Your doctor may occasionally change your dose. 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. Comments: drugs a-z list Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. There may be other medicines to treat your condition that have a lower chance of birth defects. If required, longer intervals between dose adjustments can be used. The clinical significance of these findings is not known. Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. It improves the flow of urine by relaxing. Subset analyses of the antiepileptic efficacy of TOPAMAX tablets in these studies showed no differences as a function of gender, race, age, baseline seizure rate, or concomitant AED. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. This medicine is available only with your doctor's prescription. This may help increase the flow of urine or decrease the symptoms. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, and Cmax was reduced by 18% and 25%, respectively. 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. Topiramate doses are sometimes based on weight in children. Dosage form: oral capsule (0.4 mg) The following adverse reactions have been identified during post approval use of TOPAMAX. . 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. The primary measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure severity. The most common (2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion. Multiple dosing of topiramate (100 mg every 12 hours) in 24 healthy volunteers (14 males, 10 females) did not affect the pharmacokinetics of single-dose sumatriptan either orally (100 mg) or subcutaneously (6 mg). seizures. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. Get emergency medical help if you have signs of an allergic reaction to Topamax (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Newborns of mothers treated with TOPAMAX should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Call your healthcare provider right away if you have any of the symptoms above. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. However, having a seizure during pregnancy could harm both the mother and the baby. The clinical significance of these various changes in vital signs has not been clearly established. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. What should I avoid while taking TOPAMAX? 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. These eye problems can lead to permanent loss of vision if not treated. Pharmacokinetics of topiramate were evaluated in patients age 2 to <16 years. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Keep TOPAMAX and all medicines out of the reach of children. A generally similar profile was observed in older pediatric patients [see ADVERSE REACTIONS]. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. 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. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see WARNINGS AND PRECAUTIONS]. Manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Last updated on Jan 16, 2023. 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]. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Some of the cases were reported after exposure to elevated environmental temperatures. For the monotherapy epilepsy population, the incidence of somnolence was dose-related. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Difficulty with concentration/attention occurred in 3 topiramate-treated patients (5%) and 0 placebo-treated patients. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. 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). The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in adults in the 400 mg/day TOPAMAX group and at an incidence higher ( 10 %) than in the 50 mg/day group were: paresthesia, weight loss and anorexia (see Table 5). Do not start a new medicine without talking with your healthcare provider. Call your doctor for medical advice about side effects. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. information is beneficial, we may combine your email and website usage information with USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Objective: To compare the efficacy and tolerability of the alpha 1 A-subtype selective drug tamsulosin with the nonsubtype-selective agent alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. 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]. For the adjunctive epilepsy population, the incidence of fatigue, appeared dose related. Not all possible drug interactions are listed here. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. Advise patients to contact their healthcare provider if they have missed more than one dose. Two hundred fifty-five patients completed the entire 26-week double-blind phase. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Table 8 includes those adverse reactions that occurred in the placebo-controlled trials where the incidence in any TOPAMAX treatment group was at least 3% and was greater than that for placebo patients. Know the medicines you take. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. You may report side effects to FDA at 1-800-FDA-1088. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. 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. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. It should not be stored for future use. Using Topamax with other drugs that make you drowsy can worsen this effect. There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. TOPAMAX Sprinkle Capsules contain small, white to off-white spheres. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. In both studies, there were no apparent differences in treatment effect within age or gender subgroups. How can I watch for early symptoms of suicidal thoughts and actions? Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If you stop using this medicine, do not start it again without your doctor's advice. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone [see DRUG INTERACTIONS]. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. TOPAMAX increases the risk of kidney stones. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients [see WARNINGS AND PRECAUTIONS]. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Table 9 also shows adverse reactions in pediatric patients in the controlled migraine trials when the incidence in a TOPAMAX dose group was at least 5 % or higher and greater than the incidence of placebo. You stop using this medicine, do not start a new medicine without talking with doctor... Temperature and decrease sweating, leading to life-threatening dehydration ( especially in children ) of breakthrough bleeding see... Of effectiveness were the percent reduction in AUC24 for glyburide during topiramate administration various changes vital. Approximately 1 to 2 hours children ) decreased even in the absence of breakthrough bleeding [ WARNINGS! 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