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Warn patients about the possible development of hyperammonemia with or without encephalopathy. TOPIRAMATE - ORAL. The significance of these findings is uncertain. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Symptoms include acute onset of decreased visual acuity and/or ocular pain. health information, we will treat all of that information as protected health Tell your doctor about all your current medicines. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Some people may need to be hospitalized for this condition. Table 10: Summary of AED Interactions with TOPAMAX. In some patients, hyperammonemia can be asymptomatic. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. Alfuzosin may also be used for purposes not listed in this medication guide. The prostate may continue to get larger. Talk to your healthcare provider if TOPAMAX has caused metabolic acidosis during your pregnancy. These drugs work in your brain to help prevent seizures. to prevent migraine headaches in adults and adolescents 12 years and older. You should not drink alcohol while taking TOPAMAX. You will need frequent medical tests. The solubility in water is 9.8 mg/mL. Medically reviewed by Sophia Entringer, PharmD. other information we have about you. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. privacy practices. The elderly subject population had reduced renal function (creatinine clearance [-20%]) compared to young adults. Warnings You should not take alfuzosin if you have moderate to severe liver disease. 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. The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. The recommended total daily dose of TOPAMAX as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. The significance of these findings is uncertain. Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state [see WARNINGS AND PRECAUTIONS]. 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 TOPAMAX dose and 1.7 for placebo. The 100 mg TOPAMAX dose produced a statistically significant treatment difference relative to placebo of 28% reduction from baseline in the monthly migraine attack rate. Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room. Topiramate is cleared by hemodialysis. You may report side effects to FDA at 1-800-FDA-1088. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. The clearance of topiramate was reduced by 42% in subjects with moderate renal impairment (creatinine clearance 30 to 69 mL/min/1.73 m2) and by 54% in subjects with severe renal impairment (creatinine clearance <30 mL/min/1.73 m2) compared to subjects with normal renal function (creatinine clearance >70 mL/min/1.73 m2) [see DOSAGE AND ADMINISTRATION]. The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in the preventive treatment of migraine trials was 26% in patients taking TOPAMAX monotherapy at 100 mg/day, and 14% in patients taking TOPAMAX at 50 mg/day, compared to 9% in patients taking placebo. The incidence of some adverse reactions (e.g., fatigue, dizziness, paresthesia, language problems, psychomotor slowing, depression, difficulty with concentration/attention, mood problems) was dose-related and much greater at higher than recommended TOPAMAX dosing (i.e., 600 mg - 1000 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (200 mg to 400 mg daily) range. The differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p=0.008 and p <0.001, respectively). All rights reserved. This interaction has not been evaluated in humans. Do not start or stop taking this medicine without your doctor's advice. 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). How can I watch for early symptoms of suicidal thoughts and actions? 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. Call your doctor if your seizures get worse or you have them more often while taking Topamax. Enter other medications to view a detailed report. Avoid becoming overheated or dehydrated in hot weather. Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. information submitted for this request. After titration, patients entered a 12-week stabilization period. The percent reduction from baseline to the last 12 weeks of the double-blind phase in average monthly migraine attack rate is shown in Table 13. Carefully follow the swallowing instructions for your medicine. In clinical trials, 3% of patients were over age 60. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. The noeffect dose (0.2 mg/kg/day) for pre- and postnatal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. The bioavailability of topiramate is not affected by food. Sometimes people with metabolic acidosis will: Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX. Figure 1: Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure in Study 1. This will be based on how well it is working for you and any side effects you may experience. Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed occurred more commonly in pediatric patients treated with topiramate compared to pediatric patients treated with placebo [see CLINICAL PHARMACOLOGY]. Topamax can increase the level of acid in your blood (metabolic acidosis). Tamsulosin oral capsule is used. (TOE-PA-MAX) When topiramate (0, 20, 100, or 500 mg/kg/day) was administered to pregnant mice during the period of organogenesis, incidences of fetal malformations (primarily craniofacial defects) were increased at all doses. 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. 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). In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years. The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. The median percent reductions in seizure rates and the responder rates (fraction of patients with at least a 50% reduction) by treatment group for each study are shown below in Table 12. Included as part of the "PRECAUTIONS" Section. Important Safety Information BPH can occur with other more serious conditions, including prostate cancer. The adverse reactions associated with discontinuing therapy in the TOPAMAX-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%). 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. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. The incidence of some adverse reactions (e.g., allergy, fatigue, headache, anorexia, insomnia, somnolence, and viral infection) was dose-related and greater at higher than recommended TOPAMAX dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily). Counsel patients, their caregivers, and families that AEDs, including TOPAMAX, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). The clinical significance of these findings is not known. Before taking TOPAMAX, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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]. . TOPAMAX Sprinkle Capsules should be stored in tightly-closed containers at or below 25C (77F). The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4.0 23.0) as compared to the risk in a background population of untreated women. Similarly, topiramate half-life was longer (13%) in the elderly. (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. In this rapid titration regimen, these dose-related adverse reactions began in the titration or in the maintenance phase, and in some patients these events began during titration and persisted into the maintenance phase. Medically reviewed by Sophia Entringer, PharmD. The longterm effects of this are not known. Body as a Whole-General Disorders: oligohydrosis and hyperthermia [see WARNINGS AND PRECAUTIONS], hyperammonemia, hyperammonemic encephalopathy [see WARNINGS AND PRECAUTIONS], hypothermia with concomitant valproic acid [see WARNINGS AND PRECAUTIONS], Gastrointestinal System Disorders: hepatic failure (including fatalities), hepatitis, pancreatitis, Skin and Appendage Disorders: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [see WARNINGS AND PRECAUTIONS], pemphigus, Urinary System Disorders: kidney stones, nephrocalcinosis [see WARNINGS AND PRECAUTIONS], Vision Disorders: acute myopia, secondary angle closure glaucoma [see WARNINGS AND PRECAUTIONS], maculopathy. 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. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX. There are 284 drugs known to interact with tamsulosin, along with 4 disease interactions, and 2 alcohol/food interactions. Copyright 1996-2023 Cerner Multum, Inc. Do not drink alcohol. Suicidal thoughts or actions can be caused by things other than medicines. 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. The following serious adverse reactions are discussed in more detail in other sections of the labeling: The data described in the following sections were obtained using TOPAMAX Tablets. In Table 10, 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. Tamsulosin (Flomax) is typically only prescribed for men, but it can be effective for women with some form of bladder obstruction. Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Following baseline, patients were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. 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). 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%). Topamax is the brand name for the drug topiramate.Topamax is approved to treat seizure disorders, like epilepsy, and to prevent migraine in adults.. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. 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