The Pharmaceutical Journal
Vol 276 No 7383 p36-37
14 January 2006

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Products

New medicines
• Negaban
Prescription Products
• Neulasta
• Serevent
• Tilade
SPC changes
• Aranesp
• Cordarone X
• Taxotere
• Viramune
Discontinued products
• Benylin
Products miscellany
• Lescol
• Mucodyne
• Navispare
• Normax
• Trasidrex
• Sanofi-aventis
• Senokot

Recall Ephedrine hydrochloride and Slozem 300mg capsules

New medicines

Negaban

Composition: Temocillin sodium 1g.
Presentation: Powder for solution for injection/infusion.
Class: Beta-lactam antibiotic.
Indications: Treatment of septicaemia, urinary tract infection and lower respiratory tract infection where susceptible gram-negative bacilli are suspected or confirmed. In mixed infections where gram-positive or anaerobic bacteria are also liable to be implicated, co-administration with other appropriate antibacterial agents should be considered.
Dosage: In adults 1–2g every 12 hours by intravenous injection, intermittent intravenous infusion or intramuscular injection. In the treatment of acute, uncomplicated urinary tract infections 1g daily, as a single or divided dose, may be used. In patients with moderate or severe renal impairment, the interval between doses should be increased. Temocillin is removed by haemodialysis.
Precautions: Bleeding has occurred in some patients receiving beta-lactam antibiotics and is more likely in patients with renal failure. In case of severe persistent diarrhoea, the possibility of antibiotic-induced, life-threatening pseudomembranous colitis should be considered. Potassium levels should be monitored in patients with low potassium reserves.
Side effects: Undesirable effects are typical of the injectable penicillins, including diarrhoea, pain at injection site, rash, angioedema and anaphylaxis.
Legal category: POM.
Net price: 1g vial, £25.45.
Contact details: Eumedica, Winston Churchill Avenue 67, B-1180 Brussels, Belgium. Telephone 020 8444 3377, fax 020 8444 6866.

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Prescription Products

Neulasta
Neulasta (pegfilgrastim) SureClick pre-filled pen 10mg/ml is now available from Amgen. Net price, £714.24. Legal category: POM.

Serevent
Serevent (salmeterol) CFC-free Evohaler 25µg/dose is now available from GlaxoSmithKline. Net price, 120 doses, £29.26. Legal category: POM.

Tilade
Tilade (nedocromil) CFC inhaler is now available from sanofi-aventis. Net price, 112 doses, £39.96. Legal category: POM. This product replaces the Tilade inhaler and synchroner, which have been discontinued. Further information available on 01483 505515.

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SPC changes

Aranesp
The summary of product characteristics for Aranesp (darbepoetin alfa; Amgen) now includes pure red cell aplasia as a possible adverse event and dyspnoea as a rare allergic reaction. The indication for anaemia has also been amended, with “symptomatic anaemia” replacing “anaemia” and “individual therapeutic objective” replacing “12g/dL” as the haemoglobin target. The SPC now states that Hb should not exceed 13g/dL and recommends a dose reduction if the rise in Hb exceeds 2g/dL within four weeks. See SPC.

Cordarone X
The summary of product characteristics for Cordarone X (amiodarone hydrochloride; sanofi-aventis) intravenous has been updated to include information on cardiopulmonary resuscitation. It now states that the recommended dose for ventricular fibrillations/ pulseless ventricular tachycardia resistant to defibrillation is 300mg (or 5mg/kg) diluted in 20ml 5 per cent dextrose and rapidly injected. An additional 150mg (or 2.5mg/kg) intravenous dose may be considered if ventricular fibrillations persist. It also states that the contraindications listed in the SPC do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock-resistant ventricular fibrillation. See SPC.

Taxotere
The summary of product characteristics for Taxotere (docetaxel; sanofi-aventis) has been updated to include severe hand and foot syndrome as an undesirable effect. Toxic epidermal necrolysis has also been included as a very rare undesirable effect. In addition, it states that ileus and intestinal obstruction have been reported rarely rather than very rarely. See SPC.

Viramune
The summary of product characteristics for Viramune (nevirapine; Boehringer Ingelheim) has been updated to include an interaction with lopinavir/ritonavir. It now states that administering nevirapine with lopinavir/ritonavir 400/100mg (three capsules) twice daily results in a decline in liponavir levels. It recommends that the dose of liponavir/ritonavir is increased to 533/133mg (four capsules) twice daily. In children, an increase in dose to 300/75mg/m² should be considered, it states.

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Discontinued products

Benylin
Benylin with Codeine (codeine, diphenhydramine, menthol) 300ml has been discontinued by Pfizer Consumer Healthcare. Other Benylin products remain available.

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Products miscellany

Lescol
The triangular Sandoz logo will no longer appear on Lescol (fluvastatin; Novartis) capsules 20mg and 40mg.

Mucodyne
Mucodyne (carbocisteine) capsules 375mg are now available in a 120-capsule pack size. Net price, 120, £16.68. Legal category: POM. The 30-capsule pack size has been discontinued.

Navispare
All orders and enquiries for Navispare (cyclopenthiazide, amiloride hydrochloride; Novartis) should now be directed to Goldshield.

Normax
KoGEN has taken over responsibility for Normax (co-danthrusate; UCB) capsules. From this date, orders, medical information enquiries and adverse event reporting should be directed to koGEN on 028 3833 3933 (fax 028 3833 6665; e-mail info@kogen.co.uk).

Trasidrex
All orders and enquiries for Trasidrex (oxprenolol hydrochloride, cyclopenthiazide; Novartis) should now be directed to Goldshield.

Sanofi-aventis
Responsibility for sales, marketing and medical information for the following products has been transferred from sanofi-aventis to Winthrop Pharmaceuticals: acebutolol tablets, Celectol (celiprolol) tablets, celiprolol tablets, Flagyl (metronidazole) tablets, suppositories and suspension, co-amilofruse tablets, gentamicin intrathecal, gentamicin paediatric, Motilium (domperidone) tablets, suppositories and suspension, prochlorperazine capsules, trazadone tablets and capsules (generic only), trimipramine tablets, prednisolone tablets, loprazolam tablets, daunorubicin, and ramipril tablets and capsules (generic only).

Senokot
Senokot (sennosides; Reckitt Benckiser) syrup has been reformulated and is now sugar free. Net price, 150ml, £4.99. Legal category: GSL.

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