The Pharmaceutical
Journal
Vol 270 No 7242 p433
29 March 2003
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The Pharmaceutical
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Prescription Products Presentation: Film-coated tablets. Class: HMG-CoA reductase inhibitor. Indications: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (eg, exercise , weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Dosage: The recommended start dose is 10mg once daily. A dose adjustment to 20mg can be made after four weeks. A doubling of this dose to 40mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk who do not achieve their treatment goal on 20mg and in whom routine follow-up will be performed. Major cautions and contra-indications: Rosuvastatin is contraindicated in: active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding three times the upper limit of normal; severe renal impairment (creatinine clearance <30ml/min); myopathy; patients receiving ciclo-sporin; pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures. Assessment of renal function should be considered during routine follow-up of treatment with a dose of 40mg. Rosuvastatin should be used with caution in patients with predisposing factors for rhabdomyolysis and treatment should not be started if creatinine kinase levels are significantly elevated (>5 times upper limit of normal). Rosuvastatin should not be used in any patient with acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. While taking rosuvastatin, patients should be asked to report inexplicable muscle pain, weakness or cramps immediately. Use of rosuvastatin in combination with gemfibrozil is not recommended. Side effects: Common (>1 per cent, <10 per cent) adverse events are headache, dizziness, constipation, nausea, abdominal pain, myalgia and asthenia. Legal category: POM. Net price: 10mg 28 £18.03, 20mg 28 £29.69, 40mg £29.69. Contact details: AstraZeneca, Horizon Place, 600 Capability Green, Bedfordshire LU1 3LU (tel 01582 836836). See SPC for further details. Promixin (colistimethate sodium) powder for nebuliser solution has been launched (Profile Pharma); net price, 30 x 1 million iu vial £69. Promixin is indicated for the treatment, by nebulisation, of lung infections where sensitivity testing suggests that the cause is susceptible Pseudomonas aeruginosa. Promixin is supplied with a Prodose Disc for use with a new delivery device, Prodose AAD System. Further information about the Prodose AAD System can be obtained from Profile Respiratory Systems (tel 0870 770 3430). |
SPC changesThe licence indications for Caspofungin (caspofungin acetate) MSD infusion have been updated (Merck Sharp & Dohme). Caspofungin is now additionally licensed for the treatment of invasive candidiasis in non-neutropenic adult patients. |
Discontinued productsTagamet (cimetidine) effervescent tablets, pack size 60, have been discontinued (GlaxoSmithKline). |
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Composition: Rosuvastatin (as calcium) 10mg, 20mg and 40mg tablets.