The Pharmaceutical
Journal
Vol 270 No 7230 p10
4 January 2003
|
|
The Pharmaceutical
Journal |
Products |
|
Prescription ProductsMicardisPlus (telmisartan with hydrochlorothiazide) 40/12.5mg and 80/12.5mg tablets are being launched (Boehringer Ingelheim); net price, 40/12.5mg 28 £12.60, 80/12.5mg 28 £15.75. Alpharma has launched loratadine 10mg tablets; net price, 7 £2.20, 30 £7.57. Erythromycin oral suspension 125mg/5ml, pack size 100ml, is now available with a child resistant cap (Alpharma). |
SPC changesThe summary of product characteristics for Clozaril (clozapine) tablets has been updated (Novartis Pharmaceuticals). Clozaril is now additionally licensed for the treatment of psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed. Clozaril is contraindicated in the following instances: patients unable to undergo regular blood tests; history of toxic or idiosyncratic granulocytopenia/agranulocytosis; paralytic ileus. Clozaril treatment must not be started concurrently with drugs known to have substantial potential for causing agranulocytosis. Additional information regarding cardiac warnings have been added to the special warning and precautions for use and undesirable effects sections. The pharmacodynamics section notes that improvement in some aspects of cognitive function has been described. It also states that compared with classic antipsychotics, Clozaril produces fewer major extrapyramidal reactions and in contrast to classic antipsychotics, it produces little or no protactin elevation. See SPC. The summary of product characteristics for Enbrel (etanercept) has been updated (Wyeth Pharmaceuticals). The special warnings and precautions for use section says that allergic reactions associated with administration have been reported commonly and in post marketing experience have included angioedema and urticaria. Caution should be exercised when using etanercept is patients who have congestive heart failure (CHF). Information regarding CHF has been added. The undesirable effects section has been rewritten. See SPC. The summary of product characteristics for Nalorex (naltrexone hydrochloride) tablets has been updated (Bristol-Myers Squibb Pharmaceuticals). It notes changes in the markings on the tablets as now having R11 on one side and 50 on the other instead of 11 on one side and Dupont on the other. In addition the excipients of pale yellow opadry have been included. The marketing authoriasation holder has been changed from DuPont Pharmaceuticals to Bristol-Myers Squibb Pharmaceuticals. See SPC. The summary of product characterisitics for ReFacto (recombinant coagulation factor VIII ) injection has been updated (Wyeth Pharmaceuticals). The special warning and precaution for use section states that in post-marketing experience, high and low titre neutralising antibodies (inhibitors) have been observed in previously treated patients. The following paragraph has also been added: "Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the postmarketing setting. The reported lack of effect has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset bleeding. When switching to ReFacto it is important to individually titrate and monitor each patient's dose in order to ensure an adequate therapeutic response." It is recommended that, wherever possible, every time that ReFacto is administered, the name and batch number of the product is recorded. See SPC. The summary of product characteristics for Solian (amisulpride) tablets and solution has been updated (Sanofi-Synthelabo). Solian is now contraindicated in combination with the following medicines which could induce torsades de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; class III antiarrhythmic agents such as amiodarone and sotalol; other medicines such as bepridil, cisapride, sultopride, thioridazine, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine and sparfloxacin. Information regarding amisulpride inducing a dose-dependent prolongation of the QT interval has been added to the special warnings and precautions for use section. The following medicines which enhance the risk of torsades de pointes have been added to the interactions section: bradycardia-inducing medicines such as beta-blockers, bradycardia-inducing calcium channel blockers (such as diltiazem and verapamil, clonidine, guanfacine) and digitalis; medicines which induce hypokalaemia such as hypokalaemic diuretics, stimulant laxatives, intravenous amphotericin B, glucocorticoids, tetracosactides; neuroleptics such as pimozide, haloperidol, lithium and imipramine and other antidepressants. The undesirable effects section now states that cases of QT interval prolongation and very rare cases of torsades de pointes have been reported. See SPC. The summary of product characteristics for Betaferon (interferon beta-1b) have been amended (Schering Health Care). The special precautions for storage section now states: "The user may store unreconstituted Betaferon outside the refrigerator for up to three months, but not above 25C and not exceeding the expiry date." See SPC. |
Discontinued productsTerramycin (oxytetracycline) 250mg tablets will be discontinued from 25 February because of ongoing manufacturing difficulties (Pfizer). Information can be obtained from the company's medical information department (tel 01737 331111). Pavulon (pancuronium bromide) injection will be discontinued when current stocks are exhausted (Organon Laboratories). |
Supply problemsTemazepam 10mg tablets, pack size 500, and temazepam 20mg tablets, pack size 250, are back in stock from Alpharma. Mackenzies Smelling Salts, 17ml, will be out of stock until March (Alpharma). |
Home | Journals | News | Notice-board | Search | Jobs Classifieds | Site
Map | Contact us
©The Pharmaceutical Journal