The Pharmaceutical Journal
Vol 278 No 7448 p452-453
21 April 2007

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Products

New medicines
• Januvia
Prescription Products
• Efexor
• Premarin 0.3mg
• VAQTA Paediatric
SPC changes
• Bondronat
• Xalatan and Xalacom
• Calcichew
Safety information
• Desmopressin nasal sprays

New medicines

Januvia

Composition: Sitagliptin.

Presentation: Film-coated tablet.

Class: dipeptidyl peptidase 4 (DPP-4) inhibitor.

Indications: Improvement of glycaemic control for patients with type 2 diabetes mellitus, in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control. For patients with type 2 diabetes mellitus in whom use of a thiazolidinedione is appropriate, Januvia is indicated in combination with the thiazolidinedione when diet and exercise plus the thiazolidinedione alone do not provide adequate glycaemic control.

Dosage: 100mg once daily.

Precautions: Januvia is not recommended for use in patients below 18 years of age. Januvia should not be used for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Patients with moderate to severe renal insufficiency should not be treated with Januvia.

Side effects: In combination with metformin: common (>1/100, <1/10) nausea. In combination with thiazolidinediones: common (>1/100, <1/10) hypoglycaemia, flatulence, peripheral oedema.

Legal category: POM.

Net price: 28 x 100mg, £33.36.

Contact details: Merck Sharp & Dohme, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU (tel 01992 467272).

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Prescription Products

Efexor
Efexor XL (venlafaxine; Wyeth) capsules are now available in 14 x 75mg packs and 14 x 150mg packs. Net price: 14 x 75mg, £11.71; 14 x 150mg, £19.52. Legal category: POM. Efexor (venlafaxine; Wyeth) tablets are now available in 28 x 37.5mg packs and 28 x 75mg packs. Net price: 28 x 37.5mg, £11.71; 28 x 75mg, £19.51. Legal category: POM.

Premarin 0.3mg
Premarin (conjugated oestrogens) tablets 0.3mg are now available from Wyeth. Net price: 84, £9.72. Legal category: POM.

VAQTA Paediatric
VAQTA Paediatric (hepatitis A vaccine, inactivated; Sanofi Pasteur MSD) is now available as a pre-filled syringe. Net price: 1, £15.65. Legal category: POM.

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SPC changes

Bondronat
The summary of product characteristics for Bondronat (ibandronic acid; Roche) has been updated. It now states that the dose should be infused over at least 15 minutes and that a shorter (ie, 15 minute) infusion time should only be used for patients with normal renal function or mild renal impairment. See SPC.

Xalatan and Xalacom
The summaries of product characteristics for Xalatan (latanoprost; Pharmacia) and Xalacom (latanoprost, timolol; Pharmacia) now include the following additional adverse events: arthralgia, blurred vision, conjunctivitis, darkening of palpebral skin of eyelids, dizziness, dry eye, headache, keratitis, localised skin reaction on eyelids, myalgia, palpitations. See SPCs.

Calcichew
The summaries of product characteristics for Calcichew and Calcichew Forte tablets (calcium carbonate; Shire) and Calcichew-D3 and Calcichew-D3 Forte (calcium carbonate, colecalciferol; Shire) now include updated advice on the treatment of hypercalcaemia. See SPCs.

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Safety information

Desmopressin nasal sprays
The indication for the treatment of primary nocturnal enuresis (PNE) has been removed from all desmopressin nasal spray products, including Desmospray (Ferring Pharmaceuticals Ltd), Presinex Nasal Spray (Pliva Pharma Ltd), Nocutil Desmopressin Nasal Spray (Norgine Ltd) and Desmopressin Spray (PH&T SpA), at the request of the Medicines and Heathcare products Regulatory Agency. Compared with oral formulations of desmopressin, nasal forms have been associated with most of the serious adverse drug reactions reported in patients with PNE.

Patients may complete their current course of treatment. At the next routine review, patients who need ongoing treatment should be prescribed only an oral form of desmopressin. All patients who start treatment with oral desmopressin should start at the lowest recommended dose.

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