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Return to PJ Online Home Page The Pharmaceutical Journal Vol 266 No 7139 p370
March 17, 2001

Products

    Prescription Products Discontinued medicines Counter medicines Miscellany Recall

Prescription Products

Uftoral capsules

Composition: Combination of tegafur 100mg and uracil 224mg per capsule.

Presentation: Capsules.

Storage and stability: Do not store above 25C.

Action: Cytotoxic antimetabolite.


Indications:
First-line treatment of metastatic colorectal cancer in combination with calcium folinate.

Contraindications: Hypersensitivity to 5-fluorouracil, tegafur, uracil or excipients; pregnant or attempting to become pregnant; breast feeding; adolescents, children or infants; severe hepatic impairment; evidence of bone marrow suppression from previous radiotherapy or antineoplastic agents; deficiency of hepatic CYP2A6.

Dosage and administration: A dose of 300mg/m2/day of tegafur and 672mg/m2/day should be taken at the same time as calcium folinate 90mg/day, in three divided doses (preferably every eight hours). Doses should be taken at least one hour before before or one hour after meals for 28 days. Subsequent cycles should be started after seven days without Uftoral and calcium folinate. See SPC for number of capsules per body surface area, daily dosing schedule and dose modification guidelines for managing toxicity.

Adolescents, children and infants, should not be used. Safety and efficacy has not been established.

Elderly, use with caution.

Renal impairment, use with caution. Monitor for emergent toxicities.

Hepatic impairment, use with caution.

Overdosage: Manifestations of overdose might include nausea, vomiting, diarrhoea, gastrointestinal ulceration, bleeding and bone marrow suppression. No specific antidote is available, but supportive care should be provided.

Precautions: Use with care in patients who are known or suspected to have a dihydropyrimidine dehydrogenase deficiency. Use with caution in patients with signs and symptoms of bowel obstruction.

Drug interactions: Uftoral should not be administered with any product that acts by inhibiting dihydropyrimidine dehydrogenase, because of the potential for increased toxicity. Marked elevations in prothrombin time (PT) or international normalised ratio (INR) have been reported in patients stabilised on warfarin therapy.

Side effects: Very common (>=10 per cent) undesirable effects include diarrhoea, nausea, stomatitis, anorexia, vomiting, abdominal pain and asthenia. Common (>=1 per cent, <10 per cent) undesirable effects include constipation, flatulence, dyspepsia, mucositis, dry mouth, eructation, anorexia, intestinal obstruction, fever, headache, malaise, chills, pain, moniliasis, dehydration, cachexia, taste perversion, taste loss, somnolence, dizziness, insomnia, depression, paresthesia, confusion, lacrimation and conjunctivitis, peripheral oedema, deep thrombo-phlebitis, dyspnoea, increased coughing, pharyngitis, alopecia, rash, exfoliative dermatitis, skin discoloration, pruritus, photosensitivity, sweating, dry skin, nail disorder, myalgia, back pain and arthralgia. See SPC for uncommon undesirable effects and for hepatobiliary and haematological laboratory abnormalities.

Net price: 21 £119.91, 28 £159.88, 35 £199.88, 42 £239.82.

Supplier: Bristol-Myers Squibb Pharmaceuticals, Bristol-Myers Squibb House, 141-149 Staines Road, Hounslow, Middlesex TW3 3JA. Tel 020 8754 3740, fax 020 8754 3677.

Legal class: POM.

Femoston 1/10 tablets

The licensed indications for Solvay Healthcare's Femoston 1/10 (estradiol 1mg, dydrogesterone 10mg) tablets have been extended. This strength of Femoston, along side Femoston 2/10 and Femoston 2/20, is now additionally licensed for the prevention of osteoporosis in women at risk of developing fractures.

Tritace capsules

Aventis Pharma is launching Tritace (ramipril) 2.5mg capsules, pack size 7 (net price, £1.88).

Generics (UK) products

Generics (UK) has launched co-codamol 8/500mg tablets (net price, 100 £1.65) and trazodone capsules (net price, 50mg 84 £17.31, 100mg 56 £20.38).

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Discontinued medicines

Achromycin ointment

Wyeth Laboratories has discontinued Achromycin ointment 3 per cent (tetracyline hydrochloride), pack size 30g.

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Counter medicines

Rhinolast Allergy


The name of ASTA Medica's Rhinolast Hayfever (azelastine hydrochloride) nasal spray has been changed to Rhinolast Allergy.

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Miscellany

Drisorb sterile wound pad

Vernon Carus's Drisorb sterile wound pads, size 10cm x 20cm, will be included in the Drug Tariff from April 1 (net price, 25 £4.25).

St John's Wort liquid

Kira has added a liquid tincture formulation to its St John's Wort range. The company says that 20 drops of the new product provides the same dosage as one tablet of Kira Original. The recommended dosage is 20 drops two to three times daily (retail price, 50ml £7.99). For more information, contact the UK distributor, Food Brokers (tel 02392 222500).

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Recall

Valium ampoules recalled

Roche Porducts is recalling the following batches of Valium Roche (diazepam) 10mg/2ml ampoules:

Valium Roche (diazepam) Batch numbers Expiry date
10mg/2ml ampoules B1013 and B1014 October, 2003
  B1021 April, 2004
  B1026 August, 2004

This is because during stability testing the company has detected visible particles in samples of over three year old.

Recipients are requested to quarantine stock of these batches and return it to their supplier for credit or replacement. Further information can be obtained from Roche customer services (tel 0800 7315711).

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