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PJ Online homeThe Pharmaceutical Journal
Vol 278 No 7443 p305
17 March 2007

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Products

    New medicines Prescription Products SPC changes

New medicines

Byetta

ByettaComposition: Exenatide.

Presentation: Solution for injection, prefilled pen.

Action: Incretin mimetic.

Indications: Treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Dosage: Treatment should be initiated at 5µg twice daily, by subcutaneous injection, administered at any time within an hour before the morning and evening meal (or the two main meals of the day at least six hours apart). After at least one month the dose can be increased to a maximum of 10µg twice daily.

Contraindications: Type 1 diabetes mellitus, diabetic ketoacidosis, end-stage renal disease or severe renal impairment, and severe gastrointestinal disease.

Precautions: Byetta should not be administered after a meal. When Byetta is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia. Caution is advised for patients receiving oral medicines that require rapid gastrointestinal absorption and medicines with a narrow therapeutic index. Caution with dose escalation is recommended for patients with moderate renal impairment. There is no experience of Byetta use in children and adolescents below 18 years old.

Side effects: Very common (>1/10) hypoglycaemia, nausea, vomiting, diarrhoea.

Legal category: POM.

Net price: 1 pen (60 doses) 5µg/20µl, £68.24; 1 pen (60 doses) 10µg/40µl, £68.24.

Contact details: Eli Lilly, Lilly House, Priestly Road, Basingstoke, Hampshire RG24 9NL (tel 01256 315 000).

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Prescription Products

Cefalexin
Cefalexin oral suspension and tablets are now available from Pliva. Net price (oral suspension): 100ml x 125/5ml, £1.43; 100ml x 250/5ml, £2.87. Net price (tablets): 28 x 250mg, £1.99, 21 x 500mg, £2.27. Legal category: POM.

Seroxat 10mg
Sexorat (paroxetine) tablets 10mg are now available from GlaxoSmithKline. Net price: 28 x 10mg, £12.32. Legal category: POM.

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SPC changes

Neulasta
The summary of product characteristics for Neulasta (pegfilgrastim; Amgen) now includes the following information. Sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging results. Cutaneous vasculitis and isolated cases of sickle cell crises have been added as rare undesirable events. See SPC.

Syntocinon
The summaries of product characteristics for Syntocinon (oxytocin; Alliance) 5iu and 10iu ampoules now include additional information about: administration of oxytocin at excessive doses; risk of postpartum disseminated intravascular coagulation; the combined antidiuretic effect of oxytocin and intravenous fluid administration; risk of fetal abnormalities; breast feeding; driving; and operating machines. See SPC.

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