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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7334 p107
29 January 2005

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Products

    New medicines Prescription Products Products miscellany

Recall IVAX lorazepam tablets


New medicines

Mimpara
Composition: Cinacalcet (as hydrochloride).
Presentation: Film-coated tablets.
Class: Anti-parathyroid agent.
Indications: Treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy. May be used as part of a regimen including phosphate binders and/or vitamin D sterols. Reduction of hypercalcaemia in patients with parathyroid carcinoma.
Dosage: Secondary hyper-parathyroidism: Recommended starting dose 30mg once daily. Mimpara should be titrated every two to four weeks to a maximum dose of 180mg once daily to a target parathyroid hormone (PTH) level of 150–300pg/ml. See SPC. Parathyroid carcinoma: Recommended starting dose 30mg twice daily, titrated every two to four weeks through sequential doses of 30mg twice daily, 60mg twice daily, 90mg twice daily and 90mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal. See SPC.
Precautions: Mimpara should not be initiated in patients with a serum calcium below the lower limit of the normal range. Adynamic bone disease may develop if PTH levels are chronically suppressed. Mimpara should be used with caution in patients with moderate to severe hepatic impairment, or when being used concomitantly with strong inhibitors or inducers of CYP3A4 or CYP1A2.
Side effects: Very common (>1/10) nausea, vomiting. Common (>1/100) include anorexia, dizziness, paraesthesia, myalgia, asthenia, hypocalcaemia.
Legal category: POM.
Net price: 30mg 28 £126.28, 60mg 28 £232.96, 90mg 28 £349.44.
Contact details: Amgen, 240 Cambridge Science Park, Milton Road, Cambridge CB4 OWD. Telephone 01223 420305.

Xagrid
Composition: Anagrelide hydrochloride.
Presentation: Opaque white hard capsules.
Class: Platelet lowering agent.
Indications: Reduction of elevated platelet counts in at-risk essential thrombocythaemia patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Dosage: Recommended starting dose 1mg/day, administered orally in two doses of 0.5mg. The starting dose should be maintained for at least one week, after which it may be titrated to the lowest effective dosage required to maintain a platelet count below 600 x 109/L. The dosage increment should not exceed 0.5mg/day in any one week and the single dose should not exceed 2.5mg.
Precautions: The potential risks and benefits of anagrelide therapy in a patient with mild or moderate impairment of hepatic function or with impairment of renal function should be assessed before treatment starts. Patients should be closely supervised clinically, including full blood counts and assessment of liver and renal function.
Contraindications: Patients with severe hepatic impairment. Patients with severe renal impairment (creatinine clearance <30ml/min).
Side effects: Very common (>1/10) headache. Common (>1/100) anaemia, fluid retention, palpitations, tachycardia, nausea, diarrhoea, abdominal pain, flatulence, vomiting, rash, fatigue.
Legal category: POM.
Net price: 0.5mg 100 £337.14.
Contact details: Shire Pharmaceuticals, Hampshire International Business Park, Basingstoke, Hampshire RG24 8EP. Tel 01256 894000.

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Prescription Products

Adipine XL
Adipine (nifedipine) XL tablets are now available from Trinity Pharmaceuticals; net price 30mg 28 £5.95, 60mg 28 £8.95. Legal category: POM.

CymbaltaCymbalta
Cymbalta (duloxetine) capsules have been launched by Eli Lilly and Boehringer Ingelheim. Cymbalta is licensed for the treatment of major depressive episodes. Starting and maintenance dose is 60mg once daily. Therapeutic response is usually seen after two to four weeks, and treatment is recommended for several months after establishing response, to avoid relapse. Net price, 60mg 84 £83.16, 60mg 28 £27.72, 30mg 28 £22.40. Legal category: POM. A guide for health care professionals has been developed to help distinguish Cymbalta from Yentreve (duloxetine, licensed for moderate to severe stress urinary incontinence, PJ, 18 September 2004, p373). The guide is available from Eli Lilly on 01256 315999.

Durogesic DTransDurogesic DTrans
Durogesic DTrans (fentanyl) transdermal patches will be available from 31 January and will replace the original Durogesic patches (Janssen-Cilag). Durogesic DTrans are “matrix” patches with the fentanyl dissolved evenly in each layer, in contrast to the original patches which used reservoir technology. Durogesic DTrans patches are bioequivalent to the original patches but are smaller and thinner. Net price, 5 patches, 25µg/h £27.52, 50µg/h £51.40, 75µg/h £71.66, 100µg/h £88.32. Legal category: Schedule 2 Controlled Drug.

Nebido
Nebido (testosterone undecanoate) 1,000mg/4ml, solution for injection has been launched by Schering Health Care. It is licensed for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. The dose is 1,000mg (one ampoule) injected every 10 to 14 weeks. Legal category: POM. Net price, 4ml £76.70.

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Products miscellany

Emla cream
Emla (prilocaine and lidocaine) cream 5 per cent has been reclassified as a Pharmacy medicine (AstraZeneca). New “P” packs will be phased in over the next few months.

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