The Pharmaceutical Journal
Vol 272 No 7305 p799
26 June 2004

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Products

Prescription Products
• Abilify
SPC changes
• Zerit
• Sustiva
Discontinued products
• Tranquilyn
• Stiedex
• Salbulin
• Rynacrom
Supply issues
• Ledermycin capsules
• Baratol tablets
• Stelazine Spansules
Products miscellany
• Enlive Plus

Prescription Products

Abilify
Composition: aripiprazole.
Presentation: tablets.
Class: antipsychotic.
Indications: treatment of schizophrenia.
Dosage: recommended starting and maintenance dose 15mg per day. Maximum daily dose should not exceed 30mg.
Major cautions: the 30mg dose should be used with caution in patients with severe hepatic impairment. The aripiprazole dose should be reduced when concomitant administration of potent CYP3A4 or CYP2D6 inhibitors occurs and increased with concomitant administration of potent CYP3A4 inducers. Dose reduction or discontinuation should be considered if the patient develops signs of tardive dyskinesia. Aripiprazole must be discontinued if signs of neuroleptic malignant syndrome develop, or if the patient presents with unexplained high fever. Aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Side effects: common (>1/100, <1/10) include light-headedness, insomnia, blurred vision, nausea, headache. See SPC.
Net price: 10mg or 15mg 28 £101.63, 30mg 28 £203.26.
Contact details: Bristol-Myers Squibb, 141–149 Staines Road, Hounslow, Middlesex TW3 3JA (tel 020 8572 7422).
Otsuka Pharmaceuticals (UK), Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW (tel 020 8600 6770).

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SPC changes

Zerit
The summary of product characteristics for Zerit (stavudine) capsules and powder for oral solution now includes a warning that nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a degree of mitochondrial damage (Bristol-Myers Squibb). The main adverse effects reported are haematological and metabolic disorders. Any child exposed in utero to nucleoside and nucleotide analogues should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant symptoms. These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. See SPC.

Sustiva
The summary of product characteristics for Sustiva (efavirenz) hard capsules, oral solution and tablets now states that its safety and efficacy has not been established in patients with significant underlying liver disorders, and the drug is contraindicated in patients with severe hepatic impairment (Bristol-Myers Squibb). Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse events. Patients with pre-existing liver dysfunction have an increased frequency of liver function abnormalities during combination antiretroviral therapy. Discontinuation of treatment should be considered if there is evidence of worsening liver disease or persistent elevations of serum transaminases. See SPC.

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Discontinued products

Tranquilyn
All presentations of Tranquilyn (methylphenidate hydrochloride) tablets will be discontinued at the end of the month (Link).

Stiedex
Stiedex LP (desoximetasone 0.05 per cent) oily cream 100g has been discontinued (Stiefel Laboratories). Stiedix LP 30g remains available.

Salbulin
Salbulin (salbutamol) inhaler CFC-free has been discontinued (IVAX). Salamol CFC-free inhaler remains available.

Rynacrom
Rynacrom Compound and Rynacrom Allergy (sodium cromoglicate 2 per cent and xylometazoline hydrochloride 0.025 per cent) nasal sprays have been discontinued (Pantheon Healthcare). Rynacrom 4 per cent nasal spray (sodium cromogylcate) remains available.

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Supply issues

Ledermycin capsules
Ledermycin (demeclocycline) capsules 150mg x 28 are back in stock (Goldshield) and are available from local wholesalers or from UDG (tel 01773 510123, fax 01773 810644).

Baratol tablets
Baratol (indoramin) 25mg tablets are back in stock (Shire Pharmaceuticals). Further details from Shire customer services on 01256 894107).

Stelazine Spansules
Stelazine Spansules 2mg x 60 will be unavailable for six to nine months owing to a change in the manufacturing (Goldshield). Goldshield is making unlicensed packs of 2mg x 250 available on a named patient supply basis, net price £19.38. Pharmacists wishing to obtain this product for a patient should complete an unlicensed product order form from Mark Corrigan, Distriphar, 1 Progress Park, Bedford MK42 9XE (tel 0870 871 0002, fax 01234 248705).

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Products miscellany

Enlive Plus
Enlive Plus, a nutritional supplement drink has been launched by Abbott Laboratories. 100ml provides 150kcal energy, 4.80g protein and 32.7g carbohydrate. The product is Advisory Committee on Borderline Substances approved and comes in eight flavours. Net price, 27 x 220ml £44.82.

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