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

Composition: Aliskiren.

Presentation: Film-coated tablets.

Class: Renin inhibitor.

Indications: Treatment of essential hypertension.

Dosage: 150mg once daily. Dose may be increased to 300mg once daily in patients whose blood pressure is not adequately controlled.

Contraindications: Pregnancy.

Precautions: Patients receiving other medicines that inhibit the renin-angiotensin system, and those with reduced kidney function or diabetes, are at increased risk of hyperkalaemia.

Stop therapy in the event of severe and persistent diarrhoea. Use with caution in patients with heart failure, those with severe renal impairment, a history of dialysis, nephrotic syndrome or renovascular hypertension and those with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney.

Correct volume- and salt-depletion (eg, in patients receiving high doses of diuretics) before starting aliskiren to prevent symptomatic hypotension.

Monitor electrolytes and renal function in patients with diabetes, kidney disease or heart failure.

Side effects: Common (>=1/100, <1/10) diarrhoea.

Legal category: POM.

Net price: 28 x 150mg, £19.80; 28 x 300mg, £23.80.

Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Surrey GU16 7SR (tel 01276 698370).

Prescription Products

Solpadol Effervescent
The 30-tablet pack size for Solpadol Effervescent (paracetamol 500mg, codeine phosphate 30mg; Sanofi-Aventis) has been replaced with a 32 tablet pack size.
Net price: 32, £2.69
Legal category: POM

Zydol SR
Zydol SR (tramadol hydrochloride) prolonged-release tablets 50mg will be available from Grünenthal from 10 September 2007.
Net price: 60, £5.35
Legal category: POM

SPC changes

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

Cellcept
New information about drug interactions with ciclosporin, rifampicin, sirolimus, sevelamer, co-trimoxazole, norfloxacin/metronidazole and tacrolimus has been added to the summaries of product characteristics for Cellcept (mycophenolate mofetil; Roche).

Additional information about management of Cellcept overdose has also been added.

Cipralex
Cipralex (escitalopram; Lundbeck) is now indicated for use in obsessive-compulsive disorder (OCD). The summary of product characteristics for Cipralex now includes dosing information and clinical data for the new indication. The initial dose for OCD is 10mg once a day, increased to a maximum dose of 20mg per day depending on patient response.

“As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. Treatment benefits and dose should be re-evaluated at regular intervals,” the SPC states.

Depixol
Information about an increased risk of cerebrovascular adverse events has been added to the summaries of product characteristics for Depixol (flupentixol; Lundbeck).

The SPCs now recommend that flupentixol be used with caution in patients with risk factors for stroke. In addition they advise that Depixol should be used with caution for patients susceptible to QT prolongation or with a history of cardiovascular disorders, and that co-administration of Depixol with other antipsychotics and with drugs known to significantly increase the QT interval should be avoided.

The overdose sections of the SPCs now state that electrocardiogram changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when Depixol is administered in overdose together with drugs known to affect the heart.

Norvir
Norvir (ritonavir; Abbott) is now contraindicated for use in combination with clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam. The summaries of product characteristics for Norvir include new information about the risk of extreme sedation and respiratory depression from these drug combinations, and a warning about concomitant use of Norvir with parenteral midazolam.

Discontinued products

Calcort
Shire has discontinued Calcort (deflazacort) tablets 100 x 1mg and 30 x 30mg. Calcort tablets 60 x 6mg remain available. Further information on 01256 894000.

Supply issues

Fersaday
Fersaday (ferrous fumarate) tablets are available again from Goldshield after being out of stock.

Isoket
Isoket (isosorbide dinitrate) injection 0.1 per cent and 0.05 per cent 50ml bottles are available again from Schwarz Pharma after being out of stock.

Products miscellany

Mizollen
The distribution of Mizollen (mizolastine) has been taken over by Sanofi-Aventis from Schwarz Pharma.

Nepro Tetrapak
Nepro Tetrapak is now available from Abbott Nutrition in strawberry flavour, approved by the Advisory Committee on Borderline Substances (ACBS).
Net price: 200ml pack, £2.28