New medicines
Protelos
Composition: Strontium ranelate.
Presentation: Yellow granules for oral suspension.
Class: Bone disease treatment.
Indications: Treatment of postmenopausal osteoporosis to reduce the risk
of vertebral and hip fractures.
Dosage: Recommended dose is one 2g sachet once daily by oral administration.
Intended for long-term use. See SPC.
Major cautions: Hypersensitivity to the active substance or to any of
the excipients. Contains a source of phenylalanine, which may be harmful
for people with phenylketonuria. Use with caution in patients at increased
risk of venous thromboembolism, including patients with a past history
of VTE.
Contraindications: Not recommended in patients with a creatinine clearance
below 30ml/min. Periodic assessment of renal function is recommended
in patients with chronic renal impairment.
Side effects: common (>1/100): headache, nausea, diarrhoea, loose
stools, dermatitis, eczema.
Legal category: POM
Net price: 28 sachets £25.60
Contact details: Servier Laboratories, Gallions, Wexham Springs, Framewood
Road, Wrexham, Slough SL3 6RL. Tel 01753 662744.
Inspra
Composition: Eplerenone.
Presentation: Film-coated tablets.
Class: Aldosterone antagonist.
Indications: In addition to standard therapy including beta-blockers,
to reduce the risk of cardiovascular mortality and morbidity in stable
patients with left ventricular dysfunction and clinical evidence of heart
failure after recent myocardial infarction.
Dosage: Recommended dosage 50mg once daily. Treatment should be initiated
at 25mg once daily and titrated to 50mg once daily preferably within
four
weeks, taking into account serum potassium levels (see SPC).
Precautions: Serum potassium should be measured before initiation of
therapy, within the first week and at one month after the start of treatment
or dose adjustment. Potassium levels should be assessed periodically,
thereafter, depending on patient risk (eg elderly patients, patients
with renal insufficiency or diabetes). Eplerenone should not be administered
in patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption. Lithium,
ciclosporin and tacrolimus should be avoided during treatment with eplerenone.
Contraindications: Patients with serum potassium level >5.0mmol/L
at initiation, moderate to severe renal insufficiency, severe hepatic
insufficiency, receiving potassium-sparing diuretics, potassium supplements
or strong inhibitors of CYP3A4.
Side effects: Common (>1/100) hyperkalaemia, dizziness, hypotension,
diarrhoea, nausea, abnormal renal function.
Legal category: POM.
Net price: 25mg or 50mg, 28 £42.72.
Contact details: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey
KT20 7NS.
Tel 01304 616161.
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