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PJ Online homeThe Pharmaceutical Journal
Vol 280 No 7503 p621
24 May 2008

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

    New medicines Supply issues

New medicines

Lotemax

Composition: Loteprednol etabonate.

Presentation: Eye drops.

Class: Topical corticosteroid.

Indications: Treatment of post-operative inflammation following ocular surgery.

Dosage: One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period. The duration of treatment should not exceed two weeks.

Contraindications: Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infection of the eye and fungal diseases of ocular structures; untreated purulent acute infections which, similarly to other infectious diseases, can be masked and worsened by corticosteroids; “red eye” with unknown diagnosis; and infection caused by amoeba.

Precautions: Prolonged use of corticosteroids may result in ocular hypertension or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Steroids should be used with caution in the presence of glaucoma.

Prolonged use of corticosteroids may suppress the host response and increase the possibility of secondary ocular infections.

In diseases causing thinning of the cornea or sclera, perforations can occur with the use of topical steroids.

In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Long-term treatment with corticosteroids can allow fungal disease to occur, which should be considered in the differential diagnosis when a corneal ulcer persists.

Lotemax contains benzalkonium chloride, which may cause eye irritation.

Contact with soft contact lenses should be avoided.

Patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated and if Lotemax is used for 10 days or longer intraocular pressure should be monitored.

Side effects: Common (>1/100, <1/10) corneal defect, eye discharge, ocular discomfort, dry eye, epiphora, foreign body sensation in eyes, conjunctival hyperaemia, ocular itching, instillation site burning, headache.

Legal category: POM.

Net price: 5ml x 0.5 per cent, £4.95.

Contact details: Bausch & Lomb UK Ltd, 106 London Road, Kingston-upon-Thames, Surrey KT2 6TN (tel 020 8781 2900).


Tasigna

Tasigna

Composition: Nilotinib.

Presentation: Hard capsule.

Class: Protein-kinase inhibitor.

Indications: Treatment of adults with chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.

Dosage: 400mg twice daily. No food should be consumed for two hours before and for at least one hour after the dose is taken.

Precautions: Tasigna may need to be temporarily withheld or the dose reduced for haematological toxicities (neutropenia, thrombocytopenia) that are not related to underlying leukaemia.

Complete blood counts should be performed every two weeks for the first two months and then monthly thereafter, or as clinically indicated.

For grade 3–4 serum lipase elevations or grade 3–4 bilirubin elevations treatment should be reduced to 400mg once daily or interrupted.

Patients with hepatic impairment should be treated with caution.

Tasigna has been shown to prolong cardiac ventricular repolarisation, as measured by the QT interval, in a concentration-dependent manner.

Significant prolongation of the QT interval, which could be fatal, may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors, with medicinal products with a known potential to prolong QT, or with food.

Hypokalaemia and hypomagnesaemia may further enhance this effect.

Tasigna should be used with caution for patients who have or who are at significant risk of developing QT prolongation.

Concomitant use of Tasigna with medicinal products that are potent inducers of CYP3A4 is likely to reduce levels of nilotinib to a clinically relevant extent.

Concomitant use of antacids, H2 blockers, or proton pump inhibitors with Tasigna is not recommended.

Side effects: Very common (>=1/10) headache, nausea, constipation, diarrhoea, rash, pruritus, fatigue, increased lipase.

Common (>=1/100, <1/10) vomiting, abdominal pain, alopecia, myalgia, arthralgia, muscle spasms, bone pain, anorexia, asthenia, peripheral oedema, palpitations, electrocardiogram QT prolonged, febrile neutropenia, pancytopenia, dizziness, paraesthesia, vertigo, dyspnoea, exertional dyspnoea, cough, dysphonia, abdominal discomfort, dyspepsia, flatulence, night sweats, eczema, urticaria, erythema, hyperhidrosis, dry skin, musculoskeletal chest pain, musculoskeletal pain, hypomagnesaemia, hyperkalaemia, hyperglycaemia, hypertension, flushing, pyrexia, insomnia; increased blood amylase, alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase, gamma-glutamyltransferase and creatinine phosphokinase; increased and decreased weight.

Legal category: POM.

Net price: 112 x 200mg, £2,432.85.

Contact details: Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR (tel 01276 692255).

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Supply issues

Daktarin Gold
Daktarin Gold (ketoconazole) is currently unavailable from Janssen-Cilag and this is likely to continue until the end of June 2008. Supplies of Nizoral (ketoconazole) cream are unaffected. Medical information on 01494 567444.

Ergocalciferol
UCB Pharma’s ergocalciferol tablets and injection are currently out of stock. UCB expects manufacturing issues with the injection to be resolved mid July 2008. Further information on 01753 534655.

Leustat
Janssen-Cilag is experiencing difficulties supplying Leustat (cladribine) and normal supply could be disrupted for several months. Enquiries about stock for patients who cannot be changed to an alternative treatment should be directed to Janssen-Cilag’s medical information department on 01494 567567.

Regranex
Regranex (becaplermin) gel 0.01 per cent is currently out of stock. Janssen-Cilag expects new product to be available from mid June 2008. Medical information on 01494 567444.

Sublimaze
Sublimaze (fentanyl citrate; Janssen-Cilag) injection is expected to be out of stock until the first week of June 2008. Medical information on 01494 567444.

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