The Pharmaceutical Journal
Vol 273 No 7317 p377
18 September 2004

This article
Reprint   Photocopy

PDF 50K, Acrobat Reader

Products

New medicines
• Yentreve
Prescription Products
• Co-cyprindiol
• Lisinopril tablets
• Metformin tablets
• Pravastatin tablets
• Simvastatin tablets
SPC changes
• Influvac
• Femara
Discontinued products
• Cidomycin intrathecal
Supply issues
• Diloxanide and Nivemycin
• Diltiazem MR and levobunolol
Counter products
• Creon Micro

New medicines

Yentreve
Composition: Duloxetine hydrochloride.
Presentation: Hard gastro-resistant capsules.
Class: Combined serotonin and noradrenaline reuptake inhibitor.
Indications: Treatment of moderate to severe stress urinary incontinence in women.
Dosage: 40mg twice daily. May be reduced to 20mg twice daily if a woman experiences troublesome adverse events beyond four weeks of treatment, although limited data support the efficacy of this dose. Combining duloxetine with a pelvic floor muscle training programme may be more effective.
Precautions: Caution should be exercised in patients with a history of mania or a diagnosis of bipolar disorder or seizures, in patients with increased intra-ocular pressure or those at risk of acute narrow-angle glaucoma, in patients taking antidepressants or anticoagulants and in patients with bleeding tendencies. Patients should report any distressing feeling to their doctor since isolated cases of suicidal ideation have been reported during therapy. The benefit of treatment should be reassessed at regular intervals. It is recommended that the dose be tapered for two weeks before discontinuation of therapy. See SPC.
Contraindications: Liver disease resulting in hepatic impairment, pregnancy and lactation. Duloxetine should not be used in combination with non-selective, irreversible monoamine oxidase inhibitors or CYP1A2 inhibitors (eg fluvoxamine, ciprofloxacin or enoxacine).
Side effects: Very common (Ž 10 per cent): insomnia, nausea, dry mouth, constipation, fatigue. See SPC.
Legal category: POM
Net price: 20mg or 40mg 56 £30.80.
Contact details: Yentreve will be jointly marketed by Eli Lilly (Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, tel 01256 315999) and Boehringer Ingelheim.

Back to Top

Prescription Products

Co-cyprindiol
Co-cyprindiol (cyproterone acetate and ethinylestradiol) tablets 2000/35 are now available from PLIVA Pharma; net price, 3 x 21 £10.55.

Lisinopril tablets
Lisinopril tablets are now available from APS/Numark; net price, 2.5mg 28 £0.76, 5mg 28 £0.93, 10mg 28 £1.16, 20mg 28 £1.59. Numark members can order these products on 01827 841200.

Metformin tablets
Metformin tablets 500mg are now available from APS/Numark; net price, 28 £0.28.

Pravastatin tablets
Pravastatin sodium tablets are now available from PLIVA Phama; net price, 10mg 28 £16.12, 20mg 28 £29.57, 40mg 28 £29.57.

Simvastatin tablets
Simvastatin tablets are now available from PLIVA Pharma; net price, 10mg 28 £18.03, 20mg 28 £29.69, 40mg 28 £29.69.

Back to Top

SPC changes

Influvac
The summary of product characteristics for Influvac Sub-unit (influenza vaccine, surface antigen, inactivated) injection has been updated to include the surface antigens for the strains for the 2004/2005 season (Solvay). The new strains are A/Fujian/411/2002(H₃N₂)-like and B/Shanghai/361/2002-like strain. The A/New Caledonia/20/99(H₁N₁)-like strain antigens remain in the vaccine. The SPC now states that limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. Use of the vaccine may be considered from the second trimester of pregnancy. For pregnant women with increased risk of complications from flu, administration is recommended irrespective of their stage of pregnancy. See SPC.

Femara
Femara (letrozole) is now additionally indicated for the treatment of early invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy (Novartis). The SPC now states that following standard adjuvant tamoxifen therapy, treatment with Femara should continue for three years or until tumour relapse occurs, whichever comes first. Optimal duration of therapy has not yet been established. Women with osteoporosis or at risk of it should have their bone mineral density formally assessed at regular intervals. Treatment or prophylaxis for osteoporosis should be initiated and monitored as appropriate. The undesirable effects section has been updated and data from the clinical trial supporting this new indication is now included. See SPC.

Back to Top

Discontinued products

Cidomycin intrathecal
Cidomycin (gentamicin) intrathecal solution for injection 5mg/ml has been discontinued (Aventis). All orders have been cancelled. Further details from customer services on 0870 5133347.

Back to Top

Supply issues

Diloxanide and Nivemycin
Diloxanide furoate tablets 500mg x 30 and Nivemycin (neomycin) tablets 500mg x 100 are out of stock (Sovereign Medical). New supplies are not expected until February 2005. Details from medical information on 01268 535233.

Diltiazem MR and levobunolol
Diltiazem modified-release tablets 60mg x 84 and levobunolol eye drops 0.5 per cent are now back in stock (IVAX).

Back to Top

Counter products

Creon Micro
Creon Micro (pancreatin 60.36mg) gastro-resistant granules are now available from Solvay Healthcare; net price, 20g £35. Legal category: P.

Back to Top