

Major cautions: Hypersensitivity to the active substance or to any of the excipients. Contains a source of phenylalanine, which may be harmful for people with phenylketonuria. Use with caution in patients at increased risk of venous thromboembolism, including patients with a past history of VTE.

Contraindications: Not recommended in patients with a creatinine clearance below 30ml/min. Periodic assessment of renal function is recommended in patients with chronic renal impairment.

Side effects: common (>1/100): headache, nausea, diarrhoea, loose stools, dermatitis, eczema.

Legal category: POM

Net price: 28 sachets £25.60

Contact details: Servier Laboratories, Gallions, Wexham Springs, Framewood Road, Wrexham, Slough SL3 6RL. Tel 01753 662744.

Inspra
Composition: Eplerenone.

Presentation: Film-coated tablets.

Class: Aldosterone antagonist.

Indications: In addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction and clinical evidence of heart failure after recent myocardial infarction.

Dosage: Recommended dosage 50mg once daily. Treatment should be initiated at 25mg once daily and titrated to 50mg once daily preferably within four weeks, taking into account serum potassium levels (see SPC).

Precautions: Serum potassium should be measured before initiation of therapy, within the first week and at one month after the start of treatment or dose adjustment. Potassium levels should be assessed periodically, thereafter, depending on patient risk (eg elderly patients, patients with renal insufficiency or diabetes). Eplerenone should not be administered in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Lithium, ciclosporin and tacrolimus should be avoided during treatment with eplerenone.

Contraindications: Patients with serum potassium level >5.0mmol/L at initiation, moderate to severe renal insufficiency, severe hepatic insufficiency, receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP3A4.

Side effects: Common (>1/100) hyperkalaemia, dizziness, hypotension, diarrhoea, nausea, abnormal renal function.

Legal category: POM.

Net price: 25mg or 50mg, 28 £42.72.

Contact details: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS.

Tel 01304 616161.

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Prescription Products

Qvar Easi-Breathe
Qvar Easi-Breathe (beclometasone dipropionate) is now available in 50µg and 100µg per dose presentations (Ivax); net price, 50µg £8.24, 100µg £18.02. Legal category: POM.

Zomig Rapimelt
Zomig Rapimelt (zolmitriptan) tablets 5mg are now available (AstraZeneca); net price, 6 £26.16. Legal category: POM.

Diovan tablets
Diovan (valsartan) tablets 40mg are now available (Novartis). Net price, 7 £3.69. Legal category: POM.

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SPC changes

Nexium
Nexium (esomeprazole) is now also indicated for the treatment of gastric ulcers and prevention of peptic ulcers in patients requiring continuous non-steroidal anti-inflammatory drug therapy (AstraZeneca); the SPC now includes clinical data supporting these indications. See SPC.

NeisVac-C
NeisVac-C (suspension of polysaccharide antigen of Neisseria meningitidis group C, conjugated to tetanus toxoid protein, adsorbed onto aluminium hydroxide) is now approved as a two-dose regimen (Baxter). See SPC.

Diovan
Diovan (valsartan) is now licensed for the treatment of post myocardial infarction patients (Novartis); the SPC now includes clinical data supporting this indication. Therapy may be initiated 12 hours after myocardial infarction. After an initial dose of 20mg twice daily, valsartan therapy should be titrated to 40mg, 80mg, and 160mg twice daily over the next few weeks. See SPC.

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Discontinued products

Decadron
Decadron (dexamethasone) tablets 0.5mg have been discontinued (Merck Sharp & Dohme).

Xylotox
Xylotox 2 per cent E80 Dental (lidocaine hydrochloride 2 per cent with adrenaline 1:80,000) is being discontinued when stocks are exhausted (Dentsply). The company expects this to occur at the end of the year.

Euglucon
Euglucon (glibenclamide) tablets 2.5mg have been discontinued (Aventis). All outstanding orders have been cancelled.

Agenerase
Agenerase (amprenavir) capsules 150 mg will be discontinued on 24 December (GlaxoSmithKline). Agenerase capsules 50mg and oral solution 15mg/ml will continue to be available.

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Supply issues

Alu-Cap capsules
3M Health Care has announced that the manufacture and supply of Alu-Cap capsules (aluminium hydroxide) is being maintained. Details on 01509 613265.

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Products miscellany

Campto responsibility
Responsibility for Campto (irinotecan hydrochloride), formerly with Aventis Pharma,
has been transferred to Pfizer.

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