Topamax. 50 mg. 28 tablets. JANSSEN CILAG
• Monotherapy in patients with newly diagnosed epilepsy or conversion to Monotherapy-
drink in patients with epilepsy;
• adjunctive therapy in adults and children / or over 2 years with partial seizures or generalized tonic-clonic seizures;
• adjunctive therapy in adults and children with seizures associated with syndrome Lennox_Gastaut.
Topamax. 50 mg. 28 tablets. JANSSEN - CILAG
WHAT TOPAMAX AND WHAT IT IS USED FOR ?
Topamax Topiramate contains as the active substance .
Topamax is indicated ;
• Monotherapy in patients with newly diagnosed epilepsy or conversion to Monotherapy -
drink in patients with epilepsy;
• adjunctive therapy in adults and children / or over 2 years with partial seizures or generalized tonic- clonic seizures ;
• adjunctive therapy in adults and children with seizures associated with syndrome Lennox_Gastaut.
TOPAMAX has been indicated for the prevention of migraine in adults. Topamax for treatment of acute attacks of migraine is not yet studied .
2 . BEFORE YOU TAKE TOPAMAX
Do not take Topamax
• if you are allergic (hypersensitive ) to the active substance or to any of the other
ingredients of this medicine.
Take special care with Topamax
In patients with / or without a history of seizures or epilepsy, antiepileptic drugs , including Topamax should be withdrawn gradually to minimize the appearance of seizures or increase their frequency . In clinical trials, daily dosages were reduced to weekly intervals from 50 to 100 mg, in adults with epilepsy and at intervals of 25 to 50 mg, in adults taking Topamax in a dosage of up to 100 mg / day for the prevention of migraine . In clinical trials in children Topamax withdrawn gradually over a period of two to eight weeks.
Unchanged topiramate and its metabolites are eliminated primarily by the kidneys. Eliminated by this pathway is dependent on renal function and does not depend on age. In patients with moderate or severe renal insufficiency, it may take 10-15 days to reach steady-state plasma concentrations , compared in patients with normal renal function, this is 4-8 days.
As with all patients , the appointment of the regimen must be based on clinical
results , ie seizure control and prevention of side effects , keeping in mind that for patients with renal failure may be needed over a longer period of time to attain steady state at each dose .
Proper hydration Lo during treatment with Topamax is very important. Hydration may reduce the risk of nephrolithiasis (see below) . Proper hydration before and during activities associated with physical exertion or exposure to high temperatures can reduce the risk of side effects associated with heat ( see , possible side effects) .
Mood / Depression
Observed are more common manifestations of mood swings and depression during treatment topiramate.
Small number of people being treated with antiepileptics such as topiramate have had thoughts of hurt myself -tion or suicide. If you have these thoughts, immediately contact your doctor.
In some patients , and in particular susceptible to nephrolithiasis , the risk of kidney stone formation and the associated signs and symptoms such as renal colic , lumbar pain , or pain and the groin , can be larger .
Risk factors for nephrolithiasis include a history of prior stone formation , a family history of nephrolithiasis and hypercalciuria ( svrahizhvarlyane of salts in the urine ) , none of these risk factors can not be sure predictor of kidney stones during treatment with toliramat .
Furthermore, the increased risk may be and patients treated with other medications associated with risk of nephrolithiasis .
Reduced hepatic function
In patients with a change in liver function are recommended prescription tapiramat caution , because it can reduce the purification of this medicament .
Acute myopia and secondary angle closure glaucoma
A syndrome , comprising acute myopia and secondary angle closure glaucoma is described in patients treated with Topamax . Early symptoms include a sharp reduction in visual acuity and / or ocular pain . Ocular findings include myopia, anterior chamber edema , ocular hyperemia (redness ) and increased intraocular pressure. There may be , and may not have mydriasis ( dilation of the pupils and iris) . This syndrome may be associated with accumulation of fluid supratsiliarno resulting in displacement of the front lens and the iris , with secondary angle closure glaucoma . Symptoms usually occur one month after initiation of treatment with TOPAMAX . Unlike narrow-angle primary glaucoma, which is rare in people under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in children than in adults. Treatment includes discontinuation of Topamax as quickly as possible and on the advice of the doctor , and adequate measures to reduce intraocular pressure. These measures generally lead to lower intraocular pressure.
Svrahkiselinnata metabolic acidosis, without a loss of the anion , i.e. the reduction of serum bicarbonate levels below normal reference without respiratory alkalosis is associated with topiramate . This drop in serum bicarbonate is due to the inhibitory esrekt topiramate on renal carbonic anhydrase. Typically, the decrease in the bicarbonate occurs at the beginning , but can occur at any time during treatment. The reduction of the bicarbonate is usually mild to moderate (mean decrease of 4 mmol / l , at a dose equal to or greater than 100 mg topiramate per day for adults and about 6 mg / kg / day for children . Rarely occurs in some patients, a decrease in values below 10 mmol / L. The clinical or therapeutic conditions which predispose to the occurrence of acidosis, e.g., renal disease , severe respiratory disease , status epilepticus , diarrhea , surgery , ketogenic diet, or certain drugs , may have an additive effect on the reduction of bicarbonate induced by topiramate Chronic metabolic acidosis in children can slow growth, the effect of topiramate on growth and the effect on the bone has not been studied systematically in children or adults. depending on the accompanying conditions during topiramate treatment , it is recommended that do research in plasma bicarbonate . If the show metabolic acidosis and continues, to be taken to reduce the dose or discontinuing topiramate (using dose tapering ) .
Should be considered include supplements or increase food intake by patients who lose weight during treatment with this medication .
Taking Topamax with other medications
Effects of topamax on other antiepileptic drugs
Adding Topamax to other antiepileptic drugs ( phenytoin , carbamazepine, valproic acid , phenobarbital or primidone ) does not affect the plasma concentrations at steady state , with the exception of individual cases where the addition of TOPAMAX phenytoin may result in increased plasma concentrations phenytoin . This is probably due to inhibition of a specific isoform of the polymorphic enzyme ( SYR2S19 ) . Therefore, in any patient undergoing treatment with phenytoin , wherein the signs and symptoms of toxicity , must be carried out monitoring of plasma levels of phenytoin. Pharmacokinetic interaction studies in patients with epilepsy suggests that the addition of topiramate to lamotrigine had no effect on its plasma concentrations of topiramate dose of 100 to 400 mg / day. Furthermore , there is no change in the plasma concentrations of topiramate during and after discontinuation of lamotrigine ( average dose 327 mg / day ) .
Effects of other antiepileptic drugs on topamax
Phenytoin and karbamazelin lowering plasma concentrations of toliramat . Addition or withdrawal of phenytoin or carbamazepine, in conducting therapy with TOPAMAX , may require adjustment of dosage him . These changes must be made after evaluation of clinical effect. Adding or interruption of treatment with valproic acid does not cause clinically significant changes in plasma concentrations of topiramate and therefore , in this case , it is not necessary to make a change in the dosage of Topamax
Other interactions Digoxin
In single-dose study , the area under the curve ( AUC) of plasma concentration of serum digoxin decreased by 12% due to concomitant administration of TOPAMAX . The clinical relevance of this observation has not been determined. When you add or discontinue topamax in patients treated with digoxin should pay special attention to the routine monitoring of serum levels of digoxin.
Depressants of the central nervous system
Coadministration of topamax and alcohol or other drugs depressing the central nervous system has not been evaluated in clinical trials. It is not recommended to use simultaneously Topamax with alcohol or other drugs that depress the central nervous system ,
In a study on the pharmacokinetic interactions in healthy volunteers assigned concurrent combination contraceptive product containing 1 mg norethindrone +35 mcg ethinylestradiol and topamax , taken in the absence of other medications at doses of 50 to 200 mg / day was not associated with statistically significant changes in mean exposure ( AUC ) of any component of oral contraceptives . In another study, ethinyl estradiol is reduced by a statistically significant at doses of Topamax 200.400 and 800 mg / day (18% , 21% and 30% respectively ) , when administered as adjunctive therapy in patients taking valproic acid . In both studies, Topamax (50 mg / day to 800 mg / day did not significantly affect } effect of norethindrone . Although there is a dose- dependent reduction of ethinyl - effects at doses between 200-800 mg / day , no significant dose-dependent change in etiniestradiop - exposure at doses between 50 and 200 mg / day. clinical significance of the changes observed is not known. could avoid the possibility of a reduction in contraceptive effectiveness and increase breakthrough bleeding in patients taking combination oral contraceptive products with Topamax . Patients taking estrogen containing contraceptives should be asked to report any changes in their menstruation, contraceptive efficacy may be reduced even in the absence of breakthrough bleeding .
In healthy volunteers saw a reduction of 18% of ADR in systemic exposure of lithium during concomitant topiramate 200 mg / day. In patients with bipolar disease , the pharmacokinetics of the lithium is not affected during the treatment with topiramate to 200 mg / day. Moreover , it is observed an increase of 26% of the systemic exposure to A11S of lithium after topiramate therapy at doses up to 600 mg / day. Serum lithium levels should be monitored when prescribing with topiramate.
Drug interaction studies performed with single or multiple dose in healthy volunteers and patients with bipolar have produced similar results. Risleridon when used concomitantly with topiramate at escalating doses on 100 200 n 400 mg / day. nastygva reduction in the systemic exposure of risperidone (16% and 33% of the AUC at steady state topiramate at dosages of 250 and 400 mg / day, respectively ) , when given in doses ranging between 1 and 6 mg / day. Throughout the active antipsychotic fraction ( risperidone and 9 - hydroxyrisperidone ) were observed minimal changes in pharmacokinetics as not observed in isolated 9- hydroxyrisperidone . There were no clinically significant changes in systemic exposure to the total active fraction of risperidone and topiramate . Therefore, this interaction is probably not clinically significant.
Hydrochlorothiazide ( NSTZ )
A drug interaction study in healthy volunteers evaluated the steady state pharmacokinetics of NST2 (25 mg / day) and topiramate (96 mg for 12/12 hours) taken separately or simultaneously. The survey results showed that Cmax of combed -mate has increased by 25% and AUC increased by 29% after the addition of topiramate to NST2 . The clinical significance of this change is unknown. Adding NSTZ to treatment with topiramate may require adjustment of the dose of topiramate. Steady-state pharmacokinetics of NSTZ not changed significantly since the adoption of topiramate Laboratory results showed a decrease in serum potassium after topiramate or adopting NSTZ . This decrease is more pronounced when the adoption of topiramate and NSTZ simultaneously .
Study conducted in healthy volunteers for drug-drug interaction evaluated the steady state pharmacokinetics of metformin and topiramate in plasma when teyopsh was given alone and when teyoggsh and topiramate were given simultaneously. The study results showed that the average C max and average AUC 0-12h . increased by 18% and 25% , while the average CL / F decreased 20% when metformin was co-administered with topiramate. Toriramat not affect Tmah metformin . The clinical significance of the effect of topiramate tip metformin pharmacokinetics is unclear. Oral plasma clearance of topiramate was decreased when administered with metformin. The degree of change in the clearance is unclear. The clinical significance of the effect of metformin on the pharmacokinetics of topiramate is not clear. When topiramate is added or discontinued in patients treated with metformin, attention must be given to the routine monitoring for adequate control of their diabetes.
Drug interaction study conducted in healthy volunteers evaluated the equilibrium concentration of topiramate and pioglitazone when administered alone and in combination . There is a 15% reduction in the AUC of pioglitazone unchanged with no statistical monitoring max.Tova znachimostpri active A hydroxy and 60% decrease in Cmax and AUC for the active keto- metabolite . The clinical significance of these findings is unknown. Upon addition of topiramate to treatment with pioglitazone or if pioglitazone is added to topiramate therapy , careful routine prospedyavane patients for adequate control of their diabetes.
A study of drug interaction in patients with diabetes type II, assess pharmaco- kinetics at steady state of glyburide ( 5mg/dnevno ) and topiramate ( 150mg/dnevno ) taken separately or simultaneously. Was noted a 25% reduction of AUC 24 of glyburide when given topiramate . Systemic exposure to the active metabolite 4-trans- hydroxy- glyburide (M1) and 3- cis -hydroxy- glyburide decreased by 13% and 15 %, respectively , steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide . When topiramate is given concomitantly with glyburide or vice versa, should pay special attention to routine monitoring for adequate control of diabetes.
Medications that predispose to nephrolithiasis
When used in conjunction with other medications that may predispose to nephrolithiasis , Topamax can increase the risk of nephrolithiasis . During treatment with Topamax to avoid these drugs , as they can establish a physiological medium , which could increase the risk of formation of kidney stones .
Co-administration of topiramate and valproic acid was coupled with svrahamoniemiya with / or without encephalopathy in patients who tolerated these drugs when they are administered separately . In most cases, the signs and symptoms disappear after cessation of treatment . This undesirable effect is not due to a pharmacokinetic interaction . No association was found between svrahamoniemiyata and topiramate therapy or concomitant treatment with other anti- epileptic drug.
Results from clinical studies indicate that topiramate was associated with a mean decrease of 4 mmol / l of serum bicarbonate (see Special considerations Topamax ) .
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medication.
All women of childbearing age (who may become pregnant ) should get specialist advice before starting treatment , because of the increased risk of congenital malformations. Treatment with protivoepiliptichni medications must be assessed again when the woman is planning to become pregnant . 06iknoveno risk of congenital malformations is 2-3 times greater in children pregnant women treated with the antiepileptic drug during pregnancy . The most common malformations affecting the lips and oral cavity, the cardiovascular system and the neural tube .
Treatment with other anti-epileptic drugs ( polytherapy ) is associated with a higher risk of congenital malformations than treatment with a single medicament ( Monotherapy ) . Whenever possible, polytherapy regimens should be simplified.
Treated with antiepileptic drugs should not be stopped abruptly , as can uvepichi risk of epileptic seizures with serious consequences for the mother and / or fetus.
In preclinical studies , topiramate showed teratogenic in studies in animal models ( rats , rats, and rabbits) . In rats , topiramate crosses the placental barrier.
No studies on the use of Topamax in pregnant women. However , Topamax should be used during pregnancy only when the potential benefits to the mother outweigh the potential risk to the fetus.
Topiramate is excreted in milk of lactating mice. The excretion of topiramate in human milk has not been evaluated in controlled trials . Limited observations in patients suggest prolonged excretion of topiramate in human milk. Because many drugs are hp - kretirat in milk should be given to the decision to discontinue nursing or the drug , depending on the importance of the drug to the mother's health . In the post -marketing period , cases of hypospadias in newborn boys out intraute - rinno topiramate with or without other anticonvulsant drugs. Causal relationship with topiramate , however, has not been established .
Driving and using machines
Topamax acts on the central nervous system and can cause drowsiness , dizziness , and the like symptoms. These otherwise mild or moderate adverse effects can be potentially dangerous in patients driving or operating Masic , especially to identify the individual effects of the drug on Asseco patient.
Important information about some of the ingredients of Topamax
Topamax coated tablets contain lactose and urea sodium glycolate, if your doctor has advised that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Topamax capsules contain sucrose . If your doctor has advised that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 . HOW TO TAKE TOPAMAX
Take Topamax always under medical prescriptions . Talk to your doctor or pharmacist if you have any doubts .
For perfect control , both in adults and in children , it is recommended to start treatment
low dose , followed by an indication of the dosage until the effective dose.
Topamax produce tablets and capsules. Not recommended breakage of tablets .
The capsules may be taken by patients who can not swallow tablets , for example children and elderly
Topamax capsules may be swallowed whole or after opening the capsule .
Intake with food:
You can pour the contents of the capsule on a small portion ( teaspoon ) of soft food
compote of apples , milk , ice cream , porridge or yoghurt.
Hold the cartridge facing up so that the inscription read "TOP" . Gently turn the transparent part of the capsule. Easier to perform this operation on a small portion of soft food that will mix the granules with the contents of the capsule.
Pour the entire contents of capsule on soft food portsiykata and make sure that all content is poured over food.
Make sure the patient is immediately swallowed whole portion of soft food . You should not chew. To make sure that all food is swallowed , immediately give the fluid of the patient. Never keep the drug mixed with food for future use.
Approval without food:
Topamax capsules may be taken and goals.
There is no need routinely plasma concentrations of topiramate for the optimization of
treatment with Topamax rarely giving topamax with phenytoin may require an adjustment of the dose of phenytoin to get a favorable clinical outcome. Giving or withdrawal of phenytoin and carbamazepine as adjunctive therapy with TOPAMAX , may require adjustment of the dose of Topamax .
Topamax can be taken regardless of meals.
Adjunctive therapy for epilepsy Adults
TOPAMAX therapy should start with 25-50 mg nightly for one week. It has been reported for the use of a lower dose , but this was not studied systematically . Thereafter, for a week or two-week dose interval should be increased by 25-50 [ 100 ] mg daily and assumed to be in two divided doses , increasing the dose should be depending on the clinical picture. In some patients can achieve effect once-daily dosing . In clinical studies, the lowest dose tested and effective as adjunctive therapy was 200 mg. Hence, it is considered the minimum effective dose. The usual daily dose is from 200 to 400 mg in two divided doses . Individual patients may receive doses of up to 1600 mg per day.
Since fours Topamax was removed from plasma by hemodialysis , an extra dose Topamax equal to approximately half of the daily dose to be administered on the day of dialysis. The supplemental dose should be taken in divided doses - at the beginning and after the completion of hemodialysis . The additional dose may vary according to the characteristics of the dialysis equipment .
These doses are recommended to apply to all adults including the elderly , provided that there is no underlying renal disease (see Special warnings Topamax ) .
Children / or over 2 years
Entire recommended daily dose Topamax as adjunctive therapy is approximately 5-9 mg / kg / day in two divided doses . Dose determination should be initiated with 25 mg ( or at least on the basis of a variation of 1 to 3 mg / kg / day), administered in the evening for the first week . The amount may be increased by a week or two weeks , with a magnification of 1 to 3 mg / kg / day , in two divided doses per day , in order to obtain the optimal clinical response . Dose determination must be made in accordance with clinical rezultati.Bili were examined daily doses up to 30 mg / kg / day, and usually these doses have been well tolerated .
Monotherapy for epilepsy Background
When an interrupt of the simultaneous administration of anti drugs to achieve monotherapy topiramate should be given to the effects that can occur on the control of seizures .
Provided that for security reasons require sudden discontinuation of concomitant antiepileptic drugs , it is recommended to gradually reduce the dose by approximately one-third of taking concomitant antiepileptic drug for two weeks. When stopping the enzyme inducers , topiramate levels increase. If clinically appropriate , it may be necessary to reduce the dose of TOPAMAX .
Topamax therapy should be initiated at 25 mg every evening , for one weeks, titers uitsa / tion can be increased to 25 or 50 mg / day. at intervals of 1 or 2 weeks , administered in two divided doses . If the patient does not tolerate the specified amount can be made smaller increments or longer intervals between each dose increase . Dosing should be done in accordance with clinical outcome .
The recommended dose for topiramate monotherapy in adults is 100 mg / day, the maximum recommended dose is 500 mg / day. Some patients with epilepsy refrakgerni forms took 1000 mg / day topiramate alone. These therapeutic recommendations apply to all adults, including elderly people, when they have kidney disease.
Treating children / or over two years should start with 0.5 to 1 mg / kg / dneeno taken in the evening for one week. This dose can be increased by 0.5 to 1 mg / kg / day , administered twice at an interval of 1 or 2 weeks. If the child does not tolerate the dosage regimen may proceed to smaller increments or longer intervals between each dose increase . Dosing should be done in accordance with clinical outcome . The recommended starting dose for topiramate monotherapy for children / or more than 2 years of D to 6 mg / kg / day. Children with newly diagnosed partial seizures were treated at doses up to 500 mg / day.
Prevention of Migraine
Dosing should begin at 25 mg, administered in the evening , for one week. Then, the dosage should be increased by 25 mg / day , with an interval of 1 week. If the patient does not tolerate the dosage regimen may consider larger intervals of dosing and dose adjustment . The total daily dose of topiramate recommended for migraine prevention is 100 mg / day in two divided doses . Some patients may experience an improvement in a total daily dose of 50 mg / day. Some patients receive a total daily dose of 200 mg / dneeno . In all cases, the dose and speed of upwards must be consistent with the clinical results.
If you take more dose TOPAMAKS Signs and symptoms
There are reports of overdoses topiramate. Signs and symptoms included convulsions , drowsiness, speech disturbances, blurred vision, diploliya , disturbed consciousness , lethargy , abnormal coordination , stupor , hypotension , abdominal pain , agitation , confusion and depression. Clinical complications in most cases are not serious , but there have been reports of fatalities after taking more drugs in overdose , including topiramate.
Toliramat overdose may lead to severe metabolic acidosis ( See , Special warnings Topamax ) .
Patient who ingested a dose calculated to be between 96 and 110 g topiramate was admitted to hospital with coma lasting 20-24 hours followed by full recovery after 3-4 days.
In acute condition caused by the intake of topiramate overdose , if the intake has been recently , the stomach should be emptied immediately by lavage or by induction of emesis. The activated carbon absorbs topiramate in vitro. Must be adequately supportive care. Hemodialzata proved an effective means for separating the body from toliramat . Patients may be needed to be well hydrated.
4 . POSSIBLE SIDE EFFECTS
The reported adverse events were classified using a glossary of OMS - ART , Most side effects most frequently observed in clinical trials were mild to moderate and dose dependent. These adverse effects , depending on dose, are usually present in the phase of the titration, is retained in the maintenance phase dose rndko but appear in the early phase of the maintenance dose . A quick titration , and high initial dose is associated with more side effects leading to discontinuation .
Clinical trials as adjunctive therapy for epilepsy
Since TOPAMAX is administered in combination with other anti-epileptic drugs , can not be determined which are the drugs that are associated with the occurrence of these adverse reactions.
In a double- fusing clinical trials , some of which include rapid initial titration period have experienced adverse reactions with an incidence Lo greater than or equal to 5%. Were observed in a higher percentage in elderly patients treated with topiramate compared with placebo include: drowsiness , dizziness , nervousness, ataxia , fatigue, speech disorders / related speech problems , psychomotor slowing , abnormal vision , difficulty with memory ( non-specific symptoms ), confusion , paresthesia , diplopia , anorexia , nystagmus , nausea, weight loss , speech problems , impaired concentration , depression , abdominal pain, asthenia, and mood problems .
Adverse reactions that occurred with less frequency include: change in taste , agitation, nonspecific cognitive problems , emotional lability, coordination problems , gait disturbance , apathy, symptoms of psychosis or psychotic symptoms, suicide attempts , aggressive behavior or reactions , leucopenia and nephrolithiasis . Isolated cases of thrombosis have also been described , although a causal relationship to medicinal product has not been established .
In a double- slepi clinical trials adverse reactions that occur with a frequency of about 5% higher incidence in children treated with toliramat compared with those in the placebo group include: lethargy, anorexia , fatigue, anxiety , personality disorders, difficulties in concentration and attention , aggressive reactions , reducing weight , gait disorders , mood problems , ataxia, salivation , nausea , difficulty in memorizing , hyperkinesia , dizziness, speech disorders / related speech problems, paresthesia . Adverse reactions have occurred very often, but considered potentially important from a clinical point of view include: emotional lability , agitation , apathy, non-specific cognitive problems , psychomotor slowing , confusion , hallucinations, depression and leukopenia .
Clinical trials as monotherapy for epilepsy
Quality , the type of adverse reactions observed in clinical trials as monotherapy are generally similar to those observed in studies of adjunctive therapy . With the exception of paraesthesia and fatigue, these side effects are common with a similar or lower incidence in clinical trials as monotherapy .
In a double- blind clinical trials , clinically significant side effects such as paresthesia , headache, fatigue , dizziness, drowsiness , decreased INa weight , nausea and anorexia, occur with a frequency greater than or equal to 10 % in patients treated with topiramate adults
In a double- blind clinical trials , clinically significant adverse reactions such as headache, fatigue , anorexia, and somnolence occurred with an incidence greater than or equal to 10 % in patients treated with tspiramat children.
Clinical studies for the prevention of migraine
In a double- blind clinical trial the following clinically significant adverse effects among others, found in 5% or more cases or more frequent in patients on topiramate than in those taking placebo : fatigue , paresthesia , dizziness , hipes paresthesia , speech disorder, nausea , diarrhea , dyspepsia, dry mouth, weight loss, anorexia , drowsiness , memory disorders , disorders of the concentration / attention , insomnia , anxiety , mood swings , depression , flavor changes , visual disturbance , in patients taking topiramate, has varying the weight , which is dose-dependent . Such changes in body weight was observed in the group of patients receiving placebo. On average, the variation in the weight of the patients in the placebo group was 0.0% , while in the group of 50,100 and 200 mg topiramate 2 - , 3%, 5.2% and 3.8% respectively .
Postmarketing experience and other
The reported side effects reported during the phase of post-market Topamax are tabulated below.
Adverse reactions are ranked by frequency , calculated on the sick for years .
Often > 1/10
Often 21/100 and <1/10
Not often > 1/1000i <1/100
Rarely > 1/10000i < 1/1000
Very rare < 1/10000
The disclosed ratios reflect frequencies of adverse reactions reported spontaneously and are not accurate estimates in comparison with those which can be obtained by clinical studies.
Received isolated reports of hepatitis and hepatic failure occurred in patients who take different medicines while being treated with TOPAMAX . There are also some cases of skin rashes and effects of the mucosa , including erythema multiforme syndrome Stevens-Jonson and toxic epidermal necrolysis . Most of these cases occurred in patients who are receiving other medications also associated with the occurrence of skin rash, mucosal reactions ,
Rarely reported oligohidroza patients treated with topiramate. Most of these cases relate to children.
Reported side effects reported during the phase of post-market :
Blood and lymphatic system disorders
Very rare: leucopenia and neutropenia , thrombocytopenia
Metabolism and nutrition
Very rare metabolic acidosis, weight loss appetite hyperammonemia
Rare: depression, anxiety and drowsiness
Very rare: insomnia , confusional state , psychotic changes , aggression, hallucinate , intent on suicide , suicide attempt and suicide , changes in the expression
Nervous System Disorders
Rare: paresthesia , convulsions, headache.
Very rare: changes in speech , dysgeusia , amnesia, memory changes , seizures due to discontinuation
Rare change in vision , blurred vision
Very rare: myopia, angle-closure glaucoma , ocular pain
Very rare: diarrhea , abdominal pain and vomiting
Skin and subcutaneous tissue disorders
Rare hair loss
Very rare: erythema
Renal and urinary disorders
General disorders and administration myastotona
Very rare: pyrexia , feeling of malaise, asthenia
Additional diagnostic tests
Rare: weight reduction
5 . Storage Topamax
Be stored at temperatures below 25 ° C in a dry place .