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The Pharmaceutical Journal
Vol 269 No 7220 p563
19 October 2002

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    Prescription Products

Prescription Products

Ebixa tablets and oral drops

Composition: Memantine hydro-chloride tablets 10mg, oral drops 10mg/g.
Presentation: Film-coated tablets and oral drops.
Class: N-methyl-D-aspartate (NMDA) receptor antagonist.
Indications: Treatment of moderately severe to severe stages of Alzheimer’s disease.
Dosage: Treatment should be started with 5mg (10 drops) daily for the first week, followed by 10mg daily for the second week and 15mg daily for the third week. The recommended maintenance dose, from the fourth week, is 20mg daily. Maximum daily dose is 20mg.
Major cautions: Memantine is not recommended in patients with severe renal impairment. Caution is recommended in patients with epilepsy. Some factors that may raise urine pH may necessitate careful monitoring of the patient. Concomitant use of NMDA-antagonists such as amantadine, ketamine or dextromethorphan should be avoided. Interactions between memantine and the following drugs may occur: L-dopa, dopaminergic agonists, anticholinergics, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide. Memantine should not be used during pregnancy unless clearly necessary. Women taking memantine should not breast-feed. Safety and efficacy in children and adolescents under the age of 18 years have not been established.
Side effects: Common (1–10 per cent) adverse reactions are hallucinations, confusion, dizziness, headache and tiredness.
Legal category: POM.
Net price: Tablets 28 £37.10, 56 £74.20, 112 £148.40; oral drops 50g £66.25, 100g £132.50.
Contact details: Lundbeck, Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes MK7 8LF. Tel 01908 649966, fax 01908 647888.
See SPC for further details.

Tracleer tablets

Composition: Bosentan 62.5mg and 125mg.
Presentation: Film-coated tablets.
Class: Endothelial receptor antagonist.
Indications: Treatment of pulmonary hypertension to improve exercise capacity and symptoms in patients with grade III functional status.
Dosage: Treatment should be initiated at a dose of 62.5mg twice daily for four weeks and then increased to a maintenance dose of 125mg twice daily.
Major cautions and contra-indications: Bosentan should only be initiated if the systolic blood
pressure is higher than 85mmHg. Bosentan is contraindicated in the following: moderate to severe hepatic impairment (Child-Pugh Class B or C); baseline values of liver aminotransferases (aspartate aminotransferases and/or alanine amino-
transferases) greater than three times the upper limit of normal; concomitant use of ciclosporin A; pregnancy; women of childbearing potential who are not using a reliable method of contraception. Liver aminotransferase levels must be measured and it is recommended that haemoglobin concentrations be checked. Bosentan should not be used concomitantly with glibenclamide and concomitant use with fluconazole, a CYP3A4 inhibitor (such as ketoconazole, itraconazole and ritonavir) or a CYP2CP inhibitor (such as voriconazole) is not recommended. Nursing mothers taking bosentan should be advised to discontinue breast-feeding. Safety and efficacy in patients under 12 years have not been established.
Side effects: Adverse reactions that occurred more frequently in patients taking bosentan (Ž3 per cent) than in those taking placebo are headache, flushing, abnormal hepatic function, leg oedema and anaemia.
Legal category: POM.
Net price: Both strengths 56 £1,615.
Contact details: Actelion Pharmaceuticals, 500 Chiswick High Road, Chiswick, London W4 5RG. Tel 020 8956 2601, fax 020 8956 2512.
See SPC for further details.

Elidel cream

Composition: Pimecrolimus 10mg/g.
Presentation: Cream.
Action: Blocks synthesis of inflammatory cytokines in T cells.
Indications: For short-term treatment of signs and symptoms, and intermittent long-term treatment for prevention of progression to flares, in patients with mild to moderate atopic dermatitis (eczema) aged two years and over.
Dosage: A thin layer of pimecrolimus cream should be applied to the affected skin twice daily.
Major cautions and contra-indications: Pimecrolimus should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chickenpox). Before starting treatment, clinically infected atopic dermatitis treatment sites should be cleared of infections. In the presence of herpes simplex skin infections, pimecrolimus should be discontinued at the site of the infection until the infection has cleared. Pimecrolimus can not be recommended in patients with erythroderma and is not recommended in patients with Netherton’s syndrome. Pimecrolimus should not be used concomitantly with topical corticosteroids or other topical anti-inflammatory products. Excessive exposure of the skin to ultraviolet light should be avoided. Pimecrolimus should not be used during pregnancy. Breast-feeding mothers may use pimecrolimus but should not apply it to the breast.
Side effects: Very common (Ž10 per cent) adverse event is application site burning. Common adverse events are application site reactions (irritation, pruritus and erythema), skin infections (folliculitis).
Legal category: POM.
Net price: 30g £19.69.
Contact details: Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR. Tel medical information 01276 698370; customer care (for orders) 0845 741 9442.
See SPC for further details.

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