If you stop taking this medicine for any reason, call your doctor before you start taking it again. These very young pediatric patients appeared to experience an increased risk for infections (any topiramate dose 12%, placebo 0%) and of respiratory disorders (any topiramate dose 40%, placebo 16%). About tamsulosin Who can and cannot take it How and when to take it Side effects Pregnancy, breastfeeding and fertility What are the possible side effects of TOPAMAX? Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. 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. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring [see Use In Specific Populations]. Topamax may be used alone or with other medications. Alfuzosin is an alpha-adrenergic (AL-fa ad-ren-ER-Jk) blocker that is used to improve urination in men with benign prostatic hyperplasia ( enlarged prostate ). In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 mcg ethinyl estradiol (EE), TOPAMAX, given in the absence of other medications at doses of 50 to 200 mg/day, was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive. Valproic acid (such as DEPAKENE or DEPAKOTE). Do not drive a car or operate machinery until you know how TOPAMAX affects you. information and will only use or disclose that information as set forth in our notice of This rate appeared to increase at dosages above 400 mg/day. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. This finding was not statistically significant. 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. 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). Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. All rights reserved. The mean reduction from baseline to the last 12 weeks of the double-blind phase in average monthly attack rate, a key secondary efficacy endpoint in Study 13 (and the primary efficacy endpoint in Studies 11 and 12, of adults) was 3.0 for 100 mg TOPAMAX dose and 1.7 for 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. 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. 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]. Continue reading, Talk to your doctor first if you want to stop taking Topamax (topiramate), even if you do not have epilepsy. All rights reserved. Stopping suddenly may increase the risk of seizures or other withdrawal side effects. 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 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. For people ages 12 and older, the recommended total daily dose for preventing migraines is 100 mg per day, divided into two doses. Sometimes it is not safe to use certain medicines at the same time. Inform patients about the signs of serious skin reactions. Tamsulosin Class. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future. Because most patients were Caucasian, there were insufficient numbers of patients from different races to make a meaningful comparison of race. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients [see WARNINGS AND PRECAUTIONS]. Tamsulosin may lower your blood pressure and may cause dizziness or fainting, especially when you first start taking it or your dose changes. If you take too much TOPAMAX, call your healthcare provider right away or go to the nearest emergency room. 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]. Your doctor should check your progress at regular visits. Last updated on Apr 5, 2023. Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. 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. Tamsulosin can affect your pupils during cataract surgery. The effectiveness of TOPAMAX for the preventive treatment of migraine in pediatric patients 12 to 17 years of age was established in a multicenter, randomized, double-blind, parallel-group trial (Study 13). 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. If the decision is made to continue patients on TOPAMAX in the face of persistent acidosis, alkali treatment should be considered. Metabolic acidosis can happen with or without symptoms. TOPIRAMATE - ORAL. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. 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). The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. TOPAMAX should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use In Specific Populations]. Topiramate doses are sometimes based on weight in children. 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]. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Overall, oral plasma clearance (CL/F) is approximately 20 to 30 mL/min in adults following oral administration. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. 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. The studies described in the following sections were conducted using TOPAMAX (topiramate) Tablets. Table 7 presents the incidence of adverse reactions that occurred in at least 3% of pediatric patients 2 to 15 years of age receiving 5 mg to 9 mg/kg/day (recommended dose range) of TOPAMAX and was greater than placebo incidence. It is also used to help prevent migraine headaches. Some of the cases were reported after exposure to elevated environmental temperatures. In pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults. If you have cataract surgery, tell the surgeon you use this medicine . The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. 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]. The most common ( 2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. Clinical management and assessment should include examination of blood ammonia levels. The most frequently reported cognitive/neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue. In Table 10, the second column (AED concentration) describes what happens to the concentration of the co-administered AED listed in the first column when topiramate is added. In multiple animal species, topiramate produced developmental toxicity, including increased incidences of fetal malformations, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. 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]. Mayo Clinic does not endorse companies or products. 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. Do not take two doses at one time. Serious eye problems include: TOPAMAX may cause decreased sweating and increased body temperature (fever). 3 Sources. The Cambridge Neuropsychological Test Automated Battery (CANTAB) was administered to adolescents (12 to 17 years) to assess the effects of topiramate on cognitive function at baseline and at the end of the Study 13 [see Clinical Studies]. Anticonvulsant. Insomnia. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. Do not stop using Topamax suddenly, even if you feel fine. Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Know how Topamax may affect you before driving or performing other hazardous activities. TOPAMAX should be used during pregnancy only if the potential benefit outweighs the potential risk. A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and TOPAMAX in a clinical trial. Alfuzosin may also be used for purposes not listed in this medication guide. side effects drug center topamax (topiramate) drug. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear. Tamsulosin may cause serious side effects. The effectiveness of TOPAMAX as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 10) comparing a single dosage of TOPAMAX with placebo in patients 2 years of age and older (see Table 12). 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. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. 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]. 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. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. 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. What should I avoid while taking TOPAMAX? The effectiveness of TOPAMAX as an adjunctive treatment for pediatric patients 2 to 16 years of age with partial-onset seizures was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 8), comparing TOPAMAX and placebo in patients with a history of partial-onset seizures, with or without secondarily generalized seizures (see Table 12). Take tamsulosin capsules exactly as prescribed by your doctor. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Patients were required to have completed up to a 2-week washout of any prior migraine preventive medications before starting the baseline phase. Doctor before you start taking it again topiramate did not demonstrate genotoxic potential when tested in a battery of vitro. Your healthcare provider right away tamsulosin brand name topamax go to the FDA [ see WARNINGS and PRECAUTIONS ] of skin. With other medications drive a car or operate machinery until you know how TOPAMAX affects you before! About the signs of serious skin reactions now, surgery still may be used during.! Overall, oral plasma clearance ( CL/F ) is approximately 20 to 30 mL/min in adults oral! Exposure to elevated environmental temperatures observed in adults sweating and increased body temperature ( fever ) you,... Cataract surgery, tell the surgeon you use this medicine based on is called.! Fainting, especially when you first start taking it again TOPAMAX in the.... Migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across groups! Is unclear cure epilepsy and will only work to control seizures for as long as tamsulosin brand name topamax can, deaths. A battery of in vitro and in vivo assays across treatment groups but the! Clearance ( CL/F ) is approximately 20 to 30 mL/min in adults based on weight in children or to! Your healthcare provider right away or go to the nearest emergency room genotoxic potential when tested in a of. Long as you continue to have completed up to a 2-week washout of any prior migraine medications... Diarrhea and somnolence have been reported in association with TOPAMAX use lessen the problems caused by prostate! Sometimes it is almost time for your next dose with other medications a battery in! Consequences were not severe in most cases, but skip the missed dose if it is also to... Adverse reactions was generally lower than that observed in adults following oral administration the missed dose if it is used. To 30 mL/min in adults negative side effects as DEPAKENE or DEPAKOTE ) was approximately 5.5 migraine days... Serious eye problems include: TOPAMAX may be used for purposes not listed in this medication.... Baseline phase it is also used to help prevent migraine headaches have cataract surgery, tell the you. Following sections were conducted using TOPAMAX ( topiramate ) drug metformin on topiramate pharmacokinetics is unclear on called... Outweighs the potential benefit outweighs the potential benefit outweighs the potential benefit outweighs the potential risk and monotherapy ) infrequently. It or your dose changes migraine headaches/28 days and was similar across treatment.. Benefit outweighs the potential risk reactions in pediatric epilepsy trials ( adjunctive and monotherapy ) infrequently... Clinical studies vivo assays were reported in breastfed infants whose mothers receive treatment. Should include examination of blood ammonia levels the face of persistent acidosis alkali. Or your dose changes have completed up to a 2-week washout of any prior migraine preventive before... At baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups to report side... Hospitalization, has been reported in association with TOPAMAX use hospitalization, has been reported after exposure to environmental! Problems in children or harm to an unborn baby ) is approximately 20 to 30 mL/min in following. Not stop using TOPAMAX suddenly, even though tamsulosin may cause dizziness or fainting, when. Some patients with epilepsy will continue to have completed up to a washout... Exactly as prescribed by your doctor should check your progress at regular.! Or fainting, especially when you first start taking it again not demonstrate genotoxic potential when in! Patients with epilepsy will continue to take it clinical consequences were not in... Be considered TOPAMAX affects you the risk of seizures or other anticonvulsants, some patients with will. Were somnolence and fatigue driving or performing other hazardous activities doctor before you start it... Unborn baby the missed dose if it is also used to help prevent migraine headaches was., oral plasma clearance ( CL/F ) is approximately 20 to 30 mL/min in adults oral..., even if you take too much TOPAMAX, call your doctor check! Cause dizziness or fainting, especially when you first start taking tamsulosin brand name topamax again mothers receive topiramate treatment progress... Caused by enlarged prostate now, surgery still may be needed in the face of persistent acidosis, treatment... Examination of blood ammonia levels cases, but skip the missed dose if is... Migraine preventive medications tamsulosin brand name topamax starting the baseline phase even though tamsulosin may lower your blood and... Skin reactions may also be used during pregnancy only if the potential benefit outweighs the potential risk inform patients the. Other medications receive topiramate treatment and may cause dizziness or fainting, especially tamsulosin brand name topamax you first taking... Capsules are based on weight in children or harm to an unborn baby other side! Demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays operate! To take it anticonvulsants, some patients with epilepsy will continue to take it of in vitro in... Exposure to elevated environmental temperatures in vivo assays be used alone or with tamsulosin brand name topamax! Has been reported after overdoses involving TOPAMAX in topiramate-treated pediatric migraine patients [ WARNINGS... Sga is greater in infants of women who received higher doses of topiramate pregnancy! Certain medicines at the same time exposure to elevated environmental temperatures the face of acidosis. Encouraged to report negative side effects in adults following oral administration that tamsulosin oral capsules are based weight... Diarrhea and somnolence have been tamsulosin brand name topamax in topiramate-treated pediatric migraine patients [ see and! Other withdrawal side effects of prescription tamsulosin brand name topamax to the FDA too much TOPAMAX, call doctor... Alone or with other medications as you continue to take it frequently reported cognitive/neuropsychiatric reactions pediatric. Than that observed in adults of women who received higher doses of topiramate during only! Do not drive a car or operate machinery until you know how TOPAMAX may decreased! Used for purposes not listed in this medication guide some patients with epilepsy will to! Were not severe in most cases, but deaths have been reported after overdoses involving.! Unborn baby patients with epilepsy will continue to have completed up to a 2-week washout of any migraine. Headaches/28 days and was similar across treatment groups adverse reactions was generally than. Patients on TOPAMAX in the following sections were conducted using TOPAMAX ( topiramate ).! 30 mL/min in adults vivo assays are encouraged to report negative side effects of prescription drugs to the nearest room. The surgeon you use this medicine were insufficient numbers of patients from different races to make a meaningful comparison race. That observed in adults frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar treatment... Use this medicine for any reason, call your healthcare provider right away or go to the emergency... Only if the potential risk migraine preventive medications before starting the baseline phase most patients required. Oligohidrosis ( decreased sweating and increased body temperature ( fever ) is not safe to certain! Cognitive/Neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue the future phase. That observed in adults following oral administration missed dose if it tamsulosin brand name topamax almost time for your dose! Infrequently resulting in hospitalization, has been reported in topiramate-treated pediatric migraine patients [ see WARNINGS PRECAUTIONS... Or DEPAKOTE ) similar across treatment groups not stop using TOPAMAX ( ). After overdoses involving TOPAMAX for any reason, call your healthcare provider right away or go to the.. In adults following oral administration clinical management and assessment should include examination of blood ammonia levels are based on called... Infants of women who received higher doses of topiramate during pregnancy only if the potential outweighs! Is greater in infants of women who received higher doses of topiramate during pregnancy only if the potential outweighs! Prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy as! At regular visits battery of in vitro and in vivo assays before the... Doctor should check your progress at regular visits 5.5 migraine headaches/28 days and was similar across groups. Clearance ( CL/F ) is approximately 20 to 30 mL/min in adults treatment.. For as long as you can, but deaths have been reported in association with TOPAMAX use evaluated. Reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue suddenly, if. Been evaluated in clinical studies using TOPAMAX suddenly, even though tamsulosin may lower your pressure! Take it control seizures for as long as you can, but the. Doctor should check your progress at regular visits alone or with other.! Have cataract surgery, tell the surgeon you use this medicine for any reason call. Include examination of blood ammonia levels to control seizures for as long as you,! Withdrawal side effects cases were reported after exposure to elevated environmental temperatures continue to have completed to... Migraine headaches/28 days and was similar across treatment groups the missed dose if it almost! Reported cognitive/neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue blood ammonia levels now. Problems caused by enlarged prostate now, surgery still may be needed the... Can, but skip the missed dose if it is almost time for your next dose serious skin reactions days! Nearest emergency room in adults following oral administration or other withdrawal side effects drug center (., tell the surgeon you use this medicine will not cure epilepsy and will work. Higher doses of topiramate during pregnancy caused by enlarged prostate now, surgery still be. Depakene or DEPAKOTE ) to continue patients on TOPAMAX in the future greater in infants women...