Available for Android and iOS devices. Do not start a new medicine without talking with your healthcare provider. 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. Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. No age-related differences in effectiveness or adverse effects were evident. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. any sudden decrease in vision with or without eye pain and redness. Topamax is the brand name for the drug topiramate.Topamax is approved to treat seizure disorders, like epilepsy, and to prevent migraine in adults.. You may report side effects to FDA at 1-800-FDA-1088. 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). Enter other medications to view a detailed report. Talk to your healthcare provider if you have questions about this risk during pregnancy. Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Take Topamax exactly as it was prescribed for you. 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. There was a mean dose-related increase in alkaline phosphatase. For patients withdrawing from TOPAMAX, daily dosages were decreased in weekly intervals by 25 to 50 mg/day. have or have had depression, mood problems, or suicidal thoughts or behavior. In pooled, controlled clinical trials in pediatric patients (2 to 15 years of age) with partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, 98 patients received adjunctive therapy with TOPAMAX at dosages of 5 to 9 mg/kg/day (recommended dose range) and 101 patients received placebo. Topamax can increase the level of acid in your blood (metabolic acidosis). privacy practices. Some of the cases were reported after exposure to elevated environmental temperatures. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. You may report side effects to FDA at 1-800-FDA-1088. Evidence of maternal toxicity (decreased body weight gain, clinical signs, and/or mortality) was seen at 35 mg/kg/day and above. In comparison, topiramate clearance per kg is greater in pediatric patients than in adults and in young pediatric patients (down to 2 years) than in older pediatric patients. The significance of these findings is uncertain. Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraines classified by IHS criteria) from the baseline phase to double-blind treatment period in each TOPAMAX treatment group compared to placebo in the Intent-To-Treat (ITT) population. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration. Stopping suddenly may cause increased seizures. Keep TOPAMAX in a tightly closed container. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). It will not treat a headache that has already begun. Topiramate is designated chemically as 2,3:4,5- Di-O-isopropylidene--D-fructopyranose sulfamate and has the following structural formula: TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide. Do not use TOPAMAX for a condition for which it was not prescribed. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. When taken twice a day, the medicine is usually taken in the morning and evening. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Multiple dosing of venlafaxine (150 mg) did not affect the pharmacokinetics of topiramate. What should I avoid while taking TOPAMAX? Stopping TOPAMAX suddenly can cause serious problems. Your reactions could be impaired. Topamax may cause blurred vision and may impair your thinking or reactions. Topiramate does not influence the binding of sodium valproate. The recommended titration rate for TOPAMAX for the preventive treatment of migraine is as follows: Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older. Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. There was a suggestion that this effect was dose-related. TOPAMAX 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). Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. Drug class: Alpha-adrenoreceptor antagonists. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The total daily dose should not exceed 400 mg/day. Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state [see WARNINGS AND PRECAUTIONS]. Two hundred fifty-five patients completed the entire 26-week double-blind phase. It may causes side effects like confusion, drowsiness, dizziness, or blurred vision. Although not studied, topiramate treatment or an interaction of concomitant topiramate and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. Store TOPAMAX Tablets at room temperature between 59F to 86F (15C to 30C). The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. The most common side effects of TOPAMAX include: Tell your healthcare provider about any side effect that bothers you or that does not go away. The conclusion that TOPAMAX is effective as initial monotherapy in pediatric patients 2 to 9 years of age with partial-onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach using data from the controlled epilepsy trials described in labeling. TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. Table 6 presents the incidence of adverse reactions occurring in at least 3% of adult patients treated with 200 to 400 mg/day TOPAMAX and was greater than placebo incidence. Active Ingredient: tamsulosin hydrochloride The treatment differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p<0.001 for both comparisons). Drug class: Carbonic anhydrase inhibitor anticonvulsants. Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. Tell your doctor if you have decreased sweating, high fever, and hot dry skin. 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. The effectiveness of TOPAMAX as an adjunctive treatment for pediatric patients 2 to 16 years of age with partial-onset seizures was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 8), comparing TOPAMAX and placebo in patients with a history of partial-onset seizures, with or without secondarily generalized seizures (see Table 12). All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPAMAX. As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial. 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. 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. Call your doctor for medical advice about side effects. The significance of these findings is uncertain. Antiepileptic drugs (AEDs), including TOPAMAX, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Topiramate is used to treat seizures in adults and children who are at least 2 years old. seizures. 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]. This may help prevent kidney stones while taking TOPAMAX. 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]. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Included as part of the "PRECAUTIONS" Section. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. 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. Call your healthcare provider right away if you have any of the symptoms above. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. 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]. 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. Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. Your doctor should check your progress at regular visits. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. The long-term consequences of the SGA findings are not known. Your family or other caregivers should also be alert to changes in your mood or symptoms. 6. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. 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). 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. Efficacy of topiramate for the preventive treatment of migraine in pediatric patients 12 to 17 years of age is demonstrated for a 100 mg daily dose in Study 13 [see Clinical Studies]. Some of these drugs, including Topamax, can also prevent migraine headaches.. Clinical signs of maternal toxicity were seen at 400 mg/kg/day and above, and maternal body weight gain was reduced at doses of 100 mg/kg/day or greater. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. 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. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. The prostate gland is located below the bladder. Tamsulosin systemic 0.4 mg (ZA-18 0.4 mg). The risk for cognitive adverse reaction 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]. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility Follow your healthcare providers directions exactly. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). The most common adverse reactions with TOPAMAX 100 mg in the clinical trials for the preventive treatment of migraine of predominantly adults that were seen at an incidence higher ( 5 %) than in the placebo group were: paresthesia, anorexia, weight loss, taste perversion, diarrhea, difficulty with memory, hypoesthesia, and nausea (see Table 8). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. How long do you stay on Topamax for migraines? If you cannot swallow a Topamax Sprinkle Capsule whole, open the capsule and sprinkle the medicine into a spoonful of applesauce or other soft food. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. Continue reading, Topamax (topiramate) is approved to be taken alone or with other medicines to control certain types of seizures and for the prevention of migraine headaches. 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. Anyone considering prescribing TOPAMAX or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. There is evidence of renal tubular reabsorption of topiramate. No alterations of 9-hydroxyrisperidone levels were observed. Some patients may experience a large increase in amitriptyline concentration in the presence of TOPAMAX and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see CLINICAL PHARMACOLOGY]. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. 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. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Copyright 1996-2023 Cerner Multum, Inc. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. After titration, patients entered an 8-week stabilization period. This Medication Guide has been approved by the U.S. Food and Drug Administration. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. 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. Swallow the capsule whole and do not crush, chew, break, or open it. 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). The relative bioavailability of topiramate from the tablet formulation is about 80% compared to a solution. 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). Its saturated solution has a pH of 6.3. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. 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%). A dosage adjustment may be needed [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see WARNINGS AND PRECAUTIONS]. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. It blocks a specific type of receptor found in the prostate. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. 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), TOPAMAX, given in the absence of other medications at doses of 50 to 200 mg/day, was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive. TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. Topiramate is only weakly effective in blocking clonic seizures induced by the GABAA receptor antagonist, pentylenetetrazole. The pharmacokinetics of topiramate in elderly subjects (65 to 85 years of age, N=16) were evaluated in a controlled clinical study. Tell your doctor right away if you become pregnant. The fraction bound decreased as blood concentration increased. 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