The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Adrenaline tartrate pre-filled pens (Jext®) have been accepted for the emergency treatment of severe acute allergic reactions. It is noted that this product has a longer shelf life compared to existing products.
Bromfenac eye drops (Yellox®) have been rejected for the treatment of postoperative ocular inflammation following cataract extraction in adults. The manufacturer failed to make a submission.
Fluorouracil and salicylic acid solution (Actikerall®) has been accepted for the topical treatment of grade I or II hyperkeratotic actinic keratosis in immunocompetent adult patients.
Olmesartan / amlodipine / hydrochlorothiazide tablets (Sevikar HCT®) has been accepted as a substitution therapy in adult patients whose blood pressure is adequately controlled on these three agents in different formulations.
Quetiapine modified release tablets (Seroquel XL®) have been rejected as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD). The manufacturer failed to make a submission.
Rosuvastatin tablets (Crestor®) have been rejected for the prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event. The manufacturer failed to present a sufficiently robust economic analysis to gain acceptance.
Vardenafil orodispersible tablets (Levitra®) have been accepted for restricted use in the treatment of erectile dysfunction (ED) in adult men in whom an orodispersible tablet is an appropriate formulation.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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