Print ACNR MJ05 v4 - Advances in Clinical Neuroscience and ...

NOW LICENSED AS A NEW SPECIALIST OPTION IN MIGRAINE PROPHYLAXISHelp keepmigrainesand patientsapartTopamax 100 mg/day reducedmigraine frequency by:• ≥ 50% in 46%of patients 1• ≥ 75% in over 25%of patients 1Every migraine-free day is a good dayTOPAMAX® Abbreviated Prescribing Information. Please read Summary of Product Characteristics beforeprescribing. Presentation: Tablets: 25, 50, 100, 200 mg topiramate. Sprinkle Capsules: 15, 25, 50 mgtopiramate. Uses: Epilepsy: Monotherapy: Newly diagnosed epilepsy (age ≥ 6 years): generalised tonicclonic/partialseizures, with/without secondarily generalised seizures. Adjunctive therapy of seizures: partial,Lennox Gastaut Syndrome and primary generalised tonic-clonic. Conversion from adjunctive to monotherapy:efficacy/safety not demonstrated. Migraine prophylaxis when 3 or more attacks/month; attacks significantlyinterfere with daily routine. Six monthly review. Use in acute treatment not studied. Initiation: specialist care.Treatment: specialist supervision/shared care. Dosage and Administration: Oral. Do not break tablets.Low dose initially; titrate to effect. Renal disease may require dose modification. Epilepsy: Monotherapy: Over16 years: Initial target dose: 100 mg/day (two divided doses; maximum 400 mg/day). Children 6 to 16: Initialtarget dose: 3-6 mg/kg/day (two divided doses). Initiate at 0.5-1 mg/kg nightly with weekly or fortnightlyincrements of 0.5–1 mg/kg/day. Doses less than 25 mg/day: Use Topamax Sprinkle Capsules. Adjunctive therapy:Over 16 years: Usually 200-400 mg/day (two divided doses; maximum 800 mg/day). Initiate at 25 mg daily withweekly increments of 25 mg. Children 2 to 16: Approx. 5-9 mg/kg/day (two divided doses). Initiate at 25 mgnightly with weekly increments of 1-3 mg/kg. Migraine: Over 16 years: Usually 100 mg/day (in two divideddoses). Initiate at 25 mg nightly with weekly increments of 25 mg. Longer intervals can be used between doseadjustments. Children under 16 years: Not studied. Sprinkle Capsules: take whole or sprinkle on small amount(teaspoon) of soft food and swallow immediately. Contra-indications: Hypersensitivity to any component.Precautions and Warnings: Withdraw gradually. Renal impairment delays achievement of steady-state. Cautionwith hepatic impairment. May cause sedation; so caution if driving or operating machinery. Depression/moodalterations have been reported. Monitor for signs of depression; refer for treatment, if appropriate. Suicidalthoughts: Patients/caregivers to seek immediate medical advice. Acute myopia with secondary angle-closureglaucoma reported rarely; symptoms typically occur within 1 month of use and require discontinuation ofTopamax and treatment. Increased risk of renal stones. Adequate hydration is very important. Bicarbonate levelmay be decreased so monitor patients with conditions/drugs that predispose to metabolic acidosis and reducedose/discontinue Topamax if acidosis persists. Galactose intolerant, Lapp lactase deficiency, glucose-galactosemalabsorption: do not take. Migraine: Reduce dose gradually over at least 2 weeks before discontinuation tominimise rebound headaches. Significant weight loss may occur during long-term treatment. Regularly weighand monitor for continuing weight loss. Food supplement may be required. Interactions: Possible with phenytoin,carbamazepine, digoxin, hydrochlorothiazide, pioglitazone, oral contraceptives, haloperidol and metformin.Caution with alcohol/CNS depressants. Pregnancy: If benefits outweigh risks. Discuss possible effects/risks withpatient. Contraception recommended for women of childbearing potential (oral contraceptives should containat least 50 µg oestrogen). Lactation: Avoid. Side Effects: Abdominal pain, ataxia, anorexia, anxiety, CNS sideeffects, diarrhoea, diplopia, dry mouth, dyspepsia, headache, hypoaesthesia, fatigue, mood problems, nausea,nystagmus, paraesthesia, weight decrease, agitation, personality disorder, insomnia, increased saliva,hyperkinesia, depression, apathy, leucopenia, psychotic symptoms (such as hallucinations), venousthrombo-embolic events, nephrolithiasis, increases in liver enzymes. Isolated reports of hepatitis and hepaticfailure when on multiple medications. Acute myopia with secondary acute-angle closure glaucoma, reducedsweating (mainly in children), metabolic acidosis reported rarely. Suicidal ideation or attempts reporteduncommonly. Bullous skin and mucosal reactions reported very rarely. Pharmaceutical Precautions: Tabletsand Sprinkle Capsules: Do not store above 25°C. Keep container tightly closed. Legal Category: POM PackageQuantities and Prices: Bottles of 60 tablets. 25 mg (PL0242/0301) = £20.92, 50 mg (PL0242/0302) = £34.36;100 mg (PL0242/0303) = £61.56; 200 mg (PL0242/0304) = £119.54. Containers of 60 capsules. 15 mg(PL0242/0348) = £16.04, 25 mg (PL0242/0349) = £24.05, 50 mg (PL0242/0350) = £39.52 Product licenceholder: JANSSEN-CILAG LIMITED, SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP14 4HJ. UK.Date of text revision: August 2005. APIVER150805.Reference: 1. Bussone G, Diener H-C, Pfeil J et al. Topiramate 100mg/day in migraine prevention: a pooledanalysis of double blind randomized controlled trials. Int J Clin Pract 2005; 59(8): 961-968.00005127