Topamax 50 Janssen medicine treats local epilepsy, prevention of migraine (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Topiramate
Ingredient
| Composition information | Content |
| Topiramate | 50mg |
Uses
Indications
Topamax drug are indicated in the following cases:
This impact is not inhibited by flumazenil, a antagonist with benzodiazepin, and Topiramat does not increase the time to open the channel. The difference between Topiramat and the Barbiturates is to adjust the GABA receptor.
Because the anti -epileptic properties of Topiramat are completely different from the properties of benzodiazepin, Topiramat can adjust one under the group (substype) of the GABA receptor, less sensitive to benzodiazepine. Topiramat loses the ability of Kainat to activate Kaina/Ampa (Alpha-Amino-3-Tydroxy-5-Methyl-Isoxazole-4-Propionic Acid), which is one under the irritation of the amino acid receptor (Glutamat), but does not have a clear effect on the activity of N-Methyl-Dpartat (NMDA) in the group (SUBDA) in the group (Subp) in the group (SUBP) NMDA. The effects of Topiramat depends on the concentration, within the concentration range from 1 mem to 200 mem, with the at least observation activity is at the concentration of 1 mem to 10 mem.
In addition, Topiramat inhibits a few isenzymes of carbon dioxide. This pharmacological effect of Topiramat is much weaker than the effect of acetazolamid, which is a known carbon dioxide inhibitor, and is not thought to be a major mechanism of Topiramat's anti -epileptic activity. In animal research, Topiramat has anti -convulsions in rats and rats in tests with maximum electrical shock (MES) and is effective in grams to suffer from epilepsy, including spasms and epilepsy like the absence of spontaneous epilepsy (Ser) and seizures of seizures in rats by the irritation of the almondic region or the almonds. Topiramat only has weak effects in inhibiting seizures of seizures due to the impact of the antagonist of the GABA receptor, pentylenetetrazol.
Research on mice simultaneously use Topiramat and Carbamazepin or Phenobarbital shows that anti -convulsions are bronze. In control clinical trials, using Topiramat as a combination drug, there is no correlation between the bottom concentration of Topiramat in plasma with the clinical effect of this drug. There is no evidence of human tolerance.
Clinical trials: The results of controlled clinical studies have determined the effectiveness of Topamax tablets and capsules containing small Topamax seeds in monomers for adults and children (from 6 years old) to be epilepsy, coordinated therapy in adults and children from 2 to 16 years old suffering from local stomach or convulsions - convulsions with patients from 2 years old with patients from 2 years old with patients from 2 years old with patients from 2 years old with convulsions with 2 -year -olds and patients with 2 years old and consecutive. Lennox-Gastaut.
Unit of treatment
Efficiency of Topiramat in monomers in adults and children aged 6 and older, newly diagnosed with epilepsy, has been identified by four groups of parallel, double, random group studies. Researching EPMN-106 performed over 487 patients (aged 6 to 83) to be diagnosed with epilepsy (local starting, or all) or diagnosed with recurrent epilepsy while not taking anti-epileptic drugs.
Patients randomly divided use Topiramat 50 mg/day or Topiramat 400 mg/day. Patients are still in the double blind stage, until there is a local output or convulsions of the whole whole, until the end of the 6 -month blind period, after the last division of the patient, or until it is withdrawn from the study, it is prescribed by the research outline.
Evaluation is mainly based on the comparison between Topiramat's dose groups in time until the first battle or convulsions of the whole whole body while still in the double period. By comparing the Kaplan-Meier survival curve of time before the first attack, Topiramat is 400 mg/day, more beneficial than Topiramat 50 mg/day (P = 0.0002, Log Rank Test).
The separation between groups in a favorable direction for a higher dose group is premature, even in the period of adjusting the dose, and has statistical significance in two weeks after the random subgroup (P = 0.046), when by complying with the dose adjustment schedule each week, the larger dose patient reaches the maximum of Topiramat dose of the maximum of 100 mg/day. Considering the percentage of patients all based on Kaplan-Meier estimates show that the higher dosage group will be more advantageous than the lower dosage group, with a minimum of 6 months (82.9% compared to 71.4%, P = 0.005), and with a minimum of 1 year (75.7% compared to 58.8%, P = 0.001).
The ratio of risk frequency over time until the first attack is 0.516 (95%trust range, 0.364 to 0.733). When considering the time until the first attack, the effectiveness of treatment is consistent, although considering the type of division by age, gender, geographical area, weight, basic seizures, time from the time of diagnosis, and the use of anti -epileptic drugs.
In Yi study, is a central monochromatic study, patients aged 15 to 63 suffered from local resistance attacks (n = 48), transferred from drugs being used to single -dose topamax therapy 100 mg/day or 1000 mg/day. The high -dose group has a clearer advantage over a low -dose group, when considering the effective variables. 54% of patients with high doses achieved the effectiveness of the treatment, when compared to 17% in the low -dose group, with the difference between the dose is statistically significant (P = 0.005). The average escape time in the group talls is significantly higher (P = 0.002). The overall assessment of clinical response shows that higher dose is more statistically significant (
In the study of EPMN -104, adult patients and children (aged 6-85) were diagnosed with epilepsy (n = 252), randomly arranged in a low -dose group (25 or 50 mg/day) or high -dose group (200 or 500 mg/day), based on body weight. In summary, 54% of patients with high doses and 39% of low doses were reported as all seizures during the double blind research period (P = 0.022). High -dose groups have more advantages than low -dose groups, when considering the distribution of epilepsy frequency (P = 0.008), and considering the time difference in the coming time when there is the first attack, through 3 levels of plasma topiramate (P = 0.015).
In the study of EPMN-L05, patients aged 6 to 84 were diagnosed with epilepsy (n = 613), randomly divided by 100 or 200 mg/day Topamax, or standard epilepsy treatment (Carbamazepine or Valproat). Topamax proved to be effective at least with carbamazepin or valproat in reducing the attack in these patients; 95% confidence range for the difference between the two treatment groups is narrow and includes the Zero point, proving that there is no difference with the significance of statistical between the two groups. The two treatment groups are equivalent to clinical benefits and final effects, including time, the percentage of patients out of attack, and the first time.
Coordination therapy
Control studies in patients with local start -up seizures.
Adults suffered from local bounds: Topiramat's effectiveness when using coordinated therapy on adults suffered from local bouts has been identified in six multicolored studies, random, double blindness and placebo control, including two comparison of Topiramat doses with fake, and four studies comparing files with pharmacologicals, used in terms of local or non -localized or non -bi -bodied patients with non -biococials, with non -localized or non -biococcosis secondary form.
Patients in these studies are allowed to use up to the maximum of two anti -epileptic drugs, combining Topamax or placebo tablets. In each study, in the initial period that lasted 4 to 12 weeks, the patient was stabilized at the optimal dose of anti -epileptic drugs. Patients in the initial period had a minimum number of local bonds before (12 episodes in the first 12 weeks, 8 attacks in the first 8 weeks, 3 attacks in the first 4 weeks), with or not accompanied by a secondary comprehensive attack, which will be randomly arranged in the placebo or used the prescribed dose of Topamax in combination with anti -epileptic drugs that are currently in use.
After the random stage, the patient begins to the stage of double blind research. Of those 5 of these 6 studies, patients who are started to treat drugs at the dose of 100 mg/day, then the dose increases gradually, every week or every 2 weeks increases by 100 or 200 mg/day, until the dose is achieved, unless the drug is not tolerated, it can not increase the dose anymore. In the 6th study, Topiramat dose started 25 or 50 mg/day, and then the week increased by 25 or 50 mg/day until reaching the destination dose of 200 mg/day. After adjusting the dose, the patient was put into a stable stage of 4, 8 or 12 weeks.
In Table 1 and Table 2, there is a number of patients who are randomly divided by each dose, median doses and average (Mean) in the period of dose stability.
Pediatric patients aged 2-16 suffered from local outputs
The effectiveness of Topiramat in combination treatment in 2-16 -year -old pediatric patients suffered from local bouts was identified in a multi -centered study, random, double blind and controlled with placebo, including comparison of Topiramat and placebo in patients with a history of local barriers, with or not accompanied by secondary bonds. Patients in this study are used up to two anti -epileptic drugs, combining Topamax or placebo tablets.
In this study, patients were stabilized at the optimal dose of anti -epileptic drugs used for 8 weeks of the first phase. Any patient in the early stages has at least 6 local outputs, accompanied by or not accompanied by a secondary comprehensive attack, they are coordinated in a random coordination of Topamax or placebo tablets along with anti -epileptic drugs in use.
After randomly divided, patients began to be treated in the double blind stage. The patient taken at 25 or 50 mg/day, then increased the dose gradually, every 2 weeks from 25 to 150 mg/day, until reaching the destination dose 125, 175, 225 or 400 mg/day, based on the patient's weight, so that the dose of about 6 mg/kg/day, unless the condition is not tolerated, it cannot increase the dose. After adjusting the dose, the patients were put into a stable stage of 8 weeks.
The test with control in patients with spasms - convulsions of the whole primary. The effectiveness of Topiramat in coordinated therapy for all-of-primary spasms, in patients 2 years and older, has been identified in a multi-center study, random, double blind, and placebo, comparison of single dose of Topiramat and placebo. Patients in this study are used up to two anti -epileptic drugs, combining Topamax or placebo tablets.
Patients are stabilized at the optimal dose of anti -epileptic drugs used for 8 weeks of the first phase. Patients in the early stages have at least 3 spasms - jersey of whole primary, they are randomly included for using more Topamax or placebo tablets. After randomly divided, patients began to be treated in the double period.
Patients take the beginning of 50 mg/day for 4 weeks. Then gradually increase the dose, every 2 weeks add from 50 to 150 mg/day, until the destination of 175, 225 or 400 mg/day, based on the patient's weight, so that the dose is about 6 mg/kg/day, unless the condition is not tolerated, it cannot increase the additional dose. After adjusting the dose, the patients were put into a stable period of 12 weeks.
Control tests in patients with Lennox -Gastaut syndrome: Topiramat's effectiveness in coordinated therapy for attacks with Lennox - Gastaut syndrome, in patients aged 2 and older, has been identified in a multicolor study, random, double blind, and control with placebo, comparison of the loneliness of Topiramat with placebo. Patients in this study are used up to 2 anti -epileptic drugs, combining Topamax or placebo tablets. Patients with at least 60 attacks in 1 month before being studied, they are stabilized at the optimal dose of anti -epileptic drugs used during the first 4 weeks of the first stage.
Following the early stages, the patient was randomly introduced for additional Topamax or placebo tablets. The drug is adjusted to start the starting dose of 1 mg/kg/day for 1 week. Then increase the dose to 3 mg/kg/day for 1 week, then 6 mg/kg/day. After adjusting the dose, the patients were put into a stable stage of 8 weeks. The basic measurement index for the effectiveness of the drug is the percentage of reduction of stroke (Drop Attack) and the initial overall evaluation scale of the severity of the attacks. In all coordinated treatment studies, people measure the degree of frequency reduction of attacks compared to the early stages during the double blind period.
Clinical trials migraine
Clinical programs to evaluate the effectiveness of Topamax in migraine prevention include two key multi-central studies, random, double blindness with placebo, parallel groups conducted in North America (Migr-001 and Migr-002). The main criterion of effective evaluation is a decrease in migraine level, by calculating the change of migraine frequency in 4 weeks, from the early stages, to the double blind stage, in each group using Topamax, compared with the placebo in patients intended to be treated.
The results from two key studies when evaluating Topamax at the dose 50 (n = 233), 100 (n = 244) and 200 mg/day (n = 228), showed the median (Median) percentage decreased in terms of monthly migraine levels monthly as 35%, 51% and 49%, compared to 21% of the placebo group (n = 229). Topamax dose 100 and 200 mg/day is better than a placebo. Remarkably, 27% of patients taking Topamax 100 mg/day have achieved at least 75% reduction in the frequency of migraine, while 52% of patients reach at least 50%. A study that supports MIGR-003, has shown that Topamax 100 mg/day has been effective in terms of effect with Propranolol 160 mg/day. There is no statistical significance between the two groups in terms of effective evaluation.
Pharmacokinetics
absorption
Topiramat absorbs well and fast. After taking 100 mg Topiramate, healthy people have an average peak concentration in plasma (cmax) of 1.5 mg/ml achieved within 2 to 3 hours (TMAX). Based on the recovery of radioactive activity from urine, the average absorption range of 100 mg of Topiramat oral dose is at least 81%. Food does not have a significant clinical impact on the bioavailability of Topiramat.
Distribution
In general, about 13-17% Topiramat is connected to plasma proteins. A position with low cohesion for Topiramat in/on red blood cells and can be saturated with a 4 mg/ml plasma concentration. The integral distribution is inversely proportional to the dose. The average apparent volume of drug distribution is 0.08 - 0.55 l/kg when using a single dose from 100 - 1200 mg. Gender is found to have an impact on the distribution of the drug, in women about 50% compared to men. This is thought to be due to the higher percentage of fat in the female's body and this is not clinically significant.
Metabolism
Topiramat is not much metabolized (about 20%) in healthy volunteers. Topiramat is metabolized up to 50% in patients using simultaneously with anti -epileptic drugs that induce drug metabolic enzymes. Six metabolites, formed through hydroxylation, hydrolysis and glucuro - complexes have been isolated, accumulated from plasma, urine and fertilizer. Each metabolite present is below 3 of the total radioactive activity excreted after using Topiramat. Two metabolites are almost still tested for Topiramat and are tested and found that there is a little or no anti -convulsions.
Elimination
In humans, the main elimination path of Topiramat is constant and its metabolites are through the kidney (at least 81% of the dose). About 66% of the Topiramat dose is excreted in a constant form in the urine within 4 days. After the dose of 50 mg and 100 mg Topiramat twice a day, the average renal clearance is about 18 ml/min and 17 ml/min.
There is evidence of the reabsorption through the renal tubules of Topiramat. This evidence is supported by mice research in simultaneously used Topiramat and Probenecid, and there is a significant increase in the kidney clearance of Topiramat. In general, plasma clearance is about 20-30 ml/min in humans after taking Topiramat. Topiramat has a change in plasma concentrations between different individuals and therefore can predict pharmacokinetics.
Linear pharmacokinetics of Topiramat with the stable remains of plasma and the area under the curve of plasma concentrations increases proportional to the only dose of 100 to 400 mg in healthy people. Patients with normal kidney function can take 4 to 8 days to achieve plasma concentrations in the constant state. The average CMAX is 6.76 mg/ml after using 100 mg/twice a day in healthy people. After using multiple doses of 50 mg and 100 mg/twice a day, the average selling time in plasma is about 21 hours.
Before taking Topamax 50 Janssen medicine treats local epilepsy, prevention of migraine (6 blisters x 10 tablets)
How to use
There is no need to control Topiramat concentration in plasma to optimize treatment with Topamax. In rare cases, using Topamax with Phenytoin may need to adjust Phenytoin dose to achieve optimal clinical effect. Topamax dose can be adjusted if added or stopped phenytoin and carbamazepine in combination treatment with Topamax.
Topamax is in the form of tablets, oral use. Recommendation when using Topamax tablets. You can drink topamax without caring for meals.
Dosageshould start the low dose and adjust the dose then to achieve an effective dose level.
epilepsy - Coordination treatment
Adults
start at a dose of 25 to 50 mg at night in a week. It has been reported that the starting dose is lower but has not been systematically studied. Then every week or every two weeks, an additional dose of 25 to 50 mg/day should be divided into 2 times a day.
The dose adjustment must be based on clinical response. Some patients may achieve treatment effect when taking a dose once a day. In clinical trials when combined treatment, 200 mg dose is effective and the lowest dose of research. Therefore, this dose can be considered as a minimum dosage effect.
The usual daily dose is 200 to 400 mg, divided into two times. Some patients have been used at high doses of 1600 mg/day. The recommendations of this dose apply to all adults, including the elderly currently without kidney disease.
Children 2 years of age and older
Topamax's daily daily dose when combined treatment is recommended about 5 to 9 mg/kg/day, divided into twice. The dose adjustment should be started with 25 mg (or lower, based on the dose range from 1 to 3 mg/kg/day) every night of the first week. Then to achieve optimal clinical response, after every 1 or 2 weeks, the dose increases within 1 to 3 mg/kg/day (divided into two drinks).
The dose adjustment should be based on clinical response. Daily dose of up to 30 mg/kg/day has been researched and generally tolerated.
epilepsy - Unit of treatment
When stopping anti -epileptic drugs to achieve a single therapy with topiramat, it is advisable to consider the possible effects of this on the control of epilepsy. The dose of anti -epilepsy drugs is recommended to decrease slowly at a rate of about 1/3 every two weeks unless it is necessary to immediately stop the anti -epileptic drugs in combination because of safety. When stopping the medications causing enzyme, the concentration of Topiramat will increase. Topamax dose may be reduced if clinical indications.
Adults
The dose adjustment should start at the dose of 25 mg every night in a week. Then, every week or every two weeks, an additional dose of 25 or 50 mg/day should be divided into 2 times a day. If the patient is unable to tolerate the dose mode like that, the dose should be increased less or extend the time between the dose increase. Dosage and dose rate should be based on clinical response.
The starting dose is recommended when single -therapeutic treatment in adults between 100 to 200 mg/day is divided into 2 times and the maximum daily dose is recommended for 500 mg/day divided into 2 times. Some patients with anti -tolerant bodies with topiramat 6 dose 1000 mg/day in single therapy. These recommendations apply to all adults, including the elderly without kidney disease.
Children 6 years of age and older
Children 6 years of age and older should start with a dose of 0.5 mg to 1 mg/kg in the evening, in the first week. Then every 1 or 2 weeks, increasing the dose of about 0.5 to 1 mg/kg/day, divided into 2 drinks. If the child cannot tolerate the above dose mode, the dose should be less than the dose or pull the time between the dose increases. Dosage and dose rate should be based on clinical response.
The starting dose is recommended when single -age treatments in children aged 6 and older are from 100 to 400 mg/day. Children have just diagnosed with local starting episodes that have been used by doses of up to 500 mg/day.
migraine
Adults
Topiramat's daily recommended daily dose in migraine prophylaxis is 100 mg/day, divided into 2 times. The dose adjustment should start at a dose of 25 mg every night in a week. Then every week should increase by 25 mg/day. If the patient is unable to tolerate the dose mode like that, it should be longer than the time between the dose adjustments.
In some patients, it has been effective with a total daily dosage of 50 mg/day. Some patients have used a total daily dose of up to 200 mg/day. Dosage and dose rate should be based on clinical response.
Special patient
kidney failure
In patients with renal impairment (creatinine clearance
In patients with end -stage renal impairment, because Topamax is eliminated from plasma when dialysis, should add half of Topamax dose used daily on dialysis days. Topamax dose added when dialysis should be divided at the beginning and at the end of the dialysis process. The additional dose may vary based on the characteristics of the blood separator.
Hepatic failure
Topiramat should be used cautiously in patients with hepatic failure.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?
Symptoms and signs
Topiramat overdose has been reported. Signs and symptoms include: convulsions, drowsiness, language disorders, blurred vision, double look, mental decline, lethargy, abnormal coordination, stunning, lower blood pressure, abdominal pain, agitation, dizziness and depression. In most cases, clinical progress is not serious, except for deaths that are reported after the overdose of many drugs including Topiramat.
Topiramat overdose causes severe metabolic acidosis (see warning and caution - metabolic acidosis). The highest Topiramat overdose report is calculated at about 96 and 110 g Topiramat and leads to a coma that lasts 20 - 24 hours, then recovers all after 3 to 4 days.
Treatment
In case of an overdose, if the patient has just taken, it is advisable to empty stomach immediately by lavage or vomiting. Activated carbon has the ability to absorb Topiramat in vitro. Should use appropriate support measures. Dialysis is an effective way for Topiramat to remove the body. Patients should be fully rehydrated.
What to do when forgetting 1 dose?
Not recorded.
Side Effects
When using topamax , you may experience unwanted effects (ADR).
Frequency> 1%, in adults
Nervous system disorders: drowsiness, dizziness, abnormalities, unusual coordination, vibration of eyeball, lethargy, dysfunction, memory decrease, attention disorders, tremor, forgetting, balance disorders, sensory decrease, tremor of attention, disorder, mental decline, language disorders.
Gastrointestinal disorders : Nausea, diarrhea, upper abdominal pain, constipation, stomach discomfort, indigestion, dry mouth, abdominal pain.
Frequency
Disorders of the digestive system: discomfort in the abdomen, lower abdominal pain, dull abdominal pain, smell -smelling breath, epigastric unpleasant, flatulence, tongue pain, decreased sensation in the mouth, mouth pain, pancreatitis, salivation increased.
Systemic disorders: Lime stagnation, bile edema, abnormal feeling, drunkenness, feeling of restlessness, difficulty living, peripheral cold, drowsy. Other: reducing blood bicarbonate, with crystals in urine, abnormal gait when going step, reducing the number of white blood cells. Frequency> 2%, in pediatric patients Mental disorders: aggression, abnormal behavior, confusion, mood change, slow mental. Respiratory disorders, chest and mediastinum: Nose bleeding. frequency Metabolic and nutrient disorders: hyperactive hyperactive acidosis, hypokalemia, appetite. Mental disorders: anger, indifference, crying, scattered attention, speech disorders, nombers of sleep, insomnia, insomnia between sleep, 2 -way mood, repetitive evidence, sleep disorders, suicide ideas, suicide behavior. Nervous system disorders: day -to -day sleep disorders, speech, convulsions, taste disorders, large seizures, sensory decline, mental decline, eyeball, olfactory disorder, poor quality sleep, increase mental activity, impaired mental skills, fainting, fainting, tremor. Disorders of ear and ear canal: Ear pain. Systemic disorders: abnormal temperament, high body temperature, discomfort, drowsiness. Rare 1/10000 ≤adr Very rare ADR Immune system disorders: allergies, conjunctival edema. eye disorders: Perseverance in the eye, increased eye pressure closed angle, eye movement disorders, eyelid edema, yellow, myopia disease. Kidney disorders and urinary systems: renal tubular acidosis. Systemic disorders: Systemic edema, influenza. Other: weight gain. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Topamax drug contraindicated in the following cases:
Be cautious when using
should stop topamax
In patients with or without a history of seizures, or epilepsy, it must be stopped slowly against anti -epileptic drugs, including Topamax, in order to minimize the risk of seizures, or the risk of increasing seizure frequency. In clinical trials, every week reduces the daily dosage of 50 to 100 mg for adults with epilepsy, and 25 to 50 mg for adults who are using Topamax to 100 mg/day for migraine prevention.
In children's clinical trials, Topamax is slowly reduced the dose within 2 to 8 weeks. In cases where medical reasons should be forced to stop Topamax quickly, recommending appropriate monitoring.
Patients with renal failure
The main elimination line of Topiramat is constant and its metabolites are through the kidney. The excretion of the kidney depends on the function of the kidneys and does not depend on age. Patients with medium or severe renal failure may need 10 to 15 days for plasma concentration to achieve a stable state while in patients with normal kidney function only need from 4 to 8 days.For all patients, the dose mode must be instructed by clinical response (such as seizure control, avoiding adverse effects). In addition, it should be noted that the patient already knows that renal failure may take a longer time for the concentration of the drug to achieve the status of the status at each dose.
Water compensation
Reducing sweat and no sweat has been reported to be related to the use of Topiramat. Reducing sweating and increasing body temperature can occur especially in young children in high temperature environments. The full use of water while using Topiramat is very important. Using water can reduce the risk of kidney stones. Use enough water before and in activities, such as training or high temperatures, which can reduce the risk of adverse effects related to heat.
Disorders of mood/depression
There is an increase in mood disorders and depression recorded during treatment with Topiramat.
suicide/intend to commit suicide
Increased the risk of suicide in thoughts or behaviors in patients using anti -glass drugs, including Topamax, for any indications. A comprehensive analysis of random and placeborn tests of anti -epileptic drugs shows an increase in the risk of suicide or suicide behavior (0.43 in anti -epilepsy drugs with 0.24% of placebo). The mechanism of this risk is unknown.
In double clinical trials, suicidal events (suicide intentions, suicide trying, and suicide) occur with a frequency of 0.5% of patients treated with Topiramat (46 of 8652 patients treated) compared to 0.2% of placebo (8 out of 4045 patients). A suicide case is reported in a double blind test in patients with bipolar disorder using Topiramat. Therefore, patients should monitor the signs of suicide intentions and behaviors and should consider appropriate treatment. It is recommended that patients (and family members when necessary) should have medical advice immediately when there are signs of intentions and suicide behavior.
kidney stones
Some patients, especially those who are likely to have kidney stones, may increase the risk of kidney stones and symptoms and signs related, such as kidney cramps, kidney pain, or side pain. Risk factors for kidney stones include: Previous formation of stones, family history with kidney stones and hypercalcium. These risk factors cannot be reliable for forming stones during topiramat treatment. Moreover, patients who are taking other drugs that cause kidney stones are increasing.
Hepatic failure
In people with liver failure, Topiramat should be used carefully, because the clearance of Topiramat may be reduced.
NEAD NEATER AND GLAY AN ARTICIES
A syndrome that includes acute myopia with secondary angle -closed -angle glaucomes has been reported in Topamax taken patients. Symptoms include a decrease in drama vision and/or eye pain. The manifestations of eye exams include: nearsightedness, agricultural room, eye congestion (red eye) and increased internal pressure. Maybe or not to relax the pupils. This syndrome may be associated with the effusion on the eyelashes leading to occupying the front of the lens and iris with secondary angle glaucoma. Typical symptoms usually occur within the first month of using Topamax.
Contrary to the primary narrow -angle glaucoma is very rare in people under 40 years old, the secondary -corner glaucoma is related to Topiramat encountered in pediatric patients as well as in adults. Treatment includes Topamax stopping as quickly as possible under the decision of the treating doctor and lowering pressure by appropriate measures. These measures often help lower pressure. Tabula increases due to any cause, if not treated can lead to serious sequelae including permanent vision eye.
Visual defects
Visual defects that are not related to glaucoma have been reported in patients treated with Topiramat. In clinical trials, most of these events can recover after stopping Topiramat. If visual problems occur at any time during the Topiramat treatment process, it is advisable to consider to stop taking the drug.
Metabolic acidosis
Increases chlorine in the blood, no anion space, metabolic acidosis (for example, decreased plasma bicarbonate below normal limits without respiratory alkaline) is associated with treatment with topiramat. Reducing plasma bicarbonate is due to the inhibitory effect of topiramat on renal carbon enzymes. In general, this decrease in bicarbonate occurs at the early stage of treatment, although it can still occur at any time during treatment. The level of usually reduced from mild to medium (the average decrease is 4 mmol/l at a dose of 100 mg/day or more in adults and about 6 mg/kg/day in pediatric patients). Rarely the degree of reduction to value is less than 10 mmol/l.
Conditions or therapy can lead to acidosis (such as kidney disease, severe respiratory disorders, epilepsy, diarrhea, surgery, ketone birth diet, or certain medications) may increase the decrease in the Bicarbonate effect of Topiramat. Chronic metabolic acidosis in pediatric patients may slow down the growth rate. Topiramat's influence on growth and bone -related defects have not been systematically tested in pediatric patients or adults.
Depends on each situation where appropriate reviews include serum levels of bicarbonate recommended when treated with Topiramat. If metabolic acidosis appears and lasts, considering reducing the dose or may stop using Topiramat (decreasing dose).
Nutrient supplements
Can consider providing supplements or dietary supplements, if the patient lose weight while taking this medication.
Cognitive decline
Cognitive decline in epilepsy is caused by many factors, possibly due to background disease, epilepsy or epilepsy treatment. There have been reports in literature on cognitive function decline in adults when treating with Topiramat that had to request a dose reduction or stop treatment. However, specialized research on children's awareness has been treated with Topiramat is incomplete and its influence needs to be clarified.
Hyperiac hyperniagia and encephalopathy
Hypergonia hypernamina with or not related to brainstorming is reported when treated with Topiramat. The risk of hyper ammonia blood ammonia when using Topiramat occurs related to the dose. Hyper energy hyperglycemia is reported more often when used simultaneously Topiramat with Valproic acid. The clinical symptoms of enhancement of hyperglycemia include acute alertness changes and/or cognitive function with manifestation of coma.
In most cases, enhancement of hyperglycemia decreases when stopping treatment. Patients appear coma with unknown causes, or mental changes due to combined treatment or single therapy with Topiramat, should think of enhancement due to hypercemolity of blood ammonia and Anmoniac concentration.
Lactose intolerance
Topamax tablets contain lactose. This drug should not be used in patients who are not able to tolerate lactose in rare genetic diseases, lactose deficiency or glucose-galactose absorption disorders.
The ability to drive and operate machinery
Topamax has a slight or medium impact on the ability to drive and operate machinery. Topamax works on the central nervous system, which can cause drowsiness, dizziness or other related symptoms. It can cause visual disorders and/or blurred vision. These adverse effects can be dangerous for patients when driving or operating machinery, especially until the experience of taking drugs on each patient is established.
Pregnancy
Topiramat causes teratogenic rats, rats and rabbits. In mice, Topiramat passed the placenta fence. Data from the British maternity control organization and maternity control organization with anti -epileptic drugs of North America (NaAED) pointed out that infants who have been exposed to Topiramat single therapy in the first 3 months of pregnancy may be increased by the risk of birth defects (for example, skull defects and face such as palms/open palate, low urinary defects, and abnormalities related to other body systems).
Data from the NaAED maternity control organization indicates that the birth defect rate of the Topiramat group is 3 times higher than the group not using anti -epileptic drugs. Moreover, the percentage of mild infant (
Epilepsy
During pregnancy, Topiramat should be prescribed after adequate notice to the mother about the risk of non -control epilepsy for pregnant women and potential risks to the fetus.
Preventive Preventive Prevention
Topiramat is contraindicated for pregnant women and women of reproductive age without effective contraceptive methods.
The period of breastfeeding
Animal research has shown that Topiramat is excreted in milk. Topiramat's excretion in breast milk has not been assessed in control tests. In a few patients, there is a more than Topiramat secretion into breast milk. Because many drugs are excreted through breast milk, it is necessary to decide to stop/avoid using Topiramat or stop breastfeeding, depending on the importance of the drug for the mother.
Drug interaction
The impact of Topamax on other anti -epileptic drugs
The combination of topamax while being treated with other anti -epileptic drugs (phenytoin, carbamazepin, valproic acid, phenobarbital, primidon) does not affect the concentration of stable state in the plasma of these drugs. Except for some patients, the combination of Topamax while being treated with phenytoin may increase the concentration of phenytoin in plasma. This may be due to the inhibition of a specific polymorphic enzyme (CYP2C19). Therefore, any patient who is using phenytoin has signs or clinical symptoms of drug toxicity, so check the concentration of phenytoin.
A dynamic interactive study in epilepsy patients showed that if they were taking Lamotrigin, adding topiramat at the dose of 100 - 400 mg/day would not affect Lamotrigin concentration in a stable state in plasma. Moreover, there is no change in Topiramat concentration in a stable state in plasma while or after stopping treatment with lamotrigin (the average dose is 327 mg/day).
The impact of other anti -epileptic drugs on topamax
Phenytoin and carbamazepine reduce plasma concentrations of Topamax. When coordinating or stopping phenytoin or carbamazepin while being treated with Topamax, Topamax's dose may be needed. This dose adjustment should be based on clinical efficiency. Additional or stopping Valproic acid does not significantly change the clinical change in plasma concentrations in Topamax and therefore, no need to adjust the dose of Topamax.
These interactions are summarized as follows:
Sharing other epilepsy drugs
concentration of other anti -epileptic drugs
Topamax concentration
phenytoin ↔ ** ↓ (48%)
Carbamazepin (CBZ) ↔ ↓ (40%)
↔ ↔
lamotrigin
↔
↔
phenobarbital ↔ ns
Primidon ↔ ns
**: The concentration increases depending on the individual
↓: The decreasing concentration
NS: No research.
Other drug interactions
digoxin
In the study of the single dose, the area under the curve (AUC) of the Digoxin concentration in serum decreased by 12% when used simultaneously with Topamax. The clinical correlation of this observation has not been set. When Topamax is coordinated or stopped in patients who are being treated with digoxin, pay attention to the regular Digoxin in serum.
Central nervous system inhibitors
The common use of Topamax with alcohol or other central nervous system inhibitors has not been evaluated in clinical studies. Therefore, it is recommended not to share Topamax with alcohol or other central nervous system inhibitors.
Oral contraceptives
In the pharmacokinetic interaction study in healthy volunteers being used simultaneously with oral contraceptives combined with 1 mg of norethindron (Net) and 35 MCG Ethinyl Estradiol (EE), Topamax is simply used at a dose of 50 - 200 mg/day without significant statistical significance in medium exposure (AUC) of the ingredients contained in oral contraceptives. In another study, exposure to EE has a statistical significance at a dose of 200, 400 and 800 mg/day (equivalent to 18%, 21%and 30%) when used in combination in patients who are using Valproic acid.
In both studies, Topamax (50 mg/day to 800 mg/day) does not significantly affect the exposure to the net. Although in the Topamax dose of 200 - 800 mg/day, EE exposure has a decrease in the dose dependence, but in the Topamax dose of 50 - 200 mg/day, EE exposure does not change significantly dependent. No clinical significance of these changes has not been observed.
The ability to reduce the effectiveness of oral contraceptives and increase the risk of unexpected bleeding should be noted in patients who are taking oral contraceptives simultaneously with Topamax. Patients who are taking birth control pills contain estrogen should be told to report any changes in their hemorrhage. The effectiveness of birth control pills can be reduced even without bleeding.
lithium
On a healthy volunteer, observing a system exposure with lithium (18% of the area under the serum concentration curve - AUC), when used with Topiramat 200 mg/day. In patients with bipolar disorders, lithium pharmacokinetic disorders are not affected during treatment with Topiramat 200 mg/day; However, after using Topiramat to 600 mg/day, there is an increase in system exposure (26% AUC). When used with topiramat, lithium concentration needs to be monitored.
risperidon
Interactive studies between drugs - drugs on healthy volunteers and patients with bipolar disorders, under the conditions of single -dose, and multiple dose, gives similar results. When used with Topiramat, at Topiramat doses increased by hiccups of 100, 250 and 400 mg/day, there is a reduction in system exposure (16% and 33% AUC in the status state, with doses of 250 and 400 mg/day) of Risperidon (doses from 1 to 6 mg/day).
There are very little changes in pharmacokinetic pharmacokinetics of the entire activity (risperidon and 9- hydroxyrisperidon), and there is no change in pharmacokinetic changes of 9-hydroxyrisperidon. There is no clinical significance in exposure to the system of the entire activity of Risperidon, or Topiramat, so the drug interaction between these two drugs is not clinically significant.
hydrochlorathiazid (HCTZ)
A study of drug-or-interactive interaction above healthy volunteers, in order to evaluate the kinetics in the stable state of HCTZ (dose of 25 mg every 24 GID) and Topiramat (96 mg every 12 hours), when used alone, or combined together. Research results show that Topiramat's CMAX increased by 27% and AUC increased by 29% when further coordinated with HCTZ. The clinical significance of these changes is unknown.
HCTZ combination treatment with Topiramat may need to adjust the Topiramat dose. Pharmacokinetics in the stable state of HCTZ are not significantly affected by simultaneous use of Topiramat. Clinical test results show that there is a decrease in serum after taking Topiramat or Hictz, a decrease more when these two drugs are used at the same time.
metformin
Evaluation of pharmacokinetic stable state of Metformin and Topiramat in plasma when using Metformin alone or simultaneously using Metformin and Topiramat. The results of the study showed that CMAX and AUC0-12H average of Metformin increased by 18% and 25%, while the average CL/F value decreased by 20% when Metformin was simultaneously used with Topiramat. Topiramat does not affect Metformin's TMAX. The clinical significance of the impact of Topiramat on the pharmacokinetics of Metformin is unknown.
Plasma clearance when taking Topiramat decreases when used with metformin. The degree of change of clearance is not known. The clinical significance of the impact of metformin on pharmacokinetics of Topiramat is unknown. When Topamax is used in combination or stopping in patients being treated Metformin, special attention must be paid to regularly monitoring to appropriate diabetes.
pioglitazon
Research on drug interactions - drugs conducted in healthy volunteers to evaluate pharmacokinetics in a stable state of Pioglitazon and Topiramat when used alone or simultaneously. Observations see a 15% reduction of pioglitazon AUC without changing CMAX. This result has no statistical significance. In addition, there are 13% cmax reduction; and 16% AUC; of active hydroxy metabolites, and 60% cmax and auc of keto metabolites are active.
Clinical significance of these findings is unknown. While treating Pioglitazon and adding topamax, or when being treated Topamax and adding pioglitazon, pay attention to the patient regularly to control the appropriate diabetes.
glybid
Research on drug interactions - drugs conducted in type 2 diabetes patients to evaluate pharmacokinetics in a stable state of Glybid (5 mg/day) for lone or simultaneous use with Topiramat (150 mg/day). Seeing a 25% discount of Glyburid's AUC while using Topiramat. Exposure to the system of active metabolites, 4-trans-Hydroxyglybid (M1) and 3-Cis-Hydroxyglybid (M2), also reduced by 13% and 15% respectively. Pharmacokinetics in the stable state of Topiramat are not affected when used simultaneously with Glybid. While glyburid treatment is added to Topiramat, or when being treated Topiramat and adds glybid, it is necessary to closely monitor patients regularly, in order to control the condition of diabetes appropriately.
Other types of interactions
The drugs are likely to cause kidney stones
Topamax, when used simultaneously with drugs that can cause kidney stones, can increase the risk of kidney stones. While using Topamax, it is advisable to avoid simultaneously with these drugs because they can create physiological environment, increasing the risk of kidney stones.
Valproic acid
When using Topiramat with Valproic acid on patients who are tolerated with each drug if used alone, there is a phenomenon of hyper ammonia that may have or not accompanied by brain disease. In most cases, symptoms and signs will decrease when one of two drugs stopped. This adverse reaction is not due to pharmacokinetic interaction.
Reduce body temperature, defined as a decrease in the intention of body temperature to below 35 ° C, which has been reported related to simultaneous use of Topiramat and Valproic Acid (VPA) with or not combined with hypercalcemia. This adverse reaction in patients with simultaneous use of Topiramat and Valproat may occur after starting treatment with Topiramat or after increasing the daily dose of Topiramat.
Interactive studies have been dynamic for supplements
Clinical studies have been conducted to assess pharmacokinetic interactions possible between Topiramat and other drugs. The change of CMAX or AUC due to interaction is summarized below. The second column (the concentration of combined drugs) describes the changes for the concentration of combined drugs listed in column 1 when used in combination with Topiramat. The third column (Topiramat concentration) describes the shared use of the drugs listed in column 1 will affect the Topiramat concentration.
Summary of the results of pharmacokinetic interactive drugs of supplements
Collaborative drug concentration Topiramat concentration ↔ Increase 20% of the maximum concentration and area under the curve of Nortriptylin metabolites ns
(oral and subcutaneously)
↔
↔
Haloperidol
↔
Increasing 31% of the area under the curve of the metabolites decreased
ns
↔ Increase 17% of the maximum concentration for 4-Oh propranolol (TPM 50 mg every 12 hours)
increased by 9% and 16% of the maximum concentration, up 9% and 17% of the area under the curve (corresponding to 40 mg and 80 mg of propranolol every 12 hours)
Sumatriptan
(oral and subcutaneously)
↔
ns
↔
↔
Diltiazem
Discount 25% under the curve of the diltiazem and down 18% in the DEA, and ↔ for DEM*
Increasing 20% of the area under the curve
↔
↔
flunarizin Increasing 16% of the area under the curve (TPM 50 mg every 12 hours) ↔
↔ does not affect the maximum concentration and the area under the curve (change
ns = no research.
DEA = DES acetyl diltiazem, dem = n-demethyl diltiazem.
The area under the curve of flunarizin increased by 14% and patients with single -drinking flunarizin. This increase may be due to the accumulation of drugs during the period of stability in plasma.
Storage
Leave a cool place, avoid light, temperature below 30⁰C
Other drugs
- AMINOPLASMAL 10% SOLUTION FOR INFUSION
- CO-DIOVAN 160/25MG TABLETS
- FEFOL SPANSULE CAPSULES
- GLIBENCLAMIDE 5MG TABLETS
- IBUCALM 200MG TABLETS
- TETRAVAC SUSPENSION FOR INJECTION
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