The Pharmaceutical Journal
Vol 274 No 7333 p89
22 January 2005

This article
Reprint   Photocopy

PDF 45K, Acrobat Reader

Products

New medicines
• Alvesco
Prescription Products
• Abilify tablets
• APO-go pre-filled syringe
• Microgynon 30
SPC changes
• Lipostat
• Amias
• HeliClear and HeliMet
Discontinued products
• Axid hospital pack
Products miscellany
• Kent amoxicillin
• Celltech ampoules

Recall SP10 Drug Tariff dressing packs

New medicines

Alvesco
Composition: Ciclesonide 160µg per activation.
Presentation: Solution for pressurised inhalation.
Class: Corticosteroid.
Indications: Prophylactic treatment of persistent asthma in patients aged 18 years or older.
Dosage: The recommended starting dose is 160µg once daily. This is also the maximum dose. Dose reduction to 80µg may be an effective maintenance dose for some patients.
Precautions: Alvesco should be administered with caution in patients with active or quiescent pulmonary tuberculosis or fungal or viral infections. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods, including: adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Side effects: Common (>1 per cent): paradoxical bronchospasm.
Legal category: POM.
Net price: 120-dose unit £33.60.
Contact details: Altana Pharma, 3 Globeside Business Park, Marlow, Buckinghamshire SL7 1HZ. Tel 01628 646400.

Back to Top

Prescription Products

Abilify tablets
Abilify (aripiprazole) tablets 5mg are now available (Bristol-Myers Squibb). Net price 28, £101.63. Legal category: POM.

APO-go pre-filled syringe
APO-go (apomorphine hydrochloride) is now available from Britannia as a pre-filled syringe 5mg/ml 10ml. Net price: 5 syringes £73.11. Legal category: POM.

Microgynon 30
Microgynon (ethinylestradiol with levonorgestrel) 30 be will available in February as a triple pack (three packs of 21 tablets) (Schering Health Care). Net price; £2.85. Legal category: POM. The triple pack replaces the current single cycle pack which will be discontinued.

Back to Top

SPC changes

Lipostat
The summary of product characteristics for Lipostat (pravastatin) now includes the following statement: “The recommended dose range is 10–20mg once daily between 8 and 13 years of age… and 10–40mg daily between 14 and 18 years of age.” The SPC also now recommends that special caution is taken in adolescent females of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy. See SPC.

Amias
The summary of product characteristics for Amias (candesartan cilexetil) has been updated (Takeda). Amias is now additionally indicated for the treatment of patients with heart failure and impaired left ventricle systolic function, as add-on therapy to angiotensin-converting enzyme inhibitors or when ACE inhibitors are not tolerated. The usual recommended initial dose for this indication is 4mg once daily. Up-titration to the target dose of 32mg once daily or the highest tolerated dose is done by doubling the dose at intervals of at least two weeks. See SPC.

HeliClear and HeliMet
The summaries of product characteristics for HeliClear (clarithromycin, lansoprazole and amoxicillin) and HeliMet (clarithromycin, lansoprazole and metronidazole) have been updated to incorporate changes to the safety information (Wyeth). The list of drugs whose serum levels may be elevated if taken concurrently with clarithromycin now includes cilostazol, methylprednisolone, oral anticoagulants, quinidine, sildenafil, alprazolam, vinblastine and valproate. The SPC now also describes reports of torsade de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide. See SPC.

Back to Top

Discontinued products

Axid hospital pack
Axid (nizatidine) capsules 150mg hospital pack of 28 tablets is being discontinued from 1 March (Lilly). All other presentations remain available.

Back to Top

Products miscellany

Kent amoxicillin
There is an error on the leaflet label of Kent Pharmaceuticals amoxicillin sugar-free suspension 250mg/5ml 100ml bottle (batches 04N001, 04N002, 04N003, 04N004, 04N005, 04N006 and 04N007). The right panel erroneously states: “Each 5ml spoonful of reconstituted suspension contains Amoxicillin Trihydrate BP equivalent to 125mg amoxicillin”. When the leaflet label is removed, the text of the base label remaining is correct. The main left panel correctly states the strength of the product as “250mg/5ml” in large yellow type.

Celltech ampoules
Celltech Pharmaceuticals has noted an increase in the number of reports of irregular breaking of the ring snap of its morphine sulphate 10mg in 1ml ampoules and further production has been halted. However, due to a current product shortage, a number of batches will be released with the following labelling: “This batch may exhibit irregular breaking of the ring snap and increased care should be taken during opening. This batch has been supplied to help with product shortages and meets regulatory requirements.” Enquiries should be directed to medical information on 01753 447690.

Back to Top