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The Pharmaceutical Journal
Vol 268 No 7196 p608
4 May 2002

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Products

    Prescription Products SPC changes Supply problems

Prescription Products

Kineret injection

Composition: Anakinra 150mg/ml.

Presentation: Prefilled syringe.

Class: Immunosuppressive agent.

Indications: Treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.

Major cautions and contra-indications: Anakinra should not be used in patients with severe renal impairment (creatinine clearance <30ml/min) and used with caution in patients with moderate renal impairment (creatinine clearance 30–50ml/min). Treatment should not be initiated in patients with neutropenia. Caution should be exercised when administering anakinra to patients with a history of recurring infections. Use in patients with pre-existing malignancy is not recommended. Anakinra should be used with caution in the elderly (Ž65 years). There is insufficient data to recommend use in children and adolescents under 18 years of age. Use in pregnancy and in women who are breast-feeding is not recommended.

Side effects: Very common (>10 per cent) undesirable effects are injection site reaction and headache. Common (1–10 per cent) undesirable effects are serious infections requiring hospitalisation and neutropenia.

Legal category: POM.

Net price: 28 prefilled syringes £573.08.

Contact details: Amgen, 240 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire CB4 0WD. Tel 01223 420305, fax 01223 423049.

See SPC for further details.

Dovobet ointment

Composition: Calcipotriol (as hydrate) 50µg/g, betamethasone 0.5mg/g

Presentation: Ointment.

Indications: Initial topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

Major cautions and contra-indications: Dovobet is contraindicated in patients with severe hepatic disorders as well as guttate, erythrodermic, exfoliative and pustular forms of psoriasis. Application and accidental transfer to the scalp, face, mouth and eyes should be avoided. Dovobet should not be used for more than four weeks. Treatment of more than 30 per cent of the body area should be avoided. Dovobet is not recommended for use in children and adolescents under the age of 18 years.

Side effects: Common (>1 per cent, <10 per cent) undesirable effects are pruritus, rash and folliculitis.

Legal category: POM.

Net price: 120g £55.

Contact details: Leo Pharmaceuticals, Longwick Road, Princes Risborough, Buckinghamshire HP27 9RR. Tel 01844 347333, fax 01844 342278.

See SPC for further details.

Omeprazole capsules

CP Pharmaceuticals has launched omeprazole capsules; net price, 10mg 28 £18.91, 20mg 28 £28.56, 40mg 7 £14.28.

Doxazosin tablets

Doxazosin tablets are being launched, pack size 28 (Lagap Pharmaceuticals); net price, 1mg £10.56, 2mg £14.08, 4mg £17.60.

Zineryt solution

The Zineryt (erythromycin 40mg/ml, zinc acetate 12mg/ml) solution applicator is now supplied in a new holder (see right) (Yamanouchi).

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SPC changes

Movicol sachets

The summary of product characteristics for Movicol sachets has been updated (Norgine). Movicol sachets are now licensed for extended use in the care of patients with severe chronic or resistant constipation, constipation secondary to multiple sclerosis or Parkinson's disease and constipation induced by regular constipating medication, in particular opioids and antimuscarinics. For extended use the dose can be adjusted to one or two sachets daily.

Oxis Turbohaler

The licensed indications for Oxis (formoterol fumarate dihydrate) Turbohaler 6 and Oxis Turbohaler 12 have been extended (Astra Pharmaceuticals). They are now additionally licensed for the prevention of exercise-induced symptoms in asthmatics (aged six years and over) when treatment with corticosteroids is not sufficient.

Xalatan new indication

Xalatan (latanoprost) eye-drops are now licensed for use as first-line treatment for the reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension (Pharmacia).

Biorphen liquid

The summary of product characteristics for Biorphen (orphenadrine hydrochloride) 25mg/5ml liquid has been amended (Alliance Pharmaceuticals). The following statement has been added to the undesirable effects section: "Occasionally dry mouth, disturbances of visual accommodation, gastrointestinal disturbances, dizziness and micturition difficulties may occur; these usually disappear spontaneously or may be controlled by a slight reduction in dosage. Less commonly, tachycardia, hypersensitivity, nervousness, euphoria, hallucinations, confusion and co-ordination disturbances and insomnia may be seen." The overdose section now includes the following statement: "Effects seen on overdose are anticholinergic in nature and include agitation, confusion, hallucinations, inco-ordination, delirium, tachycardia and occasionally convulsions." See SPC.

Wyeth's HRT products

The summaries of product characteristics for Premarin tablets, Premarin vaginal cream, Premique tablets, Premique Cycle calendar pack and Prempak-C calendar packs have been updated to include recommendations from the Committee on Safety of Medicines on the physical examination of women taking hormone replacement therapy (Wyeth Laboratories). See SPC.

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Supply problems

Symmetrel syrup

Supplies of Symmetrel (amantadine hydrochloride) 50mg/5ml syrup are now back in stock. Orders for the product should be placed with the Alliance sales office (tel 01249 466974, fax 01249 466976, e-mail salesoffice@alliancepharma.co.uk).

Alpharma products

The following Alpharma products are out of stock:

• Temazepam 10mg tablets, pack size 500. New stock is expected to be available by the end of August.

• Temazepam 20mg tablets, pack size 250. New stock is expected to be available by the end of August.

• Naftidrofuryl oxalate 100mg capsules, pack size 84. New stock is expected to be available in July.

• Norethisterone 5mg tablets, pack size 30. New stock is expected to be available by the end of July.

Further information can be obtained from Alpharma (tel 01271 311200).

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