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. Concomitant administration of TOPAMAX and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. 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]. Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age. Brand Name: Flomax Generic Name: Tamsulosin hydrochloride (HCl) Relevant IND: IND 30,365 . To provide you with the most relevant and helpful information, and understand which Clinical management and assessment should include examination of blood ammonia levels. Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see WARNINGS AND PRECAUTIONS]. Brand names: Topamax, Topamax Sprinkle, Topiragen, Trokendi XR, Qudexy XR Sprinkle, Topiramate ER (Eqv-Qudexy XR), Eprontia Dosage forms: oral capsule (15 mg; 25 mg), oral capsule, extended release (100 mg; 150 mg; 200 mg; 25 mg; 50 mg), oral solution (25 mg/mL), oral tablet (100 mg; 200 mg; 25 mg; 50 mg) Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. The mean migraine headache frequency rate at baseline was approximately 5.5 migraine headaches/28 days and was similar across treatment groups. Metabolic acidosis was commonly observed in adult and pediatric patients treated with TOPAMAX in clinical trials. Inform patients about the signs of serious skin reactions. 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. Dosing in patients 2 to 9 years of age is based on weight. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and >5 mEq/L decrease from pretreatment) in these trials was up to 11%, compared to 2% for placebo. This will be based on how well it is working for you and any side effects you may experience. Medically reviewed by Sophia Entringer, PharmD. 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. This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. 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. Reduced topiramate clearance resulted in slightly higher maximum plasma concentration (23%) and AUC (25%) in elderly subjects than observed in young adults. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children). Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. Tell your eye surgeon ahead of time that you are using this medication. TOPAMAX Sprinkle Capsules should be stored in tightly-closed containers at or below 25C (77F). TOPAMAX Sprinkle Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. Topiramate is a sulfamate-substituted monosaccharide. Carbamazepine and phenytoin do not alter the binding of topiramate. Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX-treated patient were fatigue (1%), headache (1%), and somnolence (1%). 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. Some patients may experience a large increase in amitriptyline concentration in the presence of TOPAMAX and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see CLINICAL PHARMACOLOGY]. For the migraine population, the incidences of both fatigue and somnolence were dose-related and more common in the titration phase. This product is available in the following dosage forms: There is a problem with This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA). The clinical significance of this change is unknown. 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]. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. Patients and methods: The study comprised 256 patients with benign . to prevent migraine headaches in adults and adolescents 12 years and older. Some people have thoughts about suicide while taking seizure medicine. Hair loss (also called alopecia) has been reported in 1% to 4% of children ages 6 to 16 years of age, and in 3% to 4% of patients older than 16 years of age. Topiramate is not extensively metabolized and is primarily eliminated unchanged in the urine (approximately 70% of an administered dose). The gelatin capsules are white and clear and are marked as follows: TOPAMAX Tablets should be stored in tightly-closed containers at controlled room temperature (59 to 86F, 15 to 30C). Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. 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]. Patients in these studies were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX tablets or placebo. Any medical care provider who treats you should know that you take seizure medication. Lithium levels should be monitored when co-administered with high-dose TOPAMAX [see CLINICAL PHARMACOLOGY]. Topamax may cause vision problems that can be permanent if not treated quickly. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. It may harm them. Figure 2: Reduction in 4-Week Migraine Headache Frequency Patients with a history of cluster headaches or basilar, ophthalmoplegic, hemiplegic, or transformed migraine headaches were excluded from the trials. The recommended dose for TOPAMAX monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving TOPAMAX. Dosage Dosage can depend on many factors but typically it is 0.4 mg. You should, however, follow your doctor's specific dosing instructions. Topiramate doses are sometimes based on weight in children. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. TOPAMAX may cause serious side effects including: See What is the most important information I should know about TOPAMAX?. 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). There was a 12% increase in AUC and Cmax for amitriptyline (25 mg per day) in 18 healthy subjects (9 males, 9 females) receiving 200 mg/day of TOPAMAX. You may opt-out of email communications at any time by clicking on TABLETS, for oral use, TOPAMAX If you stop taking this medicine for any reason, call your doctor before you start taking it again. Patient selection was based on IHS criteria for migraines (using proposed revisions to the 1988 IHS pediatric migraine criteria [IHS-R criteria]). Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. Topamax was originally FDA-approved as a seizure medicine, also called an anticonvulsant. 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). Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Benign enlargement of the prostate is a problem that can occur in men as they get older. There are many other drugs that can interact with this medicine. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4.0 23.0) as compared to the risk in a background population of untreated women. Topamax can make birth control pills less effective. You may report side effects to FDA at 1-800-FDA-1088. 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). Patients in Study 10 were permitted a maximum of two antiepileptic drugs (AEDs) in addition to TOPAMAX or placebo. seizures. The gelatin capsules are white and clear. Hemodialysis is an effective means of removing topiramate from the body. Tell your doctor right away if you become pregnant. Table 10: Summary of AED Interactions with TOPAMAX. The study enrolled 103 patients (40 male, 63 female) 12 to 17 years of age with episodic migraine headaches with or without aura. 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 you are a Mayo Clinic patient, this could Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities. 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). Mayo Clinic does not endorse companies or products. 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.. TOPAMAX Sprinkle Capsules contain topiramate-coated beads in a hard gelatin capsule. Swallow the capsule whole and do not crush, chew, break, or open it. In all adjunctive trials, the reduction in seizure rate from baseline during the entire double-blind phase was measured. Keep TOPAMAX in a tightly closed container. Advertising revenue supports our not-for-profit mission. Tamsulosin may cause serious side effects. Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX. The relevance of this finding to human carcinogenic risk is uncertain. Two hundred sixty-five patients completed the entire 26-week double-blind phase. Adults and Pediatric Patients 10 Years of Age and Older. Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor slowing and decreased verbal fluency. How long do you stay on Topamax for migraines? The long-term consequences of the SGA findings are not known. The following serious adverse reactions are discussed in more detail in other sections of the labeling: The data described in the following sections were obtained using TOPAMAX Tablets. Patients who experienced at least three primary generalized tonic-clonic seizures during the baseline phase were randomly assigned to placebo or TOPAMAX in addition to their other AEDs. Metabolic acidosis can happen with or without symptoms. 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 most common side effects of TOPAMAX include: Tell your healthcare provider about any side effect that bothers you or that does not go away. Protect from moisture. Table 8: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adultsa,b. Your family or other caregivers should also be alert to changes in your mood or symptoms. The brand-name medication that tamsulosin oral capsules are based on is called Flomax. In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency [see Clinical Studies]. Revised: Jun 2020. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant TOPAMAX administration. To make sure tamsulosin capsules are safe for you, tell your doctor if you have ever had: Tamsulosin can affect your pupils. Topamaxmay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. However, having a seizure during pregnancy could harm both the mother and the baby. The recommended total daily dose of TOPAMAX as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. As in the general population, the incidence of stone formation among TOPAMAX-treated patients was higher in men. This list is not complete. Call your doctor for medical advice about side effects. In vitro studies indicate that topiramate is a mild inhibitor of CYP2C19 and a mild inducer of CYP3A4. In some patients, hyperammonemia can be asymptomatic. In general, the adverse reaction profile for TOPAMAX in this population was similar to that of older pediatric patients, although results from the above controlled study and an open-label, long-term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions/toxicities (not previously observed in older pediatric patients and adults; i.e., growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Keep TOPAMAX and all medicines out of the reach of children. The noeffect dose (0.2 mg/kg/day) for pre- and postnatal developmental toxicity in rats is less than the MRHD for epilepsy or migraine on a mg/m2 basis. We comply with the HONcode standard for trustworthy health information. TOPAMAX can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). TOPAMAX is a carbonic anhydrase inhibitor. 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]. 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. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. There may be other medicines to treat your condition that have a lower chance of birth defects. The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice. Follow all directions on your prescription label and read all medication guides or instruction sheets.. Tamsulosin capsules are usually taken once a day, within 30 minutes after the same meal each day. This drug/food mixture should be swallowed immediately and not chewed. It improves the flow of urine by relaxing. Controlled Substances Act (CSA). Tamsulosin oral capsule is available as a brand-name drug and a generic drug. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Following randomization, patients began the double-blind phase of treatment. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Included as part of the "PRECAUTIONS" Section. The median percent reductions in seizure rates and the responder rates (fraction of patients with at least a 50% reduction) by treatment group for each study are shown below in Table 12. Do not take two doses at one time. decreased feeling or sensitivity, especially in the skin. Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Store tightly closed at room temperature, away from moisture and heat. Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. information is beneficial, we may combine your email and website usage information with Instruct patients to immediately report behaviors of concern to their healthcare providers [see WARNINGS AND PRECAUTIONS]. The prostate may continue to get larger. Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. Fetal body weights and skeletal ossification were reduced at the highest dose tested in conjunction with decreased maternal body weight gain. The effect of TOPAMAX on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Tamsulosin pregnancy and breastfeeding warnings, Drug class: alpha-adrenoreceptor antagonists. This Medication Guide has been approved by the U.S. Food and Drug Administration. Efficacy of topiramate (2 to 3 mg/kg/day) for the preventive treatment of migraine was not demonstrated in a placebo-controlled trial of 157 pediatric patients (6 to 16 years of age) that included treatment of 67 pediatric patients (12 to 16 years of age) for 20 weeks. You will need frequent medical tests. Patients received active drug beginning at 25 or 50 mg/day; the dose was then increased by 25 mg to 150 mg/day increments every other week until the assigned dosage of 125, 175, 225, or 400 mg/day based on patients' weight to approximate a dosage of 6 mg/kg/day was reached, unless intolerance prevented increases. Not alter the binding of topiramate SGA findings are not known as they get older ossification were reduced the! 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