The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. Consider the benefits and the risks of TOPAMAX when administering this drug in women of childbearing potential, particularly when TOPAMAX is considered for a condition not usually associated with permanent injury or death [see Use In Specific Populations, PATIENT INFORMATION]. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. You can enroll in this registry by calling 1-888-233-2334. Specific dosing in pediatric patients 2 to 9 years of age was derived from simulations utilizing plasma exposure ranges observed in pediatric and adult patients treated with TOPAMAX initial monotherapy [see DOSAGE AND ADMINISTRATION]. Do not stop using this medication before surgery unless your surgeon tells you to. Topiramate Class. Dosing in patients 2 to 9 years of age is based on weight. Keep TOPAMAX and all medicines out of the reach of children. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see CLINICAL PHARMACOLOGY]. 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 TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Topamax may be used alone or with other medications. Patients who were experiencing at least 60 seizures per month before study entry were stabilized on optimum dosages of their concomitant AEDs during a 4-week baseline phase. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. Patients received active drug beginning at 25 or 50 mg/day; the dose was then increased by 25 mg to 150 mg/day increments every other week until the assigned dosage of 125, 175, 225, or 400 mg/day based on patients' weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. In this analysis, the incidence of serious bleeding events for TOPAMAX and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients. Call your healthcare provider right away if you have any of the symptoms above. Benign enlargement of the prostate is a problem that can occur in men as they get older. 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). Using Topamax with other drugs that make you drowsy can worsen this effect. Yes, topiramate (Topamax) has been shown to cause weight loss when used for both seizure control and migraine prevention. This medicine will only prevent migraine headaches or reduce the number of attacks. Following baseline, patients were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. 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. Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself. The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. Carbamazepine and phenytoin do not alter the binding of topiramate. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. [5] This medication is also used to prevent migraine headaches and decrease how often you get them. When topiramate (0, 30, 90, and 300 mg/kg/day) was administered orally to rats during the juvenile period of development (postnatal days 12 to 50), bone growth plate thickness was reduced in males at the highest dose. Swallow the tablets whole and do not crush, chew, or break a tablet. Insomnia. to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older. Mayo Clinic does not endorse companies or products. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. (TOE-PA-MAX) TOPAMAX can increase the level of acid in your blood (metabolic acidosis). The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. See additional information. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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]. TOPAMAX-induced metabolic acidosis can occur at any time during treatment. This change was not seen in the placebo group. In Study 12, a total of 468 patients (406 females, 62 males), ranging in age from 12 to 65 years, were randomized and provided efficacy data. Warnings You should not take alfuzosin if you have moderate to severe liver disease. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Ask your doctor about any risks. 6. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. Sometimes it is not safe to use certain medicines at the same time. The design of both trials (Study 11 was conducted in the U.S. and Study 12 was conducted in the U.S. and Canada) 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. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Some people use Topamax to treat other . Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. The third column (topiramate concentration) describes how the co-administration of a drug listed in the first column modifies the concentration of topiramate when compared to TOPAMAX given alone. TOPAMAX is indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring [see Use In Specific Populations]. During the titration period, the initial dose of TOPAMAX is 25 mg/day nightly for the first week. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. 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. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. Systematic collection of orthostatic vital signs has not been conducted. Controlled trials of adjunctive TOPAMAX treatment of adults for partial-onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% TOPAMAX versus 2% placebo), markedly increased serum alkaline phosphatase (3% TOPAMAX versus 1% placebo), and decreased serum potassium (0.4 % TOPAMAX versus 0.1 % placebo). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. There was a mean dose-related increase in alkaline phosphatase. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Patients who experienced at least six partial-onset seizures, with or without secondarily generalized seizures, during the baseline phase were randomly assigned to placebo or TOPAMAX tablets in addition to their other AEDs. Antiepileptic drugs (AEDs), including TOPAMAX, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. information and will only use or disclose that information as set forth in our notice of 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). In the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day and 26% for 400 mg/day. 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. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. In pediatric patients (ranging from 6-17 years of age) receiving TOPAMAX for the preventive treatment of migraine, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils, The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils [see Use In Specific Populations]. 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. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age.