Oral Adjunct for seizures associated with Lennox-Gastaut syndrome
Adult: Patients ≥30 kg who are not receiving valproate: Initially, 400 mg daily in 2 equally divided doses, increased in increments of 400 mg daily every 2 days according to response. Max: 30-50 kg: 1,800 mg daily; >50-70 kg: 2,400 mg daily; >70 kg: 3,200 mg daily. Patients ≥30 kg who are also receiving valproate: Initially, 400 mg daily in 2 equally divided doses, increased in increments of 400 mg daily every 2 days according to response. Max: 30-50 kg: 1,200 mg daily; >50-70 kg: 1,600 mg daily; >70 kg: 2,200 mg daily. Dosage recommendations may vary among individual products and between countries (refer to detailed product guideline). Child: ≥1 to <4 years Patients who are not receiving valproate: Initially, 10 mg/kg daily in 2 equally divided doses (separated by approx 12 hours), increased in increments of up to 10 mg/kg daily every 3 days to the target dose of 45 mg/kg daily in 2 equally divided doses (separated by approx 12 hours) according to response. Max: 45 mg/kg daily; Patients who are also receiving valproate: Initially, 10 mg/kg daily in 2 equally divided doses (separated by approx 12 hours), increased in increments of up to 10 mg/kg daily every 3 days to the target dose of 30 mg/kg daily in 2 equally divided doses (separated by approx 12 hours) according to response. Max: 30 mg/kg daily; 4-17 years Patients <30 kg who are not receiving valproate: Initially, 200 mg daily in 2 equally divided doses, increased in increments of 200 mg daily every 3 days according to response. Max: 1,000 mg daily; Patients <30 kg who are also receiving valproate: Initially, 200 mg daily in 2 equally divided doses, increased in increments of 200 mg daily after a minimum of 2 days according to response. Max: 600 mg daily; Patients ≥30 kg who are not receiving or are also receiving valproate: Same as adult dose. Dosage recommendations may vary among individual products and between countries (refer to detailed product guideline). Elderly: Initiate at the lower end of the dosing range.
Patients undergoing haemodialysis: Dose adjustment may be necessary.
Mild to moderate: Cautious dose titration may be required. Severe: Not recommended.
FC tab; oral susp: Should be taken with food. FC Tab: May be swallowed whole/split/crushed.
Familial short QT syndrome.
Patients with history of abnormal ECG demonstrating QT interval shortening, family history of unexplained cardiac arrhythmia, risk factors for further shortening of QTc interval. Concomitant use with drugs that shorten QT interval. Avoid abrupt withdrawal. Hepatic impairment; patients undergoing haemodialysis. Children and elderly. Pregnancy and lactation.
Significant: Status epilepticus, shortened QT interval, leucopenia, suicidal ideation and behaviour, cognitive symptoms (e.g. somnolence, dizziness), coordination abnormalities (e.g. ataxia, gait disturbances). Blood and lymphatic system disorders: Anaemia. Ear and labyrinth disorders: Ear infection, vertigo. Eye disorders: Blurred vision, diplopia, nystagmus. Gastrointestinal disorders: Nausea, vomiting, upper abdominal pain, constipation, diarrhoea, dyspepsia. General disorders and administration site conditions: Fatigue. Injury, poisoning and procedural complications: Contusion, head injury. Investigations: Decreased weight. Metabolism and nutrition disorders: Decreased appetite, anorexia, eating disorder. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, tremor, convulsion, psychomotor hyperactivity, disturbance in attention. Psychiatric disorders: Insomnia, anxiety, aggression. Renal and urinary disorders: Pollakuria. Reproductive system and breast disorders: Oligomenorrhoea. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, influenza, sinusitis, rhinitis, bronchitis, pneumonia, epistaxis. Skin and subcutaneous tissue disorders: Rash, pruritus, acne. Potentially Fatal: Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS).
PO: Z (Insufficient data to conclude its safety and risk during pregnancy. Use only when benefits outweigh risks.)
Patient Counseling Information
This drug may cause dizziness, somnolence or blurred vision, if affected, do not drive or operate machinery. Women of childbearing potential must use proven birth control methods during therapy. Consider using other reliable contraceptive methods recommended by the doctor as hormonal contraceptives may be ineffective.
Obtain serum levels of the concomitant anti-seizure agents. Monitor for signs and symptoms of skin reactions (e.g. rash), suicidal ideation or behaviour, worsening depression, and/or unusual changes in mood or behaviour.
Significantly increased plasma concentrations with valproate. May decrease the effectiveness of hormonal contraceptives (e.g. ethinyl estradiol, norethisterone). May reduce the plasma concentrations of agents metabolised by CYP3A4 (e.g. triazolam), carbamazepine, and lamotrigine. May increase the risk of QT interval shortening when given with other drugs that shorten QT interval (e.g. digoxin, mexiletine, ranolazine, lamotrigine). May increase plasma concentrations of phenytoin and phenobarbital.
Increased absorption with food. Alcohol may enhance the CNS effects (e.g. dizziness) of rufinamide.
Description: Rufinamide is a triazole derivative anticonvulsant agent. The exact mechanism for its activity is unknown; however, it is suggested to modulate the activity of Na channels by prolonging their inactive state, thereby limiting the repetitive firing of Na-dependent action potentials that mediate anticonvulsant effects. Pharmacokinetics: Absorption: Slowly and extensively absorbed. Increased absorption with food. Time to peak plasma concentration: 4-6 hours. Distribution: Evenly distributed between erythrocytes and plasma. Volume of distribution: Approx 50 L. Plasma protein binding: 34%, mainly to albumin (27%). Metabolism: Extensively metabolised via carboxylesterase-mediated hydrolysis of the carboxylamide group to the inactive acid derivative, CGP 47292. Excretion: Via urine (85%; approx 66% as CGP 47292, 2% as unchanged drug). Elimination half-life: Approx 6-10 hours.
Tab: Store between 15-30°C. Protect from moisture. Oral susp: Store at 25°C.
N03AF03 - rufinamide ; Belongs to the class of carboximide derivatives antiepileptic. Used in the management of epilepsy.
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