Sunoxitol 300 Sun Pharma medicine for local epilepsy (5 blisters x 10 tablets)
Dosage form Box of 5 blisters x 10 tablets
Specifications Oxcarbazepine
Ingredient
| Composition information | Content |
| Oxcarbazepine | 300mg |
Uses
Indications
Sunoxitol is a product of Sun Pharmaceutical Industries Ltd indications for treatment in the following cases:
It resists discharge stimuli in large epilepsy, reduces the concentration of chemicals that stimulate seizures, and destroy or reduce the frequency of seizures when studying on species when Rhesus. There is no progress in tolerance (i.e. impaired anti -convulsions) when monitoring in the experiment with maximum electric shock in the mouse treated with daily dose for 5 days and 4 weeks with oxcarbazepine or MDH.
pharmacokinetics
After drinking, oxcarbazepine is absorbed almost completely and strongly metabolized into a substance that has a 10-Monohydroxy-made effect (MHD). The sale time of oxcarbazepine is about 2 hours and of MHD is about 9 hours, so MHD is the main substance in the effect of anti -epilepsy treatment.
The drug is widely distributed in the body and about 40% linked to protein in plasma. The concentration of the drug is reduced rapidly after oral oral due to metabolic into a substance that has a treatment for 10.11-dihydro-10- hydroxy-carbamazepin. Both substances have anti -epileptic effects similar to carbamazepin.
Oxcarbazepine is excreted in the urinary tract in the form of metabolites, less than 1% is excreted in a constant form. Oxcarbazepine's Thai version is about 2 hours, while MHD is about 9 hours.
In patients with renal impairment, the semi -waste time of MHD metabolites lasts up to 19 hours, when creatinine clearance drops below 30ml/minute. Therefore, adjusting the dose is necessary.
Research on pharmacokinetics in children, adults and the elderly show no difference related to gender.
Before taking Sunoxitol 300 Sun Pharma medicine for local epilepsy (5 blisters x 10 tablets)
How to use
Tablets for oral tablets.
Dosage
Oxcarbazepine is a derivative of carbamazepin that has the same effect as carbamazepine. The drug is used according to the unemployment sketch (mere treatment) or the multi -treatment regimen (combined treatment) in the treatment of local epilepsy without or accompanied by the whole secondary epilepsy with whole stiff twitching.
Initial doses in the monotherapy regimen and multiple treatment in adults are 600 mg/day, oral divided into twice. After that, the dose may increase, if needed for every week, the maximum increase is 600mg/day, until the clinical response is obtained.
Maintenance dose is usually between 600 and 1200 mg/day or up to 2400 mg/day if used according to the multi -treatment regimen or in patients with persistent diseases, which must be changed from other anti -epileptic drugs.
The initial dose is recommended for children ≥ 6 years old (according to the monotherapy regimen or multiple treatment is from 8 to 10 mg/kg by oral, divided into twice. This dose may increase if needed, every week increases a maximum of 10mg/kg/day, to the maximum dose of 46 mg/kg/day; ≥ 4 years old.
Should reduce the initial dose in patients with kidney damage.
No need to adjust the dose in patients with mild and medium liver failure, the drug has not been studied in patients Hepatic failure severe.
As for other anti -epileptic drugs, the stopping of oxcarbazepine or conversion from another anti -epileptic treatment regimen must be done slowly to avoid the case of increasing the frequency of epilepsy.
As for other anti -epileptic drugs, the stopping of oxcarbazepine or conversion from another anti -epileptic treatment regimen must be done slowly to avoid the case of increasing the frequency of epilepsy.
Used in patients with kidney damage: The initial dose of oxcarbazepine for patients with creatinine clearance
Bipolar disorder : Similar to carbamazepin, oxcarbazepine has the properties of treatment of erratic joys and sorrows, and has been tested in the control of patients with bipolar disorders.
Epilepsy: Oxcarbazepine is used to treat epilepsy and may be a useful alternative for patients with carbamazepine intolerance.
In a test that is dual in patients who are newly diagnosed with disease, oxcarbazepine has the effect and similar tolerance of Valproat for local or whole epilepsy (whole convulsions).
Oxcarbazepine is similar to Phenytoin, but better tolerance in adults and new children diagnosed with local or whole epilepsy. Random verification tests also confirm the effect and intolerance of oxcarbazepine in the multi -treatment regimen or monotherapy in patients with persistent local epilepsy in children and adults.
Oxcarbazepine is recommended as supportive treatment or simple treatment in patients with local epilepsy in children from 4-16 years old. All doses should follow the dosage regimen 2 times/day.
Oxcarbazepin may be used or not with food.
Adults
Single regimen
For patients who are not treated with anti -epileptic drugs: Start treatment with Sunoxitol at a dose of 300 mg twice a day and increase with indicators of 300 mg/day after the third day or every week, an additional 600 mg/day up to 1200 mg/day, divided into two times. Precautions for the lowest -dose patient to be effective.
Multi -treatment regimen
Start Sunoxitol treatment at 300 mg twice a day. After a week, an increase of 600 mg/day is up to 1200 mg divided 2 times/day.
Switch to a single regimen
When switching from other anti -epileptic drugs to Sunoxitol, start at a dose of 300 mg twice a day while starting to reduce the dose of other anti -epileptic drugs. Sunoxitol should be standard doses every week increasing 600 mg/day for 2 to 4 weeks to reach the recommended dose of 2400 mg/day. Completely stop using other anti -epileptic drugs that are taking after 3 to 6 weeks according to patient tolerance.
Pediatrics
Multi -treatment regimen
Do not use for children
4-16 years old: Should start a multi-treatment regimen with daily dose 8-10mg/kg, generally not exceeding 600mg/day, divided into two times.
Dosage to maintain the target (after 2 weeks), according to the weight of the patient as follows:
Treatment and monitoring:
There is no specific antidote. Treatment of symptoms and support must be applied appropriately. Eliminate drugs by lifting and/or inactivation by activated carbon.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The most unwanted reactions include dizziness, double look, loss, vomiting, nausea, drowsiness, headache, fatigue, abnormal vision, tremor, abnormal gait, rash.
The most common side effects are observation including dizziness, double view, loss, vomiting, nausea, drowsiness, headache, fatigue, abnormal vision, tremor, abnormal gait, rash.
The use of oxcarbazepine is related to side effects on the central nervous system.
These symptoms can be classified into the following 3 general groups:
In this study, 65% of patients had to stop treating because they could not tolerate oxcarbazepin at 2400 mg/day when used before using AED. The wild side effects in this study are mainly related to the central nervous system and the risk of drug -related drug stops.
In this study, 7.1% of patients were treated with oxcarbazepine and 4% of placebo patients with cognitive side effects. The risk of stopping the drug due to this side effect is 6.5 times more than the oxcarbazepine group compared to the placebo patient.
In addition, 26% of patients are treated with oxcarbazepine and 12% of patients use placebo with symptoms of sleep. The risk of stopping the drug due to sleep is about 10 times in a group of patients using oxcarbazepine compared to the placebo group. Finally, 28.7% of patients are treated with oxcarbazepine and 6.4% of patients use placebo with cashew and disorders on the body. The risk of stopping the drug of this side effect is about 7 times more than the group using oxcarbazepine compared to the placebo patient.
In a study using a monotherapy regimen, verified with a placebo to evaluate oxcarbazepine 2400mg/day, no patient in both groups stopped taking the drug because of the side effects on awareness, sleep, loss or disorders on the body.
Over 2 validated studies in the study using an Oxcarbazepine comparative regimen 2400 mg/day and 300 mg/day, 1.1% of patients in the group 2400 mg/day must stop treating because of their sleep symptoms or cognitive side effects compared to 0% on the group using 300 mg/day.
In this study, no patient stopped taking the drug because of the symptoms of ventricular or rewarded gait in both treated groups.
Notify the doctor with unwanted effects when using.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Sunoxitol contraindicated in the following cases:
Oxcarbazepine is contraindicated for patients who are known to have hypersensitivity to oxcarbazepine or any ingredients of the drug.
Be cautious when using
Clinically significant sodium lowering can appear while using oxcarbazepine. In a verified study with a placebo on epilepsy over 14 people, 2.5% of patients were treated with oxcarbazepine with sodium/blood
Hypotenemic hyponatremia usually occurs in the first 3 months of oxcarbazepine treatment, although patients with symptoms of sodium lower in serum
Most patients with symptomic sodium hypoclines but patients in clinical studies are monitored and some patients have to reduce their dose, stop drugs or limit drinking water due to hypoglycry blood. It is unknown whether these measures are prevented so as not to appear more severe symptoms.
Symptoms of hypoglycemia have been reported during the use of oxcarbazepine after bringing the drug to the market. In clinical studies, patients have to stop treating with oxcarbazepine due to hypoglycemia, which often recovers bloody sodium to reward within a few days without any further treatment.
Consider measuring serum sodium concentrations for patients during treatment with oxcarbazepine, especially if patients are taking other drugs, which are known to reduce serum sodium levels (for example, non -suitable ADH drugs) or if symptoms may show that blood hypocopy occurs (such as nausea, muscle pain, fell pain, or sleep).
Should be cautious about using drugs in patients who drink alcohol because they can increase sedative effects.
Patients with reproductive age should be warned that the simultaneous use of oxcarbazepine with endocrine contraceptives can reduce the effect of birth control pills. It is recommended to supplement other contraceptives when using oxcarbazepine.
Use drugs for women during pregnancy and lactation
There is no complete and well -controlled study of oxcarbazepine in pregnant women. Oxcarbazepine is closely related to structure with carbamazepine, which is considered to be a monster in humans. In animal research, Oxcarbazepine has been shown to have a negative impact on the development of embryos, including the monster effect. Therefore, Oxcarbazepine should be used during pregnancy only if the benefits beyond the potential risk for the fetus.
Oxcarbazepine and its metabolites (MHD) are excreted through breast milk. The ratio in milk and plasma is 0.5 reported. The decision to use the drug during breastfeeding should be carefully considered for the ability to adversely affect babies.
The effect of the drug on driving and operating machinery
Using oxcarbazepine is related to a number of side effects such as dizziness and drowsiness. Therefore, patients should be advised to be careful in the process of driving and operating machines for health and mental abilities that can be reduced when taking the drug.
Drug interaction
oxcarbazepine can inhibit CYP2C9 and CYP3A4/5 touch with significant effect on plasma concentrations of other drugs.
In addition, some anti -epileptic drugs are cytochrom P450 induction substances that can reduce the plasma concentration of oxcarbazepine. Oxcarbazepine is assessed in human liver cell microsoms to determine the ability to inhibit cytochrom P450 enzymes, which plays the role of other drugs.
The results have shown that oxcarbazepine and its active metabolites are 10-monohydroxy (MHD) with little or no function as inhibitors for most cytochrom P450 enzymes on humans.
In vitro, UDP-glucoronyl transferase concentration is increased, this shows this enzyme induction.
Because MHD is the main substrate in plasma is only UDP-Glucoronyl Transfarase induction in a week, it cannot affect the drugs that are excreted mainly by combining with UDP-Glucoronyl Transferase. In addition, oxcarbazepine causes a small group of Cytochrom P450 3A (CYP3A4 and CYP3A5) that plays a role in the metabolism of calcium dihydropyridine and oral contraceptives, causing reduction in plasma concentrations of these drugs.
Because MHD is linked to low plasma proteins (40%), the clinical interactions of these drugs through competition at positions associated with protein are impossible.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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