TOPAMAX is a carbonic anhydrase inhibitor. Therefore, advise all patients taking TOPAMAX for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). Effectiveness of treatment was assessed by comparing each TOPAMAX 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). Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Carbonic anhydrase inhibitor anticonvulsants. The clinical relevance of this observation has not been established. Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole. Version: 23.01. The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. After titration, patients entered a 4, 8 or 12-week stabilization period. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX during pregnancy. 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). Reductions in length and weight were correlated to the degree of acidosis [see Use In Specific Populations]. Co-administration of diltiazem (240 mg Cardizem CD) with topiramate (150 mg/day) resulted in a 10% decrease in Cmax and a 25% decrease in diltiazem AUC, a 27% decrease in Cmax and an 18% decrease in des-acetyl diltiazem AUC, and no effect on N-desmethyl diltiazem. Last updated on Jan 16, 2023. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use In Specific Populations]. TOPAMAX passes into breast milk. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. This is not a complete list of side effects and others may occur. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. These eye problems can lead to permanent loss of vision if not treated. Table 13: Percent Reduction from Baseline to the Last 12 Weeks of Double-Blind Phase in Average Monthly Attack Rate: Study 13 (Intent-to-Treat Analysis Set), TOPAMAX When administered concomitantly with topiramate at escalating doses of 100, 250, and 400 mg/day, there was a reduction in risperidone systemic exposure (16% and 33% for steady-state AUC at the 250 and 400 mg/day doses of topiramate). It may harm them. TOPAMAX Sprinkle Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. Some patients with refractory epilepsy will need to avoid such activities altogether. Call your healthcare provider right away if you have any of the symptoms above. 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]. Warn patients about the possible development of hyperammonemia with or without encephalopathy. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Enter other medications to view a detailed report. Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. 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. Food and drink that may interact with this drug include: Taking tamsulosin with any food may decrease its effectiveness by 30 percent, according to the FDA . Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Efficacy of topiramate (2 to 3 mg/kg/day) for the preventive treatment of migraine was not demonstrated in a placebo-controlled trial of 157 pediatric patients (6 to 16 years of age) that included treatment of 67 pediatric patients (12 to 16 years of age) for 20 weeks. The inactive ingredients are black pharmaceutical ink, cellulose acetate, gelatin, povidone, sodium lauryl sulfate, sorbitan monolaurate, sugar spheres (sucrose and starch) and titanium dioxide. TOPAMAX (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. US Brand Name Flomax Descriptions Tamsulosin is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). The effectiveness of TOPAMAX as an adjunctive treatment for primary generalized tonicclonic seizures in patients 2 years of age and older was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 9), comparing a single dosage of TOPAMAX and placebo (see Table 12). This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. Some of the cases were reported after exposure to elevated environmental temperatures. The following adverse reactions were observed in at least 3% of patients on topiramate and were 3% to 7% more frequent than in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. 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). Your family or other caregivers should also be alert to changes in your mood or symptoms. Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. 6. Topiramate is cleared by hemodialysis. Warnings Topamax may cause vision problems that can be permanent if not treated quickly. The solubility in water is 9.8 mg/mL. Hemodialysis is an effective means of removing topiramate from the body. 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. 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. Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. Multiple dosing of topiramate (200 mg/day) in 24 healthy volunteers (12 males, 12 females) did not affect the pharmacokinetics of a 1 mg subcutaneous dose of dihydroergotamine. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Two hundred sixty-five patients completed the entire 26-week double-blind phase. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. Stopping suddenly may increase the risk of seizures or other withdrawal side effects. 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 a reference AED (0.36%) or the prevalence of infants in mothers without epilepsy and without exposure to AEDs (0.12%). The recommended total daily dose of TOPAMAX as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Reflecting the primary renal elimination of topiramate, topiramate plasma and renal clearance were reduced 21% and 19%, respectively, in elderly subjects, compared to young adults. 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. This drug/food mixture should be swallowed immediately and not chewed. The clinical significance of this change is unknown. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate resulted in an increased incidence of patients with increased creatinine (any topiramate dose 5%, placebo 0%), BUN (any topiramate dose 3%, placebo 0%), and protein (any topiramate dose 34%, placebo 6%), and an increased incidence of decreased potassium (any topiramate dose 7%, placebo 0%). Drug information provided by: Merative, Micromedex. Topiramate will not treat a migraine headache once it occurs. TOPAMAX may cause serious side effects including: See What is the most important information I should know about TOPAMAX?. 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. 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). See additional information. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. Last updated on Apr 5, 2023. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of TOPAMAX is recommended [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. decreased sensation (especially in the skin), 25 mg cream tablet (debossed OMN on one side; "25" on the other) and are available in bottles of 60 count with desiccant (, 50 mg light yellow tablet (debossed OMN on one side; "50" on the other) and are available in bottles of 60 count with desiccant (, 100 mg yellow tablet (debossed OMN on one side; "100" on the other) and are available in bottles of 60 count with desiccant (, 200 mg salmon tablet (debossed OMN on one side; "200" on the other) and are available in bottles of 60 count with desiccant (, 15 mg capsule with TOP and 15 mg on the side and are available in bottles of 60 (, 25 mg capsule with TOP and 25 mg on the side and are available in bottles of 60 (, Acute Myopia and Secondary Angle Closure Glaucoma [see, Cognitive/Neuropsychiatric Adverse Reactions [see, Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see, Hypothermia with Concomitant Valproic Acid (VPA) Use [see. 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