Drug information provided by: Merative, Micromedex. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. Topiramate Class. Available for Android and iOS devices. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. Table 6 presents the incidence of adverse reactions occurring in at least 3% of adult patients treated with 200 to 400 mg/day TOPAMAX and was greater than placebo incidence. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Your doctor should check your progress at regular visits. Tamsulosin oral capsule is used. TOPAMAX treatment can cause metabolic acidosis [see WARNINGS AND PRECAUTIONS]. Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. In addition, a 13% and 16% decrease in Cmax,ss and AUC,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUC,ss of the active keto-metabolite. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. Dose-related hyperammonemia was also seen in pediatric patients 1 to 24 months of age treated with TOPAMAX and concomitant valproic acid for partial-onset epilepsy and this was not due to a pharmacokinetic interaction. Using Topamax with other drugs that make you drowsy can worsen this effect. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). Following randomization, patients began the double-blind phase of treatment. Difficulty with concentration/attention occurred in 3 topiramate-treated patients (5%) and 0 placebo-treated patients. Table 7 presents the incidence of adverse reactions that occurred in at least 3% of pediatric patients 2 to 15 years of age receiving 5 mg to 9 mg/kg/day (recommended dose range) of TOPAMAX and was greater than placebo incidence. Avoid driving or hazardous activity until you know how this medicine will affect you. Controlled Substances Act (CSA). Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. 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]. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TOPAMAX should be used with extreme caution if used in combination with alcohol and other CNS depressants. a painful erection that lasts 4 hours or longer. 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. Copyright 2023 by RxList Inc. An Internet Brands company. 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. Active drug was titrated beginning at 1 mg/kg/day for a week; the dose was then increased to 3 mg/kg/day for one week, then to 6 mg/kg/day. Review/update the Patients received either no or a combination of other antiepileptic drugs. 10 Things People With Depression Wish You Knew, * Administered in two equally divided doses, Difficulty with concentration or attention, Placebo Patients with Events per 1000 Patients, Drug Patients with Events per 1000 Patients. Tamsulosin systemic 0.4 mg (ZA-18 0.4 mg). When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. Protect from moisture. The effectiveness of TOPAMAX as initial monotherapy in adults and pediatric patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial (Study 1). health information, we will treat all of that information as protected health Version: 23.01. signs of too much ammonia in your blood--vomiting, unexplained weakness, feeling like you might pass out. The most common cognitive adverse reaction in pooled double-blind studies in pediatric patients 12 to 17 years of age was difficulty with concentration/attention [see WARNINGS AND PRECAUTIONS]. The effectiveness of TOPAMAX as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 10) comparing a single dosage of TOPAMAX with placebo in patients 2 years of age and older (see Table 12). Benign enlargement of the prostate is a problem that can occur in men as they get older. There was also an increased incidence of markedly increased hyperammonemia at the 100 mg dose. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. The change in the mean 4-week migraine headache frequency from baseline to the double-blind phase was -1.3, -2.1, and -2.2 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. This high clearance (compared to 20 to 30 mL/min total oral clearance in healthy adults) will remove a clinically significant amount of topiramate from the patient over the hemodialysis treatment period [see DOSAGE AND ADMINISTRATION, Use In Specific Populations]. The elderly subject population had reduced renal function (creatinine clearance [-20%]) compared to young adults. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. TOPAMAX is a carbonic anhydrase inhibitor. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. 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. In pediatric patients (1-24 months) receiving adjunctive TOPAMAX for partial-onset seizures, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, alkaline phosphatase, and total protein, The incidence was also increased for a decreased result for bicarbonate (i.e., metabolic acidosis), and potassium with TOPAMAX (vs placebo) [see Use In Specific Populations]. When topiramate (0, 30, 90, and 300 mg/kg/day) was administered orally to rats during the juvenile period of development (postnatal days 12 to 50), bone growth plate thickness was reduced in males at the highest dose. Last updated on Apr 5, 2023. The most common adverse reactions in the controlled clinical trial that occurred in adult patients in the 200-400 mg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: dizziness, speech disorders/related speech problems, somnolence, nervousness, psychomotor slowing, and vision abnormal (Table 6). Avoid becoming overheated or dehydrated in hot weather. Instruct patients to immediately report behaviors of concern to their healthcare providers [see WARNINGS AND PRECAUTIONS]. Generic name: topiramate [toe-PYRE-a-mate] If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). A 15% decrease in the AUC,ss of pioglitazone with no alteration in Cmax,ss was observed. In patients who develop unexplained lethargy, vomiting or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. TOPAMAX may cause serious side effects including: See What is the most important information I should know about TOPAMAX?. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. Topamax can be prescribed for weight loss. What is tamsulosin (Flomax) used for? Topiramate is cleared by hemodialysis. Your reactions could be impaired. The risk for hyperammonemia with topiramate appears dose-related. Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. Topamax is also used with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older. Generic drugs are thought to be as safe and effective as the brand-name drug they're based on. TABLETS, for oral use, TOPAMAX As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks. Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trial (Study 1) in Adult and Pediatric Patients. Common tamsulosin side effects may include: abnormal ejaculation, decreased amount of semen; runny or stuffy nose, sore throat, cough; This is not a complete list of side effects and others may occur. Treatment with topiramate for up to 1 year was associated with reductions in Z SCORES for length, weight, and head circumference [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. The no-effect dose (90 mg/kg/day) for adverse developmental effects is approximately 2 times the maximum recommended pediatric dose (9 mg/kg/day) on a body surface area (mg/m2) basis. . Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Patients who experienced 3 to 12 migraine headaches over the 4 weeks in the baseline phase were randomized to either TOPAMAX 50 mg/day, 100 mg/day, 200 mg/day, or placebo and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). Some people have thoughts about suicide while taking seizure medicine. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. Approximately 80% or more patients in each treatment group completed the study. The risk for cognitive adverse reaction was greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age) [see WARNINGS AND PRECAUTIONS]. This will be based on how well it is working for you and any side effects you may experience. Types of Traumatic Brain Injury (TBI) Medications. Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. 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