The Pharmaceutical
Journal Vol 266 No 7151 p795
June 9, 2001
|
|
The Pharmaceutical
Journal Vol 266 No 7151 p795 |
Products |
|
Prescription ProductsPhotofrin injectionComposition: Porfimer sodium 15mg and 75mg. Presentation: Powder for solution for injection. Storage and stability: Do not store above 25C and keep container in outer carton. After reconstitution, use within 3 hours and protect from light. Action: Cytotoxic. Indications: Palliative treatment of obstructing endobronchial non-small cell lung cancer; palliative treatment of obstructing oesophageal cancer. Contraindications: Porphyria or hypersensitivity to porphyrins; severe hepatic impairment; tracheo-oesophageal or broncho-oesophageal fistula; suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage. Therapy not suitable for patients with severe acute respiratory distress caused by an obstructing endobroncial lesion. Dosage and administration: Adults and elderly, two stage process requiring administration of porfimer sodium and then up to two applications of light. Porfimer sodium should be intraveneously injected at a dose of 2mg/kg body weight over 3 to 5 minutes. See SPC for light doses. Up to two more courses of drug and light may be given with each injection separated by a minimum of 30 days. Children, should not be used. Pregnancy, should not be used unless clearly necessary. Lactation, women receiving porfimer sodium should not breast-feed. Overdosage: No information available on overdosage situations. See SPC. Precautions: Patients must avoid exposure of skin and eyes to direct sunlight or bright indoor light for at least 30 days. Exposure of skin to ambient indoor light is, however, beneficial. Before exposure to direct sunlight the patient should test for residual photosensitivity. As a result of photodynamic therapy, patients may complain of substernal chest pain which may be require short-term prescription of opiate analgesics. Conventional ultraviolet sunscreens are of no value in protecting against photosensitivity reactions. If extravasation at the injection site occurs, the area should be protected from light for a minimum of 30 days. Drug interactions: No formal interaction studies. Concomitant use of photosensitising agents could increase the photosensitivity reaction. See SPC for other interactions. Side effects: Frequent events include photosensitivity reactions and constipation. Other adverse events reported in 5 per cent or more of patients were most commonly associated with the respiratory system and included dyspnoea. Net price: 15mg 1 vial £154. 75mg 1 vial £770. Supplier: Axcan Pharma. Sinclair Pharmaceuticals (distributor) Borough Road, Godalming, Surrey GU7 2AB. Tel 01483 426644, fax 01483 860927. Legal class: POM. Zyban SPC changesThe summary of product characteristics for GlaxoSmithKline’s Zyban (amfebutamone [bupropion]) has been amended. The SPC now recommends that Zyban is taken at a dose of 150mg once daily for six days increasing to 150mg twice daily on day seven. The contraindications section has been extended to include the following: any history of seizure; known central nervous system tumour; abrupt alcohol withdrawal or benzodiazepines. The special precautions and warnings section now states that Zyban must not be used in patients with predisposing risk factors for seizure unless the clinical benefit of stopping smoking outweighs the risk of seizure. If Zyban is to be prescribed for these patients, a maximum dose of 150mg daily should be considered for the duration of treatment. Antimalarials, tramadol, quinolones and sedating antihistamines have been added to the list of examples of medicinal products that lower seizure threshold. Shire productsChanges have been made to the summary of product characteristics for Shire Pharmaceuticals’s Celevac (methylcellulose) 500mg tablets. The statement “to prevent diarrhoea in patients receiving liquid and tube fed diets” has been removed from the indication section and the statement “liquid tube fed diets: one level 5ml spoonful of granules, dispersed in hot water, added to each litre of diet mix” has been removed from the posology and method of administration section. Celevac is now contraindicated in infective bowel disease. The SPC for Topicycline (tetracycline hydrochloride 154mg) acne treatment has also been updated. Statements referring to cross resistance between tetracyclines, prolonged use of anti-infectives and photosensitisation have been added. Tazocin new indicationWyeth Laboratories has extended the licensed indications for Tazocin (piperacillin, tazobactam). Tazocin is now additionally indicated for appendicitis complicated by rupture with peritonitis or abscess formation or both in children aged two to 12 years. Xenical tabletsThe summary of product characteristics for Roche Products’s Xenical (orlistat) tablets has been amended. Biguanides have been removed from the interactions section. Tobradex eye-dropsTobradex eye-drops, containing tobramycin 0.3 per cent w/v and dexamethasone 0.1 per cent w/v, have been launched by Alcon Laboratories (net price, 5ml £5.65). The product is indicated for the reduction of inflammation and prophylaxis of infection following cataract surgery. One drop should be instilled into the conjunctival sac(s) every four to six hours, for up to 24 days. During the first 24 to 48 hours, the dose may be increased to one drop every two hours. Symbicort TurbohalerAstraZeneca has launched Symbicort (budesonide, formoterol fumarate) Turbohaler 100/6 (net price, £33) and 200/6 (net price, £38). (See p774.) |