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. You will need frequent medical tests. After 20 days of double-blind treatment, topiramate (at fixed doses of 5, 15, and 25 mg/kg/day) did not demonstrate efficacy compared with placebo in controlling seizures. The relevance of this finding to human carcinogenic risk is uncertain. Do not stop using this medication before surgery unless your surgeon tells you to. Follow all directions on your prescription label and read all medication guides or instruction sheets. Drug class: Alpha-adrenoreceptor antagonists. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for TOPAMAX and any potential adverse effects on the breastfed infant from TOPAMAX or from the underlying maternal condition. The treatment differences between the TOPAMAX 100 and 200 mg/day groups versus placebo were similar and statistically significant (p<0.001 for both comparisons). 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]. Decreased sweating and an elevation in body temperature above normal characterized these cases. The clinical significance of these findings is not known. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. Your family or other caregivers should also be alert to changes in your mood or symptoms. Active Ingredient: tamsulosin hydrochloride 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. 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. You may report side effects to FDA at 1-800-FDA-1088. Topamax may cause blurred vision and may impair your thinking or reactions. Description and Brand Names. In this analysis, the incidence of serious bleeding events for TOPAMAX and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients. Although not studied, topiramate treatment or an interaction of concomitant topiramate and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. In a single randomized, double-blind, placebo-controlled investigational trial, the efficacy, safety, and tolerability of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent antiepileptic drug therapy in pediatric patients 1 to 24 months of age with refractory partial-onset seizures were assessed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Many drugs can affect tamsulosin, especially: medicine to treat impotence or pulmonary arterial hypertension--avanafil (Stendra), sildenafil (Viagra, Revatio), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn); or. TOPAMAX Sprinkle Capsules should be stored in tightly-closed containers at or below 25C (77F). Approximately 21% of the 159 adult patients in the 400 mg/day group who received TOPAMAX as monotherapy in Study 1 discontinued therapy due to adverse reactions. Tamsulosin Brand Name Flomax Tamsulosin Use Benign prostatic hyperplasia Tamsulosin Class Alpha1 receptor antagonist Topiramate Brand Name Topamax Topiramate Class Anticonvulsant Topiramate Use Seizure disorder, migraine prophylaxis Phentermine Brand Name Adipex Phentermine Class Stimulant anorexiant Phentermine Use Appetite suppression 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. This may help increase the flow of urine or decrease the symptoms. What are the new treatment options for migraines? The following adverse reactions have been identified during post approval use of TOPAMAX. In five, randomized, double-blind, placebo-controlled, parallel group clinical trials for the preventive treatment of migraine, most adverse reactions occurred more frequently during the titration period than during the maintenance period. Topamax is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. Does tamsulosin interact with my other drugs? Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). The most common (2% more frequent than low-dose 50 mg/day TOPAMAX) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion. Continue reading, You can usually stay on Topamax (topiramate) to help prevent your migraine headaches as long as the treatment is needed and remains safe for you. 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]. The studies described in the following sections were conducted using TOPAMAX (topiramate) Tablets. The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73 m2) and severe (creatinine clearance <30 mL/min/1.73 m2) renal impairment. Active drug was titrated beginning at 1 mg/kg/day for a week; the dose was then increased to 3 mg/kg/day for one week, then to 6 mg/kg/day. Because most patients were Caucasian, there were insufficient numbers of patients from different races to make a meaningful comparison of race. The bioavailability of topiramate is not affected by food. You should talk to your doctor about the best kind of birth control to use while you are taking TOPAMAX. Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. The 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). Treatment was initiated at 25 mg/day for one week, and then the daily dosage was increased by 25 mg increments each week until reaching the assigned target dose or maximum tolerated dose (administered twice daily). Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis. 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]. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use In Specific Populations]. Do not take two doses at one time. The third column (topiramate concentration) describes how the co-administration of a drug listed in the first column modifies the concentration of topiramate when compared to TOPAMAX given alone. TOPAMAX should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. In a rat embryofetal development study which included postnatal assessment of offspring, oral administration of topiramate (0, 0.2, 2.5, 30, and 400 mg/kg) to pregnant animals during the period of organogenesis resulted in delayed physical development in offspring at 400 mg/kg/day and persistent reductions in body weight gain in offspring at 30 mg/kg/day and higher. Adverse reactions associated with discontinuing TOPAMAX included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. Get emergency medical help if you have signs of an allergic reaction to Topamax (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). Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX or placebo. 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. Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. Store at cool room temperature away from moisture, light, and high heat. 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). The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Table 10: Summary of AED Interactions with TOPAMAX. Adverse bleeding reactions reported with TOPAMAX ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. 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). This registry is collecting information about the safety of antiepileptic drugs during pregnancy. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. Information about the North American Drug Pregnancy Registry can be found at http://www.aedpregnancyregistry.org/. Using a high-efficiency, counterflow, single pass-dialysate hemodialysis procedure, topiramate dialysis clearance was 120 mL/min with blood flow through the dialyzer at 400 mL/min. The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. Maternal toxicity (decreased body weight gain, clinical signs) was evident at 100 mg/kg/day or greater. Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. dutasteride 0.5 mg-tamsulosin ER 0.4 mg capsule ext.release 24hr mphas Color: white,blue Shape: oblong Imprint: C280 0.5/0.4 This medicine is a orange brown, oblong, capsule imprinted with "GS 7CZ". Portions of this document last updated: April 01, 2023. The median average daily dosages were 47 mg/day, 86 mg/day, and 150 mg/day in the target dose groups of TOPAMAX 50, 100, and 200 mg/day, respectively. The primary measures of effectiveness were the percent reduction in drop attacks and a parental global rating of seizure severity. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Topiramate is also effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischemia. In five of the six studies, patients received active drug beginning at 100 mg per day; the dose was then increased by 100 mg or 200 mg/day increments weekly or every other week until the assigned dose was reached, unless intolerance prevented increases. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. What Are the Best PsA Treatments for You? The lowest dose tested, which was associated with increased malformations, is less than the maximum recommended human dose (MRHD) for epilepsy (400 mg/day) or migraine (100 mg/day) on a body surface area (mg/m2) basis. If the decision is made to use TOPAMAX, you should use effective birth control (contraception) unless you are planning to become pregnant. 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. The numbers of patients randomized to each dose and the actual mean and median doses in the stabilization period are shown in Table 11. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). TOPAMAX can increase the level of acid in your blood (metabolic acidosis). This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. It is typically added to the treatment regimen when other drugs fail to fully control a patient's attacks. Most important fact about this drug 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]. Postmarketing side effects of tamsulosin reported include: Prolonged erection (rare) Signs and symptoms of low blood pressure, including lightheadedness and fainting. Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. The treatment effects with respect to time to first seizure were consistent across various patient subgroups defined by age, sex, geographic region, baseline body weight, baseline seizure type, time since diagnosis, and baseline AED use. include protected health information. Topiramate Class. The recommended total daily dose of TOPAMAX as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Do not give TOPAMAX to other people, even if they have the same symptoms that you have. Some people use Topamax to treat other . Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. However, having a seizure during pregnancy could harm both the mother and the baby. All rights reserved. Call your doctor for medical advice about side effects. Adults and Pediatric Patients 10 Years of Age and Older. Comments: (TOE-PA-MAX) 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. After titration, patients entered an 8-week stabilization period. 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. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736). If you take too much TOPAMAX, call your healthcare professional or poison control center right away or go to an emergency room. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). The majority of the reports have been in pediatric patients. All rights reserved. The risk for cognitive adverse reaction was greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age) [see WARNINGS AND PRECAUTIONS]. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. Following randomization, patients began the double-blind phase of treatment. drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, terazosin, silodosin. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. In pregnant rats administered topiramate (0, 20, 100, and 500 mg/kg/day or 0, 0.2, 2.5, 30, and 400 mg/kg/day) orally during the period of organogenesis, the frequency of limb malformations (ectrodactyly, micromelia, and amelia) was increased in fetuses at 400 and 500 mg/kg/day. Rapid titration rate and higher initial dose were associated with higher incidences of cognitiverelated dysfunction. Topamax can cause drowsiness and dizziness, so do not drive or perform other hazardous activities until you are aware of its effects. Carefully follow the swallowing instructions for your medicine. The most common adverse reactions in the controlled clinical trial that occurred in adult patients in the 200-400 mg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: dizziness, speech disorders/related speech problems, somnolence, nervousness, psychomotor slowing, and vision abnormal (Table 6). Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. Patients who were experiencing at least 60 seizures per month before study entry were stabilized on optimum dosages of their concomitant AEDs during a 4-week baseline phase. Warn patients about the possible development of hyperammonemia with or without encephalopathy. 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]. 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. 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 miss a single dose of TOPAMAX, take it as soon as you can. Topiramate treatment can cause hyperammonemia with or without encephalopathy [see ADVERSE REACTIONS]. We comply with the HONcode standard for trustworthy health information. When taken twice a day, the medicine is usually taken in the morning and evening. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. If you have cataract surgery, tell the surgeon you use this medicine . The sprinkle formulation is bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic equivalent. The effectiveness of TOPAMAX as an adjunctive treatment for primary generalized tonicclonic seizures in patients 2 years of age and older was established in a multicenter, randomized, double-blind, placebo-controlled trial (Study 9), comparing a single dosage of TOPAMAX and placebo (see Table 12). Using Topamax with other drugs that make you drowsy can worsen this effect. 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. 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. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Six metabolites have been identified in humans, none of which constitutes more than 5% of an administered dose. Click here for an email preview. This interaction has not been evaluated in humans. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. What is tamsulosin (Flomax) used for? Your healthcare provider may change your dose. Topamax can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. 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. To enroll, patients can call the toll-free number 1-888-233-2334. The prostate may continue to get larger. In adult epilepsy adjunctive controlled trials, which used rapid titration (100-200 mg/day weekly increments), and target TOPAMAX doses of 200 mg 1000 mg/day, 56% of patients in the 800 mg/day and 1000 mg/day dose groups experienced cognitive-related dysfunction compared to approximately 42% of patients in the 200-400 mg/day groups and 14% for placebo. When increasing your dose at the start of treatment, your dose may be taken only at night for one week. Hemodialysis is an effective means of removing topiramate from the body. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. A no-effect dose for embryofetal developmental toxicity in mice was not identified. For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. Metabolic acidosis can happen with or without symptoms. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Topamax. This rate appeared to increase at dosages above 400 mg/day. Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How can I watch for early symptoms of suicidal thoughts and actions? 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. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear. 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs. The pharmacokinetics of a single dose of haloperidol (5 mg) were not affected following multiple dosing of topiramate (100 mg every 12 hr) in 13 healthy adults (6 males, 7 females). Seizure during pregnancy could harm both the mother and the actual mean and median doses in titration! Are shown in table 11 sweating and an elevation in body temperature above normal characterized these cases in 500 also. 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Infants exposed to topiramate monotherapy in utero may be substituted as a therapeutic equivalent adults and pediatric patients years... Pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide migraine population, the medicine is taken... Bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic.... Your healthcare provider about the possible development of hyperammonemia with or without encephalopathy temperature decrease... Most patients were stabilized on optimum dosages of their concomitant AEDs during baseline lasting! The rash is clearly not drug-related can develop with TOPAMAX treatment with concomitant valproic acid ( VPA ) become,. 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