The Pharmaceutical
Journal Vol 266 No 7153 p864
June 23, 2001
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The Pharmaceutical
Journal Vol 266 No 7153 p864 |
Products |
Recall Oxybutynin hydrochloride
tablets |
Prescription ProductsUprima sublingual tabletsComposition: Apomorphine hydrochloride 2mg and 3mg. Presentation: Sublingual tablets. Storage and stability: Store in original package. Action: D2 dopaminergic agonist. Indications: Treatment of erectile dysfunction. Contraindications: Hypersensitivity to active substance or excipients; severe unstable angina, recent myocardial infarction, severe heart failure, hypotension and other conditions where sexual activity is inadvisable. Dosage and administration: Adults and elderly, a starting dose of one 2mg tablet should be administered approximately 20 minutes before sexual activity. The dose may be increased on subsequent administrations to 3mg, if necessary, to reach the desired effect. A minimum of eight hours should be allowed to elapse before administering a subsequent dose. The patient should be advised to drink a small amount of water before taking the tablet, which should be placed under the tongue and allowed to dissolve (see SPC). Sexual stimulation is required for Uprima to be active. Compromised renal function, use with caution. The maximum dose should be limited to 2mg in patients with severe renal impairment. Compromised hepatic function, use with caution. Use in patients with significantly impaired hepatic function only if the benefits outweigh the risks (see SPC). Children, not indicated. Overdosage: In high doses, vomiting may be induced. No specific antidote. Vital signs such as blood pressure and heart rate should be monitored. See SPC. Precautions: Uprima should be used with caution in patients with anatomical penile deformity and in patients with uncontrolled hypertension, hypotension or those with a history of postural hypotension. Patients should not drive or operate machinery for at least two hours after administration. Drug interactions: Caution should be observed when administering Uprima to patients taking nitrates. Uprima should not be given in combination with other centrally-acting dopamine agonists or antagonists. Concurrent alcohol intake may cause an increase in the incidence and extent of hypotension. Use of Uprima in combination with other treatments for erectile dysfunction is not recommended. Side effects: Common (>1 per cent, <10 per cent) adverse events include nausea, headache, dizziness, yawning, rhinitis, pharyngitis, somnolence, infection, pain, increased cough, flushing, taste disorder and sweating. Net price: 2mg 2 £8.20, 4 £16.40; 3mg 2 £9.70, 4 £19.40. Supplier: Abbott Laboratories, Abbott House, Norden Road, Maidenhead, Berkshire SL6 4XE. Tel 01628 773355, fax 01628 644305. Legal class: POM. Aranesp injectionComposition: Darbepoetin alfa 10µg, 15µg, 20µg, 30µg, 40µg, 50µg, 60µg, 80µg, 100µg, 150µg. Presentation: Solution for injection in a pre-filled syringe. Storage and stability: Store at 2–8C. Keep the container in outer carton to protect from light. Action: Anti-anaemic. Indications: Treatment of anaemia associated with chronic renal failure in adults and paediatric patients Ž11 years of age. Contraindications: Hypersensitivity to active substance, recombinant human erythropoietin or excipients; poorly controlled hypertension. Dosage and administration: Administration can be either subcutaneous or intravenous. Treatment is divided into two phases. Correction phase, initial dose 0.45µg/kg body weight, as a single injection once weekly. See SPC for dosage increase or reduction depending on haemoglobin concentration and for monitoring. Maintenance phase, the exact target haemoglobin concentration above 6.8mmol/L needs to be established for individual patients (see SPC). Chronic renal failure, target haemoglobin should be determined individually. Blood pressure should be monitored. Impaired liver function, use with caution. Pregnancy, caution should be exercised as no data available. Lactation, should not be administered to women who are breast-feeding. Overdosage: No symptoms of overdose observed. Precautions: Serum potassium levels should be monitored regularly and consideration should be given to stopping therapy if elevated levels observed. In patients with evidence of ischaemic heart disease or congestive heart failure, target haemoglobin should be determined individually. Use with caution in patients with sickle cell anaemia or epilepsy. Drug interactions: No known interactions. If darbepoetin is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose adjusted as the haemoglobin concentration rises. Side effects: Common adverse reactions (>1 per cent, 10 per cent) include headache, hypertension, thrombosis of vascular access, injection site pain. Net price: Pack of four syringes, 10µg/0.4ml £67.04, 15µg/0.375ml £100.56, 20µg/0.5ml £134.08, 30µg/0.3ml £201.12, 40µg/0.4ml £268.16, 50µg/0.5ml £335.20, 60µg/0.3ml £402.24, 80µg/0.4ml £536.32, 100µg/0.5ml £670.40, 150µg/0.3ml £1005.60. Supplier: Amgen, 240 Cambridge Science Park, Milton Road, Cambridge CB4 0WD. Tel 01223 436441, fax 01223 426314. Legal class: POM. Amias tabletsThe summary of product characteristics for AstraZeneca’s Amias (candesartan cilexetil) tablets has been amended. The special warning and precautions section now refers to recommended monitoring in all patients with renal impairment (“severe” has been removed). The interaction with lithium has been updated (see SPC). Urticaria and pruritus have been added to the undesirable effects section. The following sentence has also been added: “Other adverse reactions reported for candesartan cilexetil include very rare cases of neutropenia, leucopenia and agranulocytosis.” Amias should not be given during breast-feeding. Frumil LS tabletsFrumil LS (amiloride hydrochloride 2.5mg, furose-mide 20mg) 56-tablet packs will be out of stock for the next few weeks. The company requests that the 28-tablet pack size should be ordered during this period. CosmoFer injectionCosmoFer 50mg/ml solution containing (iron (III) as iron (III)-hydroxide dextran complex has been launched by Vitaline Pharmaceuticals UK. The product is indicated for the treatment of iron deficiency and can be administered by slow intravenous injection or infusion (net price, 5 x 2ml ampoules £39.85). |
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