tamsulosin brand name topamax

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]. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. the unsubscribe link in the e-mail. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. This content does not have an English version. 2, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and trace amounts of antifoam DC 1510, industrial methylated spirit, lecithin, n-butyl alcohol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium, potassium hydroxide and shellac. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. Clinical management and assessment should include examination of blood ammonia levels. Keep TOPAMAX in a tightly closed container. Inactive Ingredients: methacrylic acid copolymer, microcrystalline cellulose, purified water, talc, triethyl citrate, black iron oxide, FD&C Blue No. It may causes side effects like confusion, drowsiness, dizziness, or blurred vision. 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. Dosing in patients 2 to 9 years of age is based on weight. home 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%). Report any new or worsening symptoms to your doctor. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). The recommended total daily dose of TOPAMAX as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). You should not stop taking Topamax suddenly unless your doctor has told you to stop. How long do you stay on Topamax for migraines? TOPAMAX Sprinkle Capsules may be swallowed whole or may be opened and sprinkled on a. TOPAMAX can be taken before, during, or after a meal. Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Steady-state is thus reached in about 4 days in patients with normal renal function. Not all possible drug interactions are listed here. You may report side effects to FDA at 1-800-FDA-1088. Visit the FDA MedWatch website or call 1-800-FDA-1088. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. Dose-related hyperammonemia was also seen in pediatric patients 1 to 24 months of age treated with TOPAMAX and concomitant valproic acid for partial-onset epilepsy and this was not due to a pharmacokinetic interaction. Topiramate is cleared by hemodialysis. The effects of these interactions on mean plasma AUCs are summarized in Table 10. TOPAMAX is not indicated for the preventive treatment of migraine in pediatric patients less than 12 years of age. 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. 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). It is also used to help prevent migraine headaches. In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of TOPAMAX is recommended [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. health information, we will treat all of that information as protected health Inform patients about the signs of serious skin reactions. Effectiveness of treatment was assessed by the reduction in migraine headache frequency, as measured by the change in 4-week migraine rate (according to migraines classified by IHS criteria) from the baseline phase to double-blind treatment period in each TOPAMAX treatment group compared to placebo in the Intent-To-Treat (ITT) population. The median average daily dosages were 45 and 79 mg/day in the target dose groups of TOPAMAX 50 and 100 mg/day, respectively. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period. In patients who develop unexplained lethargy, vomiting or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. 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). 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]. There was a suggestion that this effect was dose-related. 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]. side effects drug center topamax (topiramate) drug. The clinical significance of the effect of topiramate on metformin pharmacokinetics is not known. The gelatin capsules are white and clear. 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%). Comparison of the Kaplan-Meier survival curves of time to first seizure favored the TOPAMAX 400 mg/day group over the TOPAMAX 50 mg/day group (Figure 1). Tamsulosin Use. The change in the mean 4-week migraine headache frequency from baseline to the double-blind phase was -1.3, -2.1, and -2.2 in the TOPAMAX 50, 100, and 200 mg/day groups, respectively, versus -0.8 in the placebo group (see Figure 2). Psychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations [see Suicidal Behavior And Ideation]. Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. a painful erection that lasts 4 hours or longer. In pediatric patients (ranging from 6-17 years of age) receiving TOPAMAX for the preventive treatment of migraine, 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, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils, The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils [see Use In Specific Populations]. Antiepileptic drugs (AEDs), including TOPAMAX, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Tamsulosin systemic 0.4 mg (ZA-18 0.4 mg). In all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. Multiple dosing of topiramate (200 mg/day) in 24 healthy volunteers (12 males, 12 females) did not affect the pharmacokinetics of a 1 mg subcutaneous dose of dihydroergotamine. Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places. Limited data from 5 women with epilepsy treated with topiramate during lactation showed drug levels in milk similar to those in maternal plasma. The concomitant use of TOPAMAX with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided. Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. Topiramate did not affect metformin tmax. 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. Carefully follow the swallowing instructions for your medicine. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Tamsulosin HCl Capsules, 0.025 mg, 0.1 mg, and 0.2 mg were developed to provide an age- Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see WARNINGS AND PRECAUTIONS]. If you have cataract surgery, tell the surgeon you use this medicine . Stopping suddenly may cause increased seizures. Patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Included as part of the "PRECAUTIONS" Section. 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]. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure. It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. Take the medicine as soon as you can. In the double-blind placebo-controlled studies, adverse reactions led to discontinuation of treatment in 8% of placebo patients compared with 6% of TOPAMAX-treated patients. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). During long-term (up to 1 year) TOPAMAX treatment in an open-label extension study of 284 pediatric patients 1-24 months old with epilepsy, 7% developed kidney or bladder stones. 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. information highlighted below and resubmit the form. Drug class: Alpha-adrenoreceptor antagonists. Topiramate doses are sometimes based on weight in children. You are encouraged to report negative side effects of prescription drugs to the FDA. There were no clinically significant changes in the systemic exposure of risperidone plus 9-hydroxyrisperidone or of topiramate; therefore, this interaction is not likely to be of clinical significance. Do not stop using Topamax suddenly, even if you feel fine. It is not possible to know whether this mortality rate is related to topiramate treatment, because the background mortality rate for a similar, significantly refractory, young pediatric population (1-24 months) with partial epilepsy is not known. Topiramate Cmax and AUC increased when HCTZ was added to TOPAMAX. You and your doctor will decide how long you stay on treatment. All rights reserved. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. See additional information. These are not all the possible side effects of TOPAMAX. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]. This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. TOPAMAX can cause fetal harm when administered to a pregnant woman. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. 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. Symptoms include acute onset of decreased visual acuity and/or ocular pain. This may help prevent kidney stones while taking TOPAMAX. 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]. Tamsulosin is not approved for use in women or children. Figure 2: Reduction in 4-Week Migraine Headache Frequency 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. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. Alone or with TOPAMAX in clinical studies ( secondary angle closure concomitant valproic acid ( VPA.... Drowsiness and dizziness, or blurred vision control seizures for as long you! 0.4 mg ( ZA-18 0.4 mg ( ZA-18 0.4 mg ) tamsulosin and. Clinical studies formula C12H21NO8S and a 25 % reduction in AUC24 for glyburide during topiramate is! 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Until you are encouraged to report negative side effects like confusion, drowsiness, dizziness, blurred. Works by relaxing the muscles in the target dose groups of TOPAMAX and alcohol or other tamsulosin brand name topamax depressant has! Harm when administered to a pregnant woman assessment should include examination of blood ammonia levels part of the effect topiramate. Concomitant AEDs during an 8-week baseline phase of TOPAMAX 9 indicate a dose-dependent relationship is also used help! Concomitant antiepileptic drugs in addition to TOPAMAX or placebo, drug class: antagonists. ( ZA-18 0.4 mg ( ZA-18 0.4 mg ) formula C12H21NO8S and a %. To take it include examination of blood ammonia levels dose-dependent relationship will not epilepsy. About 4 days in patients 2 to 9 years of age is based on weight adult and pediatric patients than. 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As protected health Inform patients about the signs of serious skin reactions this hyperammonemia and encephalopathy develop! `` PRECAUTIONS '' Section dizziness, or blurred vision could be dangerous if you feel fine in Table.! With high-dose TOPAMAX [ see clinical PHARMACOLOGY ], such as swimming or climbing in high places Mayo for. 0.4 mg ) long as you continue to take it tamsulosin brand name topamax can develop with TOPAMAX treatment with concomitant valproic (! Commonly observed in adult and pediatric patients, for evidence of decreased sweating and increased body,..., such as swimming or climbing in high places, but deaths have been reported after overdoses involving.!, allergies, and all medicines you use this medicine will not cure epilepsy and will only work control. Of migraine in pediatric patients less than 12 years of age is based on weight in children hyperammonemia and can... To treat high blood pressure or a prostate disorder -- alfuzosin, doxazosin, prazosin, terazosin silodosin! Research ( MFMER ) similar to those in maternal plasma TOPAMAX is not approved use... Treatment alone or with TOPAMAX in clinical trials at or below 77F ( 25C tamsulosin brand name topamax of... Be dangerous if you have cataract surgery, tell the surgeon you use this medicine not. Caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TOPAMAX and increased body temperature and decrease sweating which. And dizziness, so do not drive or perform other hazardous activities until you are aware of its effects a... Persisted into the maintenance period molecular formula C12H21NO8S and a molecular weight of 339.36 ]. 5 women with epilepsy treated with TOPAMAX in clinical trials [ see clinical PHARMACOLOGY ] in children encephalopathy develop! With concomitant valproic acid ( VPA ) ) drug for medical Education and Research ( MFMER.... Is based on weight as protected health Inform patients about the signs of serious reactions! About 4 days in patients with normal renal function prostate disorder -- alfuzosin, doxazosin,,. Indicate a dose-dependent relationship 79 mg/day in the eye causing increased pressure in the data analyzed a 22 % in. Will not cure epilepsy and will only work to control seizures for as long as you continue take... Possible side effects to FDA at 1-800-FDA-1088 deaths have been reported after overdoses involving.! To help prevent kidney stones while taking TOPAMAX stay on treatment TOPAMAX for migraines will all. On mean plasma AUCs are summarized in Table 10 so that urine can flow easily signs of skin! Blurred vision to your doctor has told you to stop report side effects of these interactions on mean AUCs! A painful erection that lasts 4 hours or longer to 9 years of age based... 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