The Pharmaceutical Journal
Vol 268 No 7194 p531
20 April 2002

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Products

Prescription Products
• Protopic ointment
• Yasmin tablets
• Gliclazide tablets
• Omeprazole capsules and tablets
SPC changes
• Aricept tablets
• Neoral and Sandimmum
• Symbicort Turbohaler
• Ziagen oral solution
Discontinued products
• Pfizer products
• Celltech products

Prescription Products

Protopic ointment

Composition: Tacrolimus 0.03% and 0.1%.

Presentation: Ointment.

Action: Immunomodulator that inhibits T-cells.

Indications: Moderate to severe atopic dermatitis in adults (0.03% and 0.1% ointment) and children aged 2–15 years (0.03% ointment) who have failed to respond to conventional therapies.

Major cautions: Exposure of the skin to sunlight should be minimised and sources of ultraviolet light avoided during treatment. Clinical infections should be cleared from treatment sites before use. Avoid contact with eyes or mucous membranes. Emollients should not be applied within two hours of applying the treatment. Do not use during pregnancy.

Side effects: Skin irritation adverse reactions were reported by around 50 per cent of patients. Alcohol intolerance was common.

Legal category: POM.

Net price: 0.03% 30g £19.44, 60g, £36.94; 0.1% 30g £21.60, 60g £41.04.

Contact details: Fujisawa, CP House, 1st Floor, 97–107 Uxbridge Road, Ealing, London W5 5TL. Tel 020 8840 9520, fax 020 8840 9521.

See SPC for further details.

Yasmin tablets

Composition: Drospirenone 3mg, ethinylestradiol 30µg.

Presentation: Film-coated tablets.

Class: Combined oral contraceptive.

Indications: Oral contraception.

Major cautions: As for combined oral contraceptives. Women using Yasmin and concomitant medicines with the potential to increase serum potassium, such as angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, potassium-sparing diuretics or non-steroidal anti-inflammatory drugs for long-term treatment, should be tested for serum potassium during the first treatment cycle.

Side effects: Common (>=1 per cent) adverse events are menstrual disorders, intermenstrual bleeding, breast pain, headache, depressive mood, migraine, nausea, leukorrhoea, vaginal moniliasis.

Legal category: POM.

Net price: 3 x 21 £14.70.

Contact details: Schering Health Care, The Brow, Burgess Hill, West Sussex RH15 9NE. Tel 01444 232323, fax 01444 246613.

See SPC for further details.

Gliclazide tablets

A 60-tablet pack of gliclazide 80mg tablets has been launched by Alpharma; net price, £5.36.

Omeprazole capsules and tablets

Generics UK has launched omeprazole capsules and tablets. The capsules are available in 10mg (pack size 28, price £18.90), 20mg (28, £28.55) and 40mg (7, £14.27) strengths. The tablets are available in 10mg (pack size 28, price £18.91), 20mg (28, £28.56) and 40mg (7, £14.28) strengths.

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SPC changes

Aricept tablets

The summary of product characteristics for Aricept (donepezil hydrochloride) tablets has been revised (Eisai). The following statment has been added to the posology and method of administration section: "Due to possible increased exposure in mild to moderate hepatic impairment, dose escalation should be performed according to individual tolerability. There are no data for patients with severe hepatic impairment." The pregnancy and lactation section now additionally states that "no clinical data on exposed pregnancies are available". Rash, pruritus and urinary incontinence have been added to the undesirable effects section. See SPC.

Neoral and Sandimmum

The summaries of product characteristics for Neoral (ciclosporin) capsules and oral solution and Sandimmum (ciclosporin) concentrate for infusion have been updated (Novartis Pharmaceuticals). The special warnings and precautions for use sections now include information on the risk of enhanced clearance of magnesium and updated information on hyperkalaemia, malignancy and infection. The drug interactions and undesirable effects sections have been revised. The incompatibilities section of the SPC for Sandimmum concentrate for infusion contains additional information on the types of containers and stoppers that should be used during administration. See SPC.

Symbicort Turbohaler

Symbicort (budesonide, formoterol fumarate) 100/6 Turbohaler and Symbicort 200/6 Turbohaler are now licensed for use in adolescents aged 12 years and over (AstraZeneca). The recommended dosage is one to two inhalations twice daily. See SPC.

Ziagen oral solution

Ziagen (abacavir) 20mg/ml oral solution is now licensed for use in children aged three months and over. The recommended dose for children aged three months to 12 years is 8mg/kg twice daily up to a maximum of 600mg (30ml) daily. For adults and adolescents over 12 years the recommended dose is 300mg (15ml) twice daily.

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Discontinued products

Pfizer products

The following products will be discontinued from 14 June:

• Lentizol (amitriptyline) 25mg and 50mg capsules

• Nephril (polythiazide) 1mg tablets

Celltech products

The following products will be discontinued on May 1 (Celltech Pharmaceuticals):

• Furosemide 10mg/ml injection, pack size 10 x 2ml

• Morphine sulphate 15mg and 30mg suppositories, pack size 12

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