May 2020

New Products

• Cinnarizine/dimenhydrinate (Cizinate) contains dimenhydrinate, the chlorotheophylline salt of diphenhydramine, which is a potent inhibitor of histamine H₁ receptors and muscarinic acetylcholine receptors; and cinnarizine, a potent inhibitor of histamine H₁ and H₄ receptors and dopamine D₂ receptors and a less potent inhibitor of pressure sensitive potassium channels and serotonin 2 receptors. Cinnarizine primarily acts peripherally on the labyrinth, and dimenhydrinate acts predominately centrally on the vestibular nuclei and related vegetative centres in the brainstem. Cizinate is indicated for the short-term, symptomatic treatment of vertigo of various causes in adults who have not responded to alternative treatments. Cizinate is contraindicated in patients with hypersensitivity to diphenhydramine or other antihistamines of similar structure, severe renal (ClCr ≤ 25 mL/min) or hepatic impairment, angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, alcohol abuse and urine retention due to urethroprostatic disorders. Cizinate tablets contain cinnarizine 20 mg and dimenhydrinate 40 mg, and are available in pack size of 100.
   
• Cross-linked hyaluronic acid with ancillary triamcinolone hexacetonide (Cingal) contains hyaluronic acid, a major component of the extracellular matrix, found in high concentrations in the synovial fluid in joints, and is responsible for the viscoelastic properties of synovial fluid; and triamcinolone hexacetonide, an anti-inflammatory that provides short-term pain relief when used as an intra-articular injection in osteoarthritic joints. Cingal is indicated as a viscoelastic supplement or a replacement for synovial fluid in the knee. It is well suited for rapid and long-term relief of the symptoms of knee joint dysfunctions, such as osteoarthritis. The following conditions may constitute relative or absolute contraindications to the use of Cingal: pre-existing skin infections of the intended injection site, known infection of the index joint, systemic bleeding disorders, active tuberculosis, herpes simplex keratitis, acute psychoses, systemic mycoses and parasitoses. Cingal suspension for intra-articular injection contains cross-linked hyaluronic acid 22 mg/mL and triamcinolone hexacetonide 4.5 mg/mL, and is available in a pack size of 1 prefilled syringe delivering 4 mL.
   
• Stiripentol (Diacomit) has been shown, in vitro, to directly enhance GABA_A receptor-mediated transmission by acting both post-synaptically at a neuronal site coupled to the GABA_A receptor, and pre-synaptically to increase GABA release from nerve terminals. It also potentiates the efficacy of clobazam and other anticonvulsants. Diacomit is indicated for the adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate. Diacomit is contraindicated in patients with a history of psychoses in the form of episodes of delirium. Diacomit capsules and powder for oral suspension contain stiripentol 250 mg or 500 mg, and are available in packs of 60 capsules or sachets.

New Indications

• Ceftolozane sulfate/tazobactam sodium (Zerbaxa) is now indicated for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, in adults.
   
• Insulin aspart (rys) (Fiasp) is now indicated for diabetes mellitus in adolescents and children aged 1 year and above.
   
• Insulin degludec (rys)/insulin aspart (rys) (Ryzodeg 70/30) is now indicated for use in diabetes mellitus in patients aged 6 years and older.
   
• Ixekizumab (Taltz) is now indicated for the treatment of active ankylosing spondylitis in adults.
   
• Nintedanib (esilate) (Ofev) is now indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
   
• Ranibizumab (rbe) (Lucentis) is now indicated for the treatment of proliferative diabetic retinopathy in adults.
   
• Tocilizumab (rch) (Actemra) subcutaneous formulation is now indicated for the treatment of active systemic juvenile idiopathic arthritis in patients aged 1 year and older.
   

New Contraindications

• Alfentanil (hydrochloride) (Rapifen) is now contraindicated for use in patients with acute or severe respiratory disease and respiratory depression, and in chronic (long-term) non-cancer pain (CNCP).
   
• Fentanyl (Sublimaze) is now contraindicated for use in CNCP.
   
• Zolpidem tartrate (Stilnox, Stilnox CR) is now contraindicated in patients who have previously experienced complex sleep behaviours after taking zolpidem tartrate.
   

Safety Related Updates

• Hydromorphone hydrochloride (Jurnista) and methadone hydrochloride (Physeptone) are now indicated for the management of severe pain where: other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and the pain is opioid-responsive, and requires daily, continuous, long-term treatment. They are not indicated for use in chronic non-cancer pain other than in exceptional circumstances, or as an as-needed analgesic. They are not recommended for use in ambulant patients. They are now contraindicated in patients with acute or severe respiratory disease.

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.