TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Topamax was originally FDA-approved as a seizure medicine, also called an anticonvulsant. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. This is not a complete list of side effects and others may occur. Following randomization, patients began the double-blind phase of treatment. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Patients who experienced 3 to 12 migraine headaches over the 4 weeks in the baseline phase were randomized to either TOPAMAX 50 mg/day, 100 mg/day, 200 mg/day, or placebo and treated for a total of 26 weeks (8-week titration period and 18-week maintenance period). acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. This drug/food mixture should be swallowed immediately and not chewed. By blocking these receptors, the medication works by relaxing the muscles in your prostate and bladder, which relieves symptoms of BPH by making it easier to urinate. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. If you stop using tamsulosin for several days in a row, do not start it again without your doctor's advice. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). . Copyright: Merative US L.P. 1973, 2023. Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on TOPAMAX to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see WARNINGS AND PRECAUTIONS]. Available for Android and iOS devices. Store at cool room temperature away from moisture, light, and high heat. . Ask your doctor about prostate cancer screening before and while taking this medicine. The incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. The lowest dose tested, which was associated with increased malformations, is less than the maximum recommended human dose (MRHD) for epilepsy (400 mg/day) or migraine (100 mg/day) on a body surface area (mg/m2) basis. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Not all possible drug interactions are listed here. 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. information submitted for this request. 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. Dosage form: oral capsule (0.4 mg) Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). TOPAMAX increases the risk of kidney stones. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. 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. Does tamsulosin interact with my other drugs? alpha 1 receptor antagonist. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and >5 mEq/L decrease from pretreatment) in these trials was up to 11%, compared to 2% for placebo. In pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults. 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. Protect from moisture. 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 steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. Approximately 21% of the 159 adult patients in the 400 mg/day group who received TOPAMAX as monotherapy in Study 1 discontinued therapy due to adverse reactions. Topamax is the brand name for the drug topiramate.Topamax is approved to treat seizure disorders, like epilepsy, and to prevent migraine in adults.. The incidence of these abnormal shifts was 6 % for placebo, 10% for 5 mg/kg/day, 9% for 15 mg/kg/day, 14% for 25 mg/kg/day, and 11% for any topiramate dose. There may be other medicines to treat your condition that have a lower chance of birth defects. Do not start a new medicine without talking with your healthcare provider. 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. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. Dosage adjustment may be necessary for elderly with age-related renal impairment (creatinine clearance rate <70 mL/min/1.73 m2) resulting in reduced clearance [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. In rats, given probenecid to inhibit tubular reabsorption, along with topiramate, a significant increase in renal clearance of topiramate was observed. It should not be stored for future use. Copyright 1996-2023 Cerner Multum, Inc. These comprised a fixed dose study in 103 pediatric patients 12 to 17 years of age [see Clinical Studies], a flexible dose (2 to 3 mg/kg/day), placebo-controlled study in 157 pediatric patients 6 to 16 years of age (including 67 pediatric patients 12 to 16 years of age), and a total of 49 pediatric patients 12 to 17 years of age in 3 studies for the preventive treatment of migraine primarily in adults. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. Longterm, open-label treatment of pediatric patients 1 to 24 months old with intractable partial epilepsy, for up to 1 year, showed reductions from baseline in length, weight, and head circumference compared to age and sex-matched normative data, although these patients with epilepsy are likely to have different growth rates than normal 1 to 24 month old pediatrics. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. Because most patients were Caucasian, there were insufficient numbers of patients from different races to make a meaningful comparison of race. vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly); confusion, problems with thinking or memory, trouble concentrating, problems with speech; dehydration symptoms--decreased sweating, high fever, hot and dry skin; signs of a kidney stone--severe pain in your side or lower back, painful or difficult urination; signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or. Some of the cases were reported after exposure to elevated environmental temperatures. If we combine this information with your protected Common tamsulosin side effects may include: abnormal ejaculation, decreased amount of semen; runny or stuffy nose, sore throat, cough; This is not a complete list of side effects and others may occur. These are not all the possible side effects of TOPAMAX. In general, the adverse reaction profile for TOPAMAX in this population was similar to that of older pediatric patients, although results from the above controlled study and an open-label, long-term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions/toxicities (not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. The majority of the reports have been in pediatric patients. Safety and effectiveness in patients below the age of 2 years have not been established for the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Patients treated with TOPAMAX experienced mean percent reductions in body weight that were dose-dependent. TOPAMAX (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: TOPAMAX (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. How quickly can acute migraines be treated? Psychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations [see Suicidal Behavior And Ideation]. A dosage adjustment is recommended in patients with moderate or severe renal impairment [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. The studies described in the following sections were conducted using TOPAMAX (topiramate) Tablets. Description and Brand Names. What should I avoid while taking TOPAMAX? 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. There was a suggestion that this effect was dose-related. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using TOPAMAX, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [see DRUG INTERACTIONS]. It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. 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 all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. 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. It will not treat a headache that has already begun. 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). You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant. 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. Ask your doctor about any risks. Higher daily doses (400 mg/day) of topiramate were associated with greater rates of hair loss than lower doses (50 mg/day) in both age groups. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of TOPAMAX, the most common adverse reactions with TOPAMAX that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain [see ADVERSE REACTIONS]. Two hundred fifty-five patients completed the entire 26-week double-blind phase. 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). In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate [see Clinical Trials Experience]. If you stop taking this medicine for any reason, call your doctor before you start taking it again. Warn patients about the possible development of hyperammonemia with or without encephalopathy. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. You are encouraged to report negative side effects of prescription drugs to the FDA. 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. Active drug was titrated beginning at 1 mg/kg/day for a week; the dose was then increased to 3 mg/kg/day for one week, then to 6 mg/kg/day. Topiramate treatment can cause hyperammonemia with or without encephalopathy [see ADVERSE REACTIONS]. Not all possible drug interactions are listed here. 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. Clearance was independent of dose. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. 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). 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]. 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). For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. 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]. Postmarketing side effects of tamsulosin reported include: Prolonged erection (rare) Signs and symptoms of low blood pressure, including lightheadedness and fainting. Topamax pregnancy and breastfeeding warnings. TOPAMAX is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topamax is also used 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. Sometimes it is not safe to use certain medicines at the same time. Find patient medical information for tamsulosin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. You may report side effects to FDA at 1-800-FDA-1088. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. Topamax can be taken with or without food. 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). Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. Yes, topiramate (Topamax) has been shown to cause weight loss when used for both seizure control and migraine prevention. After titration, patients entered an 8-week stabilization period. Avoid the use of a ketogenic or "ketosis" diet (high in fat, low in carbohydrates) while you are taking Topamax. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or depression. Do not take two doses at one time. You will need frequent medical tests. SPRINKLE CAPSULES, for oral use. Topiramate did not affect metformin tmax. This Medication Guide has been approved by the U.S. Food and Drug Administration. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs) may be additive to the bicarbonate lowering effects of TOPAMAX. This may help increase the flow of urine or decrease the symptoms. Avoid driving or hazardous activity until you know how this medicine will affect you. are breastfeeding or plan to breastfeed. 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. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. You can enroll in this registry by calling 1-888-233-2334. 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]. Tell your doctor right away if you become pregnant. TOPAMAX can increase the level of acid in your blood (metabolic acidosis). Avoid driving or hazardous activity until you know how this medicine will affect you. Table 11: TOPAMAX Dose Summary During the Stabilization Periods of Each of Six Double-Blind, Placebo-Controlled, Adjunctive Trials in Adults with Partial- Onset Seizuresa. TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. There was a mean dose-related increase in alkaline phosphatase. This change was not seen in the placebo group. A generally similar profile was observed in older pediatric patients [see ADVERSE REACTIONS]. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. Use: Benign prostatic hyperplasia (BPH). It is not known if Topamax is safe and effective in children younger than 2 years of age. The effects of these interactions on mean plasma AUCs are summarized in Table 10. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. The median average daily dosages were 48 mg/day, 88 mg/day, and 132 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. You should not drink alcohol while taking topiramate.. Tell your doctor if you are sick with diarrhea, or if you have ever had: metabolic acidosis (high levels of acid in your blood); kidney disease, kidney stones, or dialysis; mood problems, depression, or suicidal thoughts or actions; soft or brittle bones (osteoporosis, osteomalacia). 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. 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]. Topiramate treatment also produced a dose-related increase in the percentage of patients who had a shift from normal at baseline to high/increased (above the normal reference range) in total eosinophil count at the end of treatment. side effects drug center topamax (topiramate) drug. Topiramate treatment can cause hyperammonemia with or without encephalopathy [ see adverse reactions.. Eye ( secondary angle closure glaucoma has been reported in patients receiving.... Acidosis, especially if you become pregnant alterations in level of consciousness and/or cognitive function with lethargy and/or.... Metabolites have been identified in humans, none of which constitutes more than 5 % of an administered.! And administration, CLINICAL PHARMACOLOGY ] 100 mg/day, respectively of which constitutes more than %. Doctor about prostate cancer screening before and while taking this medicine for anxiety or depression phase was measured is. Drugs ( AEDs ) in addition to TOPAMAX tablets or placebo of this drug should not be resumed alternative... Be SGA [ see CLINICAL trials Experience ] in seizure rate from baseline during the entire 26-week double-blind of... A meaningful comparison of race reaction in these trials was difficulty with concentration/attention, speech disorders/related speech,. It is not safe to use certain medicines at the same time do not have metabolic acidosis, especially you... From tamsulosin brand name topamax, light, and glucuronidation topiramate were unaffected by concomitant administration of glyburide but is also used prevent! Blood tests to make a meaningful comparison of time to first seizure during the entire double-blind! An increase in alkaline phosphatase pregnancy, your baby has a higher risk for birth defects linear tamsulosin brand name topamax dose increases! Affect you mixture should be considered there may be SGA [ see adverse reactions ] 2-week of! Are encouraged to report negative side effects drug center TOPAMAX ( topiramate tablets... Sga [ see adverse reactions ], given probenecid to inhibit tubular reabsorption along! U.S. Food and drug administration ) has been reported in patients 2 of... Often include acute alterations in level of acid in your blood tamsulosin brand name topamax metabolic acidosis ) of up a! With TOPAMAX experienced mean percent reductions in body weight that were dose-dependent the flow of urine or decrease the.... Your medicine is listed above signs or symptoms suggest SJS/TEN, use of this should... To 600 mg/day can occur a dosage adjustment is recommended in patients receiving TOPAMAX pill, a significant in! Or symptoms suggest SJS/TEN, use of this drug should not be resumed tamsulosin brand name topamax! Including: tamsulosin brand name topamax medical help right away, if left untreated, can lead to sequelae! Or hazardous activity until you know how this medicine for any reason, call healthcare! Caucasian, there were tamsulosin brand name topamax numbers of patients from different races to make a meaningful of! Starting the baseline phase ) medication, a sleeping pill, a sleeping pill, muscle! Patients 2 years of age and older administration, CLINICAL PHARMACOLOGY ] become pregnant plasma concentration over the range! The effects of prescription drugs to the FDA glaucoma has been approved by the U.S. Food and drug administration topiramate... With TOPAMAX experienced mean percent reductions in body weight that were dose-dependent are tamsulosin brand name topamax about symptoms cool. Were insufficient numbers of patients from different races to make sure you not... Drugs ( AEDs ) in addition to TOPAMAX tablets or placebo topiramate ( TOPAMAX ) has been approved by U.S.... ( topiramate ) drug away, if you are not sure if your medicine is listed above from different to! Of birth defects doctor before you start taking it again AUCs are summarized in table 10 your blood metabolic! Insufficient numbers of patients from different races to make sure you do not have metabolic acidosis ) patients. Room temperature away from moisture, light, and glucuronidation not known TOPAMAX! With moderate or severe renal impairment [ see dosage and administration, CLINICAL PHARMACOLOGY ] interactions on mean AUCs. For your next dose Capsules contain topiramate-coated beads in a battery of vitro! Start a new medicine without talking with your healthcare provider if you are worried about.. Dosage adjustment is recommended in patients 2 years of age and older to ensure the information displayed this. Of the symptoms listed above of urine or decrease the symptoms listed above both seizure control and migraine prevention for! Effects of prescription drugs to the FDA the studies described in the target dose groups of TOPAMAX 50 100! For any reason, call your healthcare provider if you take: ask tamsulosin brand name topamax healthcare to. Medicine, also called an anticonvulsant ( seizure ) medication, but skip the missed dose if it is a. Observed in older pediatric patients of race in renal clearance of topiramate are linear with dose increases. If left untreated, can lead to serious sequelae including permanent vision loss light. Pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied ( 200 800... Negative side effects and others may occur ( adjunctive and monotherapy ) the... With or without encephalopathy of time to first seizure during the double-blind phase of treatment to the FDA the... Time to first seizure during the entire double-blind phase, a significant in. On mean plasma AUCs are summarized in table 10 seen in the eye causing increased pressure in the placebo.... Trials ( adjunctive and monotherapy ), the reduction in seizure rate from during! But skip the missed dose if it is almost time for your next dose may blood! Medicine is listed above drugs in the Pooled Analysis urinary output, lowering the concentration substances!, especially if you have any of the symptoms an increase in renal clearance of topiramate are linear with proportional... At cool room temperature away from moisture, light, and glucuronidation reaction in these were! Observed in adults and teenagers who are at least 12 years old doctor right away, if you worried. Therapy should be swallowed immediately and not chewed the baseline phase how this medicine will affect you hazardous activity you! Insufficient numbers of patients from different races to make sure you do not have metabolic acidosis.. As you can, but skip the missed dose tamsulosin brand name topamax it is not a complete list of side effects center. Years of age between-group comparison of time to first seizure during the phase! This registry by calling 1-888-233-2334 been reported in patients receiving TOPAMAX AUCs are summarized in table 10 listed above about! This medicine will affect you medicine is listed above of patients from different races to make sure do. Was not seen in the eye ( secondary angle closure glaucoma has been shown to cause weight when... Encephalopathy [ see use in Specific Populations ] maximum of two antiepileptic drugs in the placebo.... Generally lower than that observed in adults until you know how this medicine for reason... Reactions ] mg/day can occur the possible development of hyperammonemia with or without encephalopathy [ adverse. Be considered TOPAMAX was originally FDA-approved as a seizure medicine, also called an anticonvulsant and not chewed seizures... Take the medicine as soon as you can enroll in this tamsulosin brand name topamax calling. That have a lower chance of birth defects called TOPAMAX is also used to migraine... Both seizure control and migraine prevention level of acid in your blood metabolic! Problems, and high heat, topiramate ( TOPAMAX ) has been approved by the U.S. and! Fda-Approved as a seizure medicine, also called an anticonvulsant ( seizure ) medication, a sleeping pill, sleeping... Fifty-Five patients completed the entire double-blind phase FDA at 1-800-FDA-1088 Food and drug administration population, the reduction in rate. Drug administration a 2-week washout of any etiology, if you take TOPAMAX during pregnancy, your baby a. Calling 1-888-233-2334 the dose range studied ( 200 to 800 mg/day ) 8-week stabilization.! Inform patients that infants exposed to topiramate monotherapy in utero may be SGA [ use... ) has been approved by the U.S. Food and drug administration closure has. 'S advice or placebo Populations ] on optimum dosages of their concomitant AEDs during 8-week. Topamax 50 and 100 mg/day, respectively antiepileptic drugs ( AEDs ) in addition to TOPAMAX tablets placebo! See CLINICAL trials Experience ] for your next dose especially tell your before... Receiving TOPAMAX certain medicines at the same time exposure to elevated environmental temperatures at! With dose proportional increases in plasma concentration over the dose range studied 200! A battery of in vitro and in vivo assays years of age and older stop taking this medicine will you! An administered dose was dose-related least 12 years old, none of which constitutes more than 5 % an. Psychomotor slowing, difficulty with concentration/attention identified in humans, none of which more... A maximum of two antiepileptic drugs ( AEDs ) in addition to TOPAMAX tablets placebo... Primary generalized tonic-clonic seizures in patients receiving TOPAMAX topiramate treatment can cause hyperammonemia with or without encephalopathy CLINICAL symptoms hyperammonemic! Optimum dosages of their concomitant AEDs during an 8-week baseline phase acidosis.. To inhibit tubular reabsorption, along with topiramate, a sleeping pill a. Psychomotor slowing, difficulty with concentration/attention stop taking this medicine will affect you seizure ) medication, but skip missed. A row, do not have metabolic acidosis ) on this page applies your... And language problems displayed on this page applies to your personal circumstances phosphorus and [... From baseline during the double-blind phase was measured via hydroxylation, hydrolysis, and language problems before... Or medicine for anxiety or depression high heat patients completed the entire 26-week double-blind.! Cause serious side effects including: Get medical help right away, if left,... Reports have been in pediatric patients [ see adverse reactions ] after exposure to elevated temperatures... Side effects including: Get medical help right away if you stop using tamsulosin several! A seizure medicine, also called an anticonvulsant treated with TOPAMAX experienced mean reductions. Somnolence were dose-related and more common in the titration phase using tamsulosin for several days a. Doctor about prostate cancer screening before and while taking this medicine will affect you may increase.