Paul Reading Maurice Curtis, Andrew Naylor, Richard Faull ... - ACNR

Today, unnecessary seizures restrict 69,000 lives 1The chance to control seizures, not livesABBREVIATED PRESCRIBING INFORMATIONZonegran® (zonisamide)Please refer to the SmPC before prescribing.Presentation: Hard capsules containing 25 mg, 50 mg or 100 mgzonisamide. Indication: Adjunctive therapy in the treatment of adultpatients with partial seizures, with or without secondary generalisation.Dose and administration: Adult: Zonegran must be added to existingtherapy. Initial daily dose is 50 mg in two divided doses. After one week,increase to 100 mg daily and then at one weekly intervals, in 100 mgincrement. Consider two weekly intervals in renal or hepatic impairmentand patients not receiving CYP3A4-inducing agents. Zonegran can beadministered once or twice daily after the titration phase. Withdrawgradually. Elderly and patients with renal or hepatic impairment:Caution (see SmPC). Not recommended in severe hepatic impairment.Children and adolescents under 18 years: Not recommended.Contra-Indications: Hypersensitivity to zonisamide, sulphonamideor any excipient. Pregnancy: Zonegran must not be used duringpregnancy unless benefit justifies the risk, in the opinion of thephysician. Specialist advice should be given to women who are likelyto become pregnant in order to consider the optimal treatment duringpregnancy. Women of childbearing potential must use contraceptionduring treatment and for one month after discontinuation. Lactation:Zonisamide is excreted into breast milk. A decision must be made toeither discontinue Zonegran or stop breast-feeding. Breast-feedingshould not be resumed until one month after stopping Zonegran.Warnings and Precautions: Serious rashes occur in associationwith Zonegran therapy, including cases of Stevens Johnson syndrome.Zonegran contains a sulphonamide group. Serious immune basedadverse reactions are associated with the sulphonamide group, e.g. rash,allergic reaction, major haematological disturbances including aplasticanaemia. Closely supervise and consider discontinuation in patientswith unexplained rash. Cases of agranulocytosis, thrombocytopenia,leukopenia, aplastic anaemia, pancytopenia and leucocytosis havebeen reported. Kidney stones have occurred. Use with caution inpatients with risk factors for nephrolithiasis, including prior stoneformation, a family history of nephrolithiasis and hypercalcuria. Usewith caution in patients treated with carbonic anhydrase inhibitors,e.g. topiramate. Decreased sweating, elevated body temperature andheat stroke have been reported. Patients should maintain hydrationand avoid excessive temperatures. Monitor pancreatic lipase andamylase levels and consider discontinuation in patients with signs andsymptoms of pancreatitis. In cases of severe muscle pain/weakness withor without fever, assess markers of muscle damage, e.g. serum creatinephosphokinase and aldolase levels, and consider discontinuation.Zonegran 100 mg hard capsules contain E110, which may cause allergicreactions. Caution in patients less than 40 kg. In patients with weight lossconsider dietary supplement, increased food intake or discontinuation.Drug Interactions: No clinically relevant pharmacokinetic effectson carbamazepine, lamotrigine, phenytoin, sodium valproate, oralcontraceptives (ethinylestradiol or norethisterone). Insufficient datawith carbonic anhydrase inhibitors, e.g. topiramate. Zonegran wasnot affected by lamotrigine or CYP3A4 inhibitors. Caution with drugsinducing urolithiasis, CYP3A4, N-acetyltransferase, glucuronic acid,or drugs which are P-gp substrates. Side effects: The most commonadverse reactions in controlled adjunctive therapy studies weresomnolence, dizziness and anorexia. Adverse reactions associatedwith Zonegran in clinical studies and post marketing surveillance: Verycommon effects (>1/10): anorexia, agitation, irritability, confusionalstate, depression, ataxia, dizziness, memory impairment, somnolence,diplopia. Common effects (>1/100, 1/1000,