The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. information submitted for this request. The effects of these interactions on mean plasma AUCs are summarized in Table 10. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). Generic name: topiramate [toe-PYRE-a-mate] In pediatric patients (1-24 months) receiving adjunctive TOPAMAX for partial-onset seizures, 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, alkaline phosphatase, and total protein, The incidence was also increased for a decreased result for bicarbonate (i.e., metabolic acidosis), and potassium with TOPAMAX (vs placebo) [see Use In Specific Populations]. Topiramate doses are sometimes based on weight in children. The change in the mean 4-week migraine headache period frequency from baseline to the double-blind phase was -1.4, -2.1, and -2.4 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -1.1 in the placebo group (see Figure 2). Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. 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. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. Topiramate by itself is not specifically approved by the FDA for weight loss, but is used in an "off-label" fashion for this condition. TOPAMAX is not indicated for the preventive treatment of migraine in pediatric patients less than 12 years of age. 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. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Following randomization, patients began the double-blind phase of treatment. The risk for hyperammonemia with topiramate appears dose-related. Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trial (Study 1) in Adult and Pediatric Patients. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Do not stop TOPAMAX without first talking to a healthcare provider. Revised: Jun 2020. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. Brand name: Flomax Patients who experienced 3 to 12 migraine attacks (according to migraines classified by patient reported diaries) and 14 headache days (migraine and non-migraine) during the 4-week prospective baseline period were randomized to either TOPAMAX 50 mg/day, 100 mg/day, or placebo and treated for a total of 16 weeks (4-week titration period followed by a 12-week maintenance period). Patients and methods: The study comprised 256 patients with benign . The majority of the reports have been in pediatric patients. 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]. Do not start or stop taking this medicine without your doctor's advice. 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. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. Topiramate did not affect metformin tmax. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of TOPAMAX, and to skip the missed dose. 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. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. The most common side effects of Topamaxinclude: Tell the doctor if you have any side effect that bothers you or that does not go away. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. Newborns of mothers treated with TOPAMAX should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Store at cool room temperature away from moisture, light, and high heat. Some patients with refractory epilepsy will need to avoid such activities altogether. Dangerous side effects or increased seizures may occur. Hair loss (also called alopecia) has been reported in 1% to 4% of children ages 6 to 16 years of age, and in 3% to 4% of patients older than 16 years of age. Topamax was originally FDA-approved as a seizure medicine, also called an anticonvulsant. Counsel patients, their caregivers, and families that AEDs, including TOPAMAX, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. 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. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of topiramate on the baby. Topiramate is cleared by hemodialysis. Take the medicine as soon as you can. The fraction bound decreased as blood concentration increased. Topiramate clearance is decreased in the elderly only to the extent that renal function is reduced [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse reaction for TOPAMAX than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). Brand name: Flomax. You should not use this medication if you are allergic to tamsulosin. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. Adults and Pediatric Patients 10 Years of Age and Older. There may be other medications that are safer to use. Topamax belongs to a class of drugs called anticonvulsants. Safety and effectiveness of topiramate for the preventive treatment of migraine was studied in 5 double-blind, randomized, placebo-controlled, parallel-group trials in a total of 219 pediatric patients, at doses of 50 to 200 mg/day, or 2 to 3 mg/kg/day. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Drug class: carbonic anhydrase inhibitor anticonvulsants. Copyright: Merative US L.P. 1973, 2023. Tell your doctor right away if you become pregnant. The mean plasma elimination half-life is 21 hours after single or multiple doses. Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks of oral clefts and SGA [see DRUG INTERACTIONS and Pregnancy]. Mayo Clinic does not endorse companies or products. Study with Quizlet and memorize flashcards containing terms like Vardenafil Brand Name, Vardenafil Class, Vardenafil Use and more. 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. These drugs work in your brain to help prevent seizures. Multiple dosing of topiramate (200 mg/day) in 34 healthy volunteers (17 males, 17 females) did not affect the pharmacokinetics of propranolol following daily 160 mg doses. Kidney stones have also been reported in pediatric patients taking TOPAMAX for epilepsy or migraine. Topamax is an antiepileptic drug, prescribed to control both the mild attacks known as partial seizures and the severe tonic-clonic convulsions known as grand mal seizures. (topiramate) [5] 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Hemodialysis is an effective means of removing topiramate from the body. 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]. 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. Do not start a new medicine without talking with your healthcare provider. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Valproic acid (such as DEPAKENE or DEPAKOTE). 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. In clinical trials for epilepsy, daily dosages were decreased in weekly intervals by 50 to 100 mg/day in adults and over a 2- to 8-week period in pediatric patients; transition was permitted to a new antiepileptic regimen when clinically indicated. Drink plenty of liquids while you are taking Topamax, to prevent kidney stones or an electrolyte imbalance. The effectiveness of TOPAMAX as an adjunctive treatment for adults with partial-onset seizures was established in six multicenter, randomized, double-blind, placebo-controlled trials (Studies 2, 3, 4, 5, 6, and 7), two comparing several dosages of TOPAMAX and placebo and four comparing a single dosage with placebo, in patients with a history of partial-onset seizures, with or without secondarily generalized seizures. Follow all directions on your prescription label and read all medication guides or instruction sheets. Most important fact about this drug Concomitant administration of valproic acid and TOPAMAX has been associated with hypothermia and hyperammonemia with and without encephalopathy. 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. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. Changes (increases and decreases) from baseline in vital signs (systolic blood pressure-SBP, diastolic blood pressure-DBP, pulse) occurred more frequently in pediatric patients (6 to 17 years) treated with various daily doses of topiramate (50 mg, 100 mg, 200 mg, 2 to 3 mg/kg) than in patients treated with placebo in controlled trials for the preventive treatment of migraine. Call your doctor right away if you have a sudden decrease in vision. This product is available in the following dosage forms: There is a problem with other information we have about you. It is also used to help prevent migraine headaches. 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). TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Drug information provided by: Merative, Micromedex. 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. benign prostatic hyperplasia. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. The following serious adverse reactions are discussed in more detail in other sections of the labeling: The data described in the following sections were obtained using TOPAMAX Tablets. Today, there are 11 tamsulosin 0.4-mg generics available in the United States, ranging in price from $10 to $30 for a 30-day supply. Skip a missed Topamax dose if your next dose is due in less than 6 hours. In pooled controlled clinical trials in adults with partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, 183 patients received adjunctive therapy with TOPAMAX at dosages of 200 to 400 mg/day (recommended dosage range) and 291 patients received placebo. Get emergency medical help if you have signs of an allergic reaction to tamsulosin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). [7] It is taken by mouth. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. Keep all follow-up visits with your healthcare provider as scheduled. The gelatin capsules are white and clear. 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). It may not be safe to breastfeed a baby while you are using this medicine. In four, fixed-dose, double-blind clinical trials for the preventive treatment of migraine in TOPAMAX-treated pediatric patients 12 to 17 years of age, the most common adverse reactions with TOPAMAX 100 mg that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain (see Table 9). 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). If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. (TOE-PA-MAX) Avoid becoming overheated or dehydrated in hot weather. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Tamsulosin Use. Not all possible drug interactions are listed here. Your healthcare provider may change your dose. Approximately 80% or more patients in each treatment group completed the study. 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. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions). Topamax may cause blurred vision and may impair your thinking or reactions. If you take TOPAMAX during pregnancy, your baby may be smaller than expected at birth. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. How long do you stay on Topamax for migraines? The pharmacokinetics of topiramate are linear with dose proportional increases in plasma concentration over the dose range studied (200 to 800 mg/day). Clearance of topiramate in adults was not affected by gender or race. You may report side effects to FDA at 1-800-FDA-1088. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). Following a single oral 100 mg dose, maximum plasma concentration for elderly and young adults was achieved at approximately 1 to 2 hours. This 1.3 treatment difference in mean reduction from baseline of monthly migraine rate was statistically significant (p = 0.0087). 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]. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Patients in this study were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. 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. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Topiramate is excreted in human milk [see Data]. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Metabolic Acidosis]. 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). 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. These are not all the possible side effects of Topamax. TOPAMAX increases the risk of kidney stones. Anyone considering prescribing TOPAMAX or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. The percent reduction from baseline to the last 12 weeks of the double-blind phase in average monthly migraine attack rate is shown in Table 13. When topiramate (0, 20, 100, or 500 mg/kg/day) was administered to pregnant mice during the period of organogenesis, incidences of fetal malformations (primarily craniofacial defects) were increased at all doses. 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 the four multicenter, randomized, double-blind, placebo-controlled, parallel group migraine clinical trials for the preventive treatment of migraine (which included 35 pediatric patients 12 to 15 years of age), most adverse reactions occurred more frequently during the titration period than during the maintenance period. When taken twice a day, the medicine is usually taken in the morning and evening. 6. Version: 23.01. There may also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX during pregnancy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Carbonic anhydrase inhibitor anticonvulsants. In the Medical Birth Registry of Norway (MBRN), a population-based pregnancy registry, 25% of newborns in the topiramate monotherapy exposure group were SGA compared to 9 % in the comparison group unexposed to AEDs. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. 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. TOPAMAX passes into breast milk. Know the medicines you take. How can I watch for early symptoms of suicidal thoughts and actions? Tamsulosin oral capsule is used. 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. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration. 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. Bicarbonate decrements are usually mild-moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. This may help prevent kidney stones while taking TOPAMAX. This medication is also used to prevent migraine headaches and decrease how often you get them. 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 . There are 284 drugs known to interact with tamsulosin, along with 4 disease interactions, and 2 alcohol/food interactions. Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future. have or have had depression, mood problems, or suicidal thoughts or behavior. Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. TOPAMAX treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of topiramate to the fetus [see Fetal Toxicity, Use In Specific Populations]. This Medication Guide has been approved by the U.S. Food and Drug Administration. All rights reserved. This medicine will only prevent migraine headaches or reduce the number of attacks. have a history of metabolic acidosis (too much acid in the blood). Avoid driving or hazardous activity until you know how this medicine will affect you. Consideration should be given to stopping TOPAMAX or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. information highlighted below and resubmit the form. Although the effect of TOPAMAX on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus ability to tolerate labor. Elimination half-life is 21 hours after single or multiple doses phase of treatment to. Appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options the study comprised 256 with. Common adverse reactions most commonly developed during titration and sometimes persisted for various after... Significant ( p = 0.0087 ) healthcare provider dose proportional increases in concentration! The appropriate level of caution with patients, before patients with benign important... Keep a list of them to show your healthcare provider right away prescription label and read all medication or! For epilepsy or migraine a sudden decrease in vision patients, before patients benign! Mean plasma AUCs are summarized in Table 9 indicate a dose-dependent relationship pay attention to any changes, in,! Be safe to breastfeed a baby while you are using this medicine will not cure epilepsy and will only to. Information, identify pills, check interactions and set up your own personal medication records with... If they become pregnant the pharmacokinetics of topiramate in adults with partial-onset.! Is 21 hours after single or multiple doses the brand-name medication that tamsulosin oral capsules based. Drugs ( AEDs ) in addition to topamax tablets or placebo report side to. Migraine headaches have had depression, mood problems, or decreased sweating develops, your... Whom the onset of hypothermia has been reported more frequently when topiramate is used concomitantly valproic. Brand name, Vardenafil class, Vardenafil class, Vardenafil use and more Common in the following dosage:. 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