The Pharmaceutical Journal
Vol 280 No 7497 p434-435
12 April 2008

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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
• Pradaxa
SPC changes
• Alphagan
• Erythropoietin products
• Nicotinell

Recall Neupro

New medicines

Pradaxa

Composition: Dabigatran etexilate (as mesilate).

Presentation: Hard capsule.

Class: Direct thrombin inhibitor.

Indication: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Dosage: 220mg once daily, taken as two 110mg capsules. Treatment should be initiated orally, within one to four hours of completed surgery, with a single capsule and continued with two capsules once daily thereafter for a total of 10 days (following elective knee replacement surgery) or 28–35 days (following elective hip replacement surgery). If haemostasis is not secured, initiation of treatment should be delayed. If treatment is not initiated on the day of surgery the starting dose should be two capsules once daily.

Contraindications: Severe renal impairment (creatinine clearance <30ml/min); active clinically significant bleeding; an organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis; hepatic impairment or liver disease expected to have any impact on survival; treatment with quinidine.

Precautions: Agents that may enhance the risk of haemorrhage should not be administered concomitantly with Pradaxa or should be co-administered with caution.

The following treatments are not recommended for concomitant use with Pradaxa:

• Unfractionated heparins and heparin derivatives
• Low molecular weight heparins
• Fondaparinux
• Desirudin
• Thrombolytic agents
• Glycoprotein IIb/IIIa receptor antagonists
• Clopidogrel
• Ticlopidine
• Dextran
• Sulfinpyrazone
• VSitamin K antagonists

Patients with moderate renal impairment (creatinine clearance 30–50ml/min) should be treated with caution.

Patients aged over 75 years should be treated with caution. The recommended dose for these patients is 150mg once daily.

Pradaxa is not recommended for treatment of patients

• Under 18 years of age
• With elevated liver enzymes (twice upper limit of normal)
• Undergoing anaesthesia with post-operative indwelling epidural catheters
• Undergoing hip fracture surgery.

Patients at risk for bleeding or patients at risk of overexposure, patients at high surgical mortality risk and patients with intrinsic risk factors for thromboembolic events should be treated with caution.

Pradaxa should not be used during pregnancy unless clearly necessary. Women of child-bearing potential should avoid becoming pregnant during treatment.

Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout treatment with Pradaxa, especially in situations that may increase the hemorrhagic risk and for patients with diseases associated with an increased risk of bleeding. When severe bleeding occurs treatment must be discontinued and the source of bleeding investigated.

Side effects: Common (>1/100, <1/10) anaemia, gastrointestinal haemorrhage, haematoma, haematuria, decreased haemoglobin, postprocedural discharge, postprocedural haematoma, postprocedural haemorrhage, skin haemorrhage, traumatic haematoma, wound secretion.

Legal category: POM

Net price:
10 x 75mg, £21
60 x 75mg, £126
10 x 110mg, £21
60 x 110mg, £126

Contact details: Boehringer Ingelheim, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS (tel 01344 424600).

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SPC changes

Alphagan
Alphagan (brimonidine tartrate; Allergan) is now not recommended for use for children under 12 years of age and is contraindicated for neonates and infants less than two years old in the product’s summary of product characteristics.

The SPC states that children over two years old (especially those aged between two and seven years or weighing under 20kg) should be treated with caution and closely monitored because of the high incidence of somnolence.

Reports of accidental ingestion and information about Alphagan’s effects on ability to drive and use machines have also been added to the SPC.

Erythropoietin products
The summaries of product characteristics for erythropoietins products are now being updated in line with European Medicines Agency (EMEA) recommendations that erythropoietins products should be used in the treatment of anaemia only if patients experience associated symptoms and that product information should stipulate a uniform target haemoglobin range of 10g/dl to 12g/dl with a warning not to exceed a concentration of 12g/dl.

Nicotinell
A statement about smoking cessation causing behavioural changes has been added to the summary of product characteristics for Nicotinell (nicotine as bitartrate; Novartis) mint lozenges.

In addition, the SPC now lists rare immune system disorders in the undesirable effects section.

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