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PJ Online homeThe Pharmaceutical Journal
Vol 276 No 7401 p588-589
20 May 2006

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Products

    New medicines Prescription Products SPC changes Discontinued products Supply issues Counter products Products miscellany

New medicines

Macugen

Composition: Pegaptanib sodium.

Presentation: Pre-filled syringe containing solution for injection 0.3mg.

Action: Inhibitor of extracellular vascular endothelial growth factor.

Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD).

Dosage: The recommended dose is 0.3mg once every six weeks (nine injections per year), administered by intravitreal injection into the affected eye.

Precautions: Macugen is contraindicated for patients with active or suspected ocular or periocular infection. If transient increase in intraocular pressure is seen after intravitreal injection, it is recommended that perfusion of the optic nerve be verified and elevation of intraocular pressure be managed appropriately. Immediate or delayed intravitreous haemorrhage may occur following Macugen injection. It is recommended that patients report any symptoms suggestive of endophthalmitis immediately and that patients should be monitored closely for endophthalmitis in the two weeks following Macugen injection. Patients may experience temporary blurred vision after Macugen injection and should not drive or use machines until this has resolved.

Side effects: Very common (>=1/10) eye disorders (see SPC); common (>=1/100 to <1/10) headache, rhinorrhoea, eye disorders (see SPC).

Legal category: POM.

Net price: 1 x 0.3mg £514.

Contact details: Pfizer Ltd, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS. Telephone 01304 616161.

Tygacil

Composition: Tigecycline.

Presentation: Vial containing powder for solution for infusion 50mg.

Class: Glycylcycline antibiotic.

Indication: Treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections.

Dosage: The recommended adult dose is 100mg followed by 50mg every 12 hours for five to 14 days, administered by intravenous infusion over 30 to 60 minutes.

Precautions: Tygacil may have adverse reactions similar to tetracycline class antibiotics. Caution is advised when treating patients with severe underlying diseases and consideration should be given to the use of combination antibacterial therapy whenever Tygacil is used to treat severely ill patients with complicated intra-abdominal infections secondary to clinically apparent intestinal perforation, or patients with incipient sepsis or septic shock. It is recommended that patients with cholestasis be closely monitored when receiving Tygacil. Coagulation tests should be used to monitor patients who receive Tygacil with anticoagulants. Patients who present with diarrhoea during, or after receiving Tygacil, should be assessed for pseudomembranous colitis and patients should be monitored during therapy for signs of super infection with non-susceptible organisms, including fungi. Tygacil may be associated with permanent tooth discolouration if used during tooth development. Tygacil may cause dizziness, which could affect the ability to drive and use machines.

Side effects: Very common (>=1/10) nausea, vomiting, diarrhoea; common (>=1/100 to <1/10) abscess, infections, prolonged activated partial thromboplastin time, prolonged prothrombin time, dizziness, phlebitis, abdominal pain, dyspepsia, anorexia, elevated serum aspartate aminotransferase, elevated serum alanine aminotransferase, bilirubinaemia, pruritus, rash, headache, elevated serum amylase, increased blood urea nitrogen.

Legal category: POM.

Net price: 10 x 50mg vials £323.10.

Contact details: Wyeth Pharmaceuticals, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH. Telephone 01628 604377.

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Prescription Products

Adartrel
Adartrel (ropinirole; GlaxoSmithKline) tablets are now available for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome. Net price, 12 x 0.25mg starter pack £3.94, 28 x 0.5mg £15.75, 84 x 0.5mg £47.26, 28 x 2mg £31.51, 84 x 2mg £94.53. Legal category: POM.

DuoTrav
DuoTravDuoTrav (travoprost 40µg/ml, timolol 5mg/ml) eye drops are now available from Alcon. Net price, 1 x 2.5ml £13.20, 3 x 2.5ml £37.62. Legal category: POM.

Metoprolol
Metoprolol tablets are now available from Alpharma. Net price, 28 x 50mg £1.64, 28 x 100mg £2.81. Legal category: POM.

Mirtazapine
Mirtazapine tablets are now available from Alpharma. Net price, 28 x 30mg £6.26. Legal category: POM.

Sumatriptan
Sumatriptan tablets are now available from Almus. Net price, 6 x 50mg £27.62, 6 x 100mg £44.64. Legal category: POM.

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SPC changes

Botox
The summary of product characteristics for Botox (botulinum A neurotoxin complex; Allergan) now states that, from a microbiological point of view, the product should be used immediately but that, if not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2–8C. The SPC also now states that each vial is for single use only. See SPC.

Combigan
The summary of product characteristics for Combigan (brimonidine, timolol; Allergan) has been updated to include the following administration information: to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus for one minute, performed immediately following the instillation of each drop. The special warnings section now includes information on the following: ocular allergic-type reactions; use for patients with severe renal impairment on dialysis; risk associated with use in conjunction with anaesthetics; caution in patients with metabolic acidosis and untreated phaeochromocytoma; acute hypoglycaemia in patients with uncontrolled diabetes; and choroidal detachment. The SPC now contains information on drug interactions with mydriatic agents such as adrenaline, anaesthetic drugs, iodine contrast products, intravenous lidocaine, cimetidine, hydralazine, alcohol and monoamine-oxidase inhibitors. The undesirable effects section now includes allergic blepharitis as an uncommon adverse reaction to Combigan, and bradycardia and respiratory failure as possible side effects of timolol. See SPC.

Ebixa
The summaries of product characteristics for Ebixa (memantine; Lundbeck) tablets and oral drops have been updated. The interaction sections now recommend close monitoring of prothrombin time or international normalised ratio for patients concomitantly treated with oral anticoagulants. Psychotic reactions and pancreatitis have been added to the adverse drug reactions tables of the SPCs, both with the frequency stated as “not known”. See SPCs.

Hespera
The summary of product characteristics for Hespera (adefovir dipivoxil; Gilead) now includes additional information about treatment cessation in patients with hepatic decompensation. See SPC.

Truvada
The summary of product characteristics for Truvada (tenofovir disoproxil, emtricitabine; Gilead) now states that in clinical trial and post-marketing experience, anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients. See SPC.

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Discontinued products

Stelazine
Stelazine Forte (trifluoperazine; Goldshield) oral solution 1mg/1ml has been discontinued. Stelazine syrup 1mg/5ml remains available. Medical information on 020 8410 2592.

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Supply issues

Efexor
Efexor (venlafaxine; Wyeth) tablets 75mg 56-tablet pack are now fully available following a short-term supply disruption.

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Counter products

Curanail
CuranailCuranail (amorolfine) nail lacquer 5 per cent w/v is now available from Galderma. Recommended retail price, 3ml £18.61. Legal category: P.

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Products miscellany

Adcal-D3
Adcal-D3 (calcium carbonate 750mg equivalent to elemental calcium 600mg, colecalciferol 400IU; ProStrakan) tablets are now available in a 56-day community pack (112 tablets) and a 28-day hospital pack (56 tablets). The 100-tablet pack will be discontinued when current stocks are exhausted.

Arcoxia
Arcoxia (etoricoxib; Merck Sharp & Dohme) tablets 60mg, 90mg and 120mg have been reformulated and repackaged. The tablets are still apple-shaped but are now smaller, and the 60mg tablet is now a darker shade of green. Further information on 01992 467272.

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