Home > PJ > Products

Return to PJ Online Home Page

The Pharmaceutical Journal Vol 268 No 7192 p463
6 April 2002

This article
Reprint
Photocopy


Products

    Prescription Products SPC changes Discontinued products Supply problems

Recall Medinol Over 6 oral suspension


Prescription Products

Arixtra injection

Composition: Fondaparinux sodium 2.5mg/0.5ml.
Presentation: Solution for injection.
Class: Antithrombotic agent.
Indications: Prevention of venous thromboembolic events in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery.
Major cautions and contra-indications: Fondaparinux is contraindicated in active clinically significant bleeding, acute bacterial endocarditis and severe renal impairment (creatinine clearance <30ml/min). Fondaparinux should be used with caution in patients with: moderate renal impairment; severe hepatic impairment; a body weight of <50kg. It should also be used with caution in the elderly and in patients who are at increased risk of haemorrhage. The following agents should not be administered concomitantly with fondaparinux: desirudin, fibrinolytic agents, glycoprotein IIb/IIIa receptor antagonists, heparin, heparinoids and low molecular weight heparins. Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, dipyridamole, sulfinpyrazone, ticlopidine and clopidogrel should be used with caution in patients taking fondaparinux. Fondaparinux should not be prescribed to pregnant women unless clearly necessary and breastfeeding is not recommended during treatment.
Side effects: Common (Ž1 per cent, <10 per cent) undesirable effects include anaemia, bleeding (at surgical site, gastrointestinal, haematuria, pulmonary, haematoma), thrombocytopenia, purura and oedema.
Legal category: POM.
Net price: 10 prefilled syringes £71.68.
Contact details: Sanofi-Synthelabo, One Onslow Street, Guildford, Surrey GU1 4YS. Tel 01483 505515, fax 01483 535432.
See SPC for further details.

Zyvox oral suspension

Zyvox (linezolid) 100mg/5ml granules for oral suspension has been launched (Pharmacia); net price, 150ml £222.50.


Back to Top


SPC changes

Imdur tablets

The undesirable effects section of the summary of product characteristics for Imdur (isosorbide mononitrate) 60mg tablets has been updated. The following has been added: “Myalgia has been reported very rarely.”

Buspar tablets

The summary of product characteristics for Buspar (buspirone hydrochloride) tablets has been updated (Bristol-Myers Squibb Pharmaceuticals). The posology and method of administration section now states: “The dosage should be reduced in renal or hepatic impairment.” Nefazodone has been included as an example of an agent that inhibits isoenzyme CYP 3A4 and interacts with buspirone. “Seizures” has been added to the undesirable effects section. See SPC.

CoAprovel tablets

The shelf-life for CoAprovel (irbesartan, hydrochlorothiazide) tablets has been increased from two to three years (Bristol-Myers Squibb Pharmaceuticals, Sanofi-Synthelabo).

Videx capsules

The summary of product characteristics for Videx EC (didanosine) capsules has been revised (Bristol-Myers Squibb Pharmaceuticals). The posology and method of administration section now states: “Because didanosine absorption is reduced in the presence of food, Videx gastro-resistant capsules should be administered on an empty stomach (at least two hours before or after a meal).” The pharmacokinetic properties section now includes information both on the administration of Videx EC before a light meal and on opening the capsules. See SPC.

Zerit capsules and powder

The special warnings and precautions for use section of the summaries of product characteristics for Zerit (stavudine) capsules and powder for oral solution now contain a box warning about lactic acidosis associated with the use of nucleoside analogues (Bristol-Myers Squibb Pharmaceuticals). See SPC.

Back to Top


Discontinued products

Inhalet spacer device

The Inhalet spacer device is being removed from packs of the following metered dose inhalers (Astra-Zeneca):
• Pulmicort (budesonide) inhaler
• Pulmicort LS inhaler
• Bricanyl (terbutaline) inhaler
The company says that patients who use the Inhalet device should be advised to use an alternative spacer device. Further information can be obtained from the company’s medical information department, Horizon Place, 600 Capability Green, Bedfordshire LU1 3LU (tel 01582 836836, fax 01582 838003).

Back to Top


Counter medicines

Hayfever and Allergy Relief

Galpharm Hayfever and Allergy Relief (cetirizine) 10mg tablets have been launched (Galpharm Healthcare). The product is available in packs of seven, as a general sale list medicine, (retail price, £2.49) and 30, as a pharmacy medicine, (retail price, £6.99).

Back to Top


Home | Journals | News | Notice-board | Search | Jobs  Classifieds | Site Map | Contact us

©The Pharmaceutical Journal