What is Rufinamide, and how does it work?
Rufinamide tablets are a prescription medicine used with other medicines to treat seizures associated with Lennox- Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older. It is not known if rufinamide tablets are safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.
What are the side effects of Rufinamide?
Rufinamide tablets may cause serious side effects including:
- Rufinamide tablets can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
Call your healthcare provider right away if you have any of the following. Symptoms may include:
- swelling of your face, eyes, lips, or tongue
- trouble swallowing or breathing
- a skin rash
- fever, swollen glands, or sore throat that do not go away or come and go
- swollen glands
- yellowing of your skin or eyes
- dark urine
- unusual bruising or bleeding
- severe fatigue or weakness
- severe muscle pain
- your seizures happen more often or become worse
Call your healthcare provider right away if you have any of the symptoms listed above.
The most common side effects of rufinamide tablets include:
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of rufinamide tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Rufinamide?
Pediatric Patients (1 Year to Less Than 17 Years)
- The recommended starting daily dose of rufinamide in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses.
- The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3,200 mg, administered in two equally divided doses, is reached.
- It is not known whether doses lower than the target doses are effective.
Adults (17 Years and Older)
- The recommended starting daily dose of rufinamide in adults with Lennox-Gastaut Syndrome is 400 mg per day to 800 mg per day administered in two equally divided doses.
- The dose should be increased by 400 mg to 800 mg every other day until a maximum daily dose of 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than 3,200 mg are effective.
- Administer rufinamide with food. Rufinamide film-coated tablets can be administered whole, as half tablets or crushed.
Dosing In Patients Undergoing Hemodialysis
- Hemodialysis may reduce exposure to a limited (about 30%) extent. Accordingly, adjusting the rufinamide dose during the dialysis process should be considered.
Dosing In Patients With Hepatic Disease
- Use of rufinamide in patients with hepatic impairment has not been studied.
- Therefore, use in patients with severe hepatic impairment is not recommended. Caution should be exercised in treating patients with mild to moderate hepatic impairment.
Dosing In Patients Taking Valproate
- Patients taking valproate should begin rufinamide at a dose lower than 10 mg/kg per day in pediatric patients or 400 mg per day in adults.
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What drugs interact with Rufinamide?
Effects Of Rufinamide On Other AEDs
Population pharmacokinetic analysis of average concentration at steady state of carbamazepine, lamotrigine. phenobarbital, phenytoin, topiramate, and valproate showed that typical rufinamide Cmax levels had little effect on the pharmacokinetics of other AEDs. Any effects, when they occur, have been more marked in the pediatric population.
Table 6 summarizes the drug-drug interactions of rufinamide with other AEDs.
Table 6: Summary of drug-drug interactions of
rufinamide with other antiepileptic drugs
|AED Co- administered||Influence of Rufinamide on AED concentrationa||Influence of AED on Rufinamide concentration|
|Carbamazepine||Decrease by 7 to 13%b||Decrease by 19 to 26% Dependent on dose of carbamazepine|
|Lamotrigine||Decrease by 7 to 13%b||No Effect|
|Phenobarbital||Increase by 8 to 13% b||Decrease by 25 to 46%c,d Independent of dose or concentration of phenobarbital|
|Phenytoin||Increase by 7 to 21%b||Decrease by 25 to 46%c,d Independent of dose or concentration of phenytoin|
|Topiramate||No Effect||No Effect|
|Valproate||No Effect||Increase by < 16 to 70%cDependent on concentration of valproate|
|Primidone||Not Investigated||Decrease by 25 to 46%c,d Independent of dose or concentration of primidone|
|Benzodiazepinese||Not Investigated||No Effect|
|a Predictions are based on rufinamide
concentrations at the maximum recommended dose of rufinamide.
b Maximum changes predicted to be in pediatric patients and in adult patients who achieve significantly higher levels of rufinamide, as the effect of rufinamide on these AEDs is concentration-dependent.
c Larger effects in pediatric patients at high doses/concentrations of AEDs.
d Phenobarbital, primidone and phenytoin were treated as a single covariate (phenobarbital-type inducers) to examine the effect of these agents on rufinamide clearance.
e All compounds of the benzodiazepine class were pooled to examine for 'class effect' on rufinamide clearance.
Phenytoin: The decrease in clearance of phenytoin estimated at typical levels of rufinamide (Cavss 15µg/mL) is predicted to increase plasma levels of phenytoin by 7 to 21%. As phenytoin is known to have non-linear pharmacokinetics (clearance becomes saturated at higher doses), it is possible that exposure will be greater than the model prediction.
Effects Of Other AEDs On Rufinamide
- Potent cytochrome P450 enzyme inducers, such as carbamazepine, phenytoin, primidone, and phenobarbital, appear to increase the clearance of rufinamide (see Table 6).
- Given that the majority of clearance of rufinamide is via a non- CYP-dependent route, the observed decreases in blood levels seen with carbamazepine, phenytoin, phenobarbital, and primidone are unlikely to be entirely attributable to induction of a P450 enzyme.
- Other factors explaining this interaction are not understood. Any effects, where they occurred, were likely to be more marked in the pediatric population.
- Patients stabilized on rufinamide before being prescribed valproate should begin valproate therapy at a low dose, and titrate to a clinically effective dose.
- Similarly, patients on valproate should begin at a rufinamide dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults).
Effects Of Rufinamide On Hormonal Contraceptives
- Female patients of childbearing age should be warned that the concurrent use of rufinamide with hormonal contraceptives may renderthis method of contraception less effective.
- Additional non-hormonal forms of contraception are recommended when using rufinamide.
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Is Rufinamide safe to use while pregnant or breastfeeding?
- There are no adequate and well-controlled studies in pregnant women.
- Rufinamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Rufinamide produced developmental toxicity when administered orally to pregnant animals at clinically relevant doses.
- Rufinamide is likely to be excreted in human milk.
- Because of the potential for serious adverse reactions in nursing infants from rufinamide, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Rufinamide tablets are a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older. It is not known if rufinamide tablets are safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.
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Epilepsy is a brain disorder in which the person has seizures. There are two kinds of seizures, focal and generalized. There are many causes of epilepsy. Treatment of epilepsy (seizures) depends upon the cause and type of seizures experienced.
Seizures Symptoms and Types
Seizures are divided into two categories: generalized and partial. Generalized seizures are produced by electrical impulses from throughout the brain, while partial seizures are produced by electrical impulses in a small part of the brain. Seizure symptoms include unconsciousness, convulsions, and muscle rigidity.
Seizure vs. Seizure Disorders (Differences and Similarities)
The differences between a seizure, epilepsy, and seizure disorders are confusing to many people. What makes it more confusing, is that they are not the same thing. A seizure begins suddenly, and is a symptom of another disease. When a seizure occurs there is uncontrolled activity in the brain that usually only lasts for a short period. While a seizure disorder is a medical condition, in which the person has episodes of uncontrolled activity in the brain producing symptoms that include one or more seizures. Epilepsy is considered a seizure disorder.There are two types of major seizures, generalized and partial seizure type and the symptoms depend upon the part of the brain affected, and may include: Loss of consciousness Thought disturbances Convulsions Eye rolling Stiff limbs Twitching on only one side or a portion of the body like an arm or leg. Involuntary urination or bowel movement Repetitive shaking or jerking of the body Staring into space, sometimes with eye blinking No loss of consciousness, but the person becomes confused for a few minutes A third type of seizure is called unclassified seizure.Seizure disorders are classified under two types of major seizures (generalized and partial), and a third type called unclassified seizures. There are about 40 types of named seizure disorders. The symptoms and signs are different depending on the part of the brain affected by the seizure. Examples of seizure disorders are: Febrile seizures Benign Rolandic epilepsy Catamenial epilepsy Absence seizures Frontal lobe epilepsy Epilepsy Sometimes there is a known cause for a seizure like alcohol, cocaine or other illegal drug abuse, drug reactions, a severe chemical imbalance in the blood, or medical problems like low blood pressure. Treatment, management, and prevention of seizures include medication and avoiding any known causes or common triggers. REFERENCES: CDC. "Types of Seizures." Updated: Apr 10, 2017.Harvard Health Publications; Harvard Medical School. "Generalized Seizures (Grand Mal Seizures)."
Migraines and Seizures (Symptoms, Auras, Medication)
Migraines are a type of headache and seizures are the main symptom of epilepsy. Migraine headaches and seizures are two different neurological problems that have similar signs, symptoms, and auras, for example, sensitivity to light (photophobia) and sound, irritability, nausea, and vomiting. Symptoms unique to migraine and migraine auras are water retention, problems sleeping, appetite changes, and talkativeness. Symptoms unique to seizure and seizures auras are depression, a feeling of heaviness, a feeling that a seizure is approaching, and depression. Many of the symptoms of migraine and seizures are the same, however, seizures do not cause migraines; however, people who have seizures are twice as likely to have migraines and vice-versa. People who have migraines are twice as likely to have seizures, and people with seizures are twice as likely to have migraines; however, one condition does not cause the other.
Epilepsy and Seizures: How to Treat?
A seizure is a sudden, uncontrolled electrical disturbance in the brain. Epilepsy is a neurological disorder where brain activities are abnormal, causing more than one or recurrent episodes of seizures. Most cases of seizures can be managed conservatively with medication and supportive treatments.
What Are the Different Types of Seizures?
A seizure is a sudden change in the brain's normal electrical activity. During a seizure, brain cells fire uncontrollably than their normal rate, temporarily affecting the way a person behaves, moves, thinks, or feels. Recurrent seizures are called epilepsy. Seizures are usually categorized into three types depending on their onset.
Can the Vagus Nerve Cause Seizures?
The vagus nerve is an important pathway to the brain in addition to helping to control seizures. Stimulation of the vagus nerve leads to the discharge of electrical energy into a wide area of the brain, disturbing the abnormal brain activity that causes seizures. The vagus nerve is used to treat seizures that do not respond to medications.
What Causes Myoclonic Seizures in Babies?
Epileptic syndromes that cause myoclonic seizures usually begin in early childhood, and last throughout life, though milder forms may improve with adulthood. Doose syndrome (myoclonic-atonic epilepsy), Dravet syndrome (severe myoclonic epilepsy of infancy [SMEI]) and Lennox-Gastaut syndrome are all childhood epilepsy syndromes that may cause seizures in babies and toddlers.
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