The Pharmaceutical
Journal
Vol 270 No 7243 p472-473
5 April 2003
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The Pharmaceutical
Journal |
Products |
Prescription Products Presentation: Film-coated tablets. Class: Fluoroquinolone. Indications: Treatment of the following bacterial infections if caused by bacteria susceptible to moxifloxacin: acute exacerbation of chronic bronchitis; community acquired pneumonia, except severe cases; acute bacterial sinusitis (adequately diagnosed). Dosage: The recommended dose is 400mg once daily. The duration of therapy for an acute exacerbation of chronic bronchitis is 5–10 days, for community acquired pneumonia is 10 days and for acute sinusitis is seven days. Major cautions and contra-indications: Moxifloxacin is contraindicated in patients with: hypersensitivity to quinolones; tendon disease or disorder related to quinolone treatment; congenital or documented acquired QT prolongation; electrolyte disturbances, particularly in uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias; impaired liver function (Child Pugh C); transaminases increase of >5-fold of the upper limit of normal; creatinine clearance below 30ml/min/1.73m2 (serum creatinine >265µmol/L) or undergoing renal dialysis. It is also contraindicated in pregnancy and lactation and in children and growing adolescents. Moxifloxacin should not be used concurrently with drugs that prolong the QT interval. About 6 hours should be left between administration of agents containing bivalent or trivalent cations and moxifloxacin. Patients should be advised to avoid exposure to either ultraviolet irradiation or extensive and/or strong sunlight. Medicines that can reduce potassium levels should be used with caution in patients receiving moxifloxacin. Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, in those with a family history of, or actual defects in glucose-6-phosphate dehydrogenase deficiency and in those with CNS disorders which may predispose to seizures or lower the seizure threshold. Side effects: Common (>=1 per cent, <10 per cent) adverse events are abdominal pain, headache, dizziness, nausea, diarrhoea, vomiting, dyspepsia, QT prolongation in patients with concomitant hypokalaemia, taste perversion and abnormal liver function tests. Legal category: POM. Net price: 5 £10.95. Contact details: Bayer, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA. See SPC for further details. Presentation: Tablets. Class: Antiviral. Indications: Treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis; decompensated liver disease. Dosage: The recommended dose is 10mg once daily. See SPC for when to consider treatment discontinuation and for dosing interval adjustments required in patients with a creatinine clearance of <50ml/min. Major cautions and contra-indications: Caution is advised in patients with a creatinine clearance of <50 ml/min and in those receiving medicinal products that may affect renal function. Renal function should be monitored in these patients — frequency tailored to individual's condition. Patients with normal renal function should be monitored for changes in serum creatinine every three months. After stopping treatment patients should be monitored for exacerbations of hepatitis every three months. Women of child-bearing potential should use effective contraception. Adefovir dipivoxil should only be used during pregnancy if potential benefit justifies risk to the fetus. Mothers should be instructed not to breast-feed. Adefovir dipivoxil should not be administered to children or adolescents under the age of 18 years and should not be used to control HIV infection. Side effects: Patients with chronic hepatitis B and compensated liver disease, very common (>10 per cent) adverse reaction possibly related to adefovir dipivoxil is asthenia. Common (> 1 per cent, 10 per cent) are nausea, flatulence, diarrhoea, dyspepsia, abdominal pain and headache. In pre- and post-transplantation patients with chronic hepatitis B and lamivudine-resistant hepatitis B virus, very common are increases in creatinine. Common are nausea, flatulence, diarrhoea, dyspepsia, asthenia, abdominal pain, headache, renal insufficiency and renal failure. Legal category: POM. Net price: 30 tablets £315. Contact details: Gilead Sciences, Granta Park, Abington, Cambridgeshire CB1 6GT. Tel 01223 897 300, fax 01223 897 282. See SPC for further details. Stock will be available from 7 April. Composition: Olopatadine (as hydrochloride) 1mg/ml. Presentation: Eye-drops. Class: Selective antiallergic/antihistaminic agent. Indications: Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis. Dosage: One drop in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months. Olopatadine may be used at the same dose in paediatric patients aged three years or older. Major cautions: Olopatadine is absorbed systemically and should be discontinued if signs of serious reactions or hypersensitivity occur. Opatanol contains benzalkonium chloride — close monitoring is required with frequent or prolonged use in dry-eye patients or in conditions where the cornea is compromised. Contact lens wearers should be advised to wait 10–15 minutes after instillation of olopatadine before inserting contact lenses and should not administer olopatadine while wearing contact lenses. Olopatadine is not recommended for use in breast-feeding mothers and caution should be exercised when prescribing to pregnant women. Side effects: The most frequently reported treatment-related undesirable effect (incidence 0.9 per cent) is ocular discomfort. Legal category: POM. Net price: 5ml £8.77. Contact details: Alcon Laboratories (UK), Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire HP2 7UD See SPC for further details. Symbicort (budesonide/formoterol) 400/12 Turbohaler has been launched (AstraZeneca); net price, 1 £38 (each inhaler contains 60 doses). Symbicort 400/12 Turbohaler is indicated for both the regular treatment of asthma where the use of a combination (inhaled corticosteroid and long-acting beta-agonist) is appropriate (see SPC) and in the treatment of chronic obstructive pulmonary disease (indication as for Symbicort 200/6 Turbohaler below). Lagap Pharmaceuticals is launching the following products: • Clindamycin 150mg capsules; net price, 24 £13.72, 100 £55.08 • Fluconazole capsules; net price, 50mg 7 £16.61, 150mg 1 £7.12, 200mg 7 £66.42 |
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Composition: Moxifloxacin (as hydrochloride) 400mg.
Composition: Adefovir dipivoxil 10mg.