Begin titration at 25 mg once daily (or less, based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Topiramate extended-release capsules may cause serious side effects, including: See What is the most important information I should know about topiramate extended-release capsules?. For patients withdrawing from immediate-release topiramate, daily dosages were decreased in weekly intervals by 25 mg/day to 50 mg/day. Package insert / product label 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 immediate-release topiramate 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). Physicians should discuss the appropriate level of caution with their patients, before patients with epilepsy engage in such activities. Of the 1,135 patients exposed to immediate-release topiramate in the adult placebo-controlled studies, 25% discontinued due to adverse reactions, compared to 10% of the 445 placebo patients. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches per 28 days and was similar across treatment groups. Counsel patients to swallow topiramate extended-release capsules whole and intact. Take topiramate extended-release capsules whole. The mean reduction from baseline to the last 12 weeks of the double-blind phase in average monthly attack rate, a key secondary efficacy endpoint in Study 13 (and the primary efficacy endpoint in Studies 11 and 12, of adults) was 3.0 for 100 mg immediate-release topiramate dose and 1.7 for placebo. Week 2: 100 mg once daily. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17 mEq/L and 5mEq/L decrease from pretreatment) in these trials was up to 11%, compared to 2% for placebo. Do not stop taking this medication without consulting your doctor. by: You and your healthcare provider should decide if you will continue to take topiramate extended-release capsules while you are pregnant. Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. 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. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see Clinical Pharmacology (12.3)]. The differences between the immediate-release topiramate 100 mg and 200 mg per day groups versus placebo were similar and statistically significant (p = 0.008 and p < 0.001, respectively). In a rat embryofetal development study which included postnatal assessment of offspring, oral administration of topiramate (0 mg/kg/day, 0.2 mg/kg/day, 2.5 mg/kg/day, 30 mg/kg/day, and 400 mg/kg/day) to pregnant animals during the period of organogenesis resulted in delayed physical development in offspring at 400 mg/kg/day and persistent reductions in body weight gain in offspring at 30 mg/kg/day and higher. The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the UK (0.2%). Keep topiramate extended-release capsules dry and away from moisture and light. A dosage adjustment may be needed [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)]. All capsule shells are imprinted with black print that contains shellac, black iron oxide, propylene glycol, FD&C Red #40, FD&C Blue #2, FD&C Blue #1 and D&C Yellow #10. 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)]. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. This medication is also used to prevent migraine headaches and decrease how often you get them. Table 4: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adults *, , * Patients in these adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. You may report side effects to Health Canada at 1-866-234-2345. The median average daily dosages were 48 mg/day, 88 mg/day, and 132 mg/day in the target dose groups of topiramate 50 mg/day, 100 mg/day and 200 mg/day, respectively. Topiramate extended-release capsules can cause fetal harm when administered to a pregnant woman. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Do not stop topiramate extended-release capsules without first talking to a healthcare provider. During the titration period, the initial dose of topiramate extended-release capsules is 25 mg/day nightly for the first week. The design of both trials was identical, enrolling patients with a history of migraine with or without aura, for at least 6 months, according to the International Headache Society (IHS) diagnostic criteria. Following randomization, patients began the double-blind phase of treatment. In the US - Call your doctor for medical advice about side effects. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Red Iron Oxide (50 mg and 100 mg capsules), FD&C Yellow #6 (25 mg, 100 mg and 200 mg capsules), All capsule shells are imprinted with black print that contains shellac, black iron oxide, propylene glycol, FD&C red #40, FD&C blue #2, FD&C blue #1 and D&C yellow #10. 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). Metabolic acidosis may have harmful effects on your baby. 6. Stopping topiramate extended-release capsules suddenly can cause serious problems. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. Topiramate is only weakly effective in blocking clonic seizures induced by the GABA-A receptor antagonist, pentylenetetrazole. 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). If the decision is made to use topiramate extended-release capsules, you should use effective birth control (contraception) unless you are planning to become pregnant. Pharmacokinetics of immediate-release topiramate were evaluated in patients ages 2 to <16 years of age. There were no clinically significant changes in the systemic exposure of risperidone plus 9-hydroxyrisperidone or of topiramate; therefore, this interaction is not likely to be of clinical significance. Encourage pregnant women using topiramate extended-release capsules to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. In the double-blind placebo-controlled studies, adverse reactions led to discontinuation of treatment in 8% of placebo patients compared with 6% of immediate-release topiramate-treated patients. Body as a Whole-General Disorders: oligohydrosis and hyperthermia [see Warnings and Precautions (5.3)], hyperammonemia, hyperammonemic encephalopathy [see Warnings and Precautions (5.13)], hypothermia with concomitant valproic acid [see Warnings and Precautions 5.15)]. You may need a different medicine. In Table 9, the second column (AED concentration) describes what happens to the concentration of the co-administered AED listed in the first column when topiramate is added. If you have epilepsy and you stop taking topiramate extended-release capsules suddenly, you may have seizures that do not stop. Bottles of 100NDC-10370-368-01 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)]. 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. Bottles of 500NDC-10370-367-05, 200 mg (yellow opaque cap and white opaque body) topiramate extended-release capsules (black print par on the cap and C368 on the body) 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)]. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate extended-release capsules may be required. Therefore, alcohol use should be completely avoided within 6 hours prior to and 6 hours after topiramate extended-release capsules administration. In 2004, topiramate was approved for the prevention of migraine in adults. In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including topiramate extended-release capsules, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency [see Clinical Studies (14)]. In general, this feeling can be a symptom of heart attack, but it may not be. Extended-Release Capsules The apparent elimination half-life was similar across age groups. Topiramate extended-release capsules can be taken without regard to meals. Placebo Patients with Events per 1,000 Patients, Drug Patients with Events per 1,000 Patients, Relative Risk: 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 immediate-release topiramate 50 mg/day, 100 mg/day, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride, and ammonia, immediate-release topiramate was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies [see Warnings and Precautions (5.4, 5.13)]. In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of topiramate extended-release capsules are recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Ask your doctor or pharmacist for details. The effects of topiramate on milk production are unknown. These very young pediatric patients appeared to experience an increased risk for infections (any topiramate dose 12%, placebo 0%) and of respiratory disorders (any topiramate dose 40%, placebo 16%). Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. 5705185. Your healthcare provider will tell you how to stop taking topiramate extended-release capsules slowly. A one-year, active-controlled study of pediatric patients treated with immediate-release topiramate demonstrated that immediate-release topiramate decreased lumbar spine bone mineral density and that this lumbar spine bone mineral density decrease was correlated (using change from baseline for lumbar spine Z score at final visit versus lowest post-treatment serum bicarbonate) with decreased serum bicarbonate, a reflection of metabolic acidosis [see Warnings and Precautions (5.10), Use in Specific Populations (8.4)]. Table 8 Summary of Immediate-release Topiramate Treatment Difference Results at 12 Months for Key Safety Outcomes, Treatment Difference in Least Square Means (95 % Confidence Interval), Annual Change in BMD Lumbar Spine (g/cm2), Annual Change in Height (cm) (4 to 9 years, Primary Analysis Population for Height) **, Annual Change in Height (cm) (4 to 15 years), Annual Change in Height (cm) (10 to 15 years), Height Velocity (cm/year) (4 to 15 years), Height Velocity (cm/year) (10 to 15 years). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of metformin (500 mg every 12 hours) and topiramate in plasma when metformin was given alone and when metformin and topiramate (100 mg every 12 hours) were given simultaneously. BIN PCN Group Member ID. 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. Next . Although continued growth was observed in both treatment groups, the immediate-release topiramate group showed statistically significant reductions in mean annual change from baseline in body weight compared to the control group. Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs. Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Talk to your pharmacist for more details. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. 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. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, reduced Cmax by 18% and 25%, respectively. OS365-01-74-3 The relevance of this finding to human carcinogenic risk is uncertain. Topiramate extended-release capsules contain the following inactive ingredients: Sugar Spheres (contains sucrose and corn starch). (mg/day) Write a review. Topiramate is a seizure medicine, also called an anticonvulsant. 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 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. How long does it take for Topamax to start working? If you miss a dose, take it as soon as you remember. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. 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)]. This dataset contained data from 1217 subjects including 258 pediatric patients age 2 years to <16 years of age (95 pediatric patients less than 10 years of age). During adjunctive epilepsy trials, the risk for kidney stones in immediate-release topiramate-treated adults was 1.5%, an incidence about 2 to 4 times greater than expected in a similar, untreated population. 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. A very serious allergic reaction to this drug is rare. If they note such changes, they should call their health care professional and measure their body temperature. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). any medicines that impair or decrease your thinking, concentration, or muscle coordination. Week 3: 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). Metabolic acidosis (serum bicarbonate <20 mEq/L) was observed in all immediate-release topiramate-treated patients at some time in the study [see Warnings and Precautions (5.4)]. Metabolic acidosis can happen with or without symptoms. Dose titration should be guided by clinical outcome. Results of a one-year active-controlled study of pediatric patients (N=63) demonstrated negative effects of immediate-release topiramate monotherapy on growth (i.e., height and weight) [see Use in Specific Populations (8.4)]. USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Topiramate extended-release capsules and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Your healthcare provider may change your dose. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. A 15% decrease in the AUC,ss of pioglitazone with no alteration in Cmax,ss was observed. Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects and advise them not to drive or operate machinery until they have gained sufficient experience on topiramate extended-release capsules to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions (5.7)]. In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 mcg ethinyl estradiol (EE), immediate-release topiramate, given in the absence of other medications at doses of 50 mg/day to 200 mg/day, was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia. Based on the recovery of radioactivity from the urine the mean extent of absorption of a 100 mg oral dose of 14 C-topiramate was at . Consideration should be given to stopping topiramate extended-release capsules or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. Lithium levels should be monitored when co-administered with high-dose topiramate extended-release capsules [see Clinical Pharmacology (12.3)]. The median average daily dosages were 45 mg/day and 79 mg/day in the target dose groups of immediate-release topiramate 50 mg/day and 100 mg/day, respectively. Ask your pharmacist about using those products safely. Advise patients taking topiramate extended-release capsules to seek immediate medical attention if they experience blurred vision, visual disturbances or periorbital pain [see Warnings and Precautions (5.1, 5.2)]. Negative effects on weight and height were seen across all immediate-release topiramate age subgroups. Topiramate extended-release capsules should be stored in well closed containers at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, topiramate extended-release capsules should be used with extreme caution if used in combination with alcohol and other CNS depressants [see Contraindications (4) and Warnings and Precautions (5.7)]. 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. Pediatric Patients 6 Years to 15 Years of Age. Any AED therapy used for temporary or emergency purposes was discontinued prior to randomization. Do not use topiramate extended-release capsules for a condition for which it was not prescribed. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. This effect can result in pregnancy. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Talk to your healthcare provider about the best way to feed your baby if you take topiramate extended-release capsules. This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Patients treated in these studies experienced mean percent reductions in body weight that were dose-dependent. How should I take topiramate extended-release capsules? birth control pills. Topiramate ER Capsules Prescribing Information, A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. 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)]. Patients received active drug beginning at 50 mg/day for four weeks; the dose was then increased by 50 mg/day to 150 mg/day increments every other week until the assigned dose of 175 mg/day, 225 mg/day or 400 mg/day based on patients' body weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. The sample size and study duration were too small to determine if fracture risk is increased. Dosing in patients 6 to 9 years of age is based on weight. What is Topamax and how is it used? After titration, patients entered a 12-week stabilization period. Forty-nine percent of subjects had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Symptoms of overdose may include: severe drowsiness, loss of consciousness. It is also used to help prevent migraine headaches. Patients who experienced 3 to 12 migraine headaches over the 4 weeks in the baseline phase were randomized to either immediate-release topiramate 50 mg/day, 100 mg/day, 200 mg/day (twice the recommended daily dosage for migraine prophylaxis) or placebo, and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period.). Table 6: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adults*,,, * Includes 35 adolescent patients age 12 to 15 years. Table 6 includes those adverse reactions that occurred in the placebo-controlled trials where the incidence in any immediate-release topiramate group was at least 3% and was greater than that for placebo patients. Drug information provided by: Merative, Micromedex Along with its needed effects, a medicine may cause some unwanted effects. Incidence is based on the number of subjects experiencing at least 1 adverse event, not the number of events. Topiramate is used to treat certain types of seizures in adults and children who are at least 2 years old. Titrate topiramate extended-release capsules according to the following schedule: Week 1: 50 mg once daily. Protect from moisture and light. 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) Overdose may include: severe drowsiness, loss of consciousness metabolites are formed via hydroxylation, hydrolysis and... 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