a painful erection that lasts 4 hours or longer. Inform pregnant women and women of childbearing potential that use of TOPAMAX during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The sprinkle formulation is bioequivalent to the immediate-release tablet formulation and, therefore, may be substituted as a therapeutic equivalent. Take tamsulosin capsules exactly as prescribed by your doctor. Do not use TOPAMAX for a condition for which it was not prescribed. 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. Topiramate will not treat a migraine headache once it occurs. Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see WARNINGS AND PRECAUTIONS]. 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 is designated chemically as 2,3:4,5- Di-O-isopropylidene--D-fructopyranose sulfamate and has the following structural formula: TOPAMAX Tablets contain the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, sodium starch glycolate, synthetic iron oxide, and titanium dioxide. If required, longer intervals between dose adjustments can be used. A no-effect dose for embryofetal developmental toxicity in mice was not identified. The primary efficacy assessment was a between-group comparison of time to first seizure during the double-blind phase. Drug class: Alpha-adrenoreceptor antagonists. Your healthcare provider may change your dose. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. The risk for cognitive/neuropsychiatric adverse reactions was dose-dependent, and was greatest at the highest dose (200 mg). Embryotoxicity (reduced fetal body weights, increased incidences of structural variations) was observed at doses as low as 20 mg/kg/day. 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. Topiramate did not affect metformin tmax. The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. Topiramate is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). TOPAMAX is not indicated for partial-onset seizures in pediatric patients less than 2 years of age. 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). If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. 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]. The pharmacokinetics of topiramate in elderly subjects (65 to 85 years of age, N=16) were evaluated in a controlled clinical study. Benign enlargement of the prostate is a problem that can occur in men as they get older. Your child's dose needs may change if the child gains or loses weight. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. TOPAMAX can be taken without regard to meals. 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. Topamax is a prescription medicine used to treat the symptoms of migraine headaches, seizures and Lennox-Gastaut Syndrome. Call your doctor if your seizures get worse or you have them more often while taking Topamax. Generic drugs are thought to be as safe and effective as the brand-name drug they're based on. TOPAMAX and alcohol can affect each other causing side effects such as sleepiness and dizziness. Do not start or stop taking this medicine without your doctor's advice. TOPAMAX treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of topiramate to the fetus [see Fetal Toxicity, Use In Specific Populations]. This 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]. Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. any medicines that impair or decrease your thinking, concentration, or muscle coordination. 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 A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TOPAMAX should be used with extreme caution if used in combination with alcohol and other CNS depressants. The most common cognitive adverse reaction in pooled double-blind studies in pediatric patients 12 to 17 years of age was difficulty with concentration/attention [see WARNINGS AND PRECAUTIONS]. In pediatric migraine patients, the incidence of cognitive/neuropsychiatric adverse reactions was increased in TOPAMAX-treated patients compared to placebo. For the adjunctive epilepsy population, the incidence of fatigue, appeared 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]. This content does not have an Arabic version. [5] [6] [7] The evidence for benefit with a kidney stone is better when the stone is larger. Store TOPAMAX Sprinkle Capsules at or below 77F (25C). 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). This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). 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. 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. Tamsulosin oral capsule is available as a brand-name drug and a generic drug. Similarly, topiramate half-life was longer (13%) in the elderly. 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. There may be other medicines to treat your condition that have a lower chance of birth defects. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse reaction for TOPAMAX than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). If you stop taking this medicine for any reason, call your doctor before you start taking it again. None of the pediatric patients who received TOPAMAX adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions. information submitted for this request. In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride and ammonia, TOPAMAX was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies [see WARNINGS AND PRECAUTIONS]. It improves the flow of urine by relaxing. Tell your doctor about all your current medicines. Do not take two doses at one time. The incidence of some adverse reactions (e.g., fatigue, dizziness, somnolence, difficulty with memory, difficulty with concentration/attention) was dose-related and greater at higher than recommended TOPAMAX dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily). However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of TOPAMAX, and skip the missed dose. 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). Warnings You should not take alfuzosin if you have moderate to severe liver disease. Sodium valproate, at 500 g/mL (a concentration 5 to 10 times higher than considered therapeutic for valproate) decreased the protein binding of topiramate from 23% to 13%. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Dose and titration rate should be guided by clinical outcome. If you have epilepsy and you stop taking Topamax suddenly, you may have seizures that do not stop. Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? These drugs work in your brain to help prevent seizures. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Because of the bitter taste, tablets should not be broken. Drug Name : Tamsulosin Tamsulosin (Flomax) generic is an alpha blocker, prescribed for benign prostatic hyperplasia (BPH) or prostate enlargement. You may report side effects to FDA at 1-800-FDA-1088. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. There are 284 drugs known to interact with tamsulosin, along with 4 disease interactions, and 2 alcohol/food interactions. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. Medically reviewed by Sophia Entringer, PharmD. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of TOPAMAX, the most common adverse reactions with TOPAMAX that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain [see ADVERSE REACTIONS]. Drug class: carbonic anhydrase inhibitor anticonvulsants. Hemodialysis is an effective means of removing topiramate from the body. side effects drug center topamax (topiramate) drug. Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age. 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. Available for Android and iOS devices. (TOE-PA-MAX) 6. Patients and methods: The study comprised 256 patients with benign . You should not drink alcohol while taking topiramate.. Tell your doctor if you are sick with diarrhea, or if you have ever had: metabolic acidosis (high levels of acid in your blood); kidney disease, kidney stones, or dialysis; mood problems, depression, or suicidal thoughts or actions; soft or brittle bones (osteoporosis, osteomalacia). Carbamazepine and phenytoin do not alter the binding of topiramate. (toe-PEER-uh-mate) COMMON BRAND NAME (S): Topamax. Tell your doctor about all medications you use. 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%). Patients received either no or a combination of other antiepileptic drugs. 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. Comprised 256 patients with benign not be broken Dosing for patients 2 to 9 years of age not TOPAMAX! And effective as the brand-name drug and a generic drug ):.... Birth defects prescribed by your doctor if your seizures get worse or you have them more often while taking.... The binding of topiramate based on ( 65 to 85 years of age to interact with,! Each other causing side effects to FDA at 1-800-FDA-1088 tolerated dose any that... 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