Formulary Group Decisions September 2008
Approved for use in NHS Grampian
Reclassification of advice
Cefixime tablets
Cephalosporins and other beta-lactams BNF 5.1.2
The formulary classification of cefixime 200mg tablets, for the treatment of gonorrhoea [400 mg as a single dose; off-label], was changed from 'recommended for hospital use only' to treatment may be initiated in the community on the recommendation of a GUM clinic consultant/specialist.
Melatonin 2 mg m/r tablets (Circadin®)
Hypnotics BNF 4.1.1
Following the
MHRA drug procurement advice, the licensed melatonin 2 mg m/r tablets (Circadin®)
have been approved for inclusion in the GJF for off-label use in paediatrics as per the current formulary recommendations. It is recognised, however, that there may be individual patients for whom the m/r product cannot meet their clinical needs. In particular, there may be some need for alternative dosage forms, or strengths, or for an immediate release product. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Hypnotics BNF 4.1.1
Following the
MHRA drug procurement advice, the licensed melatonin 2 mg m/r tablets (Circadin®)
have been approved for inclusion in the GJF for off-label use in paediatrics as per the current formulary recommendations. It is recognised, however, that there may be individual patients for whom the m/r product cannot meet their clinical needs. In particular, there may be some need for alternative dosage forms, or strengths, or for an immediate release product. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Rituximab concentrate for intravenous infusion (MabThera®)
Rituximab and alemtuzumab BNF 8.2.3
Rituximab concentrate for intravenous infusion (MabThera®) was approved for inclusion in the GJF for the treatment of previously untreated patients with stage III to IV follicular lymphoma in combination with chemotherapy. It is restricted to use only by haematologists or oncologists who have expertise in treating lymphoma and should be administered in a healthcare environment where full resuscitation facilities are available [
SMC 493/08]. Available for restricted use under specialist supervision, licensed for hospital use only.Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Clostridium botulinum neurotoxin type A (Xeomin®)
Drugs used in essential tremor, chorea, tics, and related disorders BNF 4.9.3
Clostridium botulinum neurotoxin type A (Xeomin®)
for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults. For both indications, a similar improvement in symptoms has been shown compared to another clostridium botulinum neurotoxin type A [
SMC 464/08].
for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults. For both indications, a similar improvement in symptoms has been shown compared to another clostridium botulinum neurotoxin type A [
SMC 464/08].Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Dabigatran etexilate capsules (Pradaxa®)
Oral anticoagulants BNF 2.8.2
Dabigatran etexilate capsules (Pradaxa®)
for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery [
SMC 466/08].
for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery [
SMC 466/08].Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Dexrazoxane intravenous infusion (Savene®)
Cytotoxic drugs BNF 8.1
Dexrazoxane intravenous infusion (Savene®) is not recommended for use within NHS Scotland for the treatment of anthracycline extravasation [
SMC 361/07].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Cytotoxic drugs BNF 8.1
Dexrazoxane intravenous infusion (Savene®)
is not recommended for use within NHS Scotland for the treatment of anthracycline extravasation [
SMC 361/07].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Maraviroc tablets (Celsentri®)
HIV infection BNF 5.3.1
Maraviroc tablets (Celsentri®)
is not recommended for use within NHS Scotland in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable [
SMC 458/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Pegylated liposomal doxorubicin concentrate for intravenous infusion (Caelyx®)
Anthracyclines and other cytotoxic antibiotics BNF 8.1.2
Pegylated liposomal doxorubicin concentrate for intravenous infusion (Caelyx®)
is not recommended for use within NHS Scotland in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant [
SMC 503/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Cinacalcet tablets (Mimpara®)
Hypercalcaemia and hypercalciuria BNF 9.5.1.2
Cinacalcet tablets (Mimpara®) is not recommended for use within NHSScotland for the reduction of hypercalcaemia in patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland [SMC 513/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Hypercalcaemia and hypercalciuria BNF 9.5.1.2
Cinacalcet tablets (Mimpara®) is not recommended for use within NHSScotland for the reduction of hypercalcaemia in patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland [
SMC 513/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Duloxetine 30mg capsules (Cymbalta®)
Other antidepressant drugs BNF 4.3.4
Advice in the absence of a submission from the holder of the marketing authorisation.
Other antidepressant drugs BNF 4.3.4
Advice in the absence of a submission from the holder of the marketing authorisation.
Duloxetine 30mg capsules(Cymbalta®) is not recommended for use within NHSScotland for the treatment of generalised anxiety disorder. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland [
SMC 514/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
SMC 514/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Vildagliptin tablets
Other antidiabetic drugs BNF 6.1.2.3
Vildagliptin tablets (Galvus®) and vildagliptin/metformin hydrochloride tablets (Eucreas®) as per [
SMC 435/07] and [
SMC 477/08] were not recommended for inclusion in the GJF.
Not recommended for use in NHS Grampian - will not be included in the Grampian Joint Formulary for these indications.
Other antidiabetic drugs BNF 6.1.2.3
Vildagliptin tablets (Galvus®)
and vildagliptin/metformin hydrochloride tablets (Eucreas®) as per [
SMC 435/07] and [
SMC 477/08] were not recommended for inclusion in the GJF.
Not recommended for use in NHS Grampian - will not be included in the Grampian Joint Formulary for these indications.
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