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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7354 p757
18 June 2005

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Products

    New medicines Prescription Products SPC changes Discontinued products Supply issues

New medicines

Zonegran Zonegran
Composition: Zonisamide.
Presentation: Hard capsules.
Class: Anti-epileptic agent.
Indications: Adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.
Dosage: The recommended initial daily dose is 50mg in two divided doses. After one week the dose may be increased to 100mg daily and thereafter the dose may be increased at one weekly intervals, in increments of up to 100mg. Zonegran can be administered once or twice daily after the titration phase. Caution should be exercised at initiation of treatment in elderly patients. Zonegran’s safety and effectiveness in children and adolescents under 18 years have not been established.
Precautions: Caution must be exercised in treating patients with renal impairment. Use in patients with severe hepatic impairment is not recommended. Caution must be exercised in treating patients with mild to moderate hepatic impairment.
Side effects: Very common (>1/10) anorexia, agitation, irritability, confusional state, depression, ataxia, dizziness, memory impairment, somnolence, diplopia. Common (>1/100) hypersensitivity, disturbance in attention, speech disorder, abnormal gastrointestinal pain, diarrhoea, nausea, rash, pyrexia, weight decrease.
Legal category: POM.
Net price: 25mg 14 £8.82, 50mg 56 £47.04, 100mg 56 £62.72.
Contact details: Eisai, 3 Shortlands, London W6 8EE. Telephone 020 8600 1400.

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Prescription Products

Chirocaine bags
Chirocaine (levobupivacaine hydrochloride) bags are now available from Abbott; net price, 0.625mg/ml 100ml £7.80, 0.625mg/ml 200ml £10.40, 1.25mg/ml 100ml £8.54, 1.25mg/ml 200ml £12.20. Legal category: POM.

Co-amoxiclav
Co-amoxiclav tablets and powder for oral suspension are now available from Almus Pharmaceuticals; net price, tablets 250/125 x 21 £5.77, powder for oral suspension 125/31.25 100ml £5.12, 250/62.5 100ml £6.99. Legal categories: POM.

Ciprofloxacin
Ciprofloxacin tablets 250mg are now available from Almus Pharmaceuticals; net price, 10 £1.85. Legal category: POM.

Enbrel
Enbrel (etanercept) injection 50mg is now available from Wyeth; net price, 4 x 50mg vials £715. Legal category: POM.

Lamotrigine
Lamotrigine tablets are now available from:

· IVAX Pharmaceuticals; net price, 56 tablets, 25mg £20.41, 50mg £34.70, 100mg £59.86, 200mg £101.76. Legal category: POM.

· PLIVA Pharma; net price, 56 tablets, 25mg £20.31, 50mg £34.60, 100mg £59.76, 200mg £101.66; dispersible tablets, 28 x 5mg £8.04, 56 x 25mg £20.31, 56 x 100mg £59.76. Legal category: POM.

Omeprazole
Omeprazole capsules are now available from PLIVA Pharma. Net price, 28 x 10mg £13.91, 7 x 40mg £14.28. Legal category: POM.

Penbritin
Penbritin (ampicillin) capsules 500mg are now available from Chemidex Pharma. Net price, 28 £5.28. Legal category: POM.

Reminyl XL
Reminyl XL (galantamine hydrobromide) prolonged-release capsules are now available from Shire. Net price, 28 capsules 8mg £54.60, 16mg £68.32, 24mg £84.00. Legal category: POM.

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SPC changes

Alphagan
The summary of product characteristics for Alphagan (brimonidine; Allergan) has been updated. Aphagan is now indicated as an adjunctive therapy to other intraocular pressure lowering medicines when the target intraocular pressure is not achieved with a single agent. See SPC.

CellCept
The summary of product characteristics for CellCept (mycophenolate mofetil; Roche) has been updated. CellCept is now contraindicated in women who are breastfeeding. See SPC.

Hydrea
The summary of product characteristics for Hydrea (hydroxycarbamide; Bristol-Myers Squibb) now includes a statement that Hydrea is not licensed for use in combination with antiretroviral agents for HIV and it may cause treatment failure and toxicities (in some cases fatal) in HIV patients. See SPC.

Lipitor
The summary of product characteristics for Lipitor (atorvastatin; Pfizer) has been updated. Lipitor is now indicated in children aged 10 to 17 years. The SPC states that doses above 20mg/day have not been investigated in patients aged under 18 years. See SPC.

Roaccutane
The summary of product characteristics for Roaccutane (isotretinoin; Roche) has been updated. Roaccutane is now contraindicated in women of childbearing age unless all conditions of the pregnancy prevention programme described in the SPC are met. Warnings about peanut and soya allergies have been added and the pack size has changed from 60 to 30. See SPC.

Taxotere
The summary of product characteristics for Taxotere (docetaxel; sanofi-aventis) has been updated to include two additional indications. Taxotere is now indicated in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node-positive breast cancer. The dose for this indication is 75mg/m2 administered one hour after doxorubicin 50mg/m2 and cyclophosphamide 500mg/m2 every three weeks for six cycles. Taxotere is also now indicated in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. The dose for this indication is 100mg/m2. A section on cardiac toxicity has also been added to the SPC. See SPC.

Xeloda
The summary of product characteristics for Xeloda (capecitabine; Roche) has been updated. Xeloda is now indicated for the adjuvant treatment of patients following surgery of stage III (Duke’s stage C) colon cancer. An interaction with radiotherapy has also been added. The SPC states that, when given in combination with radiotherapy, the maximum tolerated dose of Xeloda is decreased to 2,000mg/m2/day.

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Discontinued products

Cystemme
Cystemme sachets (sodium citrate/sodium bicarbonate; Abbott) are being discontinued from September.

Livostin nasal spray
Livostin (levocabastine hydrochloride; Novartis) nasal spray is being discontinued from 1 July.

Tofranil 25mg tablets
Tofranil (imipramine; Novartis) 25mg tablets are being discontinued from 1 July.

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Supply issues

Methotrexate, thiotepa and calcium leucovorin
Further information about the manufacturing status of methotrexate, thiotepa and calcium leucovorin can be obtained from Wyeth on 01628 604377 or Goldshield on 020 8410 2134 or 020 8410 2161.

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