This medication is also used to prevent migraine headaches and decrease how often you get them. Kidney stones have also been reported in pediatric patients taking topiramate for epilepsy or migraine. However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment related or reflects the patients underlying disease (e.g., patients who received higher doses may have more severe underlying disease) [see Warnings and Precautions (5.7)]. Your healthcare provider may change your dose. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. In the Medical Birth Registry of Norway (MBRN), a population-based pregnancy registry, 25% of newborns in the topiramate monotherapy exposure group were SGA compared to 9% in the comparison group who were unexposed to AEDs. tingling of the arms and legs (paresthesia), decreased feeling or sensitivity, especially in the skin. Following randomization, patients began the double-blind phase of treatment. If you are taking this drug to treat seizures, note that untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, so do not stop taking this medication unless directed by your doctor. Topiramate will not treat a migraine headache once it occurs. Alcohol use should be completely avoided within 6 hours prior to and 6 hours after topiramate extended-release capsules administration [see Warnings and Precautions (5.5)]. Adults and Pediatric Patients 10 Years of Age and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures. Before taking topiramate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. BIN PCN Group Member ID. Your doctor will gradually increase your dose to reduce your risk of side effects. If you have migraine headaches or certain types of seizures, your doctor may prescribe topiramate for you. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus [see Use in Specific Populations (8.1)]. For children, the dosage is also based on weight. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. The no-effect dose (2.5 mg/kg/day) for embryofetal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. In Study 11, a total of 469 patients (416 females, 53 males) ranging in age from 13 to 70 years, were randomized and provided efficacy data. Indications and Usage 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. In patients, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg per day; however, there was an observed increase in systemic exposure of lithium (27% for Cmax and 26% for AUC) following topiramate doses up to 600 mg per day [see Drug Interactions (7.8)]. Decreased BMD in the lumbar spine was correlated with decreased serum bicarbonate, which commonly occurs with topiramate treatment and reflects metabolic acidosis, a known cause of increased bone resorption [see Warnings and Precautions (5.4)]. by: The recommended dose for topiramate extended-release capsules monotherapy in adults and in pediatric patients 10 years of age and older is 400 mg orally once daily. In topiramate-treated pediatric patients (12 to 17 years of age) compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. The long-term consequences of the SGA findings are not known. In adolescents, increase the topiramate to 50 mg twice daily and the valproate to 500 mg twice daily. Titrate topiramate extended-release capsules for the preventive treatment of migraine according to the following schedule: Dose and titration rate should be guided by clinical outcome. In pediatric patients (1 to 24 months) receiving adjunctive topiramate for partial-onset seizures, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with immediate-release topiramate (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, alkaline phosphatase, and total protein. In general, this feeling can be a symptom of heart attack, but it may not be. Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see Warnings and Precautions (5.12)]. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate tablets or placebo. In the NAAED pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.1%) was higher than the prevalence of infants exposed to reference AEDs (0.36%), or the prevalence in infants of mothers without epilepsy and without exposure to AEDs (0.12%). Two hundred sixty-five patients completed the entire 26-week double-blind phase. Breastfed babies may be sleepy or have diarrhea. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. If you overheat, quickly look for a place to cool down and rest. In Study 7, the 25 mg/day or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 mg/day or 50 mg/day until the target dose of 200 mg/day was reached. 30 tablets at Food Lion Pharmacy. Bottles of 100NDC-10370-367-01 Topiramate is used to treat certain types of seizures in adults and children who are at least 2 years old. Topamax tablets come in four strengths: 25 milligrams (mg), 50 mg, 100 mg, and 200 mg. Topamax sprinkle capsules come in two strengths: 15 mg and 25 mg. . Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Coupon Last updated Jun 5. Inactive ingredients: Sugar Spheres (contains sucrose and corn starch), Hypromellose, Povidone, Ethylcellulose, Titanium Dioxide and Talc. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Immediate-release topiramate does not influence the binding of sodium valproate. As in adults, hepatic enzyme-inducing antiepileptic drugs decrease the steady state plasma concentrations of topiramate. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Adverse reactions associated with discontinuing therapy that occurred in more than one immediate-release topiramate-treated patient were fatigue (1%), headache (1%), and somnolence (1%). In this analysis, the incidence of serious bleeding events for topiramate and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients. Do not use a household spoon because you may not get the correct dose. Rarely, topiramate may cause a very serious eye problem, generally within 1 month of starting treatment. Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Following baseline, patients were randomly assigned to placebo or topiramate in addition to their other AEDs. Patients who experienced a pre-specified minimum number of partial-onset seizures, with or without secondary generalization, during the baseline phase (12 seizures for 12-week baseline, 8 for 8-week baseline or 3 for 4-week baseline) were randomly assigned to placebo or a specified dose of topiramate tablets in addition to their other AEDs. Alcohol use is contraindicated within 6 hours prior to and 6 hours after topiramate extended-release capsules administration [see Contraindications (4) and Warnings and Precautions (5.5)]. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of immediate-release topiramate, the most common adverse reactions with immediate-release topiramate that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain [see Adverse Reactions (6.1)]. to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 6 years and older, 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 6 years and older. This medication may decrease the effectiveness of hormonal birth control products (such as pills, patch, ring). Otherwise, call a poison control center right away. Swallow capsule whole and intact. Table 5 presents the incidence of adverse reactions that occurred in at least 3% of pediatric patients 2 to 15 years of age receiving 5 mg/kg/day to 9 mg/kg/day (recommended dosage range) of immediate-release topiramate and was greater than placebo incidence. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide (HCTZ) (25 mg every 24 hours) and topiramate (96 mg every 12 hours) when administered alone and concomitantly. Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. Specific dosing in pediatric patients 6 to 9 years of age was derived from simulations utilizing plasma exposure ranges observed in pediatric and adult patients treated with immediate-release topiramate initial monotherapy [see Dosage and Administration (2.1)]. 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 topiramate 25 mg per day for 7 days in an open-label fashion. It's not exactly clear how this medication works to prevent migraines. The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use. The apparent elimination half-life was similar across age groups. Topiramate is cleared by hemodialysis. Compared to the fasted state, high-fat meal increased the Cmax of topiramate by 37% and shortened the Tmax to approximately 8 hours following a single dose of topiramate extended-release capsules, while having no effect on the AUC. Adult Patients With Partial-Onset Seizures. Patients received either no or a combination of other antiepileptic drugs. The risk for cognitive adverse reactions 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 (5.7)]. Lithium levels should be monitored when co-administered with high-dose topiramate extended-release capsules [see Clinical Pharmacology (12.3)]. The effectiveness of topiramate 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, dose-controlled, parallel-group trial (Study 1). In a single randomized, double-blind, placebo-controlled investigational trial, the efficacy, safety, and tolerability of immediate-release topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in pediatric patients 1 to 24 months of age with refractory partial-onset seizures were assessed. The clinical relevance of this observation has not been established. Keep topiramate extended-release capsules in a tightly closed container. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. Following randomization, patients began the double-blind phase of treatment. by: In all adjunctive topiramate trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. The most frequently reported neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue. Dosage is based on your medical condition and response to treatment. The most common ( 2% more frequent than in the 50 mg/day group) adverse reactions resulting in discontinuation in this trial were difficulty with concentration/attention, fever, flushing, and confusion. The effects of topiramate on milk production are unknown. 200 mg: Hard gelatin capsule with yellow opaque cap and white opaque body, imprinted with par on the cap and C368 on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Last updated on May 1, 2023. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. This medicine is a yellow, round, film-coated, tablet imprinted with "S" and "711". None of the pediatric patients who received topiramate adjunctive therapy at 5 mg/kg/day to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions. Does topiramate oral interact with other drugs you are taking? The clinical significance of this change is unknown. Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4)]. Interaction of topiramate extended-release capsules and standard AEDs is not expected to differ from the experience with immediate-release topiramate products. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Ask your doctor Q&A What is topiramate oral tablet? If you get a migraine headache, treat it as directed by your doctor (such as by taking pain medication, lying down in a dark room).Topiramate is known as an anticonvulsant or antiepileptic drug. Over the whole study, 76% more immediate-release topiramate-treated patients experienced persistent metabolic acidosis (i.e., 2 consecutive visits with or final serum bicarbonate < 20 mEq/L) compared to levetiracetam-treated patients. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 mg/day to 50 mg/day weekly increments. TOPAMAX is indicated for: Epilepsy: initial monotherapy in patients 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and. Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. The most common adverse reactions in the controlled trial (Study 1) that occurred in pediatric patients in the 400 mg/day topiramate group and at an incidence higher ( 10%) than in the 50 mg/day group were fever and weight loss (see Table 3). Keep topiramate extended-release capsules dry and away from moisture and light. This risk for cognitive/neuropsychiatric adverse reactions was also greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age). An increase in urinary bladder tumors was observed in mice given topiramate (0 mg/kg/day, 20 mg/kg/day, 75 mg/kg/day, and 300 mg/kg/day) in the diet for 21 months. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 17% and 25%, respectively, when topiramate was added. Topiramate extended-release capsules can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). Do not share this medication with others. If you take too much topiramate extended-release capsules, call your healthcare provider right away or go to the nearest emergency room. Approximately 80% or more patients in each treatment group completed the study. In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. The recommended total daily dose of topiramate extended-release capsules as adjunctive therapy for patients 6 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Patients in Study 8 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate tablets or placebo. Similarity of exposure-response was demonstrated in pediatric patients 6 to less than 16 years of age and adults when topiramate was given as initial monotherapy. The addition of HCTZ to topiramate extended-release capsules may require a decrease in the topiramate extended-release capsules dose [see Clinical Pharmacology (12.3)]. The decrease in BMD at 12 months was correlated with decreased serum bicarbonate, suggesting that metabolic acidosis was at least a partial factor contributing to this adverse effect on BMD. Bottles of 500NDC-10370-365-05, 50 mg (flesh opaque cap and flesh opaque body) topiramate extended-release capsules (black print par on the cap and C366 on the body) Total Daily Dose In pediatric patients (ranging from 6 to 17 years of age) receiving immediate-release topiramate for the preventive treatment of migraine, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with immediate-release topiramate (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils. In clinical trials, most of these events were reversible after topiramate discontinuation. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Topiramate extended-release capsules may slow height increase and weight gain in children and adolescents when used over a long period. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs) may be additive to the bicarbonate lowering effects of topiramate extended-release capsules. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches per 28 days and was similar across treatment groups. The conclusion that topiramate is effective as initial monotherapy in pediatric patients 6 to 9 years of age with partial-onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach using data from the controlled epilepsy trials conducted with immediate-release topiramate described in labeling. In children, a once- or twice-daily dose of 25 mg topiramate or 250 mg valproate in a sustained-release form is effective for migraine prophylaxis. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Topiramate is only weakly effective in blocking clonic seizures induced by the GABA-A receptor antagonist, pentylenetetrazole. (mg/day) Indicates p-value is <0.05 (two-sided). Topiramate received FDA approval in 1996 for treating epilepsy as monotherapy or adjunctive therapy. Negative effects on weight and height were seen across all immediate-release topiramate age subgroups. : 25/82/2020 Properly discard this product when it is expired or no longer needed. Titrate topiramate extended-release capsules according to the following schedule: Pediatric Patients Ages 6 to 9 Years of Age. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. In 2004, topiramate was approved for the prevention of migraine in adults. Counsel patients that topiramate extended-release capsules, especially pediatric patients, can cause decreased sweating and increased body temperature, especially in hot weather, and they should seek medical attention if this is noticed [see Warnings and Precautions (5.3)]. The results of 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials conducted in US (Study 11) or the US and Canada (Study 12) established the effectiveness of immediate-release topiramate in the preventive treatment of migraine. Clinical signs of maternal toxicity were seen at 400 mg/kg/day and above, and maternal body weight gain was reduced at doses of 100 mg/kg/day or greater. Topiramate extended-release capsules are available in the following strengths and colors: 25 mg: Hard gelatin capsule with orange opaque cap and orange opaque body, imprinted with par on the cap and C365 on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Continue reading. 25 mg (orange opaque cap and orange opaque body) topiramate extended release capsules (black print par on the cap and C365 on the body) Placebo target dosages were as follows: Study 4 (4 tablets/day); Studies 2 and 5 (6 tablets/day); Studies 6 and 7 (8 tablets/day); Study 3 (10 tablets/day). This product may contain inactive ingredients, which can cause allergic reactions or other problems. WebMD does not provide medical advice, diagnosis or treatment. Do not start a new medicine without talking with your healthcare provider. Drug information provided by: Merative, Micromedex Along with its needed effects, a medicine may cause some unwanted effects. This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate [see Drug Interactions (7.2)]. Topiramate is associated with an increased risk for bleeding. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. Patients With Primary Generalized Tonic-Clonic Seizures. Patients in Study 9 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to topiramate or placebo. Effectiveness of treatment was assessed by comparing each immediate-release topiramate treatment group to placebo (ITT population) for the percent reduction from baseline to the last 12 weeks of the double-blind phase in the monthly migraine attack rate (primary endpoint). Rx Only, Topamax, Trokendi XR, Eprontia, Qudexy XR. 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 immediate-release topiramate treatment group compared to placebo in the Intent-To-Treat (ITT) population. This rate appeared to increase at dosages above 400 mg per day. Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate extended-release capsules and any adjustments in amitriptyline dose should be made according to the patients clinical response and not on the basis of plasma levels [see Clinical Pharmacology (12.3)]. And children who are at least 2 Years old the topiramate 100 mg cialis black phase of treatment completed the entire double-blind.., carefully measure the dose using a special measuring device/spoon, Micromedex along with its needed,... See clinical Pharmacology ( 12.3 ) ] for a place to cool down and rest carefully. Provider may check for other causes medicine is a yellow, round, film-coated, tablet imprinted with `` ''! Get them ( 12.3 ) ] closed container monotherapy or adjunctive topiramate 100 mg cialis black the clinical trials.. 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