This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. 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. 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". Pregnancy Registry: If you become pregnant while taking TOPAMAX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. How long do you stay on Topamax for migraines? Keep TOPAMAX in a tightly closed container. Stay alert to changes in your mood or symptoms. Take tamsulosin capsules exactly as prescribed by your doctor. It blocks a specific type of receptor found in the prostate. Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 to 250 g/mL. If you are a Mayo Clinic patient, this could Its saturated solution has a pH of 6.3. Take Topamax exactly as it was prescribed for you. You may report side effects to FDA at 1-800-FDA-1088. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. Tell patients that they should not take a double dose in the event of a missed dose. Topamax may cause blurred vision and may impair your thinking or reactions. the unsubscribe link in the e-mail. TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. Tamsulosin (Flomax) is an alpha-1 blocker. The no-effect dose (90 mg/kg/day) for adverse developmental effects is approximately 2 times the maximum recommended pediatric dose (9 mg/kg/day) on a body surface area (mg/m2) basis. Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trial (Study 1) in Adult and Pediatric Patients. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. . Benign enlargement of the prostate is a problem that can occur in men as they get older. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. 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 (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). If you miss a single dose of TOPAMAX, take it as soon as you can. Tamsulosin can affect your pupils during cataract surgery. Be careful if you drive or do anything that requires you to be alert. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. In clinical trials, 3% of patients were over age 60. 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. In each study, patients were stabilized on optimum dosages of their concomitant AEDs during baseline phase lasting between 4 and 12 weeks. Co-administration of topiramate with diltiazem resulted in a 16% increase in Cmax and a 19% increase in AUC12 of topiramate. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. In this study, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). Uses Warnings Before taking Dosage Side effects Interactions What is tamsulosin? Topiramate does not influence the binding of sodium valproate. The purpose of this registry is to collect information about the safety of TOPAMAX and other antiepileptic drugs during pregnancy. Tamsulosin Use. Some people have thoughts about suicide while taking an anticonvulsant. Topiramate is a white crystalline powder with a bitter taste. To provide you with the most relevant and helpful information, and understand which A dosage adjustment may be required [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Co-administration of topiramate 400 mg/day with risperidone resulted in a 14% increase in Cmax and a 12% increase in AUC12 of topiramate. Using Topamax with other drugs that make you drowsy can worsen this effect. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TOPAMAX (using dose tapering). Topamax. Avoid becoming overheated or dehydrated in hot weather. Side Effects Some w omen experience dizziness when taking tamsulosin. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, and Cmax was reduced by 18% and 25%, respectively. 3 Sources. Absorption of topiramate is rapid, with peak plasma concentrations occurring at approximately 2 hours following a 400 mg oral dose. Approximately 80% or more patients in each treatment group completed the study. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. The most frequently reported cognitive/neuropsychiatric reactions in pediatric epilepsy patients during adjunctive therapy double-blind studies were somnolence and fatigue. have a history of metabolic acidosis (too much acid in the blood). 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. Table 7: Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Epilepsy Trials in Pediatric Patients 2 to 15 Years of Agea,b. 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. If required, longer intervals between dose adjustments can be used. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). This is not a complete list of side effects and others may occur. Controlled trials of adjunctive TOPAMAX treatment of adults for partial-onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% TOPAMAX versus 2% placebo), markedly increased serum alkaline phosphatase (3% TOPAMAX versus 1% placebo), and decreased serum potassium (0.4 % TOPAMAX versus 0.1 % placebo). This medication is also used to prevent migraine headaches and decrease how often you get them. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. This list is not complete. In vitro studies indicate that topiramate does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5 isozymes. If we combine this information with your protected Based on limited information, topiramate has also been associated with pre-term labor and premature delivery. After titration, patients entered an 8-week stabilization period. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some people have thoughts about suicide while taking seizure medicine. Report any new or worsening symptoms to your doctor. In a double-blind study in 90 pediatric patients 6 to 11 years of age (including 59 topiramate-treated and 31 placebo patients), the adverse reaction profile was generally similar to that seen in pooled double-blind studies of pediatric patients 12 to 17 years of age. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. 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 has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. The effects of topiramate on milk production are unknown. 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. Stopping suddenly may cause increased seizures. Last updated on Apr 5, 2023. Do not stop using Topamax suddenly or you could have increased seizures. Similarity of exposure-response was also demonstrated in pediatric patients 6 to less than 16 years of age and adults when TOPAMAX was given as initial monotherapy. TOPAMAX passes into breast milk. A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly. health information, we will treat all of that information as protected health 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]. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. After titration, patients entered a 12-week stabilization period. 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 is an anticonvulsant (seizure) medication, but is also prescribed for other conditions such as prevention of migraine. Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Topiramate Use. The clinical significance of these findings is not known. There are many other drugs that can interact with this medicine. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. No adverse effects on male or female fertility were observed in rats administered topiramate orally at doses up to 100 mg/kg/day (2.5 times the MRHD for epilepsy and 10 times the MRHD for migraine on a mg/m2 basis) prior to and during mating and early pregnancy. Warn patients about the possible development of hyperammonemia with or without encephalopathy. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION). 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]. In Study 12, a total of 468 patients (406 females, 62 males), ranging in age from 12 to 65 years, were randomized and provided efficacy data. How can I watch for early symptoms of suicidal thoughts and actions? For more information, ask your doctor or pharmacist. Follow your healthcare providers directions exactly. Visit the FDA MedWatch website or call 1-800-FDA-1088. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. The effects of these interactions on mean plasma AUCs are summarized in Table 10. 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. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In controlled clinical trials in adults, 11% of patients receiving TOPAMAX 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older. 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. Do not take two doses at one time. Topiramate is excreted in human milk [see Data]. information and will only use or disclose that information as set forth in our notice of This may cause the symptoms to become worse over time. Qsymia, an extended-release medicine that contains phentermine and topiramate, is FDA approved for weight loss, along with diet and exercise. The fraction bound decreased as blood concentration increased. Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin. seizures. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. Benign enlargement of the prostate is a problem that can occur in men as they get older. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TOPAMAX during pregnancy. Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). 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. Food and drink that may interact with this drug include: Taking tamsulosin with any food may decrease its effectiveness by 30 percent, according to the FDA . Tell your doctor about all medications you use. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period. TOPAMAX (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Generic Topamax (topiramate) is used in combination with phentermine in a weight loss medication called Qsymia. Higher daily doses (400 mg/day) of topiramate were associated with greater rates of hair loss than lower doses (50 mg/day) in both age groups. 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 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. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of topiramate on the baby. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 5 mg to 9 mg/kg/day TOPAMAX group with an incidence higher ( 10 %) than in the placebo group were: fatigue and somnolence (Table 7). Rapid titration rate and higher initial dose were associated with higher incidences of cognitiverelated dysfunction. These changes were often dose-related, and were most frequently associated with the greatest treatment difference at the 200 mg dose level. What is tamsulosin (Flomax) used for? For the monotherapy epilepsy population, the incidence of somnolence was dose-related. Your reactions could be impaired. The significance of these findings is uncertain. This content does not have an English version. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using TOPAMAX, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [see DRUG INTERACTIONS]. Steady-state is thus reached in about 4 days in patients with normal renal function. TOPAMAX (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. In four, fixed-dose, double-blind clinical trials for the preventive treatment of migraine in TOPAMAX-treated pediatric patients 12 to 17 years of age, the most common adverse reactions with TOPAMAX 100 mg that were seen at an incidence higher (5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain (see Table 9). Dangerous side effects or increased seizures may occur. In this rapid titration regimen, these dose-related adverse reactions began in the titration or in the maintenance phase, and in some patients these events began during titration and persisted into the maintenance phase. This rate appeared to increase at dosages above 400 mg/day. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. -This drug should be administered approximately one-half hour following the same meal each day. TOPAMAX (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors: TOPAMAX (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. As in adults, hepatic enzyme-inducing antiepileptic drugs decrease the steady state plasma concentrations of topiramate.
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