The
Pharmaceutical Journal Vol 266 No 7131 p94January 20, 2001
The
Pharmaceutical Journal Vol 266 No 7131 p94
January 20, 2001
Composition: Fentanyl (as citrate) 200µg, 400µg, 600µg,
800µg, 1,200µg and 1,600µg per unit dose.
Presentation: Lozenge with integral oromucosal applicator.
Storage and stability: Do not store above 25C.
Action: Opioid antagonist.
Indications: Management of breakthrough pain in patients already receiving
maintenance opioid therapy for chronic pain.
Contraindications: Known intolerance or hypersensitivity to active substance
or excipients.
Dosage and administration: For oral transmucosal administration (see
SPC). The lozenge should be sucked and not chewed. Water may be used to moisten
the buccal mucosa in patients with a dry mouth. The lozenge should be consumed
over a period of 15 minutes and the dose should be individually titrated to
provide adequate analgesia and minimum side effects (ie, a “successful” dose).
See SPC for instructions for use, handling and disposal.
Adults, initial dose should be 200µg titrated upwards as necessary.
During titration, if adequate analgesia is not obtained within 15 minutes after
complete consumption of a single lozenge, a second lozenge of the same strength
may be consumed. No more than two lozenges should be used to treat any individual
pain episode. Once a successful dose has been established, patients should be
maintained on this dose and should limit consumption to a maximum of four lozenges
per day. See SPC for dose re-adjustment and discontinuation.
Elderly, it was observed during clinical trials that patients over 65
years of age required lower doses for successful relief of breakthrough pain.
Renal or kidney dysfunction, special care should be taken during the
titration process.
Children and adolescents (aged two to 17 years inclusive), dosage and
safety have not been established.
Pregnancy, safety has not been established and the lozenge should only
be used if the potential benefit justifies the potential risk to the foetus.
Lactation, women should not breast-feed while taking the lozenges.
Overdosage: As for intravenous fentanyl and other opioids.
Precautions: As for other opioids.
Drug interactions: As for other opioids. Potent inhibitors of cytochrome
P450 3A4 isoform (eg, erythromycin, ketoconazole and certain protease inhibitors)
may produce increased or prolonged opioid effects. Hypo- ventilation, hypotension
and profound sedation may occur. Similar effects could be seen after concurrent
ingestion of grapefruit juice (see SPC).
Side effects: As for other opioids. Opioid side effects will cease or
decrease in intensity with continued use as the patient is titrated to the required
dose.
Net price: For all doses 3 £19.44, 30 £194.40.
Supplier: Elan Pharma, Elan House, Avenue One, Letchworth, Hertfordshire
SG6 2HU. Tel 01462 707200, fax 01462 707250. Legal class: CD (Sch2), POM.
| Correction Fentanyl is an opioid agonist, not an opioid antagonist. |
Glaxosmithkline has launched Trizivir tablets. Each tablet contains a combination of abacavir 300mg, lamivudine 150mg and zidovudine 300mg (net price, 60 £581.08). The product is licensed for use in HIV-infected adults (18 years and over) and one tablet should be taken twice daily. The company recommends that for the first six to eight weeks of treatment, the individual components of the product should be given separately. In patients diagnosed with hypersensitivity reactions to abacavir, treatment must be discontinued immediately and never restarted (see p74).
Smithkline Beecham has launched ACWY Vax, a meningococcal polysaccharide vaccine for active immunisation agianst meningococcal meningitis A, C, W135 and Y. The vaccine is recommended for subjects at risk, such as those living in or travelling to areas or countries where the disease is epidemic or highly endemic. The vaccine, which can be used in adults and children over two years (children aged two months to two years may be vaccinated in some cases), is also recommended in epidemic situations and for close contacts of patients with the disease. It is available in a vial containing 0.5ml freeze-dried vaccine with an ampoule of diluent for reconstitution (net price, 1 £17.14).
Schering-Healthcare has introduced Levonelle (levonorgestrel 750µg) tablets (pharmacy status). The product is available in packs of two tablets (net price, £11.06; retail price, £19.99). Levonelle is not recommended for use by young women under 16 years of age without medical supervision.
Aurum Pharmaceuticals has launched Atropine sulphate 600µg injection, 1ml pre-filled syringes (net price 1 £4.24).
Generics (UK) has launched the following products: sulpiride 400mg tablets (net price, 28 £5.24 100 £18.73); erythromycin 250mg tablets (net price, 28 £3.08); flecainide tablets, pack size 60 (net price, 50mg £15.55, 100mg £22.21).
Cusi Ophthalmic Generics has added levobunolol 0.5 per cent eye-drops to its product range (net price, 5ml £4.66).
Saliva Orthana oral spray 50ml, 450ml and refill and Saliva Orthana lozenges have been transferred from Nycomed Amersham to A S Pharma, PO BOX 5227, Milton Keynes MK1 1XW (tel 01908 371025, fax 01908 378315). The name of the product has also been changed to AS Saliva Orthana.
From March 31, Janssen-Cilag will be discontinuing Droleptan 10mg tablets,
Droleptan oral liquid 1mg/ml and Droleptan injection 5mg/ml (droperidol),
following an extensive risk-benefit assessment (see p73)
Knoll has discontinued Akineton 5mg injection (biperiden lactate), pack
size 5 x 1ml Pharmacia is discontinuing the following products when stocks are
exhausted: Mono-Cedocard 40mg tablets (isosorbide mononitrate), pack
size 60 and Depo-Provera Oncology injection (medroxyprogesterone acetate
150mg/ml), 3.3ml vial. The company says that Farlutal (medroxyprogesterone acetate
200mg/ml) injection, 2.5ml vial, remains available as an alternative to Depo-Provera
Oncology.
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