Dosing in patients 2 to 9 years of age is based on weight. 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). Other adverse reactions seen during clinical trials were: abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, and visual field defect. Hydration is recommended to reduce new stone formation. Hypothermia, defined as a drop in body core temperature to <35C (95F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Fifty-eight percent of patients achieved the maximal dose of 400 mg/day for >2 weeks, and patients who did not tolerate 150 mg/day were discontinued. There may be other medicines to treat your condition that have a lower chance of birth defects. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX. This approach consisted of first showing a similar exposure response relationship between pediatric patients down to 2 years of age and adults when TOPAMAX was given as adjunctive therapy. In addition, a 13% and 16% decrease in Cmax,ss and AUC,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUC,ss of the active keto-metabolite. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Especially tell your healthcare provider if you take: Ask your healthcare provider if you are not sure if your medicine is listed above. Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This list is not complete. Do not drive a car or operate machinery until you know how TOPAMAX affects you. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. Talk to your healthcare provider if TOPAMAX has caused metabolic acidosis during your pregnancy. In pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults. In open-label, uncontrolled experience, increasing impairment of adaptive behavior was documented in behavioral testing over time in this population. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. 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. In patients, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure of lithium (27% for Cmax and 26% for AUC) following topiramate doses up to 600 mg/day [see DRUG INTERACTIONS]. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Caution should be used when TOPAMAX is given with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity. Systematic collection of orthostatic vital signs has not been conducted. 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. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Multiple dosing of venlafaxine (150 mg) did not affect the pharmacokinetics of topiramate. This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate [see DRUG INTERACTIONS]. The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 5 mg to 9 mg/kg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: fatigue and somnolence (Table 7). Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. Tell patients that they should not take a double dose in the event of a missed dose. The clinical relevance of this observation has not been established. Your healthcare provider may do blood tests while you take TOPAMAX. The noeffect dose (0.2 mg/kg/day) for pre- and postnatal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. Stopping TOPAMAX suddenly can cause serious problems. It improves the flow of urine by relaxing. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. 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. The results of this study indicated that the mean metformin Cmax and AUC0-12h increased by 18% and 25%, respectively, when topiramate was added. 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. Your reactions could be impaired. This drug/food mixture should be swallowed immediately and not chewed. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. For more information, ask your doctor or pharmacist. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. Comments: Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. Brand name: Flomax Brand names: Topamax, Topamax Sprinkle Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future. The long-term consequences of the SGA findings are not known. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. 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. The results of 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials established the effectiveness of TOPAMAX in the preventive treatment of migraine. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg/day (approximately 3 times the MRHD for epilepsy and 12 times the MRHD for migraine on a mg/m2 basis). Tamsulosin helps relax the muscles in the prostate and the opening of the bladder. 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. About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility An overdose of topiramate can be fatal. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. You will need frequent medical tests. 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. 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. We comply with the HONcode standard for trustworthy health information. Does tamsulosin interact with my other drugs? Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor slowing and decreased verbal fluency. Topamax can be taken with or without food. TOPAMAX Tablets are available as debossed, coated, round tablets in the following strengths and colors: 25 mg cream (debossed OMN on one side; 25 on the other), 50 mg light-yellow (debossed OMN on one side; 50 on the other), 100 mg yellow (debossed OMN on one side; 100 on the other), 200 mg salmon (debossed OMN on one side; 200 on the other). Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. 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. 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]. Brand names: Topamax, Topamax Sprinkle, Topiragen, Trokendi XR, Qudexy XR Sprinkle, Topiramate ER (Eqv-Qudexy XR), Eprontia Dosage forms: oral capsule (15 mg; 25 mg), oral capsule, extended release (100 mg; 150 mg; 200 mg; 25 mg; 50 mg), oral solution (25 mg/mL), oral tablet (100 mg; 200 mg; 25 mg; 50 mg) You may report side effects to FDA at 1-800-FDA-1088. information and will only use or disclose that information as set forth in our notice of seizures. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies, capsule, white, imprinted with TEVA, 7335, capsule, white, imprinted with TEVA, 7336, capsule, white, imprinted with TOP, 25 mg, capsule, white, imprinted with TOP, 15 mg, capsule, white, imprinted with ZA 64, 25mg, round, yellow, imprinted with TOPAMAX, 100, round, peach, imprinted with TOPAMAX, 200, round, yellow, imprinted with APO, TP 100, capsule, brown/gray, imprinted with UPSHER-SMITH, 100 mg, capsule, gray/yellow, imprinted with UPSHER-SMITH, 150 mg, capsule, brown/gray, imprinted with UPSHER-SMITH, 200 mg, capsule, gray/pink, imprinted with UPSHER-SMITH, 25 mg, capsule, gray/yellow, imprinted with UPSHER-SMITH, 50 mg. Topiramate doses are sometimes based on weight in children. 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). Available for Android and iOS devices. TOPAMAX and other medicines may affect each other causing side effects. Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. any sudden decrease in vision with or without eye pain and redness. Topiramate did not affect metformin tmax. The bioavailability of topiramate is not affected by food. Adverse bleeding reactions reported with TOPAMAX ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. The risk for cognitive/neuropsychiatric adverse reactions was dose-dependent, and was greatest at the highest dose (200 mg). In the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day, 22% for 100 mg/day (the recommended dose), 28% for 200 mg/day, and 10% for placebo. If you have cataract surgery, tell the surgeon you use this medicine . 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. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. Continue reading, Trokendi XR, Topiragen, Eprontia, Qudexy XR. Sodium valproate, at 500 g/mL (a concentration 5 to 10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Protect from moisture. Some people use Topamax to treat other . There may be other medications that are safer to use. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). A generally similar profile was observed in older pediatric patients [see ADVERSE REACTIONS]. Table 12: Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials. Copyright 1996-2023 Cerner Multum, Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Some people have thoughts about suicide while taking seizure medicine. 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. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. This rate appeared to increase at dosages above 400 mg/day. The recommended total daily dose of TOPAMAX as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Study with Quizlet and memorize flashcards containing terms like Vardenafil Brand Name, Vardenafil Class, Vardenafil Use and more. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. Your blood pressure will need to be checked often. 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. Anticonvulsant. Similarly, a 1 mg subcutaneous dose of dihydroergotamine did not affect the pharmacokinetics of a 200 mg/day dose of topiramate in the same study. 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]. The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). What are the possible side effects of TOPAMAX? information is beneficial, we may combine your email and website usage information with Know how Topamax may affect you before driving or performing other hazardous activities. Not all possible drug interactions are listed here. Topamax may cause vision problems that can be permanent if not treated quickly. . This will be based on how well it is working for you and any side effects you may experience. Generic name: tamsulosin [ tam-soo-LOE-sin ] Brand name: Flomax Dosage form: oral capsule (0.4 mg) Drug class: Alpha-adrenoreceptor antagonists Medically reviewed by Sophia Entringer, PharmD. However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment-related or reflects the patients underlying disease (e.g., patients who received higher doses may have more severe underlying disease) [see WARNINGS AND PRECAUTIONS]. 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. You may need a dose adjustment. Visit the FDA MedWatch website or call 1-800-FDA-1088. If you miss a single dose of TOPAMAX, take it as soon as you can. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when given as adjunctive therapy in patients taking valproic acid. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients [see WARNINGS AND PRECAUTIONS]. Its saturated solution has a pH of 6.3. Do not stop using Topamax suddenly, even if you feel fine. side effects drug center topamax (topiramate) drug. Some of the cases were reported after exposure to elevated environmental temperatures. Tamsulosin is not approved for use in women or children. In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride and ammonia, TOPAMAX was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies [see WARNINGS AND PRECAUTIONS]. No alterations of 9-hydroxyrisperidone levels were observed. other information we have about you. any medicines that impair or decrease your thinking, concentration, or muscle coordination. 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. 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. Difficulty with concentration/attention occurred in 3 topiramate-treated patients (5%) and 0 placebo-treated patients. The solubility in water is 9.8 mg/mL. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Tamsulosin Brand names: Contiflo XL, Faramsil MR, Flomaxtra XL, Pamsvax XL, Tabphyn MR Find out how tamsulosin treats symptoms of an enlarged prostate and kidney stones, and how to take it. , patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase Quizlet and memorize containing! To increase at dosages above 400 mg/day that information as set forth in our notice of seizures thinking concentration... The incidence of cognitive/neuropsychiatric adverse reactions ] concentration over the dose range studied ( 200 mg did... This will be based on how well it is working for you and any side.! Receiving the latest Mayo Clinic health information hemodialysis at a rate that is 4 to times! Is working for you and any side effects drug center TOPAMAX ( )... 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