September 2019

New Products

  • Clindamycin (as phosphate)/tretinoin (Acnatac) combines clindamycin, a bacteriostatic semisynthetic derivative of lincomycin, and tretinoin, which has comedolytic, anti-comedogenic and anti-inflammatory effects. Acnatac is indicated for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. Acnatac is contraindicated in patients hypersensitive to lincomycin; with regional enteritis, ulcerative colitis, pustular and deep cystic nodular acne varieties (acne conglobate and acne fulminans); with a history of antibiotic-associated colitis, acute eczemas, rosacea and perioral dermatitis; or in women who are pregnant or planning a pregnancy. Acnatac gel contains clindamycin (as phosphate) 1% w/w and tretinoin 0.025% w/w, and is available in 30 g and 60 g tubes.
     
  • Fluticasone furoate (Arnuity Ellipta) is a synthetic trifluorinated corticosteroid with potent anti‑inflammatory activity. Arnuity Ellipta is indicated for the maintenance treatment of asthma in patients 5 years or older. It is contraindicated in patients with severe milk-protein allergy and in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Arnuity Ellipta inhaler contains 30 blisters of 100 mcg or 200 mcg fluticasone furoate and is available in a pack size of 1.
     
  • Naloxone (as hydrochloride dihydrate) (Nyxoid) is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and displaces both opioid agonists and partial antagonists. Nyxoid is indicated in adults and children, intended as part of the emergency treatment, for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in the home or other non‑medical setting, or a health facility setting. For this reason, Nyxoid should be carried by persons at risk of, or likely to witness such events. Nyxoid is not a substitute for emergency medical care. Nyxoid nasal spray contains 1.8 mg/actuation naloxone in a pack size of 2 single doses.

New Presentation

  • Paracetamol/ibuprofen (as sodium dihydrate) (Maxigesic IV) is now available as a 100 mL solution for infusion containing 1000 mg paracetamol and 300 mg ibuprofen (as sodium dihydrate).

New Indications

  • Budesonide/formoterol fumarate dihydrate (Symbicort) is now indicated in patients 12 years and older for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations according to different treatment approaches: anti-inflammatory reliever therapy in patients with mild disease (200/6 only), anti‑inflammatory reliever plus maintenance therapy (100/6 and 200/6 only), or maintenance therapy.
     
  • Icatibant (as acetate) (Firazyr) is now indicated for symptomatic treatment of acute attacks of hereditary angioedema in patients aged 2 years and older with C1-esterase-inhibitor deficiency.
     
  • Influenza virus vaccine, surface antigen, quadrivalent (inactivated) (Influvac Tetra) is now indicated for the prevention of influenza, caused by influenza virus types A and B, in patients aged 3 years and older.
     
  • Pembrolizumab (rch) (Keytruda) is now indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan) or non-colorectal tumours (that have progressed following prior treatment and when there are no satisfactory alternative treatment options). The safety and effectiveness of Keytruda in paediatric patients with MSI-H central nervous system cancers have not been established.
     
  • Pomalidomide (Pomalyst), in combination with bortezomib and dexamethasone, is now indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide; and, in combination with dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
     
  • Romiplostim (rbe) (Nplate) is now indicated for the treatment of thrombocytopenia in patients aged 1 year and older with chronic immune (idiopathic) thrombocytopenic purpura who are non‑splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins; who are splenectomised and have had an inadequate response to splenectomy.

New Contraindications

  • Adapalene/benzoyl peroxide (Epiduo and Epiduo Forte) is now contraindicated in women who are pregnant or planning a pregnancy.
     
  • Carbimazole (Neo-Mercazole) is now contraindicated in patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole.
     
  • Dabigatran etexilate (as dabigatran etexilate mesilate) (Pradaxa) is now contraindicated with concomitant glecaprevir/pibrentasvir.
     
  • Telmisartan/amlodipine (as besilate) (Twynsta) is now contraindicated in severe hypotension; obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis); and in haemodynamically unstable heart failure after acute myocardial infarction.

This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.

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