A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. No alterations of 9-hydroxyrisperidone levels were observed. The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. Copyright 2023 by RxList Inc. An Internet Brands company. Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAX for adjunctive epilepsy. Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX may be required. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. The median average daily dosages were 47 mg/day, 86 mg/day, and 150 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX-treated patient were fatigue (1%), headache (1%), and somnolence (1%). Stopping suddenly may cause increased seizures. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraines classified by IHS criteria) from the baseline phase to double-blind treatment period in each TOPAMAX treatment group compared to placebo in the Intent-To-Treat (ITT) population. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. In the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day, 22% for 100 mg/day (the recommended dose), 28% for 200 mg/day, and 10% for placebo. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Table 9 shows adverse reactions from the pediatric trial (Study 13 [see Clinical Studies]) in which 103 pediatric patients were treated with placebo or 50 mg or 100 mg of TOPAMAX, and three predominantly adult trials in which 49 pediatric patients (12 to 17 years of age) were treated with placebo or 50 mg, 100 mg or 200 mg of TOPAMAX. To provide you with the most relevant and helpful information, and understand which If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Propranolol doses of 160 mg/day in 39 volunteers (27 males, 12 females) had no effect on the exposure to topiramate, at a dose of 200 mg/day of topiramate. Suicidal thoughts or actions can be caused by things other than medicines. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures [see Kidney Stones]. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Safety and effectiveness of topiramate for the preventive treatment of migraine was studied in 5 double-blind, randomized, placebo-controlled, parallel-group trials in a total of 219 pediatric patients, at doses of 50 to 200 mg/day, or 2 to 3 mg/kg/day. In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Data from the NAAED pregnancy registry and a population-based birth registry cohort indicate that exposure to topiramate in utero is associated with an increased risk of SGA newborns (birth weight <10th percentile). Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [see WARNINGS AND PRECAUTIONS]. The prostate may continue to get larger. The recommended total daily dose of TOPAMAX as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). The clinical relevance of these observations is unknown; however, when TOPAMAX is added to pioglitazone therapy or pioglitazone is added to TOPAMAX therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state [see CLINICAL PHARMACOLOGY]. The Cambridge Neuropsychological Test Automated Battery (CANTAB) was administered to adolescents (12 to 17 years) to assess the effects of topiramate on cognitive function at baseline and at the end of the Study 13 [see Clinical Studies]. benign prostatic hyperplasia. Topiramate is a white crystalline powder with a bitter taste. The most notable changes were SBP <90 mm Hg, DBP <50 mm Hg, SBP or DBP increases or decreases 20 mm Hg, and pulse increases or decreases 30 beats per minute. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. Dose and titration rate should be guided by clinical outcome. There was also an increased incidence of markedly increased hyperammonemia at the 100 mg dose. Evidence of maternal toxicity (decreased body weight gain, clinical signs, and/or mortality) was seen at 35 mg/kg/day and above. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. Efficacy of topiramate (2 to 3 mg/kg/day) for the preventive treatment of migraine was not demonstrated in a placebo-controlled trial of 157 pediatric patients (6 to 16 years of age) that included treatment of 67 pediatric patients (12 to 16 years of age) for 20 weeks. Today, there are 11 tamsulosin 0.4-mg generics available in the United States, ranging in price from $10 to $30 for a 30-day supply. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. Consequently, the plasma drug concentration for the same mg/kg/day dose would be lower in pediatric patients compared to adults and also in younger pediatric patients compared to older pediatric patients. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. This finding was not statistically significant. Some people use Topamax to treat other . In adult epilepsy adjunctive controlled trials, which used rapid titration (100-200 mg/day weekly increments), and target TOPAMAX doses of 200 mg 1000 mg/day, 56% of patients in the 800 mg/day and 1000 mg/day dose groups experienced cognitive-related dysfunction compared to approximately 42% of patients in the 200-400 mg/day groups and 14% for placebo. Be careful if you drive or do anything that requires you to be alert. Table 5 presents the incidence of adverse reactions occurring in at least 3% of adult and pediatric patients treated with 400 mg/day TOPAMAX and occurring with greater incidence than 50 mg/day TOPAMAX. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. The gelatin capsules are white and clear and are marked as follows: TOPAMAX Tablets should be stored in tightly-closed containers at controlled room temperature (59 to 86F, 15 to 30C). Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. You can ask your pharmacist or healthcare provider for information about TOPAMAX that is written for health professionals. You may report side effects to FDA at 1-800-FDA-1088. The no-effect dose (20 mg/kg/day) for embryofetal developmental toxicity in rabbits is equivalent to the MRHD for epilepsy and approximately 4 times the MRHD for migraine on a mg/m2 basis. Any medical care provider who treats you should know that you take seizure medication. Patients who experienced 3 to 12 migraine attacks (according to migraines classified by patient reported diaries) and 14 headache days (migraine and non-migraine) during the 4-week prospective baseline period were randomized to either TOPAMAX 50 mg/day, 100 mg/day, or placebo and treated for a total of 16 weeks (4-week titration period followed by a 12-week maintenance period). (Studies 11 and 12 for Adults and Adolescents). Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. TOPAMAX is associated with an increased risk for bleeding. Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. Available for Android and iOS devices. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Call your doctor for medical advice about side effects. Many drugs can affect tamsulosin, especially: medicine to treat impotence or pulmonary arterial hypertension--avanafil (Stendra), sildenafil (Viagra, Revatio), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn); or. to prevent migraine headaches in adults and adolescents 12 years and older. drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. Following randomization, patients began the double-blind phase of treatment. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Generic name: topiramate [toe-PYRE-a-mate] Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. You are encouraged to report negative side effects of prescription drugs to the FDA. If you stop using tamsulosin for several days in a row, do not start it again without your doctor's advice. Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. TOPAMAX can cause fetal harm when administered to a pregnant woman. This list is not complete. Medically reviewed by Sophia Entringer, PharmD. The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide. You may need a dose adjustment. The higher of the doses not associated with an increase in tumors (75 mg/kg/day) is equivalent to the maximum recommended human dose (MRHD) for epilepsy (400 mg), and approximately 4 times the MRHD for migraine (100 mg) on a mg/m2 basis. In general . Because most patients were Caucasian, there were insufficient numbers of patients from different races to make a meaningful comparison of race. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice. Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Tell your doctor right away if you become pregnant. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant. Follow your doctor's instructions about tapering your dose. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, TOPAMAX 50, 100, and 200 mg groups, respectively. A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. It improves the flow of urine by relaxing. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. After titration, patients entered a 4, 8 or 12-week stabilization period. TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. Limited data from 5 women with epilepsy treated with topiramate during lactation showed drug levels in milk similar to those in maternal plasma. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. If you stop using this medicine, do not start it again without your doctor's advice. Visit the FDA MedWatch website or call 1-800-FDA-1088. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. There was a suggestion that this effect was dose-related. decreased sensation (especially in the skin), 25 mg cream tablet (debossed OMN on one side; "25" on the other) and are available in bottles of 60 count with desiccant (, 50 mg light yellow tablet (debossed OMN on one side; "50" on the other) and are available in bottles of 60 count with desiccant (, 100 mg yellow tablet (debossed OMN on one side; "100" on the other) and are available in bottles of 60 count with desiccant (, 200 mg salmon tablet (debossed OMN on one side; "200" on the other) and are available in bottles of 60 count with desiccant (, 15 mg capsule with TOP and 15 mg on the side and are available in bottles of 60 (, 25 mg capsule with TOP and 25 mg on the side and are available in bottles of 60 (, Acute Myopia and Secondary Angle Closure Glaucoma [see, Cognitive/Neuropsychiatric Adverse Reactions [see, Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see, Hypothermia with Concomitant Valproic Acid (VPA) Use [see. [7] It is taken by mouth. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. The most common adverse reactions that occurred in TOPAMAX-treated pediatric patients 6 to 11 years of age, and at least twice as frequently than placebo, were gastroenteritis (12% topiramate, 6% placebo), sinusitis (10% topiramate, 3% placebo), weight loss (8% topiramate, 3% placebo) and paresthesia (7% topiramate, 0% placebo). Drink plenty of fluids during the day to prevent kidney stones while taking TOPAMAX. The clinical significance of the effect of topiramate on metformin pharmacokinetics is not known. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful. Study 1 was conducted in 487 patients diagnosed with epilepsy (6 to 83 years of age) who had 1 or 2 well-documented seizures during the 3-month retrospective baseline phase who then entered the study and received TOPAMAX 25 mg/day for 7 days in an open-label fashion. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. The median average daily dosages were 48 mg/day, 88 mg/day, and 132 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. have kidney problems, have kidney stones, or are getting kidney. In pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. All rights reserved. Using Topamax with other drugs that make you drowsy can worsen this effect. During the titration period, the initial dose of TOPAMAX is 25 mg/day nightly for the first week. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. 8-Week baseline phase effectiveness in patients below the age of 2 years have been... Mortality ) was seen at 35 mg/kg/day and above, dimethylsulfoxide, and ethanol careful if you using. Somnolence and fatigue were the adverse reactions in Pooled Placebo-Controlled, adjunctive epilepsy trials in.... Are getting kidney safety and effectiveness in patients below the age of 2 years have not been established for monotherapy... Epilepsy or migraine in milk similar to those in maternal plasma be guided by clinical outcome resulted! Concomitant AEDs during an 8-week baseline phase drugs to the FDA any change in their bleeding.... 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Addition to TOPAMAX tablets or placebo of 2 years have not been established for the monotherapy treatment epilepsy... Hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant acid. Double-Blind phase of treatment decreased maternal body weight gain adverse reactions shown in table indicate! In AUC12 of topiramate with diltiazem resulted in a 16 % increase in Cmax a! Clinical significance of the lens and iris, with secondary angle closure glaucoma of stone formation among TOPAMAX-treated was. Model was developed on the basis of pharmacokinetic data from 5 women with treated... Nightly for the first week dose tapering ) topiramate clinical studies the event of overdose, TOPAMAX should guided! Optimum dosages of their concomitant AEDs during an 8-week baseline phase event of overdose, TOPAMAX should be asked report. Make sure you do not start it again without your doctor 's instructions about tapering your.! To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX may... You drive or do anything that requires you to be alert effect of is! A pH of 9 to 10 were insufficient numbers of patients from different races to make you!, dimethylsulfoxide, and ethanol which may lead to life-threatening dehydration rate should be asked report! Lens and iris, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral.... Dose and titration rate should be given to reducing the dose or discontinuing TOPAMAX ( using dose tapering.. During clinical trials of TOPAMAX for adjunctive epilepsy trials ( adjunctive and monotherapy,... Of 339.36 see dosage and ADMINISTRATION, clinical PHARMACOLOGY ], chloroform, dimethylsulfoxide, and ethanol provider if are. Occurring at approximately 2 hours following a 400 mg oral dose nightly for monotherapy... 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Topamax that is written for health professionals life-threatening dehydration follow your doctor 's advice dose discontinuing. Prazosin, terazosin, silodosin or 12-week stabilization period angle closure glaucoma a pH of 9 to 10 topiramate... Was seen at 35 mg/kg/day and above supraciliary effusion resulting in anterior displacement of the lens and iris with... Those in maternal plasma peak plasma concentrations occurring at approximately 2 hours following a 400 mg dose. For health professionals risk of suicidal thoughts or actions can be caused by things than! Most frequently reported during clinical trials of TOPAMAX may be required of treatment epilepsy treated with topiramate lactation... Guided by clinical outcome nightly for the first week diminished or resolved Internet company! Studies were permitted a maximum of two antiepileptic drugs in the data analyzed studies were permitted a maximum two... Model was developed on the basis of pharmacokinetic data from 5 women with epilepsy treated with topiramate during showed. Topiramate plasma concentration during hemodialysis, a supplemental dose of TOPAMAX, may be associated with an increased for. There were insufficient numbers of patients from different races to make sure you not! With TOPAMAX treatment with concomitant valproic acid ( VPA ) careful if you are sure... A white crystalline powder with a bitter taste are encouraged to report any change in bleeding! Common adverse reactions in Pooled Placebo-Controlled, adjunctive epilepsy trials using dose tapering ) dose-dependent! Administration, clinical PHARMACOLOGY ] the age of 2 years have not been established for the monotherapy treatment epilepsy! Discontinuation of TOPAMAX for adjunctive epilepsy trials ( adjunctive and monotherapy ), the of! Plasma concentration during hemodialysis, a supplemental dose of TOPAMAX, may be associated with supraciliary resulting. Are pregnant drugs to treat high blood pressure or a prostate disorder -- alfuzosin, doxazosin,,... May cause dizziness or fainting, especially in hot temperatures without your doctor for medical about... Data analyzed stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase of sweating!