The
Pharmaceutical Journal Vol 266 No 7132 p130January 27, 2001
The
Pharmaceutical Journal Vol 266 No 7132 p130
January 27, 2001
Composition: Tablets, linezolid 600mg; solution for infusion, linezolid
2mg/ml; oral suspension 20mg/ml.
Presentation: Film-coated, white tablets; solution for infusion; oral
suspension.
Storage and stability: Solution for infusion, keep infusion bags in foil
overwrap and carton until ready to use. After opening use immediately.
Action: Antibacterial agent.
Indications: Treatment of the following infections when known or suspected
to be caused by susceptible micro-organisms: nosocomial pneumonia, community
acquired pneumonia, skin and soft tissue infections. Combination therapy will
be necessary if a concomitant Gram negative pathogen is documented or suspected.
Contraindications: Hypersensitivity to active substance or excipients;
patients taking any drug which inhibits monoamine oxidases A or B or within
two weeks of taking any such drug; patients taking serotonin re-uptake inhibitors;
tricyclic antidepressants; directly or indirectly acting sympathomimetic agents
(including the adrenergic bronchodilators pseudoephedrine and phenylpropanolamine
hydrochloride); vasopressive agents; dopaminergic agents; pethidine or buspirone;
patients with uncontrolled hypertension, carcinoid, phaeochromocytoma, bipolar
depression, schizoaffective disorder, acute confusional states and thyrotoxicosis.
Dosage and administration: The solution for infusion, film-coated tablets
or oral suspension may be used as initial therapy. Patients who start treatment
with the parenteral formulation may be switched to either oral presentation
with no dosage adjustment required. The solution for infusion should be administered
intravenously over a period of 30 to 120 minutes.
Adults, nosocomial pneumonia and community acquired pneumonia, 600mg
intravenously or orally twice daily for 10-14 consecutive days. Skin and soft
tissue infections, 400mg to 600mg orally or 600mg intravenously, depending on
clinical severity, twice daily for 10-14 consecutive days. Duration of treatment
is dependent on the pathogen, site of infection and its severity and on the
patients clinical response.
Children and adolescents (<18 years), insufficient data on pharmacokinetics,
safety and efficacy.
Elderly, no dosage adjustment required.
Mild to moderate renal insufficiency (creatinine clearance 30ml/min),
no dosage adjustment required. Severe renal insufficiency (creatinine clearance
30ml/min), use with caution (see SPC). Dosage should not be reduced.
Mild to moderate hepatic insufficiency (Child-Pugh class A or B), no
dosage adjustment required. Severe hepatic insufficiency (Child-Pugh class C),
use with caution. No dosage adjustment recommended.
Overdosage: No cases reported (see SPC for further details).
Precautions: Patients should be advised against ingesting excessive amounts
of food and beverages with a high tyramine content (see SPC). Haemoglobin levels
or platelet counts should be monitored in patients who have pre-existing anaemia
or thrombocytopenia, who are receiving concomitant medications that may decrease
haemoglobin levels, platelet count or function and in patients with severe renal
insufficiency, or those who receive more than 10-14 days of therapy. Patients
should be warned about the potential for dizziness and advised not to drive
or operate machinery if affected (see SPC).
Drug interactions: In normotensive volunteers, linezolid enhanced the
increases in blood pressure caused by phenylpropanolamine hydrochloride or pseudoephrine.
Doses of drugs with a vasopressive action, including dopaminergic agents, should
be carefully titrated to achieve a desired response when co-administered with
linezolid.
Side effects: Common (1 per cent, <10 per cent) adverse events included
headache, candidiasis (particularly oral and vaginal candidiasis) or fungal
infection, diarrhoea, nausea, vomiting, abnormal liver function tests, taste
perversion (metallic taste). See SPC for uncommon adverse effects.
Net price: Solution for infusion (available in 100ml, 200ml and 300ml
infusion bags) and tablets, 10 x 600mg dose £445. The oral suspension is not
expected to be available until April.
Supplier
Pharmacia & Upjohn
Davy Avenue
Knowlhill
Milton Keynes MK5 8PH
Tel 01908 661101
fax 01908 690091
Legal class: POM.
| Correction Pharmacia has advised that Zyvox (linezolid) infusion will only be available in 300ml bags in the UK. |
Composition: Valproic acid (as valproate semisodium) 250mg and 500mg.
Presentation: Tablets.
Action: Most likely mode of action is potentiation of the inhibitory
action of gamma amino butyric acid.
Indications: Acute treatment of a manic episode associated with bipolar
disorder.
Contraindications: Hypersensitivity to active substance or excipients;
active liver disease; personal or family history of severe hepatic dysfunction,
especially drug related; porphyria.
Dosage and administration: The daily dosage should be established according
to age and body weight. The tablets should be swallowed whole with a drink of
water, not chewed.
Adults, recommended initial dose 750mg daily in two to three divided
doses. The dose should be increased as rapidly as possible to achieve the lowest
therapeutic dose which produces the desired effect.
Elderly, dosage should be determined on basis of response.
Children and adolescents (<18 years), safety and efficacy not established.
Renal insufficiency, may be necessary to decrease dosage according to
clinical monitoring.
Immune disorders, in patients with systemic lupus erythematosus potential
benefit should be weighed against potential risk.
Pregnancy, see SPC.
Lactation, as for sodium valproate.
Overdosage: See SPC for signs of acute massive overdose and hospital
management.
Precautions: Liver function should be assessed before therapy and periodically
during the first six months. Blood tests recommended prior to starting therapy
or before surgery. Valproate semisodium may give false positives in the urine
testing of possible diabetics.
Drug interactions: See SPC for effects of valproate semisodium (as for
sodium valproate) and for effects of other drugs on valproate semisodium.
Side effects: Adverse events have been described from experience of sodium
valproate in epilepsy (see SPC for details).
Net price: 250mg 90 £43.19, 500mg 90 £72.19.
Supplier
Customer services
Sanofi Synthelabo
PO Box 597
Guildford
Surrey
Tel 0800 854430
Legal class: POM.
Pharmacia & Upjohn has launched temazepam 10mg and 20mg tablets (net price, 10mg 28 97p, 20mg 28 £1.66).
Bioglan Generics is launching bisoprolol 5mg and 10mg tablets, in packs of 28, on January 29 (net price, 5mg £8.56 10mg £9.61).
Beacon Pharmaceuticals is launching daunorubicin in vials containing 21.4mg daunorubicin hydrochloride (equivalent to 20mg base), on January 29. The product should be ordered directly from Distriphar, Beacons distributor, (tel 0870 513347, fax 0870 513329) (net price, 10 vials £330).
Lipitor (atorvastatin) 80mg tablets have been launched by Pfizer (net price, 28 £47.04).
Shire Pharmaceuticals says that ongoing manufacturing problems are being experienced
with the production of Baratol (indoramin hydrochloride) tab-lets. No stock
of the product is available from the company or from wholesalers.
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