New medicines / SPC changes / Prescription products / Counter products / Discontinued products / Supply issues

Composition: Paliperidone.

Presentation: Prolonged-release tablet.

Class: Atypical antipsychotic.

Indications: Treatment of schizophrenia.

Dosage: 6mg once a day. The dose can be adjusted within the recommended dosing range of 3–12mg once daily, based on clinical assessment.

Precautions:
Invega dosing should be standardised in relation to food intake.

Invega should be taken always in the fasting state or always with breakfast, but not alternating between.

For patients with mild and moderate renal impairment the recommended initial dose is 3mg once daily.

Patients with severe renal impairment should take a 3mg dose every other day, increased to 3mg daily as tolerated.

Invega is not recommended for patients with creatinine clearance below 10ml/min.

Safety and effectiveness have not been investigated in individuals younger than 18 years.

Invega should be used with caution in people with cardiovascular disease or family history of QT-interval prolongation, or in combination with other medicines that could prolong the QT interval.

Invega, and other antipsychotics, should be discontinued if a patient develops signs or symptoms of neuroleptic malignant syndrome.

Discontinuation of treatment should be considered if the patient develops tardive dyskinesia.

Invega should be used with caution in patients with a history of seizures.

Patients should be advised not to drive or operate machines until their individual response is known.

Side effects: Very common (>=1/10) headache. Common (>=1/100, <1/10) akathisia, dizziness, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, sedation, somnolence, tremor, first degree atrioventricular block, bradycardia, bundle branch block, sinus tachycardia, tachycardia, orthostatic hypotension, upper abdominal pain, dry mouth, salivary hypersecretion, vomiting, asthenia, fatigue, weight increase.

Legal category: POM.

Net price: 28 x 3mg, £97.28; 28 x 6mg, £97.28; 28 x 9mg, £145.92.

Contact details: Janssen-Cilag Ltd, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ (tel 01494 567444).

Prescription Products

Advagraf
Advagraf (tacrolimus) prolonged-release capsules are now available from Astellas. Net price: 50 x 0.5mg, £42.22; 50 x 1mg, £84.43; 100 x 1mg, £168.87; 50 x 5mg, £422.17. Legal category: POM.

Xyzal
Xyzal (levocetirizine) oral solution 0.5mg/ml is now available from UCB Pharma. Net price: 200ml, £6. Legal category: POM.

SPC changes

Baraclude
Information on reducing the dose of Baraclude (entecavir; Bristol-Myers Squibb) for patients with renal impairment has been added to the summary of product characteristics for Baraclude tablets. The daily dose should be reduced by using Baraclude oral solution, or the dosage interval increased if oral solution is not available, based on patients’ creatinine clearance (as specified by a table in the SPC).

Biorphen
A warning that Biorphen (orphenadrine hydrochloride; Alliance) contains sorbitol, and should not be taken by patients with rare hereditary problems of fructose intolerance, has been added to the product’s summary of product characteristics.

Humira
Humira (adalimumab; Abbott) has a new indication for treatment of severe, active Crohn’s disease, for patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant of or unsuitable for such therapies. The summary of product characteristics says that, for induction treatment, Humira should be given in combination with corticosteroids. However, Humira can be given as monotherapy if corticosteroids are not tolerated or continued treatment with corticosteroids is inappropriate. The SPC provides details on dosing of Humira for Crohn’s disease.

Remicade
Remicade (infliximab; Schering-Plough) has a new indication for the treatment of severe, active Crohn’s disease in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.

Ritalin
Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children with structural cardiac abnormalities, the summary of product characteristics for Ritalin (methylphenidate; Novartis) now states. The SPC also now includes warnings that Ritalin should generally not be used in patients with severe hypertension and that caution is needed when treating patients whose underlying conditions might be compromised by increases in blood pressure or heart rate. Blood pressure should be monitored at appropriate intervals in all patients taking Ritalin, especially those with hypertension.

Discontinued products

Oilatum Plus
Stiefel has discontinued Oilatum Plus 1,000ml pack. Stocks are expected to be exhausted this month. The 500ml pack remains available.

Videx
Bristol-Myers Squibb has discontinued Videx (didanosine) tablets 200mg. Videx tablets 25mg, and capsules 125mg, 200mg, 250mg and 400mg remain available.

Supply issues

Axid
Axid (nizatidine; Flynn) tablets are temporarily unavailable. Replacement stock is expected early in August. Further information on 01462 458974.

Premique Cycle
There will be a temporary supply shortage of Premique Cycle (conjugated oestrogens 0.625mg, medroxyprogesterone acetate 10mg; Wyeth) tablets over the coming weeks. Up-to-date information from www.wyeth.co.uk. Medical information on 0845 367 0098.

Counter products

Brochlor
Brochlor (chloramphenicol) ointment 1 per cent is now available from Sanofi-Aventis. Recommended retail price: 4g tube, £4.95. Legal category: P.

Crystacide
Crystacide (hydrogen peroxide) cream 1 per cent is now available in a 40g pack. Recommended retail price: £20.48. Legal category: P.