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PJ Online homeThe Pharmaceutical Journal
Vol 279 No 7481 p646, 651
8 December 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

    New medicines Prescription Products Supply issues

New medicines

Cholestagel

Composition: Colesevelam hydrochloride.

Presentation: Film-coated tablet.

Class: Bile acid sequestrant.

Indications: In conjunction with a statin as adjunctive therapy to diet to provide additive reduction in LDL-cholesterol levels for patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. As monotherapy, adjunctive to diet, for reduction in total and LDL-cholesterol levels for patients with isolated primary hypercholesterolaemia in whom statin therapy is inappropriate or poorly tolerated.

Dosage: Tablets should be taken with meals. As combination therapy with statins the recommended dose is four to six tablets per day. The maximum recommended dose is three tablets twice a day or six tablets once a day. For monotherapy, the recommended starting dose is three tablets twice a day or six tablets once a day. The maximum recommended dose for monotherapy is seven tablets per day.

Contraindications: Bowel or biliary obstruction.

Precautions: Secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, alcoholism, other drug therapies) should be excluded before starting Cholestagel.

Patients with triglyceride levels greater than 3.4mmol/L should be treated with caution because of the triglyceride-increasing effect of Cholestagel.

Caution should be exercised when treating patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or previous major gastrointestinal surgery

Cholestagel can induce or worsen constipation — this risk should be considered especially for patients with coronary heart disease or angina.

Bile acid sequestrants have been shown to reduce absorption of vitamin K and interfere with the anticoagulant effect of warfarin — patients receiving warfarin or similar medicines should have their anticoagulation monitored closely.

Side effects: Common or very common (>=1/100) vomiting, abnormal stools, headache, nausea, diarrhoea, abdominal pain, dyspepsia, constipation, flatulence.

Legal category: POM.

Net price: 180 x 625mg, £92.66.

Contact details: Genzyme, 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU (tel 01865 405200).

Ecalta

Composition: Anidulafungin.

Presentation: Powder and solvent for concentrate for solution for infusion.

Class: Echinocandin antimycotic.

Indications: Treatment of invasive candidiasis in adult non-neutropenic patients.

Dosage: A single loading dose of 200mg should be administered on day 1 followed by 100mg daily thereafter. It is recommended that treatment with Ecalta is continued for at least 14 days after the last positive culture. Ecalta should be administered at a rate not exceeding 1.1mg/minute.

Precautions: Ecalta should not be administered as a bolus injection.

There are insufficient data to support treatment for longer than 35 days.

Ecalta is not recommended for patients under 18 years of age.

The efficacy of Ecalta for neutropenic patients with candidaemia and for patients with deep tissue candidal infections or intra-abdominal abscess and peritonitis has not been established.

Each 100mg dose of Ecalta also contains 6g of ethanol, which should be considered when treating women who are pregnant or breastfeeding, children, alcoholics and people with liver disease or epilepsy.

Side effects: Common (>=1/100, <1/10) coagulopathy, convulsions, headache, diarrhoea, vomiting, nausea, rash, pruritus, hypokalaemia, flushing, increases in blood creatinine, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin and gamma-glutamyltransferase.

Legal category: POM.

Net price: 1 x 100mg, £299.99.

Contact details: Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ (tel 01304 616161).

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Prescription Products

Risperidone
Risperidone tablets will be available from 10 December 2007 from Dexcel Pharma.
Net price:
20 x 0.5mg, £6.35
20 x 1mg, £10.45
60 x 1mg, £31.36
60 x 2mg, £61.82
60 x 3mg, £90.91
60 x 4mg, £120.01
28 x 6mg, £84.85
Legal category: POM.

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Supply issues

Alphaderm
Alphaderm (hydrocortisone, urea; Alliance) cream 100g is now available following a supply disruption.

Aquadrate
Aquadrate (urea; Alliance) cream 100g is now available following a supply disruption.

Medrone
Medrone (methylprednisolone; Pfizer) tablets 100mg are out of stock. Supply is expected to resume in the next few weeks. Customer services on 0845 6088866. Medical information on 01304 616161.

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