Recalled products / New medicines / SPC changes / Prescription products / Discontinued products / Supply issues / Products miscellany

Composition: Retapamulin.

Presentation: Ointment 1 per cent (w/w).

Class: Topical antibacterial.

Indications: Short-term treatment of impetigo and of infected small lacerations, abrasions, or sutured wounds.

Dosage: A thin layer of ointment applied to the affected area twice a day for five days.

Precautions: Safety and efficacy have not been established for the treatment of impetiginous lesions exceeding 10 in number or 100cm² in total surface area, or for infected lesions exceeding 10cm in length or 100cm² in total surface area. For patients under 18 years of age the total surface area treated should be no more than 2 per cent of the body surface area.

Safety and efficacy have not been established for children less than nine months of age.

Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered.

If severe local irritation occurs, treatment should be discontinued, the ointment carefully wiped off and appropriate alternative therapy for the infection instituted.

Altargo ointment contains butylated hydroxytoluene, which may cause local skin reaction (eg, contact dermatitis), or irritation to the eyes and mucous membranes.

Altargo should not be used to treat abscesses or infections known or thought likely to be due to meticillin-resistant Staphylococcus aureus.

As with other antibacterial agents, prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.

Side effects: Common (>=1/100, <1/10) application site irritation.

Legal category: POM.

Net price: 5g tube, £7.89.

Contact details: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT (tel 0800 221441).

Prescription Products

Arcoxia
Arcoxia (etoricoxib) is now available from Merck Sharp & Dohme in 30mg tablets.
Net price: 28, £13.99
Legal category: POM

Botox
Botox (botulinum toxin type A) is now available from Allergan in 50-unit vials
Net price: £72.30
Legal category: POM

Desmopressin
Desmopressin tablets are now available from Pliva
Net price: 90 x 100µg, £45.03; 30 x 200µg, £30.04; 90 x 200µg, £90.05
Legal category: POM

Mirapexin
Mirapexin (pramipexole) tablets 350µg base/500µg salt are now available from Boehringer Ingelheim.
Net price: 30, £38.20; 100, £127.34
Legal category: POM

Rapydan
Rapydan (lidocaine 70mg/tetracaine 70mg) medicated plasters are now available from EUSA Pharma for surface anaesthesia of normal intact skin in connection with needle puncture (children from three years of age and adults) and in cases of superficial surgical procedures (adults).
Net price: 25 plasters, £98
Legal category: POM

SPC changes

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

Aranesp
An error in dosing information for paediatric patients in the summaries of product characteristics for Aranesp (darbepoetin alfa; Amgen) and Aranesp SureClick has been corrected. The “µg/week” units found in brackets in the following sentence previously read “µg/kg” in error: “The initial weekly or once every other week paediatric dose of Aranesp (µg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240.”

Avastin
A new indication for Avastin (bevacizumab; Roche) for first-line treatment of patients with advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a, has been added to Avastin’s summary of product characteristics. The dose for this new indication is 10mg/kg given once every two weeks as an intravenous infusion.

Baraclude
Baraclude (entecavir; Bristol-Myers Squibb) should not be used for HIV/hepatitis B co-infected patients who are not receiving highly active antiretroviral therapy, the product’s summaries of product characteristics now state. Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use, the SPCs add. Insomnia has been added to the list of common undesirable effects.

Januvia
Two new indications for patients with type 2 diabetes have been added to the summary of product characteristics for Januvia (sitagliptin; Merck Sharp & Dohme). They are: to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindication or intolerance; and to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. The SPC says that when Januvia is used with a sulphonylurea a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia. The undesirable effects and pharmacodynamic properties sections have been updated to reflect the new indications.

Miacalcic
The summary of product characteristics for Miacalcic (calcitonin [salmon]; Novartis) solution for injection and infusion has been updated to include the following statement: “As salmon calcitonin is a peptide, adsorption onto the plastic for the infusion set may occur. This has the potential to reduce the total dose delivered to the patient. Frequent monitoring of the clinical and laboratory response including the measurement of serum calcium is recommended especially in the early phases of treatment. The dosing of Miacalcic should be individualised to the patient’s specific requirements.” The SPC for Miacalcic nasal spray now recommends that each actuation of the spray be administered to alternate nostrils. Both SPCs now state: “Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. The dose of lithium may need to be adjusted.”

Myfortic
Upper respiratory tract infection and pneumonia are now included in the list of common side effects in the summary of product characteristics for Myfortic (mycophenolic acid as mycophenolate sodium; Novartis). The administration section also contains additional information with regard to crushing Myfortic tablets: “Where crushing of Myfortic tablets is necessary, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane.”

Discontinued products

Lederfolin
Lederfolin (calcium folinate [calcium leucovorin]) solution for injection 350mg/vial has been discontinued by Wyeth. Several generic alternatives remain available. Medical information on 0845 367 0098.

Ortho-Creme
Ortho-Creme (nonoxynol-9) contraceptive cream has been discontinued by Janssen-Cilag. An alternative product, Gygel, can be ordered from Marlborough Pharmaceuticals (see Products miscellany).

Sulpitil
Sulpitil (sulpiride) tablets 200mg have been discontinued by Pfizer. Medical information on 01304 616161.

Supply issues

Salazopyrin suspension
Pfizer has announced that existing stocks of Salazopyrin (sulfasalazine) suspension 250mg/5ml are likely to be depleted early February, and the product may remain unavailable for up to six weeks. Supplies of Salazopyrin tablets, EN-tablets and suppositories will not be affected. Customer services on 0845 608 8866. Medical information on 01304 616161.

Products miscellany

Adcal D₃ Dissolve
Adcal D3 Dissolve (calcium carbonate 1,500mg [equivalent to elemental calcium 600mg], colecalciferol 10µg) effervescent tablets are now available from ProStrakan in packs of four 14-tablet tubes.
Net price: 56, £4.99
Recommended retail price: 56, £8.80
Legal category: P

Gygel
Gygel (nonoxynol-9) contraceptive vaginal gel 2 per cent (w/w) is now available in 30g tubes from Marlborough Pharmaceuticals.
Net price: £4.25.
Recommended retail price: £7.50
Legal category: GSL