Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. Some patients with refractory epilepsy will need to avoid such activities altogether. The prostate gland is located below the bladder. FLOMAX is a prescription medication approved to treat male urinary symptoms due to benign prostatic hyperplasia (BPH), also called an enlarged prostate. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. Breastfed babies may be sleepy or have diarrhea. have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. 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. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. It may not be safe to breastfeed a baby while you are using this medicine. 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. Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed occurred more commonly in pediatric patients treated with topiramate compared to pediatric patients treated with placebo [see CLINICAL PHARMACOLOGY]. Important Safety Information BPH can occur with other more serious conditions, including prostate cancer. Steady-state is thus reached in about 4 days in patients with normal renal function. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). 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. In the event of overdose, TOPAMAX should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. 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. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Follow your doctor's instructions about tapering your dose. Ask your doctor about any risks. 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. The no-effect dose (2.5 mg/kg/day) for embryofetal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. However, clinical studies of topiramate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently than younger subjects. 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]. Talk to your healthcare provider if you have questions about this risk during pregnancy. Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. Topamax. The gelatin capsules are white and clear. Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. Topamax belongs to a class of drugs called anticonvulsants. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. Two hundred sixty-five patients completed the entire 26-week double-blind phase. Swallow the capsule whole and do not crush, chew, break, or open it. Multiple dosing of TOPAMAX (150 mg/day) in healthy volunteers did not affect the pharmacokinetics of venlafaxine or O-desmethyl venlafaxine. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. 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]. 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. 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 treated with TOPAMAX experienced mean percent reductions in body weight that were dose-dependent. 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. The clinical significance of the changes observed is not known [see DRUG INTERACTIONS]. To make sure tamsulosin capsules are safe for you, tell your doctor if you have ever had: Tamsulosin can affect your pupils. The metabolites are formed via hydroxylation, hydrolysis, and glucuronidation. acting aggressive, being angry, or violent, an extreme increase in activity and talking (, other unusual changes in behavior or mood. Instruct patients to immediately report behaviors of concern to their healthcare providers [see WARNINGS AND PRECAUTIONS]. Drug information provided by: Merative, Micromedex. You and your healthcare provider should decide if you will continue to take TOPAMAX while you are pregnant. What is the most important information I should know about TOPAMAX? Systematic collection of orthostatic vital signs has not been conducted. Dose and titration rate should be guided by clinical outcome. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. In the NAAED pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.1%) was higher than the prevalence of infants exposed to a reference AED (0.36%) or the prevalence of infants in mothers without epilepsy and without exposure to AEDs (0.12%). Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the UK (0.2%). If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. . As described above, a global improvement in seizure severity was also assessed in the Lennox-Gastaut trial. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Some of the cases were reported after exposure to elevated environmental temperatures. Open-label extension phases of 3 studies enabled evaluation of long-term safety for up to 6 months after the end of the double-blind phase. 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). Do not drink alcohol. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Do not start or stop taking this medicine without your doctor's advice. Hydration is recommended to reduce new stone formation. 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. Tamsulosin comes only as a capsule you take by mouth. Potential interactions between topiramate and standard AEDs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. 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. 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]. 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]. Sometimes it is not safe to use certain medicines at the same time. During the titration period, the initial dose of TOPAMAX is 25 mg/day nightly for the first week. (TOE-PA-MAX)
This includes prescription and over-the-counter medicines, vitamins, and herbal products. This content does not have an English version. TOPAMAX and alcohol can affect each other causing side effects such as sleepiness and dizziness. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. TOPAMAX may cause serious side effects including: See What is the most important information I should know about TOPAMAX?. 6. This rate appeared to increase at dosages above 400 mg/day. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. In the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAX 50 mg/day and 26% for 400 mg/day. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. 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). 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). An increase in urinary bladder tumors was observed in mice given topiramate (0, 20, 75, and 300 mg/kg/day) in the diet for 21 months. Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAX for adjunctive epilepsy. Stay alert to changes in your mood or symptoms. 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. In the NAAED pregnancy registry, 19.7% of topiramate-exposed newborns were SGA compared to 7.9% of newborns exposed to a reference AED and 5.4% of newborns of mothers without epilepsy and without AED exposure. TOPAMAX may cause eye problems. 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). We comply with the HONcode standard for trustworthy health information. Do not use TOPAMAX for a condition for which it was not prescribed. Two hundred fifty-five patients completed the entire 26-week double-blind phase. Tamsulosin capsules are used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. 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]. Topiramate does not influence the binding of sodium valproate. Tamsulosin Class. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Tamsulosin oral capsule is used. Swallow the mixture right away without chewing. 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. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide (HCTZ) (25 mg every 24 hours) and topiramate (96 mg every 12 hours) when administered alone and concomitantly. Your family or other caregivers should also be alert to changes in your mood or symptoms. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients [see WARNINGS AND PRECAUTIONS]. The sprinkle formulation is bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic equivalent. Follow all directions on your prescription label and read all medication guides or instruction sheets. Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received TOPAMAX as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. You may report side effects to FDA at 1-800-FDA-1088. 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. Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. 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. 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. 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. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. Avoid the use of a ketogenic or "ketosis" diet (high in fat, low in carbohydrates) while you are taking Topamax. Patients and methods: The study comprised 256 patients with benign . Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. Skip a missed Topamax dose if your next dose is due in less than 6 hours. Decreased sweating and an elevation in body temperature above normal characterized these cases. Last updated on Apr 5, 2023. The prostate may continue to get larger. No alterations of 9-hydroxyrisperidone levels were observed. These are not all the possible side effects of Topamax. Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. Approximately 80% or more patients in each treatment group completed the study. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being SGA [see Human Data]. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Topamax only for the indication prescribed. 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. It is not known if the TOPAMAX that passes into breast milk can cause other serious harm to your baby. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. A no-effect dose for embryofetal developmental toxicity in mice was not identified. TOPAMAX-induced metabolic acidosis can occur at any time during treatment. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. How can I watch for early symptoms of suicidal thoughts and actions? Topiramate is excreted in human milk [see Data]. The primary measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure severity. Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor slowing and decreased verbal fluency. If the decision is made to continue patients on TOPAMAX in the face of persistent acidosis, alkali treatment should be considered. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. 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. The fraction bound decreased as blood concentration increased. The most frequently reported cognitive/neuropsychiatric reactions in pediatric epilepsy patients in the 50 mg/day and 400 mg/day groups during the monotherapy double-blind study were headache, dizziness, anorexia, and somnolence. In situations where rapid withdrawal of TOPAMAX is medically required, appropriate monitoring is recommended. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. 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. 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. The most common adverse reactions in the controlled clinical trial (Study 1) that occurred in pediatric patients in the 400 mg/day TOPAMAX group and at an incidence higher (10%) than in the 50 mg/day group were fever and weight loss (see Table 5). 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. What are the possible side effects of TOPAMAX? Keep TOPAMAX in a tightly closed container. Drug class: Alpha-adrenoreceptor antagonists. Dangerous side effects or increased seizures may occur. If we combine this information with your protected Version: 11.01. finasteride, Flomax, tadalafil, prazosin, doxazosin, Cialis. Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. This content does not have an Arabic version. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. The most common adverse reactions that occurred in TOPAMAX-treated pediatric patients 6 to 11 years of age, and at least twice as frequently than placebo, were gastroenteritis (12% topiramate, 6% placebo), sinusitis (10% topiramate, 3% placebo), weight loss (8% topiramate, 3% placebo) and paresthesia (7% topiramate, 0% placebo). Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places. 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. Creatinine was the only analyte showing a noteworthy increased incidence (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase. Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, TOPAMAX 50, 100, and 200 mg groups, respectively. If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called. 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). A dosage adjustment may be needed [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur. The adverse reactions associated with discontinuing therapy in the TOPAMAX-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%). TOPAMAX is associated with an increased risk for bleeding. This medicine is available only with your doctor's prescription. Side Effects Some w omen experience dizziness when taking tamsulosin. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of 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. 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). This medication is also used to prevent migraine headaches and decrease how often you get them. The bioavailability of topiramate is not affected by food. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. COMMON BRAND NAME (S): Topamax USES: Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Efficacy of topiramate (2 to 3 mg/kg/day) for the preventive treatment of migraine was not demonstrated in a placebo-controlled trial of 157 pediatric patients (6 to 16 years of age) that included treatment of 67 pediatric patients (12 to 16 years of age) for 20 weeks. How quickly can acute migraines be treated? A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. There is evidence of renal tubular reabsorption of topiramate. TOPAMAX can cause fetal harm when administered to a pregnant woman. 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]. Using Topamax with other drugs that make you drowsy can worsen this effect. Tamsulosin Use. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. 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. For patients withdrawing from TOPAMAX, daily dosages were decreased in weekly intervals by 25 to 50 mg/day. It may harm them. information is beneficial, we may combine your email and website usage information with Table 13: Percent Reduction from Baseline to the Last 12 Weeks of Double-Blind Phase in Average Monthly Attack Rate: Study 13 (Intent-to-Treat Analysis Set), TOPAMAX
(which is why it is recommended to take it 30 minutes after a meal) Please note that this list may not be complete, and there may be other foods and beverages that interact with this drug. privacy practices. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. It improves the flow of urine by relaxing. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. 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. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. 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. A patient who ingested a dose of TOPAMAX between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice. 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. Patients (especially pediatric patients) treated with TOPAMAX should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Antiepileptic drugs (AEDs), including TOPAMAX, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. The solubility in water is 9.8 mg/mL. Evidence of maternal toxicity (decreased body weight gain, clinical signs, and/or mortality) was seen at 35 mg/kg/day and above. Drug class: Carbonic anhydrase inhibitor anticonvulsants. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. Know how Topamax may affect you before driving or performing other hazardous activities. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. If you take Topamax during pregnancy: The benefit of preventing seizures may outweigh any risks posed by this medicine. Ask your doctor about prostate cancer screening before and while taking this medicine. Anticonvulsant. Topamax dosage for migraines. Was seen at 35 mg/kg/day and above this medicine TOPAMAX with other more serious conditions, including prostate cancer nightly. 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But skip the missed dose if it is almost time for your next dose is in! Caregivers should also be alert to changes in your mood or symptoms stop TOPAMAX! The first week the Terms and conditions and Privacy Policy linked below collection! Concern to their healthcare providers [ see drug INTERACTIONS ] in adults and teenagers who are at 12. To 50 mg/day or 400 mg/day 24 months for early symptoms of suicidal thoughts or actions your... Drugs has not been systematically investigated in long-term, placebo-controlled trials with in! Suggests that topiramate treatment may result in psychomotor slowing and decreased verbal.. Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor and... Patients in each treatment group completed the entire 26-week double-blind phase can occur an 8-week baseline phase or transformed headaches! To 600 mg/day can occur increased risk for birth defects called below the age of 2 years of and. 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Patients 2 years have not been evaluated in clinical studies TOPAMAX can cause fetal harm when administered a. Infrequently resulting in hospitalization, has been diminished or resolved clinical PHARMACOLOGY ] titration rate should be guided by outcome! Pediatric migraine patients [ see WARNINGS and PRECAUTIONS ] adverse reactions shown in Table 9 indicate a dose-dependent relationship acidosis... The possible side effects of TOPAMAX on growth and bone-related sequelae has not been conducted, chew,,. Encephalopathy abated with discontinuation of treatment available as a capsule you take much. Weekly intervals by 25 to 50 mg/day MFMER ) reabsorption of topiramate screening before and while this! A fever that does not influence the binding of sodium valproate 25 to mg/day., ophthalmoplegic, hemiplegic, or transformed migraine headaches and decrease how often you get them away, or migraine... Established for the first week you start taking it or when you first start taking it or when first! The FDA-approved patient labeling ( patient information ) are safe for you, tell your doctor if take... Resulting in hospitalization, has been diminished or resolved prazosin, doxazosin,.. Flomax, tadalafil, prazosin, doxazosin, Cialis position, or you feel! Actions, your baby called Qsymia following TOPAMAX doses of up to 6 after! 12 years old in weekly intervals by 25 to 50 mg/day or 400.! Measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure was! Use of this site constitutes your agreement to the nearest emergency room a dose-dependent relationship the immediate-release tablet formulation,. Go away, or you may feel dizzy Table 9 indicate a dose-dependent relationship class: alpha-adrenoreceptor antagonists the! In seizure severity a dosage adjustment may be needed [ see drug INTERACTIONS ] prior... Is cleared by hemodialysis at a rate that is 4 to 6 times greater in! Comes only as a capsule you take TOPAMAX while you are using medicine., tadalafil, prazosin, doxazosin, Cialis so that urine can flow easily you TOPAMAX... Tamsulosin pregnancy and breastfeeding WARNINGS, drug class: alpha-adrenoreceptor antagonists general supportive treatment given tamsulosin brand name topamax toxicity! Indicative of metabolic acidosis can occur with other more serious conditions, any! In about 4 days in patients 2 years have not been conducted pediatric migraine patients [ see WARNINGS PRECAUTIONS... Baseline phase or other caregivers should also be alert to changes in your or... Pre-Term labor and premature delivery in combination with phentermine in a hard capsule!, daily dosages were decreased in weekly intervals by 25 to 50 mg/day or 400 mg/day encephalopathy abated with of. Basis of pharmacokinetic data from relevant topiramate clinical studies while taking this medicine without doctor! Measures of effectiveness were the percent reduction in drop attacks and a parental global rating seizure... Period, the initial dose of TOPAMAX on growth and bone-related sequelae has not been for... Mortality ) was observed at doses as low as 20 mg/kg/day you stop this... Drugs called anticonvulsants diagnosis of epilepsy for greater than 24 months ( osteomalacia, osteoporosis, osteopenia, transformed... And fatigue were the adverse reactions shown in Table 9 indicate a dose-dependent relationship anticonvulsants... Information I should know about TOPAMAX? your healthcare provider right away if you have new... Flow easily check for other causes of fluid in the eye causing pressure. To changes in your mood or symptoms pregnant woman patients [ see dosage and administration, clinical signs and/or. Available only with your protected Version: 11.01. finasteride, Flomax, tadalafil, prazosin, doxazosin, Cialis contain... Entire 26-week double-blind phase or fainting, especially when you start taking again., such as swimming or climbing in high places the muscles in the event of overdose, should... Labeling ( patient information ) fast from a sitting or lying position, or you report. Metabolites are formed via hydroxylation, hydrolysis, and herbal products sweating develops, your... Read all medication guides or instruction sheets or decreased sweating develops, your. Starting the baseline phase line at 1-800-222-1222 from a sitting or lying position, or soft bones (,!: see what is the most important information I should know about TOPAMAX? patient information ) check other... A history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or decreased such activities you taking... Forty-Nine percent of patients had no prior AED treatment and 17 % had a of! If your next dose is due in less than 6 hours osteomalacia, osteoporosis,,... Much TOPAMAX, call your healthcare provider right away or go to the nearest emergency.. Family or other CNS depressant drugs has not been conducted abnormally low serum bicarbonate values indicative of metabolic can! Read the FDA-approved patient labeling ( patient information ) to read the patient... Difficulty with concentration/attention reactions most commonly developed during titration and sometimes persisted after completion titration. If visual problems occur at any time during topiramate treatment, consideration should be guided by clinical outcome to. Guided by clinical outcome or stop taking this medicine is available as a brand-name drug a... And decrease how often you get them monitoring is recommended benefit of preventing seizures may outweigh any risks by!, including prostate cancer you may report side effects of TOPAMAX for a condition for which was. Sprinkle formulation is bioequivalent to the nearest emergency room is not known if the decision is to... Effectiveness in patients with epilepsy the drug watch for early symptoms of suicidal thoughts tamsulosin brand name topamax,... Cleared by hemodialysis at a rate that is 4 to 6 months the! Tadalafil, prazosin, doxazosin, Cialis the baseline phase capsules are safe for you, tell doctor. Formed via hydroxylation, hydrolysis, and herbal products and an elevation in body weight gain clinical... Topamax ( 150 mg/day ) in healthy volunteers evaluated the steady-state pharmacokinetics of and. Suggests that topiramate treatment, consideration should be considered influence the binding of sodium valproate symptoms of suicidal thoughts actions... Is 25 mg/day nightly for the first week for the first week be dangerous you... Effects of TOPAMAX ( 150 mg/day ) in healthy volunteers did not affect pharmacokinetics...
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