The Pharmaceutical
Journal
Vol 270 No 7235 p183
8 February 2003
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The Pharmaceutical
Journal |
Products |
Recall Erwinase (crisantaspase/asparaginase) 10,000 units/vial |
Prescription Products Presentation: Film-coated tablets. Class: Phosphodiesterase type 5 (PDE 5) inhibitor. Indications: Treatment of erectile dysfunction. Dosage: One 10mg tablet to be taken between 30 minutes and 12 hours before anticipated sexual activity. The effects may persist for up to 24 hours post-dose. If 10mg is ineffective, subsequently a 20mg dose may be tried. Maximum dosing frequency is once daily but daily use is strongly discouraged. Contraindications: Tadalafil is not indicated for use in women or individuals below 18 years of age. Its use is contraindicated in men taking organic nitrates and those for whom sexual activity is inadvisable because of cardiac disease. Major cautions: The cardiovascular status of patients should be assessed before treatment starts. A decrease in spermatogenesis was seen in animal studies but has not been seen in human trials. Interactions may occur with other drugs that inhibit CYP3A4 enzymes including ketoconazole or itraconazole, erythromycin or clarithromycin, protease inhibitors, and with grapefruit juice. Side effects: Very common (>10 per cent) adverse reactions are headache and dyspepsia. Common (1–10 per cent) are dizziness, flushing, nasal congestion, back pain and myalgia. Legal category: POM. Cialis tablets are subject to Schedule 11 restrictions on National Health Service prescribing. Net price: Tablets 10mg 4 £19.34; 20mg 4 £19.34, 8 £38.67. Contact details: Lilly ICOS, 25 New Street Square, London EC4A 3LN. Medical information queries to Eli Lilly on 01256 315999. |
SPC changesThe summary of product characteristics for Cordarone X (amiodarone) intravenous ampoules has been amended. The following has been added to the contraindications section: "Cordarone X intravenous ampoules contain benzyl alcohol. There have been reports of fatal 'gasping syndrome' in neonates (hypotension, bradycardia and cardiovascular collapse) following the administration of intravenous solution containing this preservative. Cordarone X intravenous is therefore contraindicated in infants and young children up to three years old." The following has been added to the incompatibilities section: "The use of administration or devices containing plasticisers such as DEHP (di-2-ethylhexyphthalate) in the presence of amiodarone may result in leaching out of DEHP. In order to minimise patient exposure to DEHP, the final amiodarone dilution for infusion should preferably be administered through non-DEHP-containing sets. See SPC. |
Discontinued productsThe following products are being discontinued by Sanofi-Synthelabo due to ongoing production problems: Benoral granules (benorilate), Mictral (nalidixic acid, sodium citrate, anhydrous citric acid, sodium bicarbonate) and Ticlid (ticlopidine). Tarivid (ofloxacin) 100mg 50ml infusion vials are being discontinued (Aventis). The 200mg 100ml vial remains available. Rhinolast Allergy (azelastine hydrochloride) 5ml nasal spray has been discontinued (Viatris). Marketing authorisation for the 5ml spray as a pharmacy medicine has been transferred to Novartis Consumer Health under the Aller-eze brand. Rhinolast 20ml nasal spray continues to be available from VIATRIS as a prescription product. |
Supply problemsCaptopril 50mg tablets, pack size 56, are out of stock due to manufacturing problems (Alpharma). Intal (sodium cromoglicate) 5mg 112-dose inhalers are now back in stock (Aventis). Back orders have been cancelled. |
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Composition: Tadalafil tablets 10mg and
20mg.